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EN

Council of the European Union

Brussels, 28 September 2026 (OR. en)

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SAN 133 PHARM 32 MI 220 COMPET 290 ENV 204 PI 31 UK 58 CODEC 401

PARLNAT

Interinstitutional File: 2023/0132(COD)

LEGISLATIVE ACTS AND OTHER INSTRUMENTS

Subject: Position of the Council at first reading with a view to the adoption of a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the Union code relating to medicinal products for human use, and repealing Directives 2001/83/EC and 2009/35/EC

– Adopted by the Council on 28 September 2026

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DIRECTIVE (EU) 2026/…

OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of …

on the Union code relating to medicinal products for human use,

and repealing Directives 2001/83/EC and 2009/35/EC

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular

Articles 114(1) and Article 168(4), point (c), thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee1,

Having consulted the Committee of the Regions,

Acting in accordance with the ordinary legislative procedure2,

1 OJ C, C/2024/879, 6.2.2024, ELI: http://data.europa.eu/eli/C/2024/879/oj. 2 Position of the European Parliament of 10 April 2024 (OJ C, C/2025/1328, 13.3.2025,

ELI: http://data.europa.eu/eli/C/2025/1328/oj) and position of the Council at first reading

of 28 September 2026 not yet published in the Official Journal). Position of the European

Parliament of … (not yet published in the Official Journal).

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Whereas:

(1) The Union general pharmaceutical legislation laid down in, inter alia,

Directive 2001/83/EC of the European Parliament and of the Council3, was established

in 1965 with the dual objective of safeguarding public health and harmonising the internal

market for medicinal products. It has developed considerably since then, but these

overarching objectives have guided all revisions. The legislation governs the granting of

marketing authorisations for all medicinal products for human use by defining conditions

and procedures to enter and remain on the market. A fundamental principle is that a

marketing authorisation is granted only to medicinal products with a favourable

benefit-risk balance after assessment of their quality, safety and efficacy.

(2) The most recent comprehensive revision of the Union general pharmaceutical legislation

took place between 2001 and 2004 while targeted revisions on post-authorisation

monitoring (pharmacovigilance) and on falsified medicinal products were adopted

subsequently. In the almost 20 years since the last comprehensive revision, the

pharmaceutical sector has changed and has become more globalised, both in terms of

development and manufacture. Moreover, science and technology have evolved at a rapid

pace. However, there continues to be unmet medical needs, i.e. diseases without or only

with suboptimal treatments for the concerned patient populations. Moreover, some patients

might not benefit from innovation because medicinal products might be unaffordable or

might not be placed on the market in the Member State concerned. There is also a greater

awareness of the environmental impact of medicinal products. More recently, the

COVID-19 pandemic has stress tested the legal framework.

3 Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001

on the Community code relating to medicinal products for human use

(OJ L 311, 28.11.2001, p. 67, ELI: http://data.europa.eu/eli/dir/2001/83/oj).

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(3) This Directive contributes to the implementation of the One Health Approach, stressing the

well-established interconnectedness between human, animal and ecosystem health, and the

need to include those three dimensions when addressing public health threats.

Environmental stress and degradation, including biodiversity loss, contribute to the

transmission of diseases between, and the disease burden on, humans and animals. In

addition, pollution from active pharmaceutical ingredients negatively affects the quality of

waters and ecosystems and causes antimicrobial resistance to increase rapidly, posing risks

to public health globally.

(4) This Directive is part of the implementation of the ‘Pharmaceutical strategy for

Europe’ adopted by the Commission in its communication of 25 November 2020. It aims

to promote innovation, in particular for unmet medical needs, while reducing regulatory

burden and the environmental impact of medicinal products; create an attractive

environment for research, development and manufacturing of medicinal products in the

Union; ensure access, including affordability, to innovative and established medicinal

products for patients, with special attention to enhancing security of supply and addressing

risks of shortages, taking into account the challenges of the smaller markets of the Union;

and create a balanced and competitive system that ensures medicinal products remain

affordable for health systems and patients while rewarding innovation.

(5) Complementarily to this Directive, the Union takes other actions, such as the ‘Life

Sciences Strategy’ set out in the Commission communication of 2 July 2025, to strengthen

the European pharmaceutical ecosystem to accelerate research and development of new

medicinal products and support innovation.

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(6) A range of Union programmes are used to fund pharmaceutical research projects, such as

Horizon Europe, InvestEU, EU4Health, cohesion policy and the Digital

Europe Programme. The Union is also to prioritise in its research agenda participation in

cross-country collaboration enabling transnational research to meet public health needs.

(7) The essential aim of any rules governing the authorisation, manufacture, supervision,

distribution and use of medicinal products is to safeguard public health. Such rules should

also ensure the free movement of medicinal products and the elimination of obstacles to

trade in medicinal products to all patients in the Union.

(8) This Directive is consistent with the Union’s objectives with regard to promotion of

research, innovation, digitalisation, trade, international development and industrial

competitiveness.

(9) The legal framework for medicinal products for human use should also take into account

the needs of the undertakings in the pharmaceutical sector and trade in medicinal products

within the Union, without jeopardising the quality, safety and efficacy of medicinal

products.

(10) As parties to the United Nations Convention on the Rights of Persons with Disabilities

of 12 December 2006, the Union and its Member States are bound by its provisions to the

extent of their competences. This includes the right to access information as set out in

Article 21 of that Convention and the right to the enjoyment of the highest attainable

standard of health without discrimination on the basis of disability as set out in Article 25

of that Convention.

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(11) This Directive maintains the level of harmonisation that has already been achieved in

Union pharmaceutical legislation. Where necessary and appropriate, it further reduces the

remaining disparities, by laying down rules on the supervision and control of medicinal

products and the rights and duties incumbent upon the competent authorities of the

Member States with a view to ensuring compliance with legal requirements. In the light of

experience gained from the application of the Union pharmaceutical legislation and the

evaluation of its functioning, the legal framework needs to be adapted to scientific and

technological progress, the current market conditions and economic reality within the

Union. Scientific and technological developments induce innovation and development of

medicinal products, including for therapeutic areas where there is still unmet medical need.

To harness these developments, the Union pharmaceutical legislation should be adapted to

meet scientific developments such as genomics, accommodate cutting-edge medicinal

products, e.g. personalised medicinal products, novel treatments and technological

transformation such as data analytics, digital tools and the use of artificial intelligence.

These adaptations also contribute to the competitiveness of the Union pharmaceutical

industry.

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(12) The revision of Directive 2001/83/EC focuses on provisions that are relevant to achieve its

specific objectives. It therefore covers all provisions except those concerning falsified

medicinal products, homeopathic medicinal products and traditional herbal medicinal

products. Nevertheless, for the sake of clarity, it is necessary to repeal

Directive 2001/83/EC and replace it with a new Directive. The current provisions of

Directive 2001/83/EC on falsified medicinal products, homeopathic medicinal products

and traditional herbal medicinal products are therefore maintained in this Directive without

substantive changes compared to previous harmonisations. However, in view of the

changes in the governance of the European Medicines Agency (the ‘Agency’), the

Committee for Herbal Medicinal products is replaced by a working group. In addition,

labelling requirements for homeopathic medicinal products have been updated to include

additional information on the interaction between homeopathic medicinal products and

other medicinal products.

(13) Without affecting the rules laid down in this Directive, Member States remain solely

responsible for their own national security. They are responsible in defending their

essential State functions, including ensuring their territorial integrity and safeguarding

national security. In particular, under Article 346 TFEU, no Member State is obliged to

supply information the disclosure of which it considers contrary to the essential interests of

its security. For this reason, Member States should be able to waive some of the

information requirements related to the marketing of medicinal products where those

medicinal products are supplied for military or defence purposes and insofar as the

application of such requirements implies a risk to national security or defence.

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(14) Medicinal products for rare diseases and for children should be subject to the same

conditions as any other medicinal product concerning their quality, safety and efficacy, for

example as regards marketing authorisation procedures, quality and pharmacovigilance

requirements. However, specific requirements also apply to them considering their unique

characteristics. Such requirements, which are currently laid down in separate legal acts,

should be integrated in the Union general pharmaceutical legal framework in order to

ensure clarity and coherency of all the measures applicable to such medicinal products.

Furthermore, as some medicinal products authorised for use in children are authorised by

the Member States, specific provisions should be integrated in this Directive. It is

important to address problems encountered which concern medicinal products for children,

such as the failure to complete paediatric clinical studies or to obtain data required for

marketing authorisation in a timely manner, which results in significant delay in the

approval of medicinal products for children compared to approvals for medicinal products

for adults.

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(15) The system of a directive and regulation for the Union general pharmaceutical legislation

should be maintained to avoid fragmentation of national legislation on medicinal products

for human use, given that national legislation is based on a system of marketing

authorisations granted by the competent authorities of the Member States (national

marketing authorisations) and marketing authorisations granted by the Union (centralised

marketing authorisations). National marketing authorisations are granted and managed on

the basis of national law implementing the Union pharmaceutical legislation. The

evaluation of the Union general pharmaceutical legislation has not shown that the choice of

legal instrument has caused specific problems or created disharmonisation. In addition,

REFIT Platform opinion, in the 2019 Annual Burden Survey, showed that there was no

support among the Member States to turn Directive 2001/83/EC into a Regulation.

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(16) This Directive should work in synergy with Regulation (EU) 2026/… of the European

Parliament and of the Council4+ to enable innovation and promote the competitiveness of

the Union pharmaceutical industry, in particular of micro, small and medium-sized

enterprises. In this respect, a balanced system of incentives is proposed that rewards

innovation especially in areas of unmet medical need and innovation that stems from

development in the Union. Moreover, companies are incentivised to apply early for

marketing authorisations within the Union to bring innovation to the Union and its patients

faster. To make the regulatory system more efficient and innovation-friendly, this

Directive also aims to reduce administrative burden and simplify procedures for

undertakings.

4 Regulation (EU) 2026/… of the European Parliament and of the Council of … laying down

Union procedures for the authorisation and supervision of medicinal products for human use

and establishing rules governing the European Medicines Agency, amending Regulations

(EC) No 1394/2007 and (EU) No 536/2014 and repealing Regulations (EC) No 141/2000,

(EC) No 726/2004 and (EC) No 1901/2006 (OJ L, …, ELI: …). + OJ: please insert in the text the number of the Regulation in document ST 7105/26

(2023/0131(COD)) and in the corresponding footnote the number, date of adoption and

publication reference of that Regulation, including its ELI number.

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(17) The definitions and the scope of Union pharmaceutical legislation should be clarified in

order to achieve high standards for the quality, safety and efficacy of medicinal products

and to address potential regulatory gaps, without changing the overall scope, due to

scientific and technological developments, e.g. low-volume products,

bedside-manufacturing or personalised medicinal products that do not involve an industrial

manufacturing process.

(18) To avoid the duplication of requirements for medicinal products in this Directive and in

Regulation (EU) 2026/…+, the general standards in regard to quality, safety, efficacy and

environmental risk of medicinal products laid down in this Directive should be applicable

to medicinal products covered by a national marketing authorisation and also to medicinal

products covered by a centralised marketing authorisation. Therefore, the requirements for

a marketing authorisation application for a medicinal product should be valid for both, and

the rules on prescription status, product information, regulatory data protection and

regulatory market protection as well as the rules on manufacturing, supply, advertising,

supervision and controls and other requirements should also be applicable to medicinal

products covered by a centralised marketing authorisation.

+ OJ: please insert in the text the number of the Regulation in document ST 7105/26

(2023/0131(COD)).

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(19) The determination of whether a product falls within the definition of a medicinal product is

to be made on a case-by-case basis taking into account the factors set out in this Directive,

such as the product’s presentation or pharmacological, immunological or metabolic

properties.

(20) In order to take account of both the emergence of new therapies and the growing number

of so-called ‘borderline’ products between the medicinal product sector and other sectors,

certain definitions and derogations should be modified, so as to avoid any doubt as to the

applicable legislation. Similarly, it should be clarified that in situations where a product

falls within the definition of a medicinal product under this Directive, but also falls within

the definition of a product regulated under another legislative act, the rules for medicinal

products under this Directive should apply. Furthermore, to ensure the clarity of applicable

rules, it is also appropriate to improve the consistency of the terminology used in Union

pharmaceutical legislation and clearly indicate the products excluded from the scope of

this Directive.

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(21) The new definition of a substance of human origin (SoHO) introduced by Regulation

(EU) 2024/1938 of the European Parliament and the Council5 covers any substance

collected from the human body in whatever manner, whether it contains cells or not and

regardless of whether it meets the definition of ‘blood’, ‘tissue’ or ‘cell’, for example

human breast milk, intestinal microbiota and any other SoHO that may be applied to

humans in the future. Such substances of human origin, other than tissues and cells, can

become SoHO-derived medicinal products other than advanced therapy medicinal products

(ATMPs), where the SoHO is subject to an industrial process involving pooling of

donations, systematisation, reproducibility and operations performed on a routine basis or

batch-wise resulting in a product of standardised consistency. The pooling of a limited

number of donations for the preparation of SoHO is not in itself an industrial process.

Where a process concerns extraction of an active ingredient from the SoHO, other than

tissues and cells, or the transformation of a SoHO, other than tissues and cells, by changing

its inherent properties, this should also be considered a SoHO-derived medicinal product.

Where a process concerns concentrating, separating, inactivating pathogens or isolating

elements, or a combination of those processes, in the preparation of SoHO, such a process

in and of itself should normally not be considered as changing their inherent properties.

5 Regulation (EU) 2024/1938 of the European Parliament and of the Council of 13 June 2024

on standards of quality and safety for substances of human origin intended for human

application and repealing Directives 2002/98/EC and 2004/23/EC (OJ L, 2024/1938,

17.07.2024, ELI: http://data.europa.eu/eli/reg/2024/1938/oj).

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(22) According to current scientific knowledge, haptens, when combined with an endogenous

carrier substance, are allergens and should be construed as such for the purpose of

pharmaceutical legislation.

(23) For the avoidance of doubt, it is appropriate to underline that the safety and quality of

human organs intended for transplantation are regulated exclusively by

Directive 2010/53/EU of the European Parliament and of the Council6, and the safety and

quality of SoHO intended for medically assisted reproduction are regulated exclusively

by Regulation (EU) 2024/1938.

6 Directive 2010/53/EU of the European Parliament and of the Council of 7 July 2010 on

standards of quality and safety of human organs intended for transplantation

(OJ L 207, 6.8.2010, p. 14, ELI: http://data.europa.eu/eli/dir/2010/53/oj).

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(24) Advanced therapy medicinal products prepared within a Member State on a non-routine

basis in accordance with specific quality standards and used within the same Member State

in a hospital under the exclusive professional responsibility of a medical practitioner, in

order to comply with an individual medical prescription for a custom-made product to

meet the needs of an individual patient, should be subject to an exemption from the general

requirements set out in this Directive and Regulation (EU) 2026/…+, while ensuring that

relevant Union rules relating to quality and safety are not undermined (‘advanced therapy

medicinal products prepared under hospital exemption’). Experience has shown that there

are significant variations in the implementation of the hospital exemption among

Member States. To improve the implementation of the hospital exemption, this Directive

introduces measures for the collection and reporting of data as well as for the review of

such data yearly by the competent authorities and their publication by the Agency in a

repository. Furthermore, the Agency should prepare a report on the implementation of the

hospital exemption based on contributions from Member States to assess whether an

adapted framework should be developed for certain less complex ATMPs that have been

developed and used under hospital exemption. If an approval for the manufacturing and

use of an ATMP under hospital exemption is revoked due to safety concerns, the relevant

competent authority of the Member State should notify the Agency, which should then

disseminate that information to the other Member States’ competent authorities.

+ OJ: please insert in the text the number of the Regulation in document ST 7105/26

(2023/0131(COD)).

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(25) This Directive should be without prejudice to Council Directive 2013/59/Euratom7,

including with respect to justification and optimisation of the protection of patients and

other individuals subject to medical exposure to ionising radiation. In the case of

radiopharmaceuticals used for therapy, marketing authorisations, posology and

administration rules are to comply with the requirements of that Directive as regards

individual planning of exposures of target volumes, and the appropriate verification of

their delivery, taking into account that doses to non-target volumes and tissues are to be as

low as reasonably achievable and consistent with the intended radiotherapeutic purpose of

the exposure.

7 Council Directive 2013/59/Euratom of 5 December 2013 laying down basic safety standards

for protection against the dangers arising from exposure to ionising radiation, and repealing

Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom

and 2003/122/Euratom (OJ L 13, 17.1.2014, p. 1,

ELI: http://data.europa.eu/eli/dir/2013/59/oj).

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(26) In the interest of public health, a medicinal product should only be allowed to be placed on

the market in the Union if a marketing authorisation has been granted for that medicinal

product, and if the quality, safety and efficacy of the medicinal product have been

demonstrated. However, exemptions from those requirements should be provided for in

situations characterised by an urgent need to administer a medicinal product to address the

special needs of individual patients, or in the event of a suspected or confirmed spread of

pathogenic agents, toxins, chemical agents or nuclear radiation that could cause harm. In

particular, in order to meet special needs, Member States should be allowed to exempt

from the requirements set out in this Directive medicinal products supplied in response to a

bona fide unsolicited order or anticipated bona fide unsolicited order, formulated or used in

accordance with the specifications of an authorised healthcare professional and intended to

meet the special needs of individual patients under the direct personal responsibility of that

authorised healthcare professional. Member States should also be allowed to temporarily

authorise the use and distribution of an unauthorised medicinal product in response to a

suspected or confirmed spread of pathogenic agents, toxins, chemical agents or nuclear

radiation any of which could cause harm.

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(27) Pharmacies, including hospital pharmacies, play a crucial role in providing medicinal

products to patients. They prepare specific medicinal products, known as magistral

formulas, that are tailored to meet the special needs of individual patients based on the

written instructions of a doctor. In certain situations, it is necessary, in order to cater for the

needs of individual patients, to prepare those magistral formulas in advance on the basis of

anticipated medical prescriptions within a specified period. This could include situations of

urgency in which it is necessary for the magistral formula to be immediately available or

situations where advance preparations are necessary to ensure dose accuracy or the quality

of the medicinal product. Purely financial reasons should not justify the use of this

possibility.

(28) Additionally, pharmacies are responsible for preparing standard medicinal products,

referred to as officinal formulas. Those medicinal products are prepared in accordance with

established guidelines found in pharmacopoeias. Officinal formulas are designed for

general use and adhere to standardised recipes that are set by authoritative pharmaceutical

bodies. Unlike magistral formulas, they are not customised for individual patients.

Generally, those preparations should be exempt from the authorisation requirements set out

in this Directive, but remain subject to national regulations.

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(29) In exceptional cases, to ensure the availability of specific medicinal products or suitable

alternatives for patients in a Member State, it should be possible for that Member State to

exempt temporarily those medicinal products from the requirements set out in this

Directive, to meet the specific needs of individual patients in that Member State. In

addition, to mitigate shortages effectively in a Member State, it is important to address the

patients’ needs at population level and allow the preparation of such medicinal products,

subject to strict conditions. Any other reasons, such as financial interests, should not be a

justification for allowing those exemptions. Such exemptions should never aim to distort

competition and should be interpreted narrowly, and only be used to mitigate or resolve a

shortage in a Member State or in a situation where there is no relevant authorised

medicinal product available on the market. Member States should, in any event, undertake

their best efforts to find suitable alternatives under the rules set out in this Directive and

in Regulation (EU) 2026/…+.

+ OJ: please insert in the text the number of the Regulation in document ST 7105/26

(2023/0131(COD)).

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(30) It is recognised that improved access to information contributes to public awareness about

the assessment and authorisation of medicinal products. When assessing the marketing

authorisation application for a medicinal product, the competent authority of the

Member State should draw up an assessment report on the quality, safety, efficacy, and the

environmental risk assessment (ERA), as applicable, of the medicinal product and the

reasons for its opinion. The competent authority of the Member State should make publicly

available a summary of the assessment report and a summary of the ERA, after the deletion

of any information of a commercially confidential nature and written in a manner that is

understandable to the public. To the extent information under the ERA would entail

environmental information within the meaning of Directive 2003/4/EC of the European

Parliament and of the Council8, the provisions of that Directive should apply.

(31) Marketing authorisation decisions should be taken on the basis of the objective scientific

criteria of the quality, safety and efficacy of the medicinal product concerned, to the

exclusion of economic or any other considerations. However, Member States should be

able exceptionally to prohibit the use in their territory of certain medicinal products.

(32) The particulars and documents that are to accompany a marketing authorisation application

for a medicinal product should demonstrate that the therapeutic efficacy of the product

overweighs potential risks. The benefit-risk balance of all medicinal products is assessed

when they are placed on the market, and at any other time the competent authority of the

Member State or the Agency, as applicable, deems appropriate.

8 Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on

public access to environmental information and repealing Council Directive 90/313/EEC

(OJ L 41, 14.2.2003, p. 26, ELI: http://data.europa.eu/eli/dir/2003/4/oj).

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(33) In the context of the development and marketing authorisation of medicinal products, it is

crucial that particular attention is given to the composition of clinical trials, to ensure

comprehensive clinical data and, where appropriate, gender-based equity.

(34) As market forces alone have proven insufficient to stimulate adequate research into, and

the development and marketing authorisation of, medicinal products for the paediatric

population, a system of obligations, rewards and incentives should be established.

(35) It is therefore necessary to introduce a requirement for new medicinal products or when

developing paediatric indications of already authorised products covered by a patent or a

supplementary protection certificate to present either the results of studies in the paediatric

population in accordance with an agreed paediatric investigation plan or proof of having

obtained a waiver or deferral, at the time of filing a marketing authorisation application or

an application for a new therapeutic indication, new pharmaceutical form or new route of

administration. However, in order to avoid exposing patients, especially children, to

unnecessary clinical trials or due to the nature of the medicinal products, that requirement

should not apply to generic medicinal products or biosimilar medicinal products and

medicinal products authorised through the well-established medicinal use procedure, nor

should it apply to homeopathic medicinal products and traditional herbal medicinal

products authorised through the simplified registration procedures set out in this Directive.

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(36) In order to ensure that the data supporting the marketing authorisation concerning the

paediatric use of a medicinal product to be authorised under this Directive and Regulation

(EU) 2026/…+ have been correctly developed, the competent authority of the Member

State should check compliance with the agreed paediatric investigation plan and any

waivers and deferrals during the scientific assessment of a valid marketing authorisation

applications.

(37) For medicinal products covered by a supplementary protection certificate under Regulation

(EC) No 469/2009 of the European Parliament and of the Council9, a six month extension

of that certificate should be granted by way of reward where all the measures included in

the agreed paediatric investigation plan are complied with and relevant information on the

results of the studies conducted is included in the product information.

+ OJ: please insert in the text the number of the Regulation in document ST 7105/26

(2023/0131(COD)). 9 Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009

concerning the supplementary protection certificate for medicinal products

(OJ L 152, 16.6.2009, p. 10, ELI: http://data.europa.eu/eli/reg/2009/469/oj).

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(38) Certain particulars and documents that are normally to be included in a marketing

authorisation application should not be required if a medicinal product is a generic

medicinal product or a biosimilar medicinal product that is authorised or has been

authorised in the Union. Both generic medicinal products and biosimilar medicinal

products are important to ensure access to medicinal products for a wider patient

population, at more affordable prices, and create a competitive internal market. In a joint

statement, the competent authorities of the Member States confirmed that the experience

with approved biosimilar medicinal products over the past 15 years has shown that in terms

of efficacy, safety and immunogenicity they are comparable to their reference medicinal

product and are therefore interchangeable and can be used instead of their reference

medicinal product (or vice versa) or replaced by another biosimilar medicinal product of

the same reference medicinal product.

(39) Experience has shown that it is advisable to specify precisely the cases in which the results

of toxicological and pharmacological tests or clinical studies do not have to be provided in

order to obtain a marketing authorisation for a medicinal product that is essentially similar

to an authorised medicinal product, while ensuring that innovative undertakings are not

placed at a disadvantage. For such specified categories of medicinal products an abridged

procedure should allow applicants to rely on data submitted by previous applicants and

therefore to submit only some specific documentation.

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(40) For generic medicinal products, only the equivalence of the generic medicinal product with

the reference medicinal product should be demonstrated. For biosimilar medicinal

products, only the results of comparability tests and studies should be provided to the

competent authorities of the Member States or the Agency, as applicable. For hybrid

medicinal products i.e. in cases where the medicinal product does not fall within the

definition of a generic medicinal product or differs in strength, pharmaceutical form, route

of administration or therapeutic indications, compared to the reference medicinal product,

the results of the relevant non-clinical tests or clinical studies should be provided to the

extent necessary to establish a scientific bridge to the data relied upon in the marketing

authorisation for the reference medicinal product. The same applies to bio-hybrid

medicinal products i.e. in cases where the biological medicinal product does not fall within

the definition of a biosimilar medicinal product or differs in strength, pharmaceutical form,

route of administration or therapeutic indications, compared to the reference biological

medicinal product. Where applicable, a scientific bridge should establish that the active

substance of the hybrid medicinal product or bio-hybrid medicinal product does not differ

significantly in properties with regard to safety or efficacy. Where it differs significantly in

respect of those properties, the marketing authorisation applicant should submit a full

application.

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(41) It should be possible for regulatory decision-making on the development, marketing

authorisation and supervision of medicinal products to be supported by access to and

analysis of health data, including real world data i.e. health data generated outside clinical

studies, where appropriate. The competent authorities of the Member States or the Agency,

as applicable, should be able to use such data, including via the European Health Data

Space interoperable infrastructure. Data generated via in silico methods, such as

computational modelling and simulation, molecular modelling, mechanistic modelling,

digital twin and artificial intelligence, where appropriate, could also be used to support

regulatory decision making.

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(42) Any study involving the use of animals, which provides essential information on the

quality, safety and efficacy of a medicinal product, should take into account the principles

of replacement, reduction and refinement and apply them in accordance with

Directive 2010/63/EU of the European Parliament and of the Council10, where they

concern the care and use of live animals for scientific purposes, and should only be used as

necessary and be optimised in order to provide the most satisfactory results whilst using

the minimum number of animals. The procedures of such testing should be designed to

avoid causing pain, suffering, distress or lasting harm to animals and should follow the

available guidelines of the Agency and of the International Council for Harmonisation of

Technical Requirements for Registration of Pharmaceuticals for Human Use. The

marketing authorisation applicant should not carry out animal tests where scientifically

satisfactory non-animal testing methods are available. These can include, but are not

limited to, in vitro models, such as microphysiological systems including organ-on-chips,

(2D and 3D) cell culture models, organoids and human stem cells-based models; in silico

tools or read-across models. Where scientifically satisfactory non-animal testing methods

are not available, applicants that use animal testing should ensure that the rules of

Directive 2010/63/EU are applied, including the principles of reduction and refinement of

animal testing for scientific purposes with regard to any animal study conducted for the

purpose of supporting the application.

10 Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010

on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33,

ELI: http://data.europa.eu/eli/dir/2010/63/oj).

7106/2/26 REV 2 26

EN

(43) Procedures should be in place to facilitate joint animal testing, wherever possible, in order

to avoid unnecessary testing using live animals in accordance with Directive 2010/63/EU.

Marketing authorisation applicants and marketing authorisation holders should make all

efforts to reuse animal study results and make the results obtained from animal studies

publicly available. For abridged applications, marketing authorisation applicants should

refer to the relevant studies conducted for the reference medicinal product.

(44) With respect to clinical trials, in particular those conducted outside the Union, on

medicinal products destined to be authorised within the Union, it should be verified, at the

time of the evaluation of the marketing authorisation application, that the trials were

conducted in accordance with principles of good clinical practice and ethical requirements

equivalent to those in Regulation (EU) No 536/2014 of the European Parliament and of

the Council11.

11 Regulation (EU) No 536/2014 of the European Parliament and of the Council

of 16 April 2014 on clinical trials on medicinal products for human use, and repealing

Directive 2001/20/EC (OJ L 158, 27.5.2014, p. 1,

ELI: http://data.europa.eu/eli/reg/2014/536/oj).

7106/2/26 REV 2 27

EN

(45) There is the possibility, under certain circumstances, for marketing authorisations to be

granted subject to specific obligations or conditions, on a conditional basis or under

exceptional circumstances. This Directive should allow for medicinal products with a

standard marketing authorisation for new therapeutic indications to be authorised on a

conditional basis or under exceptional circumstances, under similar circumstances. The

medicinal products authorised on a conditional basis or under exceptional circumstances

should in principle satisfy the requirements for a standard marketing authorisation, with the

exception of the specific derogations or conditions outlined in the relevant conditional or

exceptional marketing authorisation, and should be subject to specific review of the

fulfilment of the specific conditions or obligations imposed. The grounds for refusal of a

marketing authorisation should apply mutatis mutandis to such cases.

(46) In justified cases, even when comprehensive safety and efficacy data have been supplied,

post-authorisation studies could be imposed by the competent authorities of the

Member States to enhance the safe and effective use of the medicinal product or to allow

for evidence-based treatment optimisation.

7106/2/26 REV 2 28

EN

(47) Furthermore, it should be possible to impose on marketing authorisation holders an

obligation to conduct post-authorisation ERA studies, to collect monitoring data or

information on use, or to implement appropriate risk mitigation measures, where identified

or potential concerns about risks to the environment or public health, including

antimicrobial resistance, need to be further investigated or mitigated after the medicinal

product has been marketed.

(48) Where the competent authorities consider that there are reasons to believe that a medicinal

product could present a potential serious risk to public health, a scientific evaluation of the

medicinal product should be undertaken, subject to the relevant procedures, leading to a

decision to maintain, vary, suspend or revoke the marketing authorisation. The competent

authorities should also be able to act where the conditions attached to the authorisation are

not complied with, including the obligation to conduct post-authorisation ERA studies.

7106/2/26 REV 2 29

EN

(49) With the exception of those medicinal products that are subject to the centralised

marketing authorisation procedure established by Regulation (EU) 2026/…+, a marketing

authorisation for a medicinal product should be granted by a competent authority in one

Member State. In order to avoid unnecessary administrative and financial burdens for

marketing authorisation applicants and the competent authorities of the Member States, a

full in-depth assessment of a marketing authorisation application for a medicinal product

should be carried out only once. It is appropriate therefore to lay down special procedures

for the mutual recognition of national marketing authorisations. Moreover, it should be

possible to submit the same marketing authorisation application through the decentralised

procedure in parallel in several Member States for the purpose of a common assessment

under the lead of one of the Member States concerned.

(50) Moreover, rules should be established under those authorisation procedures to resolve any

disagreements between Member States in a coordination group for decentralised and

mutual recognition procedures (the ‘coordination group’) relating to medicinal products

without undue delay. In the event of a disagreement between Member States about the

quality, the safety or the efficacy of a medicinal product, a scientific assessment of the

matter should be undertaken according to a Union standard, leading to a single decision on

the points of disagreement, which should be binding on the Member States concerned.

That decision should be adopted following a rapid procedure ensuring close cooperation

between the Commission and the Member States.

+ OJ: please insert in the text the number of the Regulation in document ST 7105/26

(2023/0131(COD)).

7106/2/26 REV 2 30

EN

(51) In cases of major disagreement that cannot be solved, the case should be settled by means

of a Commission Decision. However, it should be possible to refer the matter to the

Committee for Medicinal Products for Human Use for a scientific opinion before the

Commission adopts its decision by means of an implementing act.

(52) In order to better protect public health and avoid any unnecessary duplication of effort

during the examination of marketing authorisation applications for medicinal products,

Member States should systematically draw up an assessment report in respect of each

medicinal product that is authorised by them, and exchange reports upon request.

Furthermore, a Member State should be able to suspend the examination of a marketing

authorisation application for a medicinal product that is under active consideration in

another Member State with a view to recognising the decision reached by the latter

Member State.

(53) In order to ensure as broad as possible access to medicinal products, a Member State that is

interested in having access to a particular medicinal product for which a marketing

authorisation is applied for under the decentralised or mutual recognition procedure should

be able to opt into the procedure and become a Member State concerned by that procedure.

(54) In order to increase availability of medicinal products, in particular on smaller markets, in

cases where an applicant does not apply for a marketing authorisation for a medicinal

product in the context of the mutual recognition procedure in a given Member State, it

should be possible for that Member State to authorise the placing on the market of the

medicinal product where justified for public health reasons.

7106/2/26 REV 2 31

EN

(55) In the case of generic medicinal products for which the reference medicinal product has

been granted a marketing authorisation under the centralised procedure, applicants seeking

a marketing authorisation should be able to choose either of the two procedures, namely

the national procedure or the centralised procedure, on certain conditions. Similarly, the

decentralised or mutual recognition procedure should remain available as an option for

certain medicinal products, even if they represent a therapeutic innovation or are of benefit

to society or to patients. Since generic medicinal products account for a major part of the

market in medicinal products, their access to the Union market should be facilitated in the

light of the experience acquired and the procedures to involve other Member States

concerned in the marketing authorisation procedure should be therefore further simplified.

(56) The simplification of procedures should not have an impact on standards or the quality of

scientific evaluation of medicinal products to guarantee the quality, safety and efficacy of

medicinal products and therefore, the scientific evaluation period should, in principle,

remain the same. However, this Directive provides for the reduction of the overall period

for marketing authorisation procedure from 210 days to 180 days.

(57) Member States should ensure that adequate financial resources are available to the

competent authorities of the Member States in order for them to carry out their tasks under

this Directive and Regulation (EU) 2026/…+. In addition, Member States should ensure

that adequate resources are assigned by the competent authorities of the Member States for

the purpose of their contributions to the work of the Agency, taking into account the cost-

based remuneration they receive from the Agency.

+ OJ: please insert in the text the number of the Regulation in document ST 7105/26

(2023/0131(COD)).

7106/2/26 REV 2 32

EN

(58) As regards access to medicinal products, previous amendments to the Union

pharmaceutical legislation have addressed this issue by providing for accelerated

assessment of marketing authorisation applications or by allowing conditional marketing

authorisations for medicinal products which address unmet medical needs. While those

measures accelerated the authorisation of innovative and promising therapies in some

areas, certain public health priorities remain unaddressed. Additionally, those medicinal

products do not always reach the patient and patients in the Union still have different levels

of access to medicinal products. Patient access to medicinal products depends on many

factors. Marketing authorisation holders are not obliged to market a medicinal product in

all Member States; they can decide not to market their medicinal products in, or withdraw

them from, one or more Member States, often due to commercial reasons. National pricing

and reimbursement policies, the size of the population, the organisation of health systems

and national administrative procedures are other factors influencing market launch and

patient access.

7106/2/26 REV 2 33

EN

(59) Addressing unequal patient access and affordability of medicinal products have become

key priorities of the Pharmaceutical Strategy for Europe, as also highlighted by Council

conclusions of 17 June 2016 on strengthening the balance in the pharmaceutical systems in

the European Union and its Member State12 and of 15 June 2021 on access to medicines

and medical devices for a stronger and resilient EU13 and the European Parliament

resolution of 2 March 2017 on EU options for improving access to medicines14.

Member States called for revised mechanisms and incentives for the development of

medicinal products, tailored to the level of unmet medical needs, while ensuring health

system sustainability, patient access and availability of affordable medicinal products in all

Member States. Monitoring and evaluating access to medicinal products at Union level is

important to understand the results achieved.

(60) Access to medicinal products also comprises affordability. In this regard, the Union

pharmaceutical legislation respects the competence of the Member States in terms of

pricing and reimbursement. In a complementary manner, it aims to have a positive impact

on affordability and sustainability of health systems with measures that support

competition from generic medicinal products and biosimilar medicinal products. The

competition from generic medicinal products and biosimilar medicinal products should

also, in turn, improve patients’ access to medicinal products.

12 OJ C 269, 23.7.2016, p. 31. 13 OJ C 269I, 7.7.2021, p. 3. 14 OJ C 263, 25.7.2018, p. 4.

7106/2/26 REV 2 34

EN

(61) To ensure dialogue among all actors in the medicinal products lifecycle, discussions on

policy issues related to the application of the rules related to access to and availability of

medicinal products should take place in the Pharmaceutical Committee. It should be

possible for the Commission to invite bodies responsible for health technology assessment

as referred to in Regulation (EU) 2021/2282 of the European Parliament and of the

Council15 or national bodies responsible for pricing and reimbursement, as required, to

participate in the deliberations of the Pharmaceutical Committee.

(62) While pricing and reimbursement decisions are a Member State competence, the

Pharmaceutical Strategy for Europe announced actions to support cooperation of

Member States to improve affordability. The Commission has transformed the group of

National Competent Authorities on Pricing and Reimbursement and public healthcare

payers (NCAPR) from an ad hoc forum to a continuous voluntary cooperation with the aim

to exchange information and best practices on pricing, payment and procurement policies

to improve the affordability and cost-effectiveness of medicinal products and health

system’s sustainability. The Commission is committed to stepping up this cooperation and

further supporting information exchange among national authorities, including on public

procurement of medicinal products, while fully respecting the competences of

Member States in this area. It should also be possible for the Commission to invite NCAPR

members to participate in deliberations of the Pharmaceutical Committee on topics that

may have an impact on pricing or reimbursement policies, such as the market launch

incentives provided for in this Directive.

15 Regulation (EU) 2021/2282 of the European Parliament and of the Council

of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU

(OJ L 458, 22.12.2021, p. 1, ELI: http://data.europa.eu/eli/reg/2021/2282/oj).

7106/2/26 REV 2 35

EN

(63) Joint procurement, whether within a country or across countries, can improve access to as

well as affordability and security of supply of medicinal products, in particular for smaller

countries. Member States interested in joint procurement of medicinal products can make

use of Directive 2014/24/EU of the European Parliament and of the Council16, which sets

out purchasing procedures for public buyers, and Regulations (EU) 2022/237117 and

(EU, Euratom) 2024/250918of the European Parliament and of the Council. Upon request

from the Member States, the Commission can support interested Member States by

facilitating coordination to enable access to medicinal products for patients in the Union as

well as information exchange, in particular for medicinal products for rare and chronic

diseases.

16 Directive 2014/24/EU of the European Parliament and of the Council of 26 February 2014

on public procurement and repealing Directive 2004/18/EC (OJ L 94, 28.3.2014, p. 65,

ELI: http://data.europa.eu/eli/dir/2014/24/oj). 17 Regulation (EU) 2022/2371 of the European Parliament and of the Council

of 23 November 2022 on serious cross-border threats to health and repealing

Decision No 1082/2013/EU (OJ L 314, 6.12.2022, p. 26,

ELI: http://data.europa.eu/eli/reg/2022/2371/oj). 18 Regulation (EU, Euratom) 2024/2509 of the European Parliament and of the Council

of 23 September 2024 on the financial rules applicable to the general budget of the Union

(OJ L, 2024/2509, 26.9.2024, ELI: http://data.europa.eu/eli/reg/2024/2509/oj).

7106/2/26 REV 2 36

EN

(64) The establishment of a criteria-based definition of ‘unmet medical need’ is necessary to

incentivise the development of medicinal products in therapeutic areas that are currently

underserved. To ensure that the concept of unmet medical need reflects scientific and

technological developments and current knowledge in underserved diseases, the Agency

should, in the form of scientific guidelines, specify the conditions concerning clinically

relevant improvement in efficacy, or in safety with at least comparable efficacy, in

comparison with existing medicinal products or other methods of prevention, diagnosis or

treatment authorised in the Union. The guidelines should cover clinical efficacy endpoints

such as survival, symptoms and health-related quality of life, and clinical safety endpoints

such as side effects, and provide further technical details regarding their assessment. The

Agency should seek input from a broad range of authorities or bodies active along the

lifecycle of medicinal products in the framework of the consultation process established

under Regulation (EU) 2026/…+ and also take into account scientific initiatives at Union

level or between Member States related to analysing unmet medical needs, burden of

disease and priority setting for research and development. The Agency should also seek

input from other relevant stakeholders, including relevant patient populations.

(65) The inclusion of new therapeutic indications in an authorised medicinal product

contributes to improving patients’ access to additional therapies and therefore should be

incentivised.

(66) Repurposing of medicinal products to new therapeutic indications should be supported as it

can provide significant health benefits to patients in a timely and affordable manner.

+ OJ: please insert in the text the number of the Regulation in document ST 7105/26

(2023/0131(COD)).

7106/2/26 REV 2 37

EN

(67) For marketing authorisation applications for medicinal products containing a new active

substance, the submission of clinical trials that include an evidence-based existing

treatment as a comparator, in line with scientific advice provided by the Agency, should be

incentivised. This is in order to foster the generation of comparative clinical evidence that

is relevant and that can therefore be used to support subsequent health technology

assessments and decisions on pricing and reimbursement by Member States.

(68) The competent authorities of the Member States and the Agency should support the design

of comparative clinical trials, wherever possible, when providing pre-authorisation

scientific advice.

(69) The holder of a marketing authorisation for a medicinal product placed on the market in a

Member State should, within the limits of its responsibility, ensure the appropriate and

continuous supply of a medicinal product throughout its lifetime, including by maintaining

appropriate stock levels, to wholesale distributors, pharmacies or other persons authorised

to supply medicinal products so that the needs of patients in the Member State in question

are met. Member States may specify in their national legislation the obligation for the

marketing authorisation holder to ensure adequate supply of medicinal products to

wholesale distributors in order to guarantee that the needs of patients in the Member States

concerned are met.

7106/2/26 REV 2 38

EN

(70) Access to medicinal products in all Member States and guaranteeing a timely, stable,

reliable and high-quality supply of medicinal products are essential objectives to achieve

an overall high level of protection of human health in the Member States, thus contributing

to the protection of human health and human life in the Union. The responsibility of

ensuring a timely, adequate and continuous supply of medicinal products so that the needs

of patients in a Member State are covered rests, mainly, on the marketing authorisation

holder. In principle, when a marketing authorisation is granted, the medicinal product is

placed on the market by the marketing authorisation holder on its own initiative. Practice

shows, however, that in certain Member States the placing on the market of authorised

medicinal products does not occur or is delayed or occurs in quantities that do not

correspond to the needs of those Member States. Therefore, Member States should, based

on grounds of public health protection with due regard to the principle of proportionality

and in compliance with Union law, in particular concerning the free movement of goods

and competition, be able to require from the marketing authorisation holder specific

actions with a view to complying with its market launch and supply obligations under this

Directive and Regulation (EU) 2026/…+. To this aim, Member States should be able to

request the marketing authorisation holder to do one or more of the following actions: to

submit a valid pricing and reimbursement application, to participate in any relevant

national or Union procurement procedures or to establish and implement a roll-out plan

that is acceptable for the Member State concerned. The implementation of the roll-out plan

should ensure sufficient and continuous supply to meet the needs of the patients in the

Member State concerned.

+ OJ: please insert in the text the number of the Regulation in document ST 7105/26

(2023/0131(COD)).

7106/2/26 REV 2 39

EN

(71) A roll-out plan aims to ensure a predictable and continuous supply of medicinal products in

a given Member State. It responds to the need of coordinated planning between the

marketing authorisation holder and the competent authorities of the Member States. It

would allow national authorities to anticipate availability and plan public-health measures

and companies to plan manufacturing and distribution. Following a request by a

Member State, the marketing authorisation holder should prepare a draft roll-out plan

specifying the quantities and timing of supply of the medicinal product for a defined period

of time taking into account the supply needs declared by the Member State and other

objective considerations such as manufacturing or distribution capacity. Based on the draft

roll-out plan submitted by the marketing authorisation holder, the Member State concerned

and the marketing authorisation holder should discuss the plan, which will require the final

agreement of the Member State concerned. Later, both the Member State and the

marketing authorisation holder may require an update of the roll-out plan, to reflect any

important developments such as evolving demand, or changes in manufacturing or

distribution capacity. For the development, agreement, adaptation and effective

implementation of the roll-out plan, the marketing authorisation holder and the

Member State should be obliged to cooperate fully and provide timely and accurate

information.

(72) Marketing authorisation holders and Member States should do their utmost to achieve a

mutually agreed supply of medicinal products in accordance with the needs of the

Member State concerned, without unduly delaying the other party’s exercise of its rights

under this Directive or unduly impeding the exercise of those rights.

7106/2/26 REV 2 40

EN

(73) Cross-border healthcare, including under Directive 2011/24/EU, is an additional pathway

for patients to access a treatment that might otherwise not be available to them, notably in

cases where the medicinal product cannot be administered to the patient in their home

Member State.

(74) The possibility of using compulsory licences in situations of national emergency or other

circumstances of extreme urgency is explicitly provided for under the Agreement on

Trade-Related Aspects of Intellectual Property Rights (the ‘TRIPS Agreement’)19. Where a

compulsory licence has been granted by a relevant authority in the Union pursuant to

Regulation (EU) 2025/2645 of the European Parliament and of the Council20 or under

national compulsory licensing frameworks, regulatory data protection or regulatory market

protection can, if still in force, prevent the effective use of the compulsory licence as it

impedes the authorisation of generic medicinal products, and thus access to the medicinal

products needed to address a crisis. For this reason, regulatory data protection and

regulatory market protection should be suspended when a compulsory licence has been

issued. Such a suspension of the regulatory data protection and regulatory market

protection should be allowed only in relation to the compulsory licence granted and its

beneficiary. The suspension should comply with the objective, the territorial scope, the

duration and the subject matter of the granted compulsory licence.

19 OJ L 336, 23.12.1994, p. 214. 20 Regulation (EU) 2025/2645 of the European Parliament and of the Council

of 16 December 2025 on compulsory licensing for crisis management and amending

Regulation (EC) No 816/200 (OJ L, 2025/2645, 30.12.2025,

ELI: http://data.europa.eu/eli/reg/2025/2645/oj).

7106/2/26 REV 2 41

EN

(75) The suspension of the regulatory data protection and of the regulatory market protection

should be granted only for the duration of the compulsory licence in the Member States

where the compulsory licence has been granted. A suspension of the regulatory data

protection and the regulatory market protection means that the regulatory data protection

and the regulatory market protection produce no effect in relation to the particular licensee

of the compulsory licence while that compulsory licence is in effect. When the compulsory

licence ends, the regulatory data protection and the regulatory market protection should

resume. However, the period of compulsory licensing should not be recouped, and

therefore the suspension should not result in an extension of the original duration of the

regulatory protection.

7106/2/26 REV 2 42

EN

(76) It is currently possible for applicants for marketing authorisation for generic, biosimilar,

hybrid and bio-hybrid medicinal products to conduct studies, trials and activities to fulfil

the subsequent practical requirements necessary to obtain regulatory approvals for those

medicinal products during the term of protection of the patent or supplementary protection

certificate of the reference medicinal product, without this being considered as a patent or

supplementary protection certificate infringement. The application of this limited exception

is, however, fragmented across the Union and it is considered necessary, in order to

facilitate the market entry of generic, biosimilar, hybrid and bio-hybrid medicinal products,

to clarify the scope of this exception in order to ensure a harmonised application thereof in

all Member States, both in terms of beneficiaries and in terms of the activities covered. The

exception must be limited to conducting the necessary studies, trials and other activities

needed to obtain a marketing authorisation, conduct health technology assessments and

obtain pricing and reimbursement approvals as well as submit an application for

procurement tenders, to the extent that the submission of an application for procurement

tenders does not entail the sale or offering for sale of the medicinal product concerned

during the term of protection, even though those activities can require substantial amounts

of test production to demonstrate reliable manufacturing. During the term of protection of

the patent or supplementary protection certificate of the reference medicinal product, there

can be no commercial use of the final medicinal products obtained for the purposes of the

regulatory approval process.

7106/2/26 REV 2 43

EN

(77) The exception should allow inter alia, to conduct studies to support pricing and

reimbursement approvals as well as the manufacture or purchase of patent protected active

substances for the purpose of seeking marketing authorisations during the term of

protection of the patent or supplementary protection certificate of the reference medicinal

product, contributing to the market entry of generic and biosimilar medicinal products the

first day following the expiry of the term of protection of the patent or supplementary

protection certificate, and timely access to these products.

(78) The competent authorities should refuse to validate a marketing authorisation application

referring to data of a reference medicinal product only on the basis of the grounds set out

in this Directive. The same applies to any decision to grant, vary, suspend, restrict or

revoke a marketing authorisation. The competent authorities cannot base their decision on

any other grounds. In particular, such decisions should not be based on the patent or

supplementary protection certificate status of the reference medicinal product. It also stems

from those rules that the protection of intellectual property rights is not a valid ground to

refuse, revoke or suspend decisions related to relevant pricing and reimbursement

approvals, health technology assessment procedures, or where applicable, applications for

procurement tenders. Member States remain free to introduce rules to ensure the readiness

to supply a medicinal product on their market for the period following the expiry of the

term of protection of the patent or supplementary protection certificate.

7106/2/26 REV 2 44

EN

(79) The One Health Approach is needed in order to address antimicrobial resistance, one of the

most significant, current health threats. High levels of cooperation are required across

sectors and globally. This Directive puts in place coordinated action in order to ensure

prevention and minimisation of environmental risks throughout the supply chain and use

and disposal of antimicrobials, to raise awareness among patients, consumers and

healthcare professionals and to promote the prudent and responsible use of antimicrobials.

(80) In order to address the challenge of antimicrobial resistance, where a pack of

antimicrobials is intended for direct dispensing to patient, antimicrobials should be

packaged in quantities that are appropriate for the therapy cycle relevant for that medicinal

product and national rules on antimicrobials subject to medical prescription should ensure

that those are dispensed in a way that corresponds to the quantities described by the

medical prescription.

(81) The provision of information to healthcare professionals and to patients on the appropriate

use, storage and disposal of antimicrobials is the joint responsibility of marketing

authorisation holders and of Member States. Member States should ensure that an

appropriate collection and management system is in place for all unused or expired

medicinal products.

7106/2/26 REV 2 45

EN

(82) Pharmacists and other healthcare professionals should play a role in antimicrobial

stewardship, including advising on the prudent use of antibiotics and other antimicrobials,

as well as on their correct disposal.

(83) While this Directive restricts the use of antimicrobials by setting categories of

antimicrobials that are subject to medical prescription, due to the growing antimicrobial

resistance in the Union, the competent authorities of the Member States should consider

further measures such as expanding the prescription status of antimicrobials, initiatives for

prudent use of antimicrobials in hospitals taking into account that the combined use of

several antimicrobial active substances may represent a particular risk, sufficient training

of healthcare professionals on stewardship regarding the use of antimicrobials and the

mandatory use of diagnostic tests before prescription. The competent authorities of the

Member States should consider such further measures according to the level of

antimicrobial resistance in their territory and the needs of patients. With regards to

antimicrobials for topical use, Member States should have the possibility to waive the

mandatory ‘subject to medical prescription’ status, including taking into account the

maximum single dose, the maximum daily dose, the strength, the pharmaceutical form and

certain types of packaging.

7106/2/26 REV 2 46

EN

(84) The pollution of waters and soils with pharmaceutical residues is an emerging

environmental problem, and there is scientific evidence that the presence of those

substances in the environment resulting from their manufacture, use and disposal poses a

risk to the environment and public health. The evaluation of the legislation showed that

strengthening of existing measures to reduce the impact of medicinal products’ lifecycle on

the environment and public health is required. Measures under this Directive complement

the main environmental legislation, in particular Council Directive 91/271/EEC21 as well

as Directives 2000/60/EC22, 2006/118/EC23, 2008/98/EC24, 2008/105/EC25, 2010/75/EU26

and 2020/218427 of the European Parliament and of the Council.

21 Council Directive 91/271/EEC of 21 May 1991 concerning urban waste water treatment

(OJ L 135, 30.5.1991, p. 40, ELI: http://data.europa.eu/eli/dir/1991/271/oj). 22 Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000

establishing a framework for Community action in the field of water policy

(OJ L 327, 22.12.2000, p. 1, ELI: http://data.europa.eu/eli/dir/2000/60/oj). 23 Directive 2006/118/EC of the European Parliament and of the Council of 12 December 2006

on the protection of groundwater against pollution and deterioration (OJ L 372, 27.12.2006,

p. 19, ELI: http://data.europa.eu/eli/dir/2006/118/oj). 24 Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008

on waste and repealing certain Directives (OJ L 312, 22.11.2008, p. 3,

ELI: http://data.europa.eu/eli/dir/2008/98/oj). 25 Directive 2008/105/EC of the European Parliament and of the Council of 16 December 2008

on environmental quality standards in the field of water policy, amending and subsequently

repealing Council Directives 82/176/EEC, 83/513/EEC, 84/156/EEC, 84/491/EEC,

86/280/EEC and amending Directive 2000/60/EC of the European Parliament and of the

Council (OJ L 348, 24.12.2008, p. 84, ELI: http://data.europa.eu/eli/dir/2008/105/oj). 26 Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010

on industrial and livestock rearing emissions (integrated pollution prevention and control)

(OJ L 334, 17.12.2010, p. 17, ELI: http://data.europa.eu/eli/dir/2010/75/oj). 27 Directive (EU) 2020/2184 of the European Parliament and of the Council

of 16 December 2020 on the quality of water intended for human consumption (OJ L 435,

23.12.2020, p. 1, ELI: http://data.europa.eu/eli/dir/2020/2184/oj).

7106/2/26 REV 2 47

EN

(85) Marketing authorisation applications for medicinal products in the Union should include an

ERA and risk mitigation measures. However, when preparing their ERAs, the applicants

for marketing authorisations of generic medicinal products and biosimilar medicinal

products should be able to refer to ERA studies conducted for the reference medicinal

product or to ERA studies conducted for any other medicinal product containing the same

active substances. The same applies to hybrid medicinal products and biohybrid medicinal

products as well as to fixed-dose combination medicinal products. If applicants fail to

submit a complete or sufficiently substantiated ERA or if they do not propose risk

mitigation measures to sufficiently address the risks identified in the ERA, the marketing

authorisation should be refused. The ERA should be updated when new data or knowledge

about relevant risks become available.

7106/2/26 REV 2 48

EN

(86) Marketing authorisation applicants should take into account risk assessment procedures

under other Union legal frameworks that may apply to chemicals depending on their use.

In addition to this Directive, there are four main other legal frameworks: (i) Regulation

(EC) No 1907/2006 of the European Parliament and of the Council28 (industrial chemicals

(REACH)); (ii) Regulation (EU) No 528/2012 of the European Parliament and of the

Council29 (biocides); (iii) Regulation (EC) No 1107/2009 of the European Parliament and

of the Council30 (pesticides); and (iv) Regulation (EU) 2019/6 of the European Parliament

and of the Council31 (veterinary medicinal products). In its communication on the

European Green Deal of 11 December 2019, the Commission proposed a ‘one-substance

one-assessment’ (OS-OA) approach for chemicals, in order to increase the efficiency of the

registration system, reduce costs and unnecessary animal testing.

28 Regulation (EC) No 1907/2006 of the European Parliament and of the Council

of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction

of Chemicals (REACH), establishing a European Chemicals Agency, amending

Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission

Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission

Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006,

p. 1, ELI: http://data.europa.eu/eli/reg/2006/1907/oj). 29 Regulation (EU) No 528/2012 of the European Parliament and of the Council

of 22 May 2012 concerning the making available on the market and use of biocidal products

(OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj). 30 Regulation (EC) No 1107/2009 of the European Parliament and of the Council

of 21 October 2009 concerning the placing of plant protection products on the market and

repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1,

ELI: http://data.europa.eu/eli/reg/2009/1107/oj). 31 Regulation (EU) 2019/6 of the European Parliament and of the Council

of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC

(OJ L 4, 7.1.2019, p. 43, ELI: http://data.europa.eu/eli/reg/2019/6/oj).

7106/2/26 REV 2 49

EN

(87) The emissions and discharges of antimicrobials to the environment from manufacturing

sites can lead to antimicrobial resistance, which is a global concern regardless where the

emissions and discharges take place. Therefore, the scope of the ERA should be extended

to cover the risk of antimicrobial resistance selection throughout the entire life cycle of

antimicrobials, including manufacturing. In order to specify technical details to conduct the

ERA, the Agency should issue guidelines on how to measure antimicrobial resistance other

than antibiotic resistance.

(88) This Directive should also include provisions for a risk-based approach regarding the ERA

obligations of marketing authorisation holders before October 2005 and the setting-up of

an ERA monograph system for active substances. This ERA monograph system should be

available to applicants for use when conducting an ERA for a new marketing authorisation

application.

7106/2/26 REV 2 50

EN

(89) For medicinal products authorised prior to October 2005, which have not been the subject

of an ERA, specific provisions should be introduced to set up a risk-based prioritisation

programme for the ERA submission or update by the marketing authorisation holders. For

generic, biosimilar, hybrid and bio-hybrid medicinal products and fixed-dose combination

medicinal products, for which the reference medicinal product was authorised

before 30 October 2005 and is included in that programme, the ERA could be submitted

after the outcome of the ERA for the relevant reference medicinal product has been made

publicly available by the Agency, unless the marketing authorisation holders concerned

have participated in a joint ERA study conducted for the relevant active substance. The

same should apply for new marketing authorisation applications for such generic,

biosimilar, hybrid and bio-hybrid medicinal products and fixed-dose combination

medicinal products for which the reference medicinal product was authorised

before 30 October 2005 and is included in that programme.

7106/2/26 REV 2 51

EN

(90) Northern Ireland has historically relied on the supply of medicinal products from or

through parts of the United Kingdom other than Northern Ireland. Following the

withdrawal of the United Kingdom of Great Britain and Northern Ireland from the

European Union and the European Atomic Energy Community, to prevent shortages of

medicinal products and ultimately to ensure a high level of public health protection,

specific provisions have been put in place. This Directive replaces Directive 2001/83/EC

listed in point 20 of Annex 2 to the Protocol on Ireland / Northern Ireland (the ‘Windsor

Framework’) and would therefore apply to and in the United Kingdom in respect of

Northern Ireland in accordance with Article 5(4) of the Windsor Framework, read in

conjunction with Article 13(3) thereof. To ensure the continued effectiveness of the

specific provisions that have already been put in place, it is therefore appropriate to

stipulate that certain provisions of this Directive should not apply to and in the United

Kingdom in respect of Northern Ireland. The power to adopt acts in accordance with

Article 290 of the Treaty on the Functioning of the European Union should be delegated to

the Commission in order to amend or supplement certain rules whose application is to be

suspended where the Commission finds that the level of protection of public health ensured

by the United Kingdom is no longer essentially equivalent to that guaranteed within the

Union or where sufficient information is not available to the Commission to enable it to

establish whether an essentially equivalent level of protection of public health is ensured

by the United Kingdom and that situation is not remedied within the specified time limit. It

is of particular importance that the Commission carry out appropriate consultations during

its preparatory work, including at expert level, and that those consultations be conducted in

accordance with the principles laid down in the Interinstitutional Agreement

of 13 April 2016 on Better Law-Making32. In particular, to ensure equal participation in the

preparation of delegated acts, the European Parliament and the Council receive all

documents at the same time as Member States’ experts, and their experts systematically

have access to meetings of Commission expert groups dealing with the preparation of

delegated acts.

32 OJ L 123, 12.5.2016, p. 1, ELI: http://data.europa.eu/eli/agree_interinstit/2016/512/oj.

7106/2/26 REV 2 52

EN

(91) To ensure that all children in the Union have access to medicinal products specifically

authorised for paediatric use, when an agreed paediatric investigation plan has led to the

authorisation of a paediatric indication for a medicinal product already marketed for other

therapeutic indications, the marketing authorisation holder should be obliged to place the

medicinal product on the same markets within two years of the date on which the

medicinal product is authorised for that paediatric indication.

(92) It is necessary in the interest of public health to ensure the continuing availability of safe

and effective medicinal products authorised for paediatric indications. Therefore, if a

marketing authorisation holder intends to withdraw such a medicinal product from the

market, arrangements should be in place so that the paediatric population can continue to

have access to the medicinal product in question. In order to help achieve this, the

competent authorities of the Member States or the Agency, as applicable, should be

informed in good time of any such intention and should make that intention publicly

available.

(93) To avoid unnecessary administrative and financial burdens both for the marketing

authorisation holders and the competent authorities of the Member States or the Agency, as

applicable, certain streamlining measures should be introduced, in line with the digital by

default principle. Electronic applications for marketing authorisations and for variations of

the terms of marketing authorisations should be introduced.

7106/2/26 REV 2 53

EN

(94) As a general rule, risk management plans should not be developed or submitted for generic

medicinal products and biosimilar medicinal products, considering that the reference

medicinal product has such a plan, except in specific cases where a risk management plan

should be provided. In addition, risk management plans for hybrid medicinal products and

bio-hybrid medicinal products should be limited to the differences between those

medicinal products and the reference medicinal product, as indicated in the marketing

authorisation application, provided that no additional risk minimisation measures exist for

the reference medicinal product and that the marketing authorisation for the reference

medicinal product has not been withdrawn prior to the submission of the application.

(95) As a general rule, marketing authorisations should be granted for an unlimited period.

Where, by way of derogation, a national marketing authorisation has been granted for a

limited period, it should be possible for the marketing authorisation holder to submit an

application for a renewal of that authorisation. Decisions on renewals should be based only

on a re-evaluation of the benefit-risk balance of the medicinal product.

(96) In the event of a risk to public health, the marketing authorisation holder or the competent

authorities of the Member States or the Commission should be able to impose urgent safety

or efficacy restrictions on their own initiative. In such cases, when the Union interest

referral procedure is launched, any duplication of assessments should be avoided.

7106/2/26 REV 2 54

EN

(97) To address patients’ needs, an increasing number of innovative medicinal products derive

from or are combined with other medicinal products that may be manufactured or tested

and regulated under more than one Union legal framework. Similarly, the same sites are

increasingly overseen by authorities established under different Union legal frameworks.

To ensure safe and efficient production and supervision of such products and appropriate

delivery to patients, it is important to ensure consistency between those frameworks.

Consistency and proper alignment can only be ensured through appropriate cooperation in

the development of the practices and principles applied under the different Union legal

frameworks. Appropriate cooperation should therefore be embedded within several

provisions of this Directive, such as those regarding classification advice, supervision, or

the development of guidelines.

(98) For products that combine a medicinal product and a medical device including an in vitro

diagnostic medical device, the applicability of two regulatory frameworks, namely

Regulation (EU) 2017/74533 or (EU) 2017/746 of the European Parliament and of the

Council34, as applicable, should be specified and the appropriate interaction between this

Directive and the two other applicable regulatory frameworks should be ensured. The same

should apply to combinations of medical products with products other than medical

devices.

33 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017

on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and

Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC

and 93/42/EEC (OJ L 117, 5.5.2017, p. 1, ELI: http://data.europa.eu/eli/reg/2017/745/oj). 34 Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017

on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission

Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176,

ELI: http://data.europa.eu/eli/reg/2017/746/oj).

7106/2/26 REV 2 55

EN

(99) To ensure that the competent authorities have all the information needed for their

assessment in the case of integral combinations of a medicinal product with a medical

device, or of combinations of a medicinal product with a product other than a medical

device, the marketing authorisation applicant should submit data demonstrating the safe

and effective use of the integral combination of the medicinal product with the medical

device or of the combination of a medicinal product with the other product. The competent

authority should assess the benefit-risk balance of the integral combination of the

medicinal product with the medical device or of the combination of the medicinal product

with the product other than a medical device, taking into account the suitability of the use

of the medicinal product together with the medical device or with the other product.

(100) To ensure that the competent authorities of the Member States or the Agency, as

applicable, have all the information needed for their assessment of medicinal products in

exclusive use with a medical device or with an in vitro diagnostic medical device, that is to

say, medicinal products that are presented in a package with a medical device or with an

in vitro diagnostic medical device, or that are to be used with a medical device or with an

in vitro diagnostic medical device referenced in the summary of product characteristics, the

marketing authorisation applicant shall submit data demonstrating the safe and effective

use of the medicinal product taking into account its use with the medical device or in vitro

diagnostic medical device. The competent authorities of the Member States or the Agency,

as applicable, should assess the benefit-risk balance of the medicinal product, taking into

account the use of the medicinal product with the medical device or the in vitro diagnostic

medical device.

7106/2/26 REV 2 56

EN

(101) This Directive also clarifies that a medical device that is part of an integral combination of

a medicinal product with a medical device should comply with the general safety and

performance requirements set out in Annex I to Regulation (EU) 2017/745. A medicinal

product in exclusive use with a medical device or with an in vitro diagnostic medical

device needs to meet all of the requirements of Regulation (EU) 2017/745 or

(EU) 2017/746, as applicable. If the action of a medicinal product in exclusive use with a

medical device or with an in vitro diagnostic medical device is not ancillary to that of the

medical device or the in vitro diagnostic medical device, the medicinal product should

comply with the requirements of this Directive and of Regulation (EU) 2026/…+ taking

into account its use with the medical device or in vitro diagnostic medical device, without

prejudice to the specific requirements of Regulation (EU) 2017/745 or (EU) 2017/746, as

applicable.

+ OJ: please insert in the text the number of the Regulation in document ST 7105/26

(2023/0131(COD)).

7106/2/26 REV 2 57

EN

(102) For integral combinations of a medicinal product with a medical device, medicinal

products in exclusive use with a medical devices or with an in vitro diagnostic medical

device and combinations of a medicinal product with a product other than a medical

device, the competent authorities of the Member States or the Agency, as applicable,

should also be able to request the marketing authorisation applicant to transmit any

additional information needed and the marketing authorisation applicant should be bound

to submit any such information requested. For medicinal products in exclusive use with a

medical device or with an in vitro diagnostic medical device that is not ancillary to that of

the medical device or the in vitro diagnostic medical device, the marketing authorisation

applicant should also, upon request from the competent authorities of the Member States or

the Agency, as applicable, submit any additional information relating to the medical device

or in vitro diagnostic medical device, taking into account its use with the medicinal

product, and that is relevant for the post-authorisation monitoring of the medicinal product,

without prejudice to the specific requirements of Regulation (EU) 2026/…+.

(103) For integral combinations of a medicinal product with a medical device and for

combinations of a medicinal product with a product other than a medical device, the

marketing authorisation holder should also bear the overall responsibility for the whole

products in terms of compliance of the medicinal product with the requirements of this

Directive and Regulation (EU) 2026/…+ and should ensure coordination of the information

flow between the sectors throughout the assessment procedure and the lifecycle of the

medicinal product.

+ OJ: please insert in the text the number of the Regulation in document ST 7105/26

(2023/0131(COD)).

7106/2/26 REV 2 58

EN

(104) In order to ensure the quality, safety and efficacy of medicinal products at all stages of

manufacturing and distribution, the marketing authorisation holder should be responsible,

when necessary, for tracing back an active substance, excipient or any other substance that

is used in the manufacture of a medicinal product and intended to be part of the medicinal

product or expected to be present in the medicinal product, for example impurities,

degradation products or contaminants.

(105) In the interest of public health, marketing authorisation holders should be able to ensure

the traceability of any substance that is used, intended or expected to be present in a

medicinal product at all stages of manufacturing and distribution, and should be able to

identify any natural or legal person from whom they have been supplied these substances.

Therefore, procedures and systems should be put in place to provide that information

where necessary to ensure the quality, safety or efficacy of medicinal products.

(106) It is recognised that the development of pharmaceuticals is an area where neither science,

nor technology stand still. The last decades have seen new categories of medicinal products

emerging, such as biological medicinal products, biosimilar medicinal products, advanced

therapy medicinal products and, in the future, phage therapies. Those categories of

products, in some instances, require adapted rules to fully take account of their specific

characteristics. For that reason, a forward-looking legal framework should include

provisions to enable such adapted frameworks subject to strict criteria and under a

Commission empowerment guided by the scientific input of the Agency.

7106/2/26 REV 2 59

EN

(107) The adaptations required for certain medicinal products or categories of medicinal products

can entail specific requirements and targeted technical adaptations of the requirements

compared to standard medicinal products. They could in particular include changes to the

dossier requirements for such medicinal products, the way their quality, safety and efficacy

is demonstrated by applicants or tailored manufacturing controls and good manufacturing

practice requirements, as well as additional control methods prior and during their

administration and use. Those adaptations should however not go beyond what is

necessary for the attainment of the objective of adaptation to the specific characteristics or

methods related to the medicinal product or category of medicinal products concerned.

(108) In order to increase preparedness and response capacity against health threats, in particular

the emergence of antimicrobial resistance, adapted frameworks could prove useful in

facilitating rapid changes to antimicrobials composition in order to preserve their efficacy.

The use of established platforms would allow efficient and timely adaptation of those

medicinal products to the clinical context.

7106/2/26 REV 2 60

EN

(109) To optimise the use of resources for both marketing authorisation applicants and competent

authorities and to avoid duplication of assessments of chemical active substances of

medicinal products, marketing authorisation applicants should be able to rely on an active

substance master file certificate or a certificate of suitability to the monograph of the

European Pharmacopoeia, instead of submitting the relevant data as required in accordance

with Annex II. It should be possible for an active substance master file certificate to be

granted by the Agency in cases where the relevant data on the active substance concerned

are not already covered by a monograph of the European Pharmacopoeia or by another

active substance master file certificate. Where a certificate of suitability to a monograph of

the European Pharmacopoeia or an active substance master file certificate is used as part of

the marketing authorisation application, it should be possible to provide additional quality

data that are not covered by those processes, as part of the marketing authorisation dossier

to demonstrate the suitability of the active substance in the context of its intended use in

the medicinal product. The Commission should be empowered to establish the procedure

for the single assessment of an active substance master file. To further optimise the use of

resources, the Commission should be empowered to allow the use of a certification scheme

also for additional quality master files i.e. for active substances other than chemical active

substances, or for other substances present or used in the manufacture of a medicinal

product, required in accordance with Annex II, e.g. in case of novel excipients, adjuvants,

radiopharmaceutical precursors and active substance intermediates, when the intermediate

is a chemical active substance by itself or used in combination with a biological substance.

7106/2/26 REV 2 61

EN

(110) The concept of platform technology master files allows the reliance on data –

encompassing aspects of quality, non-clinical, and clinical information – that have been

pre-evaluated in the marketing authorisation application of a medicinal product. Platform

technologies include, but are not limited to, viral and bacterial vector systems, recombinant

protein-based methods, nucleic acid sequences, viral and bacterial vectors and synthetic

biology approaches such as oligonucleotides and mRNA. The platform technology master

file that documents the platform technology should be certified by the Agency to allow

future uses. In the context of applying for marketing authorisations, products developed

and manufactured using platform technology master files are to focus on the customisation

of the platform to address the particular attributes of the medicinal product in question.

This methodology avoids the duplication of assessments and minimizes the repetition of

studies, thereby streamlining the development and regulatory evaluation processes for

medicinal products. A fundamental requirement for the effective application of platform

technology is the presence of a common dataset that remains applicable across medicinal

products using the same technology. To qualify the use of a platform technology master

file, applicants are obliged to demonstrate the applicability of the common dataset,

substantiate the development and manufacturing platform, and furnish scientific

justification that underscores the relevance of the platform data to the medicinal product in

question. While the owner of a platform technology master file and the marketing

authorisation holder are not necessarily the same, for example, some platform technologies

can emanate from academic research and development, the marketing authorisation holder

relying on a platform technology master file should retain full responsibility for its

marketing authorisation, including the parts covered by the master file.

7106/2/26 REV 2 62

EN

(111) For reasons of public health and legal consistency, and with a view to reducing the

administrative burden and strengthening predictability for economic operators, variations

of all types of marketing authorisations should be subject to harmonised rules.

(112) It should be possible for the terms of a marketing authorisation for a medicinal product to

be varied after it has been granted. While the core elements of a variation are laid down in

this Directive, the Commission should be empowered to complement those elements by

laying down further necessary elements, to adapt the system to scientific and technological

progress, including digitalisation, and to ensure that unnecessary administrative burden is

avoided for both the marketing authorisation holders and the competent authorities of the

Member States.

(113) The competent authorities of the Member States should have the power to evaluate

additional evidence that can affect the benefit-risk balance of medicinal products, beyond

what is provided by marketing authorisation holders. Where justified, the competent

authorities of the Member States should be able to recommend that the marketing

authorisation holder varies the terms of its marketing authorisation.

7106/2/26 REV 2 63

EN

(114) Scientific and technological progress in data analytics and data infrastructure provide

valuable support to the development, marketing authorisation and supervision of medicinal

products. The digital transformation has affected regulatory decision-making, making it

more data-driven and multiplying the possibilities for regulatory authorities to access

evidence across the lifecycle of a medicinal product. This Directive recognises the

competent authorities of the Member States’ capacity to access and analyse data submitted

independently from the marketing authorisation applicant or marketing authorisation

holder. On that basis, the competent authorities of the Member States should take the

initiative to recommend that the summary of product characteristics be updated in case

new efficacy or safety data have an impact on the benefit-risk balance of a medicinal

product.

7106/2/26 REV 2 64

EN

(115) Access to individual patient data from clinical studies in structured format allowing for

statistical analyses can assist regulators in understanding the submitted evidence and

inform regulatory decision-making on the benefit-risk balance of a medicinal product. The

introduction of such a possibility in the legislation is important to further enable data-

driven benefit-risk assessments at all stages of the lifecycle of a medicinal product. This

Directive therefore empowers competent authorities of Member States to request, as

necessary, such data as part of the assessment of initial and post-marketing authorisation

applications. Due to the sensitive nature of health data, the competent authorities should

safeguard its processing operations and ensure that they respect the data protection

principles of lawfulness, fairness and transparency, purpose limitation, data minimisation,

accuracy, storage limitation, integrity and confidentiality. Where the processing of

personal data is necessary for the purposes of this Directive, such processing should be

done in accordance with Union law on the protection of personal data. Any processing of

personal data under this Directive should take place in accordance with Regulations

(EU) 2016/67935 and (EU) 2018/172536 of the European Parliament and of the Council.

35 Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016

on the protection of natural persons with regard to the processing of personal data and on the

free movement of such data, and repealing Directive 95/46/EC (General Data Protection

Regulation) (OJ L 119, 4.5.2016, p. 1, ELI: http://data.europa.eu/eli/reg/2016/679/oj). 36 Regulation (EU) 2018/1725 of the European Parliament and of the Council

of 23 October 2018 on the protection of natural persons with regard to the processing of

personal data by the Union institutions, bodies, offices and agencies and on the free

movement of such data, and repealing Regulation (EC) No 45/2001 and Decision

No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39,

ELI: http://data.europa.eu/eli/reg/2018/1725/oj).

7106/2/26 REV 2 65

EN

(116) Pharmacovigilance rules are necessary for the protection of public health in order to

prevent, detect and assess adverse reactions to medicinal products placed on the Union

market, as the full safety profile of medicinal products can only be known after they have

been placed on the market.

(117) In order to ensure the continued safety of medicinal products in use, it is necessary to

ensure that pharmacovigilance systems in the Union are continually adapted to take

account of scientific and technical progress.

(118) It is necessary to take account of changes arising as a result of international harmonisation

of definitions, terminology and technological developments in the field of

pharmacovigilance.

7106/2/26 REV 2 66

EN

(119) The increasing use of electronic networks for communication of information on adverse

reactions to medicinal products marketed in the Union is intended to allow competent

authorities to share the information at the same time. In order to simplify the reporting of

suspected adverse reactions, the marketing authorisation holders and the Member States

should report those reactions only to the Union pharmacovigilance database and data-

processing network referred to in Regulation (EU) 2026/…+ (the ‘Eudravigilance

database’). The Eudravigilance database will be equipped to immediately forward reports

on suspected adverse reactions received from marketing authorisation holders to the

Member States on whose territory the reaction occurred. It should be possible for the

Agency, in consultation with the Commission, Member States and marketing authorisation

holders, to draw up and publish a detailed guide regarding the monitoring of relevant

adverse reaction databases maintained outside the Union and the entry of relevant

information from those databases into the Eudravigilance database.

+ OJ: please insert in the text the number of the Regulation in document ST 7105/26

(2023/0131(COD)).

7106/2/26 REV 2 67

EN

(120) Member States and marketing authorisation holders should operate a pharmacovigilance

system to collect information that is useful for the monitoring of medicinal products,

including information on suspected adverse reactions arising from use of a medicinal

product within the terms of the marketing authorisation as well as from use outside the

terms of the marketing authorisation, including off-label use, overdose, misuse, abuse and

medication errors by patients and healthcare professionals. Mistakes in the prescribing,

dispensing, storing, preparation and administration of a medicine are common types of

medication errors. Suspected adverse reactions should be recorded and reported by

Member States and marketing authorisations holders to the Eudravigilance database for the

monitoring of safety of medicinal products. The reports should be part of the continuous

evaluation of the benefit-risk balance of the medicinal products. Summaries of data

relevant to the benefit-risk balance should be included in periodic safety update reports.

Marketing authorisation holders should also record and report information on adverse

reactions occurring in the context of post-authorisation studies, including

post-authorisation studies in specific populations such as children, for evaluation of the

benefit-risk balance.

(121) It is the interest of the Union to ensure that the pharmacovigilance systems for centrally

authorised medicinal products and those authorised by other procedures are consistent.

(122) Marketing authorisation holders should be proactively responsible for on-going

pharmacovigilance of the medicinal products they place on the market including for an

appropriate period after the marketing authorisation has been withdrawn or revoked.

7106/2/26 REV 2 68

EN

(123) The use of colours in human and veterinary medicinal products is currently regulated by

Directive 2009/35/EC of the European Parliament and of the Council37 and is restricted to

those authorised in accordance with Regulation (EC) No 1333/2008 of the European

Parliament and of the Council38, for which specifications are laid down in Commission

Regulation (EU) No 231/201239. The use of excipients other than colours in medicinal

products is subject to the Union rules on medicinal products and is evaluated as part of the

overall benefit-risk profile of a medicinal product.

(124) Experience has shown the need to maintain to a certain extent the principle of the use in

medicinal products of those colours authorised as food additives. However, it is also

appropriate to provide for a specific assessment of the use of a colour in medicinal

products when a food additive is removed from the Union list of authorised food additives.

Therefore, in this specific case, the Agency should carry out its own assessment of the use

of the colour concerned in medicinal products, taking into account the European Food

Safety Authority opinion and its underlying scientific evidence, as well as any additional

scientific evidence and giving particular consideration to the use of the colour concerned in

medicinal products. The Agency should also be responsible for following any scientific

evidence for the colours retained for specific medicine use only. Directive 2009/35/EC

should therefore be repealed.

37 Directive 2009/35/EC of the European Parliament and of the Council of 23 April 2009 on

the colouring matters which may be added to medicinal products (OJ L 109, 30.4.2009,

p. 10, ELI: http://data.europa.eu/eli/dir/2009/35/oj). 38 Regulation (EC) No 1333/2008 of the European Parliament and of the Council

of 16 December 2008 on food additives (OJ L 354, 31.12.2008, p. 16,

ELI: http://data.europa.eu/eli/reg/2008/1333/oj). 39 Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for

food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the

European Parliament and of the Council (OJ L 83, 22.3.2012, p. 1,

ELI: http://data.europa.eu/eli/reg/2012/231/oj).

7106/2/26 REV 2 69

EN

(125) With regard to supervision and inspections, manufacturing and import of excipients,

functional excipients, starting materials or intermediate products should be under

surveillance due to their possible ancillary action on the active substance and to their

possible impact on the quality, safety and efficacy of the medicinal products.

(126) The main purpose of any regulation on the manufacture and distribution of medicinal

products is to safeguard public health.

(127) Manufacturing and wholesale distribution authorisations are to be subject to certain

essential conditions and it is the responsibility of the Member State concerned to ensure

that such conditions are met; each Member State is to recognise authorisations granted by

other Member States.

(128) It should be ensured that, in the Member States, the supervision and control of the

manufacture and the distribution of medicinal products are carried out by official

representatives of the competent authority who fulfil minimum conditions of qualification.

7106/2/26 REV 2 70

EN

(129) There may be cases where manufacturing activities, including testing, of medicinal

products need to take place in sites close to patients, taking into account the specific

properties of the medicinal product as well as considerations related to its quality, safety

and efficacy, for example advanced therapy medicinal products with a short shelf-life or

where proximity to the patient being treated or customisation for an individual patient is to

the patient’s benefit. In such cases, it can be necessary for manufacturing to be

decentralised to multiple sites to reach patients across the Union. The use of decentralised

manufacturing should be approved during the marketing authorisation procedure where

deemed appropriate by the competent authority of the Member State or the Agency. Where

the manufacturing steps are decentralised, they should be carried out under the

responsibility of the qualified person of an authorised central site. The decentralised sites

should not be required to obtain a manufacturing authorisation separate from the one

granted to the relevant central site but should be registered by the competent authority of

the Member State in which the decentralised site is located and supervised by that

authority. In the case of medicinal products containing, consisting of or derived from

SoHO, the decentralised sites are to be registered as SoHO entities as defined in and in

accordance with Regulation (EU) 2024/1938 for the activities of donor review and

eligibility assessment, donor testing and collection, where applicable. In respect of

decentralised sites falling within the scope of this Directive and engaging in activities

covered by other Union legal acts, in order to ensure their effective functioning, the

competent authorities of the Member States supervising the central site and the

decentralised sites should cooperate and exchange information with the authorities

supervising those activities under other Union legal acts. This cooperation should, where

appropriate, pertain to the coordination of authorisation, registration and supervision

activities, including joint inspections, related to the central site and the decentralised sites,

aiming to ensure efficiency of those activities.

7106/2/26 REV 2 71

EN

(130) The quality of medicinal products manufactured or available in the Union should be

guaranteed by requiring that the active substances used in their composition comply with

the principles of good manufacturing practice in relation to those medicinal products.

(131) Verification of compliance with the legal requirements of manufacturing, distribution and

use of medicinal products by relevant entities through a system of supervision, is of

fundamental importance to ensure that the objectives of this Directive are effectively

achieved. Therefore, the competent authorities of the Member States should be empowered

to perform on site or remote inspections, as part of the system of supervision at all stages

of manufacturing, distribution and use of medicinal products or active substances. It has

proved necessary to reinforce the Union provisions on inspections and to compile a Union

database of the results of those inspections. The competent authorities of the

Member States should have the possibility to rely on the outcome of inspections conducted

by trusted non-Union regulatory authorities. To preserve the effectiveness of the

inspections, the competent authorities should also have the possibility to perform joint

inspections and also, where necessary, unannounced inspections.

(132) The frequency of controls should be established by the competent authorities having regard

to the risk and to the level of compliance expected in different situations. That approach

should allow those competent authorities to allocate resources where the risk is highest. In

some cases, the system of supervision should be applied irrespective of the level of risk or

suspected non-compliance, for example in the context of granting manufacturing

authorisations.

7106/2/26 REV 2 72

EN

(133) Within the procedure for ‘Certification of Suitability to the monographs of the European

Pharmacopoeia’, the European Directorate for the Quality of Medicines and Healthcare of

the Council of Europe is to verify, by means of inspections, whether the data submitted by

the applicant confirms the suitability of monographs to control the chemical purity,

microbiological quality and, if relevant, Transmissible Spongiform Encephalopathy risk. It

is also to verify whether the manufacturing complies with good manufacturing practice for

active substances. Depending on the outcome of the inspection, a certificate of compliance

or non-compliance with good manufacturing practice is issued by the European Directorate

for the Quality of Medicines and Healthcare of the Council of Europe or by the

Member State participating in the inspection.

(134) Each undertaking that manufactures or imports medicinal products should set up a

mechanism to ensure that all information supplied about a medicinal product is in

conformity with the approved conditions of use.

(135) The conditions governing the supply of medicinal products to the public should be

harmonised.

(136) In relation to the supply of medicinal products to the public, persons moving around within

the Union have the right to carry a reasonable quantity of medicinal products lawfully

obtained for their personal use. It should also be possible for a person established in one

Member State to obtain a reasonable quantity of medicinal products from another

Member State, where those products are intended for that person’s personal use.

7106/2/26 REV 2 73

EN

(137) Pursuant to Regulation (EU) 2026/…+, certain medicinal products are subject to a

centralised marketing authorisation. In this context, the prescription status of medicinal

products covered by a centralised marketing authorisation needs to be established. It is

therefore important to set the criteria on the basis of which Union decisions will be taken.

(138) It is also appropriate to harmonise the basic principles applicable to the prescription status

of medicinal products in the Union or in the Member State concerned, while taking as a

starting point the principles already established on this subject by the Council of Europe as

well as the work of harmonisation completed within the framework of the United Nations

Single Convention on narcotic drugs of 1961 and the United Nations Convention on

Psychotropic Substances of 1971.

(139) Many operations involving the wholesale distribution of medicinal products can cover

several Member States simultaneously.

(140) It is necessary to exercise control over the entire chain of distribution of medicinal

products, from their manufacture or import into the Union through to their supply to the

public, so as to guarantee that such products are stored, transported and handled in suitable

conditions. The requirements that should be adopted for this purpose will considerably

facilitate the withdrawal of defective products from the market and allow more effective

efforts against counterfeit products.

+ OJ: please insert in the text the number of the Regulation in document ST 7105/26

(2023/0131(COD)).

7106/2/26 REV 2 74

EN

(141) Any person involved in the wholesale distribution of medicinal products should be in

possession of a special authorisation. Pharmacists and other persons authorised to supply

medicinal products to the public, who confine themselves to that activity, should be

exempt from obtaining a special authorisation. It is however necessary, in order to control

the complete chain of distribution of medicinal products, that pharmacists and other

persons authorised to supply medicinal products to the public keep records showing

transactions in products received.

(142) Certain Member States impose certain public service obligations on wholesale distributors

who supply medicinal products to pharmacists and on other persons authorised to supply

medicinal products to the public. Those Member States should be able to continue to

impose those obligations on wholesale distributors established within their territory. They

should also be able to impose them on holders of a wholesale distribution authorisation that

has been granted by another Member State on condition that they do not impose any

obligation more stringent than those that they impose on their own wholesale distributors

and provided that such obligations can be regarded as justified on grounds of public health

protection and are proportionate in relation to the objective of such protection.

(143) Rules should be laid down as to how the labelling and package leaflets are to be presented.

The package leaflet should be accessible, easily legible, clearly comprehensible by users,

including especially the target patient groups, and indelible. Design choices should

primarily serve function and readability, rather than aesthetics.

(144) The provisions governing the information supplied to users should provide a high degree

of consumer protection, so that medicinal products are used correctly on the basis of full

and comprehensible information.

7106/2/26 REV 2 75

EN

(145) The placing on the market of medicinal products the labelling and package leaflet of which

comply with this Directive should not be prohibited or impeded on grounds connected with

the labelling or package leaflet.

(146) The use of electronic and technological possibilities for package leaflets other than in

paper format can facilitate access to medicinal products and medicinal products

distribution. It should always guarantee equal quality of information to all patients

compared to product information in paper format. It can additionally enable other forms of

transmission of such information to persons with sensory impairments, for example

through audiovisual or other means.

(147) Member States have varying levels of digital literacy and internet access. In addition,

patient and healthcare professional needs can differ. It is therefore necessary that

Member States have discretion with respect to the adoption of measures allowing package

leaflets to be made available exclusively electronically for specific categories of medicinal

products or for all medicinal products while ensuring that no patient is left behind, taking

into account the needs of different age categories and the different levels of digital literacy

in the population, and making sure that product information is easily accessible to all

patients. Member States should, where appropriate, consider allowing package leaflets to

be made available only electronically, while ensuring full compliance with the rules on

protection of personal data, notably with Regulation (EU) 2016/679, and should prevent

the identification, profiling or tracking of individuals and should adhere to harmonised

standards developed at EU level.

7106/2/26 REV 2 76

EN

(148) Where Member States decide that the package leaflet should be made available only

electronically, the marketing authorisation holders concerned should ensure that a paper

version of the package leaflet is made available to patients upon request and free of charge.

Marketing authorisation holders should also ensure adherence to all specifications,

common standards and formats specified by the relevant implementing acts and guidance

and that the information in digital format is easily accessible to all patients, for instance by

including on the outer packaging of the product a digitally readable element, for example a

QR code, a data matrix code, a barcode, or any other appropriate technology which would

direct the patient to the electronic version of the package leaflet in a simple, user friendly

and effective manner.

(149) The use of multi-country packages that are also multilingual can be a tool for access to

medicinal products, in particular for small markets and in public health emergencies.

Where such packages are used, it should be possible for Member States to also allow the

use on the labelling and package leaflet of an official language of the Union that is

commonly understood in the Member States where the multi-country package that is also

multilingual is marketed.

7106/2/26 REV 2 77

EN

(150) Security of supply in Malta continues to be hindered by the low availability of medicinal

products with package leaflets in the official languages of that Member State. For this

reason, it is appropriate to allow for the competent authorities of Malta to maintain in force

marketing authorisations that were granted, extended or maintained in accordance with

Article 126c of Directive 2001/83/EC and that are valid at the time of entry into force of

this Directive until after the rules on electronic product information become applicable in

all Member States, taking also into account the deferred application of those rules for

medicinal products already placed on the market.

(151) To ensure a high level of transparency of public support to the research and development

of medicinal products, the reporting of any public contribution to the development of a

particular medicinal product should be a requirement for all medicinal products. Given

however the practical difficulty to identify how indirect public funding instruments, such

as tax advantages, have supported a particular medicinal product, the reporting obligation

should only concern the direct public financial support, such as direct grants or contracts,

received from any public authority, publicly funded body, philanthropic organisation, or

not-for-profit organisation or fund. Therefore, the provisions of this Directive ensure,

without prejudice to the rules on the protection of confidential and personal data,

transparency regarding any direct financial support received from any public authority or

publicly funded body, philanthropic organisation, or not-for-profit organisation or fund to

carry out any activities for the research and development of medicinal products.

7106/2/26 REV 2 78

EN

(152) To ensure the accuracy of the information on public financial support made publicly

available by the marketing authorisation holder, that information should be subject to an

audit by an independent external auditor.

(153) In order to ensure a harmonised and consistent reporting of any public contribution to the

development of a particular medicinal product, the Commission should adopt

implementing acts to lay down the principles and format to which the marketing

authorisation holder should adhere when reporting that information.

(154) This Directive is without prejudice to the application of measures adopted pursuant to

Directive 2006/114/EC of the European Parliament and of the Council40 or pursuant to

Directive 2005/29/EC of the European Parliament and of the Council41. Therefore, the

provisions of this Directive regarding the advertising of medicinal products should be

considered, where relevant, as a lex specialis with respect to Directive 2005/29/EC.

40 Directive 2006/114/EC of the European Parliament and of the Council of 12 December 2006

concerning misleading and comparative advertising (OJ L 376, 27.12.2006, p. 21,

ELI: http://data.europa.eu/eli/dir/2006/114/oj). 41 Directive 2005/29/EC of the European Parliament and of the Council of 11 May 2005

concerning unfair business-to-consumer commercial practices in the internal market and

amending Council Directive 84/450/EEC, Directives 97/7/EC, 98/27/EC and 2002/65/EC of

the European Parliament and of the Council and Regulation (EC) No 2006/2004 of the

European Parliament and of the Council (‘Unfair Commercial Practices Directive’)

(OJ L 149, 11.6.2005, p. 22, ELI: http://data.europa.eu/eli/dir/2005/29/oj).

7106/2/26 REV 2 79

EN

(155) Advertising of medicinal products, even of medicinal products not subject to medical

prescription, could affect public health and distort competition. Therefore, the advertising

of medicinal products should meet certain criteria. Persons qualified to prescribe,

administer or supply medicinal products can properly evaluate the information available in

advertising because of their knowledge, training and experience. The advertising of

medicinal products to persons who cannot properly assess the risk associated with their use

can lead to medicinal product misuse or overconsumption which is liable to harm public

health. Therefore, the advertising to the general public of medicinal products that are

available on medical prescription only should be prohibited. Furthermore, distribution of

samples free of charge to the general public for promotional ends is to be prohibited, also

teleshopping for medicinal products is prohibited under Directive 2010/13/EU of the

European Parliament and of the Council42. It should be possible, under certain restrictive

conditions, to provide samples of medicinal products free of charge to persons qualified to

prescribe or supply them so that they can familiarise themselves with new products and

acquire experience in dealing with them.

42 Directive 2010/13/EU of the European Parliament and of the Council of 10 March 2010 on

the coordination of certain provisions laid down by law, regulation or administrative action

in Member States concerning the provision of audiovisual media services (Audiovisual

Media Services Directive) (OJ L 95, 15.4.2010, p. 1,

ELI: http://data.europa.eu/eli/dir/2010/13/oj).

7106/2/26 REV 2 80

EN

(156) The advertising of medicinal products should aim to disseminate objective and unbiased

information about the medicinal product. For that purpose, it is expressly forbidden to

highlight negatively another medicinal product or to suggest that an advertised medicinal

product might be safer or more effective than another medicinal product. Comparison of

medicinal products should only be allowed if it is based on information that is supported

objectively by the summaries of product characteristics of the medicinal products

concerned. This prohibition covers any medicinal product, including biosimilar medicinal

products, and therefore it would be misleading to suggest, in the advertisement, that a

biosimilar medicinal product would not be interchangeable with the original biological

medicinal product or another biosimilar medicinal product similar to the same original

biological medicinal product. Additional strict rules about negative and comparative

advertising of competitor medicinal products should aim to prohibit claims that can

mislead persons qualified to prescribe, administer or supply them.

(157) The dissemination of information which encourages the purchase of medicinal products

should be considered to fall under the concept of advertising of medicinal products, even

where that information does not refer to a specific medicinal product but refers to

unspecified medicinal products.

(158) The advertising of medicinal products should be subject to strict conditions and effective,

adequate monitoring. Reference in this regard should be made to the monitoring

mechanisms set up by Directive 2006/114/EC.

7106/2/26 REV 2 81

EN

(159) Medical sales representatives have an important role in the promotion of medicinal

products. Therefore, certain obligations should be imposed upon them, in particular the

obligation to supply the person visited with a summary of product characteristics.

(160) Even minimal inducement can result in biased decisions with regard to prescription

behaviour by physicians. Therefore, to avoid conflicts of interest, in the absence of national

rules governing the disclosure of transfers of value, Member States should establish and

maintain a publicly available list of links to the disclosure platforms operated by trade

associations or by marketing authorisation holders for the reporting of transfers of value

related to the advertising activities.

(161) Innovative, combination medicinal products and other developed medicinal products are

complex as regards their composition and administration. Therefore, people who are

qualified to administer medicinal products, as well as people who are qualified to prescribe

such products, need to be familiar with all the characteristics of those medicinal products,

in particular their safe administration and use, including comprehensive instructions for

patients. For that purpose, providing information about medicinal products subject to

medical prescription to persons qualified to administer them is also clearly allowed.

(162) Persons qualified to prescribe, administer or supply medicinal products should have access

to a neutral, objective source of information about products available on the market. It is

nevertheless for the Member States to take all measures necessary to this end, in the light

of their own particular situation.

7106/2/26 REV 2 82

EN

(163) In order to avoid waste, reduce the burden on the environment, mitigate shortages and

realise cost savings, it is feasible to allow re-dispensing of medicinal products, under strict

conditions. Through the practice of re-dispensing, a pharmacy can take back and re-

dispense a medicinal product that has already been supplied to a patient. Member States

should ensure that re-dispensing can only be done by the same pharmacy that initially

supplied the medicinal product. A pharmacy should only be allowed to re-dispense

medicinal products to an individual patient identified by name, on the basis of informed

consent. The returned medicinal products should be allowed to be re-dispensed only after

the pharmacy has verified that the medicinal product concerned is not a falsified medicinal

product, that the expiry date has not passed and that the medicinal product has been stored

under appropriate conditions. To check these parameters, instruments such as a

tamper-proof bag and temperature logger can be used. The pharmacy should record the

medicinal product and the recipient for the purpose of inspections. Re-dispensing might

not be feasible for all medicinal products. Member States should be able to identify and list

in national legislation which specific medicinal products are allowed to be re-dispensed in

that Member State, such as oral oncological medicinal products, which could provide for a

pilot category. Member States should lay down rules on liability for potential harm

resulting from the use of the medicinal products that have been re-dispensed when such

harm is a consequence of a failure to ensure appropriate storage or transport conditions

between the initial dispensing of the medicinal product and its return to the pharmacy, or a

failure to ensure that the medicinal product re-dispensed has not been falsified. This

provision should not affect the possibility for Member States to set additional restrictive

conditions under which medicinal products can be re-dispensed. Member States should

ensure that the collection and re-dispensing of medicinal products are not used for

obtaining economic gains and allowing penetration of the re-dispensed medicinal products

to the supply chain.

7106/2/26 REV 2 83

EN

(164) In order to ensure that information on the use of the medicinal products in children are

appropriately taken into account at the moment of marketing authorisation, it is necessary

to introduce a requirement for new medicinal products or when developing paediatric

indications of already authorised medicinal products covered by a patent or a

supplementary protection certificate, to present either the results of studies in the paediatric

population in accordance with an agreed paediatric investigation plan or proof of having

obtained a waiver or deferral, at the time of submitting a marketing authorisation

application or an application for a new therapeutic indication, new pharmaceutical form or

new route of administration. In order to ensure that the data supporting the marketing

authorisation concerning the use of a medicinal product in children are adequate, the

competent authorities responsible for the authorisation of a medicinal product should check

that the studies conducted comply with the agreed paediatric investigation plan or whether

any waivers or deferrals have been granted, when validating the marketing authorisation

applications.

7106/2/26 REV 2 84

EN

(165) To provide healthcare professionals and patients with information on the safe and effective

use of medicinal products in the paediatric population, the results of the studies conducted

in accordance with a paediatric investigation plan, irrespective of whether or not those

results support the use of the medicinal product in children, should be included in the

summary of product characteristics and, if appropriate, in the package leaflet of the

medicinal product. Information on waivers should also be included in the product

information. When all the measures provided for in the paediatric investigation plan have

been complied with, that fact should be recorded in the marketing authorisation, and that

should then be the basis upon which companies can obtain rewards.

(166) Relevant data and information collected through clinical studies conducted before the

introduction in the Union of a paediatric medicines Regulation and received by the

competent authorities should be assessed without undue delay and taken into consideration

for eventual variations of existing marketing authorisations.

7106/2/26 REV 2 85

EN

(167) In order to ensure uniform conditions for the implementation of this Directive,

implementing powers should be conferred on the Commission in order to: lay down details

of the application for a hospital exemption approval, specify the content and format for the

collection and reporting of data on ATMPs prepared under hospital exemption, lay down

the practical arrangements for the exchange of knowledge between holders of a hospital

exemption approval and the modalities for the preparation and use of ATMPs under

hospital exemption, on a non-routine basis; set out the content and format of the request to

use decentralised manufacturing and specify the application of decentralised

manufacturing; establish a list of colours permitted for use in medicinal products other than

those included in the Union list of authorised food additives and to adopt decisions as to

whether a colour is to be added to that list; adopt decisions on applications, after receiving

the opinion of the Committee for Medicinal Products for Human Use or the position of the

majority of the Member States represented within the coordination group, as applicable,

and after obtaining the opinion of the Standing Committee on Medicinal Products for

Human Use, in particular, in the event of divergent positions of Member States in a

decentralised or mutual recognition procedure or in relation to harmonisation of summary

of product characteristics, in the event of divergent decisions by Member States concerning

a national marketing authorisation, its variation, suspension or revocation or the summary

of product characteristics, or in the event of divergent positions of Member States in the

context of the Union interest referral or the urgent Union procedure or the procedure for

regulatory action on periodic safety update reports or following the submission of a final

study report on non-interventional post-authorisation safety studies; lay down the

principles and format for the information on the public financial support received to be

reported;

7106/2/26 REV 2 86

EN

establish common standards and formats for the electronic version of the package leaflet,

the summary of product characteristics and the labelling, establish criteria for the provision

of such product information through secure digital platforms and services and for the

provision, establishment, management and accessibility of such digital platforms and

services, establish the procedures to validate the electronic version of the package leaflet

and to make it available to patients, specify information on the packaging on how to access

this electronic version and specify the details on how to include the commonly recognised

global antimicrobial resistance symbol in the package leaflet and information on

antimicrobial resistance and the importance of appropriate use and disposal of

antimicrobials; harmonise the performance of the pharmacovigilance activities provided

for in this Directive by setting out the content and rules on the maintenance of the

pharmacovigilance system master file, minimum requirements for the quality system for

the performance of pharmacovigilance activities, rules on the use of internationally agreed

terminology, formats and standards for the performance of such activities, minimum

requirements for the monitoring of data in the Eudravigilance database, the format and

content of the electronic transmission of suspected adverse reactions and the format and

content of electronic periodic safety update reports and risk management plans, the format

of protocols, abstracts and final study reports for the non-interventional post-authorisation

safety studies; establish a list of herbal substances, herbal preparations and combinations

thereof for use in traditional herbal medicinal products; include a third country in a list

after assessing its regulatory framework applicable to active substances exported to the

Union and apply the relevant requirements; and specify the design and the technical,

electronic and cryptographic requirements for verification of the authenticity of the

common logo that is to be displayed on the website relating to the offer for sale at a

distance to the public of medicinal products. Those powers should be exercised in

accordance with Regulation (EU) No 182/2011 of the European Parliament and of the

Council43.

43 Regulation (EU) No 182/2011 of the European Parliament and of the Council

of 16 February 2011 laying down the rules and general principles concerning mechanisms

for control by Member States of the Commission’s exercise of implementing powers

(OJ L 55, 28.2.2011, p. 13, ELI: http://data.europa.eu/eli/reg/2011/182/oj).

7106/2/26 REV 2 87

EN

(168) Due to the need to reduce the overall time taken to authorise medicinal products, the time

between the opinion of the Committee for Medicinal Products for Human Use and any

final decision from the Commission concerning national marketing authorisations, in

particular for referrals, should be reduced, in principle, to 46 days.

(169) On the basis of the opinion of the Committee for Medicinal Products for Human Use, the

Commission should adopt a draft decision on the referral or the application concerned. In

duly justified cases, it should be possible for the Commission to refer the opinion of the

Committee for Medicinal Products for Human Use or the position of the majority of the

Member States represented within the coordination group back to the Agency or to the

coordination group, as applicable, for further consideration. The Commission’s draft

decision may diverge from the opinion of the Committee for Medicinal Products for

Human Use. The Commission should adopt its final decision by means of implementing

acts after obtaining the opinion of the Standing Committee on Medicinal Products for

Human Use. Taking into account the need to make medicinal products swiftly available to

patients, it should be acknowledged that the chairperson of the Standing Committee on

Medicinal Products for Human Use is to use the available mechanisms under Regulation

(EU) No 182/2011 and notably the possibility to obtain the Committee’s opinion by

written procedure and within expeditious deadlines, which, in principle, do not

exceed 10 calendar days.

7106/2/26 REV 2 88

EN

(170) The power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of

the European Union should be delegated to the Commission to adopt any necessary

changes to Annex II in order to: take into account scientific and technical progress; amend

Annexes I to VI in order to adapt them to scientific and technical progress as well as

amend the ERA requirements as regards the obligation to indicate whether the medicinal

product or any of its ingredients or constituents is an endocrine active agent or has been

assigned to hazard classes referred to in this Directive, the obligation to include in the ERA

risk mitigation measures to avoid or limit emissions in the environment of ingredients and

constituents of medicinal products listed as pollutants in specific EU legislation and to

explain how such measures can address the identified risks to the environment, the

obligation to include in the ERA for antimicrobials an evaluation of the risk for

antimicrobial resistance selection in the environment due to the manufacturing supply

chain, use and disposal of the antimicrobial and the obligation to update the ERA with any

relevant information, including relevant information from environmental monitoring, eco-

toxicity studies, risk assessments under other Union legal acts and environmental exposure

data or, for specified ERAs, with information that has been identified as missing

concerning medicinal products that are potentially harmful to the environment; amend the

list of labelling particulars in Annex IV in order to take account of scientific progress or

patients’ needs; amend the list of medicinal products and categories of medicinal products

in Annex VII in order to take account of scientific and technical progress; amend certain

definitions in order to take account of technical and scientific progress and taking into

account definitions agreed at Union and international level without amending the scope of

the definitions; and amend the requirements as regards the degree of dilution of a

homeopathic medicinal product to guarantee its safety as laid down in this Directive in

order to take account of scientific progress.

7106/2/26 REV 2 89

EN

It is of particular importance that the Commission carry out appropriate consultations

during its preparatory work, including at expert level, and that those consultations be

conducted in accordance with the principles laid down in the Interinstitutional Agreement

of 13 April 2016 on Better Law-Making. In particular, to ensure equal participation in the

preparation of delegated acts, the European Parliament and the Council receive all

documents at the same time as Member States’ experts, and their experts systematically

have access to meetings of Commission expert groups dealing with the preparation of

delegated acts.

7106/2/26 REV 2 90

EN

(171) The power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of

the European Union should be delegated to the Commission in order to supplement certain

non-essential elements of this Directive in respect of: specifying the content and format of

ERA monographs, the procedures for adopting and updating the ERA monographs, the

procedures for submission of information, studies and data, the risk-based criteria for the

selection and prioritisation of active substances in relation to ERA monographs and the use

of ERA monographs in the context of new marketing authorisation applications for

medicinal products to support the ERA for those medicinal products; specifying the

procedure for examination of application of active substance master file certificate, the

publication of such certificates, the procedure for changes to the active substance master

file and its certificate, access to the active substance master file and its assessment report;

specifying additional quality master files to provide information on a constituent of a

medicinal product, the procedure for examination of application of a quality master file

certificate, the publication of such certificates, the procedure for changes to the quality

master file and its certificate, and access to the additional quality master file and its

assessment report; identifying the substances to which the provisions on additional quality

master file apply; determining the situations in which post-authorisation efficacy studies

may be required; laying down the adapted framework for medicinal products and

categories of medicinal products listed in Annex VII as well as the documentation to be

submitted in that regard; setting out a reduced list of mandatory labelling particulars

outlined in Annex IV that shall appear on the outer packaging of multi-country packages

that are also multilingual; laying down detailed rules for the safety features in Annex IV

setting out the characteristics and technical specifications of the unique identifier of the

safety features that enables the authenticity of medicinal products to be verified and

individual packs to be identified and setting out the lists of medicinal products or

categories subject to medical prescription that are not to bear the safety features and those

not subject to medical prescription that are to bear the safety features;

7106/2/26 REV 2 91

EN

specifying exemptions to variation and the categories in which variations should be

classified and establishing procedures for the examination of applications for variations to

the terms of marketing authorisations as well as specifying conditions and procedures for

cooperation with third countries and international organisations for examination of

applications for such variations; specifying the criteria and the verifications in relation to

the assessment of the potential falsified character of medicinal products; specifying the

annual notification to be made by the qualified person to the competent authority of the

Member State where a decentralised site is located, on the inventory of the changes that

have taken place as regards the information provided in the registration form relating to

that decentralised site; specifying the principles of good manufacturing and good

distribution practices for medicinal products and active substances, in line with other

principles of good practice established under any other Union legal framework, as well as

the rules applicable to excipients as regards the formalised risk assessment for ascertaining

the appropriate good manufacturing practice taking into account requirements under other

appropriate quality systems as well as the source and intended use of the excipients and

previous instances of quality defects; and laying down the principles applicable to the

system of supervision, the joint inspections, the exchange of information and cooperation

in the coordination of inspections in the system of supervision and the trusted non-Union

regulatory authorities. It is of particular importance that the Commission carry out

appropriate consultations during its preparatory work, including at expert level, and that

those consultations be conducted in accordance with the principles laid down in the

Interinstitutional Agreement of 13 April 2016 on Better Law-Making. In particular, to

ensure equal participation in the preparation of delegated acts, the European Parliament

and the Council receive all documents at the same time as Member States’ experts, and

their experts systematically have access to meetings of Commission expert groups dealing

with the preparation of delegated acts.

7106/2/26 REV 2 92

EN

(172) This Directive seeks to enable the right of access to preventive healthcare and the right to

benefit from medical treatment under the conditions established by national laws and

practices and to ensure a high level of human health protection in the definition and

implementation of all Union policies and activities as laid down in Article 35 of the

Charter of Fundamental Rights of the European Union.

(173) Since the objectives of this Directive, namely to establish rules on medicinal products

ensuring the protection of public health and the environment as well as the functioning of

the internal market, cannot be sufficiently achieved by the Member States as national rules

would lead to disharmonisation, unequal patient access to medicinal products and barriers

to the internal market, but can rather, by reason of their effects, be better achieved at Union

level, the Union may adopt measures, in accordance with the principle of subsidiarity as set

out in Article 5 of the Treaty on European Union. In accordance with the principle of

proportionality as set out in that Article, this Directive does not go beyond what is

necessary in order to achieve those objectives.

7106/2/26 REV 2 93

EN

(174) The European Data Protection Supervisor was consulted in accordance with Article 42(1)

of Regulation (EU) 2018/1725 and delivered an opinion on 19 June 2023.

(175) In accordance with the Joint Political Declaration of 28 September 2011 of Member States

and the Commission on explanatory documents44, Member States have undertaken to

accompany, in justified cases, the notification of their transposition measures with one or

more documents explaining the relationship between the components of a directive and the

corresponding parts of national transposition instruments. With regard to this Directive, the

legislator considers the transmission of such documents to be justified,

HAVE ADOPTED THIS DIRECTIVE:

44 OJ C 369, 17.12.2011, p. 14.

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Chapter I

Subject matter, scope and definitions

Article 1

Subject matter and scope

1. This Directive lays down rules for the placing on the market, manufacturing, import,

export, supply, distribution, pharmacovigilance, advertising, supervision, control and use

of medicinal products for human use.

2. This Directive applies to medicinal products for human use intended to be placed on the

market.

3. In addition to the medicinal products referred to in paragraph 2, Chapter XI applies also to

starting materials, active substances, excipients and intermediate products.

4. Where a product that falls within the definition of a medicinal product under this Directive

is also covered by a definition in another Union legal act, and there is a conflict between

the rules applicable to that product under this Directive and under that other Union legal

act, the rules set out in this Directive shall prevail.

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5. Except for Article 2, this Directive does not apply to:

(a) medicinal products prepared in a pharmacy in accordance with a medical prescription

or, where provided for in national law, with a written instruction of a doctor, to meet

the special needs of an individual patient (‘magistral formulas’);

(b) medicinal products prepared in a pharmacy in accordance with a pharmacopoeia and

intended to be supplied directly to the patients served by the pharmacy in question

(‘officinal formulas’).

Magistral formulas or officinal formulas shall not include medicinal products listed in

points 1 and 2 of Annex I to Regulation (EU) 2026/…+.

6. This Directive does not apply to:

(a) investigational medicinal products as defined in Article 2(2), point (5),

of Regulation (EU) No 536/2014;

(b) substances of human origin (SoHO), unless they fall within the definition of an

advanced therapy medicinal product (ATMP) or a SoHO-derived medicinal product

other than ATMPs.

+ OJ: please insert in the text the number of the Regulation in document ST 7105/26

(2023/0131(COD)).

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7. Without affecting the rules set out in Regulation (EU) 2024/1938, including as regards the

principle of voluntary and unpaid donations, this Directive and all Regulations referred to

in this Directive shall be without prejudice to the application of national legislation

prohibiting or restricting the use of any specific type of SoHO or animal cells, or the sale,

supply or use of medicinal products containing, consisting of or derived from such

substances or cells, on grounds not covered by this Directive or those Regulations.

Member States shall communicate such national legislation to the Commission.

8. This Directive shall not affect the powers of the Member States’ authorities either as

regards the setting of prices for medicinal products or their inclusion in the scope of

national health insurance schemes, on the basis of health, economic and social conditions.

9. This Directive shall not affect the application of national legislation prohibiting or

restricting the sale, supply or use of medicinal products as contraceptives or abortifacients.

Member States shall communicate such national legislation to the Commission.

Article 2

Magistral formulas and officinal formulas

1. A Member State may allow a pharmacy to supply officinal formulas to a hospital served by

it upon the request of that hospital.

Such supply shall be subject to the approval of the competent authority of the

Member State concerned.

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2. Where necessary to ensure the availability of a magistral formula to meet the special needs

of individual patients, Member States may allow pharmacies to prepare magistral formulas

in advance when duly justified, on the basis of anticipated medical prescriptions or

instructions, as relevant, for such patients.

In such cases, the magistral formula shall be prepared for:

(a) up to the following seven days; or

(b) when duly justified and taking into account the properties of the medicinal product,

up to the following three weeks.

Member States shall ensure that pharmacies keep a record of magistral formulas prepared

in advance in accordance with this paragraph, including the justifications therefor, and that

the relevant documentation is readily available for inspection.

Article 3

ATMPs prepared under hospital exemption

1. By way of derogation from Article 1(1), only this Article applies to ATMPs prepared

within a Member State on a non-routine basis in accordance with the requirements referred

to in paragraph 3, and used within that Member State in a hospital under the exclusive

professional responsibility of a medical practitioner in order to comply with an individual

medical prescription for a custom-made product to meet the needs of an individual patient

(‘ATMPs prepared under hospital exemption’).

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2. Member States shall ensure that the manufacture and use of an ATMP prepared under

hospital exemption require the approval of the competent authority of the Member State

(‘hospital exemption approval’). Member States shall notify any such approval, as well as

subsequent changes thereto, to the Agency.

The application for a hospital exemption approval shall be submitted to the competent

authority of the Member State where the hospital is located.

3. Member States shall ensure that ATMPs prepared under hospital exemption comply with

requirements that are equivalent to the good manufacturing practice and the traceability

requirements for ATMPs referred to in Article 163 of this Directive and in Article 15 of

Regulation (EC) No 1394/2007 of the European Parliament and of the Council45

respectively, and with pharmacovigilance requirements that are equivalent to those

provided for at Union level pursuant to Regulation (EU) 2026/…+.

4. Member States shall ensure that data on the use, safety and efficacy of ATMPs prepared

under hospital exemption, as well as any relevant data specified in the implementing acts

referred to in paragraph 7, are collected and reported by the holder of the hospital

exemption approval to the competent authorities of the Member States at least annually.

The data shall be collected and reported in a structured and standardised way that ensures

robust, reliable and comparable results and conclusions.

45 Regulation (EC) No 1394/2007 of the European Parliament and of the Council

of 13 November 2007 on advanced therapy medicinal products and amending

Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 121,

ELI: http://data.europa.eu/eli/reg/2007/1394/oj). + OJ: please insert in the text the number of the Regulation in document ST 7105/26

(2023/0131(COD)).

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The competent authorities of the Member States shall review the data and shall verify the

compliance of the ATMPs prepared under hospital exemption with the requirements

referred to in paragraph 3.

Upon request, the competent authorities of the Member States or the Agency shall provide

scientific and regulatory advice to developers of ATMPs for preparation and use under

hospital exemption and to holders of a hospital exemption approval on the further

development of their ATMPs and, where appropriate, for the purpose of obtaining a

marketing authorisation granted by the Union.

5. If a hospital exemption approval is revoked due to safety or efficacy concerns the

competent authority of the Member State that approved the hospital exemption shall

inform the Agency. The Agency shall inform the competent authorities of the other

Member States.

6. The competent authority of the Member State that approved the hospital exemption shall

transmit the data related to the use, safety and efficacy of the ATMP prepared under

hospital exemption to the Agency annually. The Agency shall, in collaboration with the

competent authorities of Member States and the Commission, set up and maintain a

repository of those data, including a mechanism for electronic submission.

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7. The Commission shall adopt implementing acts to specify the following:

(a) details of the application for a hospital exemption approval referred to in

paragraph 2, second subparagraph, including the evidence on quality, safety and

efficacy of the ATMPs prepared under hospital exemption for the approval and the

subsequent changes;

(b) the content and format for the collection and reporting of data referred to in

paragraph 4;

(c) the practical arrangements for the exchange of knowledge between holders of a

hospital exemption approval within the same Member State or in different

Member States;

(d) modalities for the preparation and use of ATMPs under hospital exemption on a non-

routine basis.

Those implementing acts shall be adopted in accordance with the examination procedure

referred to in Article 217(2).

8. By … [five years from the date of entry into force of this Directive] and every five years

thereafter, the Agency shall submit a report to the Commission on the experience acquired

with hospital exemption approvals. The reports shall be prepared on the basis of

contributions from Member States and the data referred to in paragraph 4. The reports shall

be made publicly available.

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Article 4

Exemptions under certain circumstances

1. A Member State may, in order to meet special needs, exempt from the requirements of this

Directive medicinal products supplied in response to a bona fide unsolicited order or

anticipated bona fide unsolicited order, formulated or used in accordance with the

specifications of an authorised healthcare professional and intended to meet the special

needs of individual patients under the direct personal responsibility of that authorised

healthcare professional. However, in such cases, the Member State shall encourage

healthcare professionals and patients to report data on the safety of the use of such

medicinal products to the competent authority of that Member State in accordance

with Article 100.

For allergen medicinal products supplied in accordance with this paragraph, the competent

authority of the Member State may request the submission of relevant information in

accordance with Annex II.

2. In duly justified cases, where a Member State considers other measures are insufficient to

ensure the availability of specific medicinal products or suitable alternatives for patients in

that Member State, it may temporarily allow the preparation and supply of medicinal

products to:

(a) mitigate or resolve a shortage in that Member State;

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(b) address the specific needs of patients in that Member State in a situation where a

marketing authorisation for a medicinal product has been withdrawn at the request of

the marketing authorisation holder for reasons unrelated to the quality, safety or

efficacy of the medicinal product; or

(c) address the specific needs of patients in that Member State in a situation where there

is an authorised medicinal product in the Union but it does not have the specific

strength, pharmaceutical form or formulation needed to address those needs.

The exemptions referred to in this paragraph shall apply only to the extent necessary to

meet the specific needs of patients in the Member State concerned and only where:

(a) there is no suitable alternative medicinal product authorised in the Union; or

(b) such an alternative exists, but is not available within that Member State or cannot be

supplied in accordance with paragraph 1 of this Article.

In addition, for the purposes of the first subparagraph, point (a), the exemption shall apply

only if the shortage in that Member State cannot be resolved through Union coordinated

actions.

The Member State shall endeavour, to the extent possible, to address the shortage referred

to in the first subparagraph, point (a), by applying this Directive and Regulation

(EU) 2026/…+, before having recourse to this paragraph. Purely financial considerations

shall not constitute specific needs to justify the application of this paragraph.

+ OJ: please insert in the text the number of the Regulation in document ST 7105/26

(2023/0131(COD)).

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For medicinal products prepared and supplied in accordance with this paragraph, the

Member State shall ensure that:

(a) the preparation of the medicinal product is approved by the competent authority of

that Member State on the basis of an assessment of the case and on public health

grounds;

(b) in the case of a shortage referred to in the first subparagraph, point (a), the approval

under point (a) of this subparagraph is revoked when the shortage is resolved or the

medicinal product can be supplied in accordance with paragraph 1;

(c) in the cases other than shortages referred to in the first subparagraph, points (b)

and (c), the approval under point (a) of this subparagraph is limited in time, the

necessity for the exemption is assessed at appropriate intervals and the approval is

revoked without undue delay when a suitable medicinal product is authorised in the

Union and available within that Member State or if the medicinal product can be

supplied in accordance with paragraph 1;

(d) appropriate oversight by the competent authority of that Member State is in place and

in particular any issues with regards to the quality and safety of the medicinal

product are monitored and evaluated;

(e) the facility preparing the medicinal product complies with the principles of good

manufacturing practice referred to in Article 163;

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(f) the quality, safety and efficacy and the favourable benefit-risk balance of the

medicinal product is confirmed by the competent authority of that Member State;

(g) the medicinal product is supplied to patients under the supervision of an authorised

healthcare professional.

3. Member States may temporarily exempt from the requirements of this Directive medicinal

products manufactured and supplied exclusively to the armed forces for military or defence

purposes and prepared under the responsibility of the national authority for military or

defence matters on the basis of national monographs for the manufacture and quality

assessment of those medicinal products.

4. Without prejudice to Article 30 of Regulation (EU) 2026/…+, Member States may

temporarily authorise the use and distribution of an unauthorised medicinal product in

response to a suspected or confirmed spread of pathogenic agents, toxins, chemical agents

or nuclear radiation any of which could cause harm.

5. Member States shall ensure that, irrespective of whether a national marketing authorisation

or a centralised marketing authorisation has been granted, marketing authorisation holders,

manufacturers and healthcare professionals are not subject to civil or administrative

liability for any consequences resulting from the use of a medicinal product otherwise than

for the authorised therapeutic indications or from the use of an unauthorised medicinal

product, where such use is recommended or required by a competent authority of a

Member State in response to a suspected or confirmed spread of pathogenic agents, toxins,

chemical agents or nuclear radiation any of which could cause harm.

+ OJ: please insert in the text the number of the Regulation in document ST 7105/26

(2023/0131(COD)).

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6. Liability for defective products, as provided for by Directive (EU) 2024/2853 of the

European Parliament and of the Council46, shall not be affected by paragraph 5 of

this Article.

Article 5

Definitions

1. For the purposes of this Directive, the following definitions apply:

(1) ‘medicinal product’ or ‘medicinal product for human use’ means:

(a) any substance or combination of substances that is presented as having

properties for treating or preventing disease in human beings; or

(b) any substance or combination of substances that may be used in or

administered to human beings with a view to either restoring, correcting or

modifying physiological functions by exerting a pharmacological,

immunological or metabolic action, or to making a medical diagnosis;

(2) ‘substance’ means any matter irrespective of origin which may be:

(a) human, such as human tissues and cells, human blood, human secretions and

human blood products;

46 Directive (EU) 2024/2853 of the European Parliament and of the Council

of 23 October 2024 on liability for defective products and repealing Council Directive

85/374/EEC (OJ L, 2024/2853, 18.11.2024, ELI: http://data.europa.eu/eli/dir/2024/2853/oj).

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(b) animal, such as whole animals, animal organs and parts thereof, animal tissues

and cells, animal secretions, toxins, extracts, animal blood and animal blood

products;

(c) vegetal, such as plants, including algae, parts of plants, plant secretions and

exudates, and extracts;

(d) chemical, such as chemical elements, naturally occurring chemical materials

and chemical products obtained by chemical change or synthesis;

(e) micro-organisms, such as bacteria, viruses and protozoa;

(f) fungi, such as micro-fungi (yeast);

(3) ‘active substance’ means any substance or mixture of substances intended to be used

in the manufacture of a medicinal product and that, when used in its production,

becomes an active ingredient of that product intended to exert a pharmacological,

immunological or metabolic action with a view to restoring, correcting or modifying

physiological functions or to making a medical diagnosis;

(4) ‘starting material’ means any material from which an active substance is

manufactured or extracted;

(5) ‘intermediate product’ means any partly processed material which must undergo

further manufacturing steps before it becomes a bulk medicinal product or finished

medicinal product;

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(6) ‘excipient’ means any ingredient of a medicinal product other than the active

substance;

(7) ‘functional excipient’ means an excipient that contributes to or enhances the

performance of a medicinal product or performs an action that is ancillary to that of

the active substance but does not make any therapeutic contribution of its own;

(8) ‘advanced therapy medicinal product’ or ‘ATMP’ means an advanced

therapy medicinal product as defined in Article 2(1), point (a),

of Regulation (EC) No 1394/2007;

(9) ‘combined advanced therapy medicinal product’ or ‘combined ATMP’ means a

combined advanced therapy medicinal product as defined in Article 2(1), point (d),

of Regulation (EC) No 1394/2007, including when a gene therapy medicinal product

is part of the combined advanced therapy medicinal product;

(10) ‘allergen medicinal product’ means any medicinal product that is intended to identify

or induce a specific acquired alteration in the immunological response to an allergen;

(11) ‘non-clinical’, as regards a study or test, means a study or a test that is conducted

in vitro, ex vivo, in silico or in chemico, or a non-human in vivo test related to the

investigation of the safety and efficacy of a medicinal product, such as simple and

complex human cell-based assays, microphysiological systems including organ-on-

chip, computer modelling and other in silico methods, other non-human or human

biology-based test methods and animal-based tests;

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(12) ‘reference medicinal product’ means a medicinal product that is or has been

authorised by a Member State or by the Commission under Article 6, in accordance

with Article 7;

(13) ‘generic medicinal product’ means a medicinal product that has the same qualitative

and quantitative composition in active substances and the same pharmaceutical form

as the reference medicinal product;

(14) ‘biological medicinal product’ means a medicinal product, the active substance of

which is produced by or extracted from a biological source and which, due to its

complexity, its characterisation and the determination of its quality, may require a

combination of physico-chemical-biological testing, together with its control

strategy;

(15) ‘biosimilar medicinal product’ means a biological medicinal product that is similar to

a reference biological medicinal product and has the same strength, pharmaceutical

form and route of administration;

(16) ‘letter of access’ means an original document, signed by the owner of the data or the

owner’s representative, giving permission to the competent authority of the

Member State or the Agency, as applicable, or to the Commission to use the data for

the benefit of a third party for the purpose of this Directive;

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(17) ‘fixed-dose combination medicinal product’ means a medicinal product consisting of

a combination of active substances intended to be placed on the market as a single

pharmaceutical form;

(18) ‘multi-medicinal product package’ means a package that contains more than one

medicinal product under a single invented name and intended to be used in a medical

treatment where the individual medicinal products in the package are administered

simultaneously or sequentially for medical purposes;

(19) ‘radiopharmaceutical’ means any medicinal product that, when ready for use,

contains one or more radionuclides (radioactive isotopes) included for a medicinal

purpose;

(20) ‘radionuclide generator’ means any system incorporating a fixed parent radionuclide

from which is produced a daughter radionuclide which is to be obtained by elution or

by any other method and used in a radiopharmaceutical;

(21) ‘kit for radiopharmaceutical preparation’ means any preparation to be reconstituted

or combined with radionuclides in the final radiopharmaceutical, usually prior to its

administration;

(22) ‘radionuclide precursor’ means any radionuclide produced for the radio-labelling of

another substance prior to administration;

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(23) ‘antimicrobial’ means any medicinal product with a direct action on micro-organisms

used for treatment or prevention of infections or infectious diseases, including

antibiotics, antivirals, antifungals and antiprotozoals;

(24) ‘antimicrobial resistance’ means the ability of a micro-organism to survive or to

grow in the presence of a concentration of an antimicrobial agent that is usually or

was previously sufficient to inhibit the growth of or to kill that micro-organism;

(25) ‘integral combination of a medicinal product with a medical device’ means a

combination of a medicinal product with a medical device and where:

(a) the two form an integral product and the action of the medicinal product is

principal and not ancillary to that of the medical device; or

(b) the medicinal product is intended to be administered by the medical device and

the two are placed on the market in such a way that they form a single integral

product that is intended exclusively for use in the given combination and where

the medical device is not reusable;

(26) ‘medicinal product in exclusive use with a medical device or with an in vitro

diagnostic medical device’ means a medicinal product presented in a package with a

medical device or intended for use with a specific medical device or with an in vitro

diagnostic medical device, and referenced in the summary of product characteristics;

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(27) ‘combination of a medicinal product with a product other than a medical device’

means a specific combination of a medicinal product with a product other than a

medical device or than an in vitro diagnostic medical device, intended for use in that

combination in accordance with the summary of product characteristics;

(28) ‘medical device’ means a medical device as defined in Article 2, point (1),

of Regulation (EU) 2017/745;

(29) ‘in vitro diagnostic medical device’ means an in vitro diagnostic medical device as

defined in Article 2, point (2), of Regulation (EU) 2017/746;

(30) ‘immunological medicinal product’ means:

(a) a vaccine, allergen medicinal product or other medicinal product eliciting an

active and specific immune response;

(b) a medicinal product consisting of toxins, serums, polyclonal or monoclonal

antibodies or other immunoglobulins and used to produce passive immunity or

to diagnose the state of immunity;

(31) ‘vaccine’ means a medicinal product that is intended to elicit an immune response for

the prevention, including post-exposure prophylaxis, and treatment of diseases

caused by an infectious agent;

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(32) ‘gene therapy medicinal product’ means a medicinal product, other than a vaccine

against infectious diseases, that contains or consists of:

(a) a substance or combination of substances intended to edit the host genome in a

sequence-specific manner or that contains or consists of cells that have been

subjected to such modification; or

(b) a recombinant or synthetic nucleic acid used in or administered to human

beings with a view to regulating, replacing or adding a genetic sequence that

mediates its effect by the long-lasting transcription or translation of the

transferred genetic materials, or that contains or consists of cells that have been

subjected to such modifications;

(33) ‘somatic cell therapy medicinal product’ means a biological medicinal product that

has the following characteristics:

(a) contains or consists of cells or tissues that have been subjected to substantial

manipulation so that biological characteristics, physiological functions or

structural properties relevant for the intended clinical use have been altered, or

of cells or tissues that are not intended to be used for the same essential

function(s) in the recipient and the donor;

(b) is presented as having properties for, or is used in or administered to, human

beings with a view to treating, preventing or diagnosing a disease through the

pharmacological, immunological or metabolic action of its cells or tissues.

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For the purposes of point (a), the manipulations listed in Annex I to Regulation

(EC) No 1394/2007, in particular, shall not be considered as substantial

manipulations.

(34) ‘platform technology’ means a technology or collection of technologies that has the

potential to be incorporated in, or used by, more than one medicinal product, that is

comprehensive, well-characterised, reproducible and standardised, that is used for

the development, the manufacturing process or quality control of medicinal products,

that relies on prior knowledge and that is established in accordance with scientific

principles for which there is reasonable scientific certainty that they will remain

unchanged across medicinal products;

(35) ‘platform technology master file’ means a document, prepared by the owner of the

platform technology, that contains a detailed description of the platform technology;

(36) ‘SoHO-derived medicinal product other than ATMPs’ means any medicinal product

containing, consisting of or deriving from a substance of human origin, other than

tissues and cells, that is of standardised consistency and is prepared by:

(a) a method involving an industrial process which includes pooling of donations;

or

(b) a process that extracts an active ingredient from the substance of human origin

or transforms the substance of human origin by changing its inherent

properties;

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(37) ‘substance of human origin’ or ‘SoHO’ means a substance of human origin as

defined in Article 3, point (1), of Regulation (EU) 2024/1938;

(38) ‘risk management plan’ means a detailed description of the risk management system;

(39) ‘risk management system’ means a set of pharmacovigilance activities and

interventions designed to identify, characterise, prevent or minimise risks relating to

a medicinal product, including the assessment of the effectiveness of those activities

and interventions;

(40) ‘environmental risk assessment’ or ‘ERA’ means the evaluation of the risks to the

environment or risks to public health, posed by the release of the medicinal product

into the environment following the use and disposal of the medicinal product, and the

identification of risk prevention, limitation and mitigation measures, and for

antimicrobials, an evaluation also of the risk for antimicrobial resistance selection in

the environment due to the manufacture, use and disposal of that medicinal product;

(41) ‘risks related to use of the medicinal product’ means any risk:

(a) relating to the quality, safety or efficacy of the medicinal product as regards

patients’ health or public health;

(b) of undesirable effects on the environment posed by the medicinal product;

(c) of undesirable effects on public health due to the release of the medicinal

product into the environment, including antimicrobial resistance;

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(42) ‘active substance master file’ means documentation prepared by the manufacturer of

the active substance that contains particulars and documents on the quality of an

active substance, including a detailed description of the manufacturing process,

quality control during manufacture and process validation;

(43) ‘paediatric investigation plan’ means a research and development programme aimed

at ensuring that the necessary data are generated to determine the conditions under

which a medicinal product may be authorised to treat the paediatric population;

(44) ‘paediatric population’ means that part of the population from birth up to 18 years of

age;

(45) ‘medical prescription’ means any medicinal prescription that is issued by a

professional person qualified to do so;

(46) ‘abuse of medicinal products’ means the intentional excessive use of medicinal

products, whether persistent or sporadic, that is accompanied by harmful physical or

psychological effects;

(47) ‘benefit-risk balance’ means an evaluation of the positive therapeutic effects of a

medicinal product in relation to the risks referred to in point (41)(a);

(48) ‘marketing authorisation holder representative’ means the person, commonly known

as the local representative, designated by the marketing authorisation holder to

represent the marketing authorisation holder in the Member State concerned;

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(49) ‘package leaflet’ means a leaflet containing information that is intended for the user

and that accompanies the medicinal product;

(50) ‘outer packaging’ means the packaging into which the immediate packaging is

placed;

(51) ‘immediate packaging’ means the container or other form of packaging that is in

direct contact with the medicinal product;

(52) ‘labelling’ means information on the immediate packaging or on the outer packaging;

(53) ‘name of the medicinal product’ means:

(a) an invented name, that is not liable to be confused with the common name, or

(b) a common name or scientific name accompanied by a trademark or by the

name of the marketing authorisation holder;

(54) ‘common name’ means the international non-proprietary name recommended by the

World Health Organization for an active substance;

(55) ‘strength’, as regards a medicinal product, means the content of the active substances

in a medicinal product, expressed quantitatively per dosage unit, per unit of volume

or per unit of weight according to the dosage form;

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(56) ‘falsified medicinal product’ means any medicinal product with a false representation

of:

(a) its identity, including its packaging and labelling, its name or its composition

as regards any of the ingredients including excipients or the strength of those

ingredients;

(b) its source, including its manufacturer, its country of manufacturing, its country

of origin or its marketing authorisation holder; or

(c) its history, including the records and documents relating to the distribution

channels used;

This definition does not include unintentional quality defects and is without prejudice

to infringements of intellectual property rights.

(57) ‘public health emergency’ means a public health emergency recognised at Union

level by the Commission under Article 23(1) of Regulation (EU) 2022/2371;

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(58) ‘not-for-profit entity’ means a natural or legal person that does not make or intend to

make profits or that is not controlled directly or indirectly by any entity that is

profit-making, and that has not concluded any agreement with such an entity

concerning sponsorship of or participation in the development of the medicinal

product and in the case of a legal person, that is not owned by such an entity;

‘entities not engaged in an economic activity’ referred to in Annex V to Regulation

(EU) 2024/568 of the European Parliament and of the Council47 shall be considered

to be not-for-profit entities;

(59) ‘micro, small and medium-sized enterprises’ means micro, small and medium-sized

enterprises as defined in Article 2 of the Annex to Commission

Recommendation 2003/361/EC48;

(60) ‘variation’ or ‘variation of the terms of a marketing authorisation’ means:

(a) any amendment to the contents of the particulars and documents referred to in

Article 7(2), Articles 10 to 15 or Article 65 of this Directive, in Annexes I

and II thereto and in Article 7 of Regulation (EU) 2026/…+; or

47 Regulation (EU) 2024/568 of the European Parliament and of the Council

of 7 February 2024 on fees and charges payable to the European Medicines Agency,

amending Regulations (EU) 2017/745 and (EU) 2022/123 of the European Parliament and

of the Council and repealing Regulation (EU) No 658/2014 of the European Parliament and

of the Council and Council Regulation (EC) No 297/95 (OJ L, 2024/568,

14.2.2024, ELI: http://data.europa.eu/eli/reg/2024/568/oj). 48 Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of

micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36,

ELI: http://data.europa.eu/eli/reco/2003/361/oj). + OJ: please insert in the text the number of the Regulation in document ST 7105/26

(2023/0131(COD)).

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(b) any amendment to the terms of the decision granting the marketing

authorisation for a medicinal product, including the summary of product

characteristics and any conditions, obligations or restrictions affecting the

marketing authorisation, or changes to the labelling or the package leaflet

related to changes to the summary of product characteristics;

(61) ‘post-authorisation safety study’ means any study relating to an authorised medicinal

product conducted with the aim of identifying, characterising or quantifying a safety

hazard, confirming the safety profile of the medicinal product, or of measuring the

effectiveness of risk management measures;

(62) ‘pharmacovigilance system’ means a system used by the marketing authorisation

holder or by Member States to fulfil the tasks and responsibilities set out in

Chapter IX and designed to monitor the safety of authorised medicinal products and

detect any change to their benefit-risk balance;

(63) ‘pharmacovigilance system master file’ means a detailed description of the

pharmacovigilance system used by the marketing authorisation holder with respect to

one or more authorised medicinal products;

(64) ‘adverse reaction’ means a response to a medicinal product that is noxious and

unintended;

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(65) ‘serious adverse reaction’ means an adverse reaction that results in death, is

life­threatening, requires inpatient hospitalisation or prolongation of existing

hospitalisation, results in persistent or significant disability or incapacity, or is a

congenital anomaly or a birth defect;

(66) ‘unexpected adverse reaction’ means an adverse reaction, the nature, severity or

outcome of which is not consistent with the summary of product characteristics;

(67) ‘homeopathic medicinal product’ means a medicinal product prepared from

homeopathic stocks in accordance with a homeopathic manufacturing procedure

described by the European Pharmacopoeia or, in the absence thereof, by the

pharmacopoeias currently used officially in the Member States;

(68) ‘traditional herbal medicinal product’ means a herbal medicinal product that fulfils

the conditions laid down in Article 138(1);

(69) ‘herbal medicinal product’ means any medicinal product, exclusively containing as

active ingredients one or more herbal substances or one or more herbal preparations,

or one or more such herbal substances in combination with one or more herbal

preparations;

(70) ‘herbal substances’ means all mainly whole, fragmented or cut plants, plant parts,

algae, fungi, lichen in an unprocessed, usually dried or fresh form, and certain

exudates that have not been subjected to a specific treatment; they are precisely

defined by the plant part used and the botanical name according to the binomial

system (genus, species, variety and author);

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(71) ‘herbal preparations’ means preparations obtained by subjecting herbal substances to

treatments such as extraction, distillation, expression, fractionation, purification,

concentration or fermentation, including comminuted or powdered herbal substances,

tinctures, extracts, essential oils, expressed juices and processed exudates;

(72) ‘corresponding product’ means a product with the same active substances,

irrespective of the excipients used, the same or similar intended purpose, equivalent

strength and posology and the same or similar route of administration as the

traditional herbal medicinal product in respect of which a traditional-use registration

has been applied for;

(73) ‘manufacture of medicinal products’ means any operation involved in producing a

medicinal product from active substances and excipients, and any related operation,

including processing, filling, sterilisation and assembly, labelling, immediate

packaging, and outer packaging operations, and repackaging, storage, quality control

testing and release;

(74) ‘decentralised manufacturing’ means a set of manufacturing activities related to

medicinal products that are carried out under the control of a central site which

supervises one or more decentralised sites where manufacturing activities take place

and that are located in sufficient proximity to patients;

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(75) ‘manufacture of active substances’ means any operation involved in producing an

active substance from starting materials and any related operation, including

processing, packaging and labelling operations, and repackaging, storage, quality

control testing and release;

(76) ‘wholesale distribution’, as regards medicinal products, means all activities

consisting of procuring, holding, supplying or exporting medicinal products, whether

for profit or not, apart from supplying medicinal products to the public; such

activities are carried out with manufacturers or their depositories, importers, other

wholesale distributors or with pharmacists and other persons authorised or entitled to

supply medicinal products to the public in the Member State concerned;

(77) ‘brokering of medicinal products’ means all activities in relation to the sale or

purchase of medicinal products, except for wholesale distribution, that do not include

physical handling and that consist of negotiating independently and on behalf of

another legal or natural person;

(78) ‘public service obligation’ means an obligation to ensure on a permanent basis an

adequate range of medicinal products to meet the requirements of a specific

geographical area and to deliver the supplies requested within a very short time over

the whole of the area in question.

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2. The Commission is empowered to adopt delegated acts in accordance with Article 218 to

amend the definitions in paragraph 1, points (2) to (7), (9), (10), (14), (17) to (23), (25),

(26), (27) and (30) to (36), to take account of technical and scientific progress and taking

into account definitions agreed at Union and international level without amending the

scope of the definitions.

Chapter II

Application requirements for national

and centralised marketing authorisations

SECTION 1

GENERAL PROVISIONS

Article 6

Marketing authorisations

1. A medicinal product shall be placed on the market of a Member State only where a

marketing authorisation has been granted in accordance with Chapter III of this Directive

(‘national marketing authorisation’) or in accordance with Regulation (EU) 2026/…+

(‘centralised marketing authorisation’).

+ OJ: please insert in the text the number of the Regulation in document ST 7105/26

(2023/0131(COD)).

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2. Where an initial marketing authorisation has been granted for a medicinal product, any

development of that medicinal product, such as additional therapeutic indications,

strengths, pharmaceutical forms, administration routes, presentations, as well as any

variations of the marketing authorisation, shall be included in the initial marketing

authorisation or covered by a separate marketing authorisation as referred to in

paragraph 1. All those marketing authorisations shall be considered as belonging to the

same global marketing authorisation, in particular for the purpose of marketing

authorisation applications under Articles 10 to 13, including as regards the expiry of the

regulatory data protection period for applications using a reference medicinal product.

Article 7

General requirements for marketing authorisation applications

1. In order to obtain a marketing authorisation, an electronic marketing authorisation

application shall be submitted to the competent authority of the Member State or the

Agency, as applicable, in a common format. The Agency shall make the common format

available after consultation with the Member States.

2. The marketing authorisation application shall include the particulars and documents listed

in Annex I in accordance with Annex II. Where appropriate, the marketing authorisation

application may include summary documents, certificates, protocols or master files in

accordance with section 4 of this Chapter and with Annex II.

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3. The documents and information concerning the results of the pharmaceutical and non-

clinical tests and the clinical studies referred to in Annex I shall be accompanied by

detailed summaries in accordance with Article 8 of this Directive and supportive raw data

in accordance with Article 32(1), point (e), of this Directive or Article 7

of Regulation (EU) 2026/…+.

4. The risk management system referred to in Annex I shall be proportionate to the identified

risks and the potential risks of the medicinal product, and the need for post-authorisation

safety data.

5. The marketing authorisation application for a medicinal product that is not authorised in

the Union at the time of entry into force of this Directive and for new therapeutic

indications, including paediatric indications, new pharmaceutical forms, new strengths and

new routes of administration of authorised medicinal products which are protected either

by a supplementary protection certificate under Regulation (EC) No 469/2009, or by a

patent which qualifies for the granting of a supplementary protection certificate, shall

include one of the following:

(a) the results of all studies conducted and details of all information collected in

compliance with an agreed paediatric investigation plan;

(b) a decision of the Agency granting a class or product-specific waiver pursuant to

Article 77 of Regulation (EU) 2026/…+;

+ OJ: please insert in the text the number of the Regulation in document ST 7105/26

(2023/0131(COD)).

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(c) a decision of the Agency granting a deferral pursuant to Article 83

of Regulation (EU) 2026/…+;

(d) a decision of the Agency taken in consultation with the Commission pursuant to

Article 85 of Regulation (EU) 2026/…+ to temporarily derogate from the provisions

referred to in points (a) to (d) of this subparagraph in the case of public health

emergencies.

The documents under the first subparagraph, points (a) to (d), shall, cumulatively, cover all

subsets of the paediatric population.

6. Paragraph 5 of this Article shall not apply to medicinal products authorised under

Articles 10, 12, 14 and 129 to 145 and medicinal products authorised under Articles 11

and 13 which are not protected either by a supplementary protection certificate under

Regulation (EC) No 469/2009, or by a patent which qualifies for the granting of a

supplementary protection certificate.

7. The marketing authorisation applicant shall demonstrate that the principle of replacement,

reduction and refinement of animal testing for scientific purposes has been applied in

accordance with Directive 2010/63/EU with regard to any animal study conducted in

support of the application.

+ OJ: please insert in the text the number of the Regulation in document ST 7105/26

(2023/0131(COD)).

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The marketing authorisation applicant shall not carry out animal testing in case

scientifically satisfactory non-animal testing methods are available. Where scientifically

satisfactory non-animal testing methods are not available, animal testing shall be carried

out in accordance with Directive 2010/63/EU.

Article 8

Expert verification

1. The marketing authorisation applicant shall ensure that the detailed summaries referred to

in Article 7(3) have been drawn up and signed by experts with the necessary technical or

professional qualifications before they are submitted to the competent authorities of the

Member State or the Agency, as applicable. The technical or professional qualifications of

the experts shall be set out in a brief curriculum vitae.

2. The experts referred to in paragraph 1 of this Article shall justify any use made of scientific

literature under Article 14 in accordance with the requirements set out in Annex II.

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Article 9

Medicinal products manufactured outside the Union

Member States shall take all appropriate measures to ensure that:

(a) their competent authorities or the Agency, as applicable, verify that manufacturers and

importers of medicinal products coming from third countries are able to carry out

manufacture of medicinal products in compliance with the particulars supplied pursuant to

Annex I and carry out controls according to the methods described in the particulars

accompanying the application in accordance with Annex I;

(b) their competent authorities or the Agency, as applicable, may allow manufacturers and

importers of medicinal products coming from third countries, in justifiable cases, to have

certain stages of manufacture or certain of the controls referred to in point (a) carried out

by third parties; in such cases, the verifications by the competent authorities shall also be

made in the establishment designated.

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SECTION 2

SPECIFIC REQUIREMENTS FOR ABRIDGED, BIBLIOGRAPHIC OR CONSENT BASED

MARKETING AUTHORISATION APPLICATIONS

Article 10

Marketing authorisation applications concerning generic medicinal products

1. By way of derogation from Article 7(2), the applicant for a marketing authorisation for a

generic medicinal product shall not be required to provide to the competent authorities of

the Member States or the Agency, as applicable, the results of non-clinical tests and of

clinical studies if equivalence of the generic medicinal product with the reference

medicinal product is demonstrated.

2. For the purpose of demonstrating the equivalence of a generic medicinal product as

referred to in paragraph 1, the marketing authorisation applicant shall:

(a) submit equivalence studies to the competent authorities of the Member States or the

Agency, as applicable, or provide a justification as to why such studies were not

performed, and

(b) demonstrate that the generic medicinal product meets the relevant criteria set out in

the relevant detailed guidelines.

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3. Paragraph 1 shall also apply if the reference medicinal product has not been authorised in

the Member State in which the marketing authorisation application for the generic

medicinal product is submitted. In this case, the marketing authorisation applicant shall

indicate in the marketing authorisation application for the generic medicinal product the

name of the Member State in which the reference medicinal product is or has been

authorised.

At the request of the competent authority of the Member State in which the marketing

authorisation application for the generic medicinal product is submitted, the competent

authority of the other Member State shall transmit within a period of one month a

confirmation that the reference medicinal product is or has been authorised together with

the full composition of the reference medicinal product and, if necessary, any other

relevant documentation.

The various immediate-release oral pharmaceutical forms shall be considered to be the

same pharmaceutical form.

4. The different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of

an active substance shall be considered to be the same active substance, unless they differ

significantly in properties with regard to safety or efficacy. The marketing authorisation

applicant for the generic medicinal product shall submit additional information to

demonstrate that the different salts, esters, ethers, isomers, mixtures of isomers, complexes

or derivatives of an active substance do not differ significantly in respect of those

properties.

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5. Where there is a significant difference in properties as referred to in paragraph 4, the

applicant shall submit additional information in order to demonstrate the safety or efficacy

of the different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives

of the authorised active substance of the reference medicinal product in a marketing

authorisation application under Article 11.

Article 11

Marketing authorisation applications for hybrid medicinal products

In case of a marketing authorisation application for a medicinal product which does not fall within

the definition of a generic medicinal product or differs in strength, pharmaceutical form, route of

administration or therapeutic indications compared to the reference medicinal product (‘hybrid

medicinal product’), the results of the relevant non-clinical tests or clinical studies shall be provided

to the competent authorities of the Member States or the Agency, as applicable, to the extent

necessary to establish a scientific bridge to the data relied upon in the marketing authorisation for

the reference medicinal product, and to demonstrate the safety and efficacy profile of the hybrid

medicinal product.

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Article 12

Marketing authorisation applications for biosimilar medicinal products

For a biosimilar medicinal product, the results of appropriate comparability tests and studies shall

be provided to the competent authorities of the Member States or the Agency, as applicable. The

type and quantity of supplementary data to be provided shall comply with the relevant criteria set

out in Annex II and the related detailed guidelines. The results of other tests and studies from the

reference medicinal product’s dossier shall not be required.

Article 13

Marketing authorisation applications for bio-hybrid medicinal products

In cases where the biological medicinal product does not fall within the definition of a biosimilar

medicinal product or differs in strength, pharmaceutical form, route of administration or therapeutic

indications compared to the reference biological medicinal product (‘bio-hybrid medicinal

product’), the results of the appropriate non-clinical tests or clinical studies shall be provided to the

competent authorities of the Member States or the Agency, as applicable, to the extent necessary to

establish a scientific bridge to the data relied upon in the marketing authorisation for the reference

biological medicinal product, and to demonstrate the safety and efficacy profile of the bio-hybrid

medicinal product.

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Article 14

Marketing authorisation applications based on bibliographic data

The marketing authorisation applicant shall, by way of derogation from Article 7(2), not be required

to provide the results of non-clinical tests or clinical studies if the marketing authorisation applicant

can demonstrate that the active substances of the medicinal product have been in well-established

medicinal use within the Union for the same therapeutic use and route of administration for at least

ten years, with recognised efficacy and an acceptable level of safety in terms of the conditions set

out in Annex II. In such cases, the test and trial results shall be replaced by appropriate

bibliographic data in the form of scientific literature, and the marketing authorisation applicant shall

establish a scientific bridge between the bibliographic data and the medicinal product concerned.

Marketing authorisation applications based on this Article shall only be submitted provided that the

marketing authorisation applicant demonstrates that:

(a) at the time of submission of the marketing authorisation application, no reference

medicinal product is or has been authorised in the Union for the active substance of the

medicinal product concerned;

(b) while a reference medicinal product has been authorised in the Union for the active

substance of the medicinal product concerned, it is not available on the market within the

Union at the time of submission of the marketing authorisation application; or

(c) the marketing authorisation application concerns a herbal medicinal product for which

efficacy and safety have been established and documented in a relevant Union herbal

monograph.

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Article 15

Marketing authorisation applications based on consent

Following the granting of a marketing authorisation, the marketing authorisation holder may, by

letter of access, allow use to be made of all documentation referred to in Article 7(2) for the purpose

of examining marketing authorisation applications relating to other medicinal products with the

same qualitative and quantitative composition in terms of active substances and the same

pharmaceutical form.

SECTION 3

SPECIFIC REQUIREMENTS FOR MARKETING AUTHORISATION APPLICATIONS

FOR CERTAIN CATEGORIES OF MEDICINAL PRODUCTS

Article 16

Fixed-dose combination medicinal products, platform marketing authorisation

and multi-medicinal product packages

1. Where duly justified for clinical purposes, a marketing authorisation may be granted for a

fixed-dose combination medicinal product.

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2. Where duly justified for clinical purposes, a marketing authorisation may be granted for a

medicinal product comprised of a fixed component and a variable component that is

pre­defined in order to, where appropriate, target different variants of an infectious agent

or, where necessary, to tailor the medicinal product to characteristics of an individual

patient or a group of patients (‘platform marketing authorisation’).

Before submitting a marketing authorisation application for such a medicinal product, the

applicant shall obtain the agreement of the competent authority of the Member State or the

Agency, as applicable, for the submission of the application.

3. Where justified for public health reasons, a marketing authorisation may be granted, in

exceptional circumstances, for a multi-medicinal product package where the active

substances cannot be combined within a fixed- dose combination medicinal product.

Before submitting a marketing authorisation application for such a multi-medicinal product

package, the applicant shall obtain the agreement of the competent authority of the

Member State or the Agency, as applicable, for the submission of the application.

Article 17

Radiopharmaceuticals

1. A marketing authorisation shall be required for radionuclide generators, kits for

radiopharmaceutical preparations, and radionuclide precursors, unless they are used as

starting materials, active substances or intermediates of radiopharmaceuticals covered by a

marketing authorisation under Article 6(1).

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2. A marketing authorisation shall not be required for a radiopharmaceutical that is prepared

at the time of use by a person or by an establishment that is authorised, in accordance with

national legislation, to use such radiopharmaceutical in an approved healthcare

establishment, and that is prepared exclusively from authorised radionuclide generators,

kits for radiopharmaceutical preparations or radionuclide precursors in accordance with the

summary of product characteristics.

Article 18

Antimicrobials

1. Where the marketing authorisation application concerns an antimicrobial, the application

shall, in addition to the information referred to in Article 7(2), contain the following in

accordance with Annex I:

(a) an antimicrobial stewardship plan;

(b) a description of the special information requirements outlined in Article 72.

2. The competent authority of the Member State or the Agency, as applicable, shall review

the information submitted in accordance with paragraph 1. The competent authority of the

Member State or the Agency, as applicable, shall impose obligations on the marketing

authorisation holder if it finds the risk mitigation measures contained in the antimicrobial

stewardship plan to be unsatisfactory.

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3. Where a pack of antimicrobials is intended for direct dispensing to patients, the marketing

authorisation holder shall ensure that the pack size of the antimicrobials corresponds to the

usual posology and duration of treatment.

Article 19

Integral combinations of a medicinal product with a medical device

1. For integral combinations of a medicinal product with a medical device, the marketing

authorisation applicant shall submit data demonstrating the safe and effective use of the

integral combination of the medicinal product with the medical device.

The competent authority of the Member State or the Agency, as applicable, shall assess the

benefit-risk balance of the integral combination of a medicinal product with a medical

device, taking into account the suitability of the use of the medicinal product together with

the medical device.

2. The relevant general safety and performance requirements set out in Annex I to Regulation

(EU) 2017/745 shall apply as far as the safety and performance of the medical device that

is part of the integral combination of a medicinal product with a medical device are

concerned.

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3. The marketing authorisation application for the integral combination of a medicinal

product with a medical device shall include documentation in accordance with Annex II to

this Directive, demonstrating the conformity of the medical device that is part of the

integral combination of a medicinal product with a medical device with the general safety

and performance requirements set out in Annex I to Regulation (EU) 2017/745

(‘conformity assessment’), including the results of the conformity assessment or, where

relevant, an opinion on the conformity of that medical device with the general safety and

performance requirements set out in Annex I to Regulation (EU) 2017/745 by a notified

body.

4. In its assessment of the integral combination of a medicinal product with a medical device,

the competent authority of the Member State or the Agency, as applicable, shall recognise

the results of the conformity assessment, including, where relevant, the results of the

assessment by a notified body.

5. The marketing authorisation applicant shall, upon request from the competent authority of

the Member State or the Agency, as applicable, submit any additional information related

to the medical device and that is relevant for the benefit-risk balance assessment of the

integral combination of a medicinal product with a medical device.

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Article 20

Medicinal products in exclusive use with a medical device

or with an in vitro diagnostic medical device

1. For medicinal products in exclusive use with a medical device or with an in vitro

diagnostic medical device, the marketing authorisation applicant shall submit data

demonstrating the safe and effective use of the medicinal product taking into account its

use with the medical device or with the in vitro diagnostic medical device.

The competent authorities of the Member States or the Agency, as applicable, shall assess

the benefit-risk balance of the medicinal product taking into account the use of the

medicinal product together with the medical device or in vitro diagnostic medical device.

2. For medicinal products in exclusive use with a medical device or with an in vitro

diagnostic medical device, the medical device or in vitro diagnostic medical device shall

meet the requirements set out in Regulation (EU) 2017/745 or (EU) 2017/746, as

applicable.

3. The marketing authorisation application for a medicinal product in exclusive use with a

medical device or with an in vitro diagnostic medical device shall include documentation

in accordance with Annex II demonstrating the conformity of the medical device or in vitro

diagnostic medical device with the general safety and performance requirements including,

where relevant, the results of the assessment or the conformity assessment report by a

notified body.

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4. In its assessment of the medicinal product in exclusive use with a medical device or with

an in vitro diagnostic medical device, the competent authorities of the Member States or

the Agency, as applicable, shall recognise the results of the assessment of the conformity

of the medical device or in-vitro diagnostic medical device concerned with the general

safety and performance requirements set out in Annex I to Regulation (EU) 2017/745 or

Annex I to Regulation (EU) 2017/746, as applicable, including, where relevant, the results

of the assessment by a notified body.

5. The marketing authorisation applicant shall, upon request from the competent authorities

of the Member States or the Agency, as applicable, submit any additional information

related to the medical device or in vitro diagnostic medical device and that is relevant for

the benefit-risk balance assessment of the medicinal product in exclusive use with a

medical device or with an in vitro diagnostic medical device, taking into account the use of

the medicinal product with the medical device or in vitro diagnostic medical device.

6. If the action of the medicinal product is not ancillary to that of the medical device or

in vitro diagnostic medical device, the medicinal product shall comply with the

requirements of this Directive and of Regulation (EU) 2026/…+, taking into account its use

with the medical device or in vitro diagnostic medical device, without prejudice to the

specific requirements of Regulation (EU) 2017/745 or (EU) 2017/746, as applicable.

+ OJ: please insert in the text the number of the Regulation in document ST 7105/26

(2023/0131(COD)).

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For the purposes of this paragraph, the marketing authorisation applicant shall, upon

request from the competent authorities of the Member States or the Agency, as applicable,

submit any additional information related to the medical device or in vitro diagnostic

medical device, taking into account its use with the medicinal product, and that is relevant

for the post-authorisation monitoring of the medicinal product, without prejudice to the

specific requirements of Regulation (EU) 2026/…+.

Article 21

Combinations of medicinal products with products other than medical devices

1. For combinations of a medicinal product with a product other than a medical device, the

marketing authorisation applicant shall submit data demonstrating the safe and effective

use of the combination of the medicinal product and the other product.

The competent authority of the Member State or the Agency, as applicable, shall assess the

benefit-risk balance of the combination of a medicinal product with a product other than a

medical device, taking into account the use of the medicinal product together with the

other product.

2. The marketing authorisation applicant shall, upon request from the competent authority of

the Member State or the Agency, as applicable, submit any additional information related

to the product other than a medical device and that is relevant for the benefit-risk balance

assessment of the combination of a medicinal product with a product other than a medical

device, taking into account the suitability of the use of the medicinal product with the other

product.

+ OJ: please insert in the text the number of the Regulation in document ST 7105/26

(2023/0131(COD)).

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3. The competent authority of the Member State or the Agency, as applicable, may request an

opinion from the authority responsible for the supervision of the product other than a

medical device.

SECTION 4

SPECIFIC DOSSIER REQUIREMENTS

Article 22

Risk management plan

1. The applicant of a marketing authorisation for a medicinal product referred to in

Articles 10 and 12 shall not be required to submit a risk management plan and a summary

thereof, provided that no additional risk minimisation measures exist for the reference

medicinal product and provided that the marketing authorisation for the reference

medicinal product has not been withdrawn prior to the submission of the marketing

authorisation application.

2. The risk management plan for medicinal products referred to in Articles 11 and 13 shall be

limited to the differences between those medicinal products and the reference medicinal

product, provided that no additional risk minimisation measures exist for the reference

medicinal product and provided that the marketing authorisation for the reference

medicinal product has not been withdrawn prior to the submission of the marketing

authorisation application.

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Article 23

ERA and other environmental information

1. When preparing the ERA to be submitted pursuant to Article 7(2), the marketing

authorisation applicant shall take into account the scientific guidelines on the ERA for

medicinal products for human use as referred to in paragraph 5 of this Article or provide

duly justified reasons for any divergence from the scientific guidelines to the competent

authority of the Member State or the Agency, as applicable, in a timely manner. Where

available, the marketing authorisation applicant shall take into account existing risk

assessments performed under other Union legal acts.

2. The ERA shall indicate whether the medicinal product or any of its ingredients or other

constituents is an endocrine active agent or has been assigned to one of the following

hazard classes in accordance with the criteria set out in Annex I to Regulation

(EC) No 1272/2008 of the European Parliament and of the Council49:

(a) persistent, bioaccumulative and toxic (PBT);

(b) very persistent and very bioaccumulative (vPvB);

(c) persistent, mobile and toxic (PMT);

(d) very persistent and very mobile (vPvM).

49 Regulation (EC) No 1272/2008 of the European Parliament and of the Council

of 16 December 2008 on classification, labelling and packaging of substances and mixtures,

amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation

(EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1,

ELI: http://data.europa.eu/eli/reg/2008/1272/oj).

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3. The applicant shall include in the ERA risk mitigation measures to avoid or, where it is not

possible, limit emissions to air, water and soil of ingredients and constituents of medicinal

products listed as pollutants in Directives 2000/60/EC, 2006/118/EC, 2008/105/EC

and 2010/75/EU. The applicant shall provide a detailed explanation as to how the proposed

risk mitigation measures are appropriate and sufficient to address the identified risks to the

environment.

4. The ERA for antimicrobials shall include an evaluation of the risk for antimicrobial

resistance selection in the environment due to the entire manufacturing supply chain inside

and outside the Union, use and disposal, including by healthcare professionals and patients,

of the antimicrobial taking into account, where relevant, the existing international

standards that have established predicted no effect concentrations (PNECs) specific for

antibiotics.

5. The Agency shall draw up scientific guidelines in accordance with Article 144(1),

point (zm), of Regulation (EU) 2026/…+, to specify technical details regarding the ERA

requirements for medicinal products for human use, including for antimicrobials other than

antibiotics. Where appropriate, the Agency shall consult the European Chemical Agency

(ECHA), the European Food Safety Authority (EFSA), the European Environmental

Agency (EEA) and the European Centre for Disease Prevention and Control (ECDC) on

the drafting of these scientific guidelines.

+ OJ: please insert in the text the number of the Regulation in document ST 7105/26

(2023/0131(COD)).

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6. If new information pertaining to the assessment criteria of an ERA becomes available and

could lead to a change to its conclusions, the marketing authorisation holder shall submit

an updated ERA without undue delay to the competent authority of the Member State or

the Agency, as applicable. The updated ERA shall include any relevant information from

environmental monitoring, including monitoring under Directive 2000/60/EC, from eco-

toxicity studies, from new or updated risk assessments under other Union legal acts, as

referred to in paragraph 1 of this Article, and environmental exposure data.

For an ERA conducted prior to … [24 months from the date of entry into force of this

Directive], the competent authority of the Member State or the Agency, as applicable, shall

request the marketing authorisation holder to update the ERA if information has been

identified as missing concerning medicinal products that are potentially harmful to the

environment.

7. For medicinal products referred to in Articles 10 to 13 and 15 and fixed-dose combination

medicinal products, the marketing authorisation applicant may, when preparing the ERA,

refer to ERA studies conducted for the reference medicinal product or to ERA studies for

any other medicinal product containing the same active substances.

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Article 24

ERA for medicinal products authorised before 30 October 2005

1. By … [30 months from the date of entry into force of this Directive], the Agency shall,

after consultation with the competent authorities of the Member States, the ECHA, the

EFSA, the EEA and the ECDC, establish a programme for those ERAs that are to be

submitted in accordance with Article 23 for medicinal products that were authorised

before 30 October 2005, that have not been the subject of an ERA, and that the Agency has

identified as potentially harmful to the environment in accordance with paragraph 2 of

this Article.

The Agency shall make the programme publicly available.

2. The Agency shall establish the scientific criteria for the identification of medicinal

products that are potentially harmful to the environment and for the prioritisation of ERAs

for such products, using a risk-based approach. For those purposes, the Agency shall

consult relevant stakeholders and may request marketing authorisation holders to submit

relevant data or information.

3. The holder of a marketing authorisation for a medicinal product identified under the

programme referred to in paragraph 1 shall submit an ERA for that medicinal product to

the Agency. The outcome of the assessment of the ERA by the competent authority of the

Member State or the Agency, as applicable, including a summary of the ERA data

submitted by the marketing authorisation holder, shall be made publicly available by the

Agency.

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4. Where there are several medicinal products identified under the programme referred to in

paragraph 1 that contain the same active substance and that are expected to pose the same

risks to the environment, the competent authority of the Member State or the Agency, as

applicable, shall encourage the marketing authorisation holders to conduct joint ERA

studies for those medicinal products, to minimise unnecessary duplication of data and use

of animals.

5. Where, for medicinal products referred to in Articles 10 to 13 and 15 and fixed-dose

combination medicinal products, a joint ERA study, as referred to in paragraph 4 of this

Article, has not been conducted and the reference medicinal product or the medicinal

product containing the same active substance is included in the programme referred to in

paragraph 1 of this Article, the ERA shall be submitted after the outcome of the assessment

of the ERA for that reference medicinal product by the competent authority of the

Member State or the Agency, as applicable, has been made publicly available by the

Agency.

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Article 25

ERA monograph system

1. The Agency shall, in collaboration with the competent authorities of the Member States,

establish an active substance-based review system of ERA data for authorised medicinal

products comprised of monographs for active substances (‘ERA monograph system’) and

publish relevant information about that system. Each ERA monograph shall include a

comprehensive set of physiochemical data, fate data and effect data based on an

assessment of the active substance by the competent authority of the Member State or the

Agency, as applicable.

2. The Agency shall select and prioritise active substances for which it shall prepare ERA

monographs. That selection and prioritisation shall be based on risk-based criteria.

3. For the purpose of an ERA monograph, the Agency may request information, studies and

data from competent authorities of the Member States and from marketing authorisation

holders.

4. In cooperation with the competent authorities of the Member States, the Agency shall

conduct a proof-of-concept pilot of ERA monographs to be completed by … [three years

from the date of entry into force of this Directive].

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5. The Commission is empowered to adopt delegated acts in accordance with Article 218 and

based on the results of the proof-of-concept pilot referred to in paragraph 4 of this Article,

to supplement this Directive by specifying the following:

(a) the content and format of ERA monographs;

(b) the procedures for adopting and updating the ERA monographs;

(c) the procedures for submission of information, studies and data referred to in

paragraph 3;

(d) the risk-based criteria for the selection and prioritisation of active substances

pursuant to paragraph 2;

(e) the use of ERA monographs in the context of new marketing authorisation

applications for medicinal products to support the ERA for those medicinal products.

Article 26

Active substance master file

1. Marketing authorisation applicants may, instead of submitting the relevant data on a

chemical active substance of a medicinal product required in accordance with Annex II,

rely on an active substance master file, an active substance master file certificate granted

by the Agency in accordance with this Article (‘active substance master file certificate’) or

a certificate confirming that the quality of the active substance concerned is suitably

controlled by the relevant monograph of the European Pharmacopoeia.

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Marketing authorisation applicants shall only rely on an active substance master file if no

certificate exists on the same active substance master file.

2. The Agency shall be responsible for granting active substance master file certificates.

3. The Agency may grant an active substance master file certificate to the manufacturer of an

active substance in cases where the relevant data on the active substance concerned are not

already covered by a monograph of the European Pharmacopoeia or by an active substance

master file certificate.

In order to obtain an active substance master file certificate, an application for an active

substance master file certificate shall be submitted to the Agency. The applicant for an

active substance master file certificate shall demonstrate that the active substance

concerned is not already covered by a monograph of the European Pharmacopoeia or an

active substance master file certificate. The Agency shall examine the application for an

active substance master file certificate and, in the case of a positive outcome, shall grant

the active substance master file certificate, that shall be valid throughout the Union. The

application for an active substance master file certificate may be submitted to the Agency

separately from a marketing authorisation application. In the case of centralised marketing

authorisations, the application for an active substance master file certificate may be

submitted as part of the marketing authorisation application for the corresponding

medicinal product.

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The Agency shall set up and maintain a repository of active substance master files and

corresponding assessment reports and certificates and ensure that personal data and

information of a commercially confidential nature are protected. The Agency shall ensure

that the competent authorities of the Member States have access to the repository.

4. The active substance master file and the active substance master file certificate shall cover

all the information on the active substance required in accordance with Annex II.

5. The holder of an active substance master file certificate shall keep the active substance

master file up to date in the light of scientific and technological progress and introduce the

changes required to ensure that the active substance is manufactured and controlled in

accordance with generally accepted scientific methods.

6. If requested by the Agency, the manufacturer of the active substance for which an

application for an active substance master file certificate has been submitted or the holder

of an active substance master file certificate shall undergo an inspection to verify the

information contained in the application for an active substance master file certificate or in

the active substance master file or their compliance with the principles of good

manufacturing practice for active substances referred to in Article 163.

If the manufacturer of an active substance refuses to undergo such an inspection, the

Agency may suspend or terminate the examination of the application for an active

substance master file certificate.

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7. If the holder of an active substance master file certificate does not fulfil the obligations set

out in paragraphs 5 and 6, the Agency may suspend or withdraw the certificate and the

competent authorities of the Member States or the Commission, as applicable, may

suspend or revoke the marketing authorisation of a medicinal product relying on that

certificate and take measures to prohibit the supply of that medicinal product.

8. The holder of a marketing authorisation for a medicinal product that has been granted on

the basis of an active substance master file certificate remains responsible and liable for

that medicinal product.

9. The Commission is empowered to adopt delegated acts in accordance with Article 218 to

supplement this Directive by specifying the following:

(a) the rules governing the content and format of the application for an active substance

master file certificate;

(b) the rules for the submission and examination of an application for an active

substance master file certificate and for the granting of the certificate;

(c) the rules for making active substance master file certificates publicly available;

(d) the rules for introducing changes to the active substance master file and the active

substance master file certificate;

(e) the rules on access to the active substance master file and to the corresponding

assessment report by competent authorities of the Member States;

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(f) the rules on access to the active substance master file and to the corresponding

assessment report by marketing authorisation applicants and marketing authorisation

holders relying on an active substance master file certificate.

Article 27

Additional quality master files

1. Marketing authorisation applicants may, instead of submitting the relevant data on an

active substance other than a chemical active substance, or on other substances present or

used in the manufacture of a medicinal product, required in accordance with Annex II, rely

on an additional quality master file, an additional quality master file certificate granted by

the Agency in accordance with this Article (‘additional quality master file certificate’) or a

certificate confirming that the quality of that substance is suitably controlled by the

relevant monograph of the European Pharmacopoeia.

Marketing authorisation applicants shall only rely on an additional quality master file

certificate if no certificate exists on the same additional quality master file.

2. Article 26, paragraphs 1, 2, 4, 5, 7 and 8 shall also apply mutatis mutandis to additional

quality master file certification.

3. The Commission is empowered to adopt delegated acts in accordance with Article 218 to

supplement this Directive by identifying, in the light of scientific progress, the substances

to which this Article shall apply. A substance shall only be identified under this paragraph

if the use of additional quality master files is scientifically justified.

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4. The Commission is empowered to adopt delegated acts in accordance with Article 218 to

supplement this Directive by specifying:

(a) the rules governing the content and format of the application for an additional quality

master file certificate;

(b) additional quality master files for which a certificate may be used in order to provide

specific information on the quality of a substance present or used in the manufacture

of a medicinal product;

(c) the rules for the examination of an application for an additional quality master file

certificate;

(d) the rules for making the additional quality master file certificates publicly available;

(e) the rules for introducing changes to the additional quality master file and the

additional quality master file certificate;

(f) the rules on access to the additional quality master file and the corresponding

assessment report by the competent authorities of the Member States;

(g) the rules on access to the additional quality master file and to the corresponding

assessment report by marketing authorisation applicants and marketing authorisation

holders relying on an additional quality master file certificate.

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5. If requested by the Agency, the manufacturer of a substance present or used in the

manufacture of a medicinal product for which an application for an additional quality

master file certificate has been submitted or the holder of an additional quality master file

certificate shall undergo an inspection to verify the information contained in the

application for the additional quality master file certificate or in the additional quality

master file.

If the manufacturer of that substance refuses to undergo such an inspection, the Agency

may suspend or terminate the examination of the application for the additional quality

master file certificate.

Article 28

Platform technology master files

1. Marketing authorisation applicants may, instead of submitting the relevant data related to a

platform technology required in accordance with Annex II, rely on a platform technology

master file that is certified in accordance with paragraph 3 of this Article. The platform

technology master file shall contain the information required in accordance with Annex II.

The marketing authorisation applicants shall take into account the scientific guidelines

published by the Agency in this regard.

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2. Marketing authorisation holders relying on a certified platform technology master file shall

keep the platform technology master file up to date in the light of scientific and

technological progress and introduce the changes required to ensure that the platform

technology is in accordance with generally accepted scientific methods and the state of the

art. The holder of a marketing authorisation for a medicinal product who is relying on a

certified platform technology master file shall remain responsible and liable for that

medicinal product.

3. For a platform technology master file to be certified, an application for a certified platform

technology master file shall be submitted to the Agency. The Agency shall examine the

application and, in the event of a positive outcome, shall certify the platform technology

master file.

4. The application for a certified platform technology master file can be submitted only after

the Agency has confirmed the eligibility of the application for a certified platform

technology master file. Once eligibility is confirmed, the application for a certified

platform technology master file shall be submitted as part of the marketing authorisation

application for the corresponding medicinal product or after the granting of the marketing

authorisation for the corresponding medicinal product.

5. The Agency shall set up and maintain a repository of certified platform technology master

files and corresponding assessments reports and ensure that personal data and information

of a commercially confidential nature are protected. The Agency shall ensure that the

competent authorities of the Member States have access to the repository.

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6. If the owner of a certified platform technology master file does not fulfil the obligations set

out in this Article, the Agency may suspend or withdraw the certification and the

competent authorities of the Member States or the Commission, as applicable, may

suspend or revoke the marketing authorisation of medicinal products relying on the

certified platform technology master file and take measures to prohibit the supply of the

medicinal products relying on that certified platform technology master file. The owner of

a certified platform technology master file shall notify the marketing authorisation holders

concerned without undue delay of any information that is relevant to fulfil their obligations

in accordance with paragraph 2.

7. If requested by the Agency or, where relevant, the competent authority of a Member State,

the platform technology shall be subject to an inspection to verify the information

contained in the platform technology master file. If the applicant for a certified platform

technology master file or the owner of the certified platform technology master file refuses

to undergo such an inspection, the Agency may suspend or terminate the examination of

the application for a certified platform technology master file or suspend or withdraw the

certification.

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Article 29

Decentralised manufacturing

1 Where justified by the specific properties of the manufactured medicinal product and

considerations related to the quality, safety and efficacy of a medicinal product, such as

short shelf life, or where proximity to the patient being treated or customisation for an

individual patient is to the patient’s benefit, the marketing authorisation applicant may

request the competent authority of the Member State or the Agency, as applicable, to

approve the use of decentralised manufacturing for the medicinal product concerned.

2. The request referred to in paragraph 1 shall be submitted as part of the marketing

authorisation application in accordance with Annex II.

3. The competent authority of the Member State or the Agency, as applicable, shall assess the

request referred to in paragraph 1 as part of the assessment of the marketing authorisation

application.

4. The competent authority of the Member State or the Agency, as applicable, shall cooperate

with all relevant regulatory authorities, including the competent authority of the

Member State supervising the central site identified in the marketing authorisation

application. The manufacturing authorisation of the central site granted under Article 146

shall be provided as part of the marketing authorisation procedure.

5. The approval to use decentralised manufacturing shall be included in the terms of the

marketing authorisation.

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6. The competent authority of the Member State or the Agency, as applicable, may withdraw

an approval to use decentralised manufacturing where it concludes that the justification

referred to in paragraph 1 is no longer valid or that the conditions for decentralised

manufacturing as referred to in Articles 146 to 152 and Articles 155 to 157 are not

complied with. The competent authority shall inform the competent authority of the

Member State supervising the central site of such circumstances without undue delay.

7. The marketing authorisation holders making use of decentralised manufacturing shall

provide the competent authority of the Member State or the Agency, as applicable, with

any new information that might entail an amendment to the terms of the marketing

authorisation as referred to in paragraph 5 of this Article, in accordance with Article 92.

8. The Commission may adopt implementing acts to set out the content and format of the

request to use decentralised manufacturing and to specify the application of paragraph 1.

Those implementing acts shall be adopted in accordance with the examination procedure

referred to in Article 217(2).

Article 30

Excipients

1. The applicant shall provide information on the excipients used in a medicinal product in

accordance with the requirements set out in Annex II.

The competent authority of the Member State or the Agency, as applicable, shall assess the

excipients as part of the medicinal product.

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2. Colours shall be used in medicinal products only if they are included in one of the

following lists:

(a) the Union list of authorised food additives in Table 1, Part B, of Annex II to

Regulation (EC) No 1333/2008, and those colours comply with the purity criteria and

specifications laid down in Commission Regulation (EU) No 231/2012;

(b) the list of colours permitted for use in medicinal products other than those included

in the Union list of authorised food additives established by the Commission

pursuant to paragraph 3.

3. The Commission may establish a list of colours permitted for use in medicinal products

other than those included in the Union list of authorised food additives.

The Commission shall, where applicable on the basis of an opinion of the Agency, adopt a

decision as to whether the colour concerned is to be added to the list of colours referred to

in the first subparagraph.

A colour may be added to the list of colours referred to in the first subparagraph only

where the colour has been removed from the Union list of authorised food additives.

Where relevant, the list of colours referred to in the first subparagraph shall include purity

criteria, specifications or restrictions applicable to the colours included in that list.

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The list of colours referred to in the first subparagraph shall be established by way of

implementing acts. Those implementing acts shall be adopted in accordance with the

examination procedure referred to in Article 217(2).

4. If a colour used in medicinal product is removed from the Union list of authorised food

additives, on the basis of the scientific opinion of the EFSA, the Agency shall, on the

request of the Commission or on its own initiative, without undue delay issue a scientific

opinion on the use of the colour concerned in medicinal products, taking into account the

opinion of the EFSA. The opinion of the Agency shall be adopted by the Committee for

Medicinal Products for Human Use referred to in Article 155 of Regulation (EU) 2026/…+

(the ‘Committee for Medicinal Products for Human Use’).

The Agency without undue delay shall send to the Commission its scientific opinion on the

use of the colour concerned in medicinal products, together with a report on the

assessment.

The Commission shall, on the basis of the Agency opinion, and without undue delay,

decide whether the colour concerned can be used in medicinal products and, where

applicable, include it in the list of colours referred to in paragraph 3, first subparagraph.

+ OJ: please insert in the text the number of the Regulation in document ST 7105/26

(2023/0131(COD)).

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5. If a colour has been removed from the Union list of authorised food additives for reasons

that do not require an EFSA opinion, the Commission shall decide on the use of the colour

concerned in medicinal products and, where applicable, include it in the list of colours

referred to in paragraph 3, first subparagraph. The Commission may, in such cases, request

an opinion from the Agency as regards the use of the colour in medicinal products.

6. A colour that has been removed from the Union list of authorised food additives can

continue to be used as a colour in medicinal products until the Commission takes a

decision on whether to include the colour in the list of colours permitted for use in

medicinal products in accordance with paragraph 3.

7. Paragraphs 2 to 6 of this Article shall also apply to colours used in veterinary medicinal

products as defined in Article 4, point (1), of Regulation (EU) 2019/6.

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SECTION 5

ADAPTED DOSSIER REQUIREMENTS

Article 31

Adapted frameworks due to the characteristics inherent to or methods

related to the medicinal product or to the category of medicinal products

1. Medicinal products or categories of medicinal products listed in Annex VII shall be subject

to adapted scientific or technical requirements with regard to the authorisation,

pharmacovigilance, control and use of those medicinal products or those categories of

medicinal products (‘adapted framework’). A medicinal product or category of medicinal

products shall be listed in Annex VII where:

(a) it is not possible to adequately assess or monitor the quality, safety and efficacy of

the medicinal product or category of medicinal products by applying the

requirements set out in this Directive, in Regulation (EC) No 1394/2007 or in

Regulation (EU) 2026/…+, due to scientific or technical characteristics inherent to

the medicinal products or due to methods related to the medicinal product or

category of medicinal products; and

+ OJ: please insert in the text the number of the Regulation in document ST 7105/26

(2023/0131(COD)).

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(b) the characteristics or methods related to the medicinal product or category of

medicinal products contribute positively to the quality, safety and efficacy of the

medicinal product or category of medicinal products as provided for in this Directive

and in Regulation (EU) 2026/…+ or make a major contribution to patient access to

prevention, diagnosis, treatment or patient care.

2. The Commission is empowered to adopt delegated acts in accordance with Article 218,

after having consulted the Agency and competent authorities of the Member States, to

amend the list of medicinal products or categories of medicinal products in Annex VII in

order to take account of scientific and technical progress.

3. The Commission is empowered to adopt delegated acts in accordance with Article 218,

after having consulted the Agency and the competent authorities of the Member States, to

supplement this Directive by laying down the adapted framework for medicinal products or

categories of medicinal products listed in Annex VII as well as the technical

documentation to be submitted by the marketing authorisation applicants for the medicinal

product or category of medicinal products for which the adapted framework is laid down.

+ OJ: please insert in the text the number of the Regulation in document ST 7105/26

(2023/0131(COD)).

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The adapted framework may entail specific requirements and targeted technical

adaptations to the requirements set out in this Directive and Regulation (EU) 2026/…+

which are necessary for the purposes of assessing whether a marketing authorisation

referred to in Article 6 of this Directive can be granted for a medicinal product or category

of medicinal products listed in Annex VII and for their life-cycle management. The

technical adaptations shall be proportionate to the risk and impact involved and shall be

based on objective and scientific considerations. In particular, any technical adaptation

shall ensure that the principles of quality, safety and efficacy set out in this Directive and

in Regulation (EU) 2026/…+ are respected. The adaptations shall be limited to the extent

that such adaptations are strictly necessary and duly justified by the characteristics or

methods related to the medicinal product or category of medicinal products. The

Commission shall regularly review and evaluate the technical adaptations.

4. A marketing authorisation for a medicinal product subject to an adapted framework as

referred to in paragraph 3 may be granted provided that the benefit-risk balance of the

medicinal product is favourable.

5. Until the adoption of technical adaptations pursuant to paragraph 3 of this Article for a

medicinal product or a category of medicinal products listed in Annex VII, an application

for a marketing authorisation for the medicinal product may be submitted in accordance

with Article 7(2).

6. When adopting delegated acts referred to in this Article, the Commission shall take into

account any available information resulting from a regulatory sandbox established in

accordance with Article 116 of Regulation (EU) 2026/…+.

+ OJ: please insert in the text the number of the Regulation in document ST 7105/26

(2023/0131(COD)).

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Chapter III

Procedures for national marketing authorisations

SECTION 1

GENERAL PROVISIONS

Article 32

Examination of marketing authorisation applications

1. In order to examine a marketing authorisation application submitted in accordance with

Articles 7 and 10 to 15, the competent authority of the Member State:

(a) shall verify that the particulars and documents submitted in support of the application

comply with Articles 7 and 10 to 15 (‘validation of the application’), and examine

whether the conditions for granting a marketing authorisation set out in

Articles 46, 47 and 48 are complied with;

(b) may submit the medicinal product, its starting materials or ingredients and, if need

be, its intermediate products or other constituents, to testing by an Official Medicines

Control Laboratory or a laboratory that a Member State has designated for that

purpose, in order to ensure that the control methods employed by the manufacturer of

medicinal products and described in the particulars accompanying the marketing

authorisation application in accordance with Annex I are satisfactory;

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(c) may, where appropriate, require the marketing authorisation applicant to provide

supplementary information in respect of the items listed in Articles 7 and 10 to 15;

(d) may consider and decide upon additional evidence that is available to the competent

authority of that Member State, independently from the data submitted by the

marketing authorisation applicant, inform the applicant of its decision and the

grounds for that decision, and require the applicant to make changes to the summary

of product characteristics;

(e) may, where appropriate, require the applicant to provide raw data concerning the

pharmaceutical and non-clinical tests and the clinical studies referred to in Annex I.

2. Where, in the course of the validation of the application referred to in paragraph 1,

point (a), the competent authority of the Member State considers that the marketing

authorisation application is incomplete or contains deficiencies to the extent that it could

prevent the evaluation of the application, it shall inform the applicant accordingly and shall

set a time limit for submitting the missing particulars and documents.

If the marketing authorisation applicant fails to provide the missing particulars and

documents within that time limit, the application shall be considered to have been

withdrawn by the applicant.

3. Where the competent authority of the Member State avails itself of the option referred to in

paragraph 1, point (c), the time limits laid down in Article 33 shall be suspended until such

time as the supplementary information required has been provided or until the time granted

to the applicant for giving explanations has expired.

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4. Where, in the course of examining a marketing authorisation application, the competent

authority of the Member State considers that the data submitted are not of sufficient quality

or maturity for it to complete its examination of the application, the examination of the

application can be terminated within 90 days of the date on which the competent authority

of the Member State has verified that the particulars and documents submitted in support

of the application comply with Article 7 and 10 to 15 (‘date of validation’).

Prior to terminating its examination of the marketing authorisation application, the

competent authority of the Member State shall summarise the deficiencies in writing. On

this basis, the competent authority of the Member State shall inform the marketing

authorisation applicant accordingly and set a reasonable time limit to address the

deficiencies. The examination of the marketing authorisation application shall be

suspended until the marketing authorisation applicant addresses the deficiencies. If the

marketing authorisation applicant fails to address those deficiencies within the time limit

set by the competent authority of the Member State, the examination shall be terminated

and the marketing authorisation application shall be considered to have been withdrawn by

the marketing authorisation applicant.

5. When making public the information on the ERA and the antimicrobial stewardship plan

referred to in Article 18, the competent authority of the Member State shall delete any

information of a commercially confidential nature.

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6. Where a potential serious risk to public health related to the reference medicinal product is

examined under a specific procedure under this Directive or Regulation (EU) 2026/…+, the

Member States shall suspend the examination of any marketing authorisation application

submitted under Articles 10 to 13 of this Directive that uses the same reference medicinal

product until the end of the procedure related to the reference medicinal product.

7. Where the competent authorities of the Member States become aware that a marketing

authorisation application is already being examined by a competent authority of another

Member State for the same medicinal product, they shall refuse to validate the marketing

authorisation application and shall advise the applicant to use the procedure referred to in

Article 37 or 39.

8. Where the competent authorities of the Member States become aware that a Member State

has already granted a marketing authorisation for the same medicinal product, they shall

refuse to validate the marketing authorisation application unless it was submitted in

accordance with the mutual recognition procedure as laid down in Article 39.

Article 33

Duration of examination of a marketing authorisation application

Member States shall take all appropriate measures to ensure that the procedure for granting a

marketing authorisation for medicinal products is completed within 180 days of the date of

validation of the marketing authorisation application.

+ OJ: please insert in the text the number of the Regulation in document ST 7105/26

(2023/0131(COD)).

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Article 34

Types of national marketing authorisation procedures

National marketing authorisations may be granted in accordance with the purely national procedure,

as laid down in Article 35, the decentralised procedure, as laid down in Articles 36 and 37, or the

mutual recognition procedure, as laid down in Articles 38 and 39.

SECTION 2

MARKETING AUTHORISATIONS VALID IN A SINGLE MEMBER STATE

Article 35

Purely national procedure

1. With a view to obtaining a national marketing authorisation for a medicinal product in one

Member State, namely an authorisation under the purely national procedure, the marketing

authorisation applicant shall submit an application to the competent authority of that

Member State.

2. The competent authority of the Member State in which the marketing authorisation is

applied for shall examine the marketing authorisation application in accordance with

Articles 32 and 33, draw up an assessment report and adopt a decision to grant or refuse a

marketing authorisation in accordance with Articles 46, 47 and 48 or Article 50, as

applicable, and with applicable national provisions.

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3. A marketing authorisation granted under the purely national procedure shall be valid only

in the Member State of the competent authority that granted it.

SECTION 3

MARKETING AUTHORISATIONS VALID IN SEVERAL MEMBER STATES

Article 36

Scope of decentralised procedure

1. With a view to obtaining a national marketing authorisation for a medicinal product in

several Member States in respect of the same medicinal product, the marketing

authorisation applicant shall submit an application to the competent authorities of the

Member States in which the applicant seeks to obtain a national marketing authorisation.

2. The competent authorities of the Member States concerned by the decentralised procedure

shall examine the marketing authorisation application in accordance with Articles 32, 33

and 37, and adopt a decision to grant or refuse a marketing authorisation in accordance

with Articles 46, 47 and 48 or Article 50, as applicable.

3. Marketing authorisations granted under the decentralised procedure shall be valid only in

those Member States whose competent authorities granted the marketing authorisations.

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Article 37

Decentralised procedure

1. The marketing authorisation applicant under the decentralised procedure shall submit a

marketing authorisation application based on an identical dossier:

(a) to the competent authority of the Member State chosen by the applicant to draw up

the assessment report on the medicinal product in accordance with Article 46(3) and

to act in accordance with this Section (‘reference Member State for the decentralised

procedure’), and

(b) to the competent authorities of the other Member States concerned by the

decentralised procedure.

2. The marketing authorisation application shall contain:

(a) the particulars and documents referred to in Articles 7, 10 to 15 and 65;

(b) a list of the Member States concerned by the decentralised procedure.

3. The marketing authorisation applicant shall inform all the competent authorities of all

Member States when submitting an application pursuant to paragraph 1.

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If necessary to meet the needs of patients in a Member State, the competent authority of

that Member State may request that its Member State become a Member State concerned

by the decentralised procedure and shall, within 30 days of the date of submission of the

marketing authorisation application, inform the marketing authorisation applicant and the

competent authority of the reference Member State for the decentralised procedure of that

request. The marketing authorisation applicant shall provide the competent authority of

that Member State with the marketing authorisation application without undue delay, on

receipt of which that Member State shall be considered as a Member State concerned by

the decentralised procedure.

4. Where, in the course of the validation of the application, the competent authority of the

reference Member State for the decentralised procedure considers that the marketing

authorisation application is incomplete or contains deficiencies to the extent that it could

prevent the evaluation of the application, it shall inform the applicant accordingly and shall

set a reasonable time limit for submitting the missing particulars and documents.

If the marketing authorisation applicant fails to provide the missing particulars and

documents within that time limit, the application shall be considered to have been

withdrawn by the applicant in the reference Member State for the decentralised procedure

and in the other Member States concerned by the decentralised procedure.

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5. Where, in the course of examining a marketing authorisation application, the competent

authority of the reference Member State for the decentralised procedure considers that the

data submitted are not of sufficient quality or maturity for it to complete its examination of

the application, the examination of the application can be terminated within 90 days of the

date of validation of the application.

Prior to terminating its examination of the marketing authorisation application, the

competent authority of the reference Member State for the decentralised procedure shall

summarise the deficiencies in writing. On this basis, the competent authority of the

reference Member State for the decentralised procedure shall inform the marketing

authorisation applicant and the competent authorities of the Member States concerned by

the decentralised procedure accordingly and set a time limit to address the deficiencies.

The examination of the marketing authorisation application shall be suspended until the

marketing authorisation applicant addresses those deficiencies. If the marketing

authorisation applicant fails to address those deficiencies within that time limit set by the

competent authority of the reference Member State for the decentralised procedure, the

examination of the application shall be terminated and the marketing authorisation

application shall be considered to have been withdrawn by the applicant in the reference

Member State for the decentralised procedure and in the other Member States concerned

by the decentralised procedure.

The competent authority of the reference Member State for the decentralised procedure

shall inform the competent authorities of the other Member States concerned by the

decentralised procedure and the marketing authorisation applicant accordingly.

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6. Within 105 days of the date of validation of the application, the competent authority of the

reference Member State for the decentralised procedure shall draw up an assessment

report, the summary of product characteristics, the labelling and the package leaflet and

shall send them to the other Member States concerned by the decentralised procedure and

to the marketing authorisation applicant.

7. Within 75 days of receipt of the assessment report, the summary of product characteristics,

the labelling and the package leaflet, and unless Article 41 applies, the competent

authorities of the Member States concerned by the decentralised procedure shall approve

the assessment report, the summary of product characteristics, the labelling and the

package leaflet and shall inform the competent authority of the reference Member State for

the decentralised procedure accordingly. The competent authority of the reference

Member State for the decentralised procedure shall acknowledge the agreement of all

Member States concerned, close the procedure and inform the marketing authorisation

applicant accordingly.

8. Within seven days of receipt of the information under paragraph 7, the marketing

authorisation applicant shall submit high quality translations of the summary of product

characteristics, the labelling and the package leaflet to the competent authority of the

reference Member State for the decentralised procedure and each of the competent

authorities of the other Member States concerned by the decentralised procedure.

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9. Within 30 days of acknowledgement of the agreement referred to in paragraph 7 of this

Article, the competent authorities of the reference Member States for the decentralised

procedure and the other Member States concerned by the decentralised procedure shall

adopt a decision in accordance with Articles 46, 47 and 48 and in conformity with the

approved assessment report, summary of product characteristics, labelling and package

leaflet.

SECTION 4

MUTUAL RECOGNITION OF NATIONAL MARKETING AUTHORISATIONS

Article 38

Scope of mutual recognition procedure

1. Where, at the time an application for a national marketing authorisation is submitted in a

given Member State, a national marketing authorisation has already been granted for the

same medicinal product in one or more other Member States in accordance with

Articles 46, 47 and 48, the national marketing authorisation that has already been granted

shall be recognised in accordance with Article 39 in the Member State where the

application for a national marketing authorisation is submitted.

2. An application for mutual recognition of a national marketing authorisation that has been

granted in a Member State in accordance with Articles 46, 47 and 48 shall be submitted in

accordance with Article 39.

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Article 39

Mutual recognition procedure

1. An application for mutual recognition of a national marketing authorisation shall be

submitted to:

(a) the competent authority of one of the Member States that granted the national

marketing authorisation (‘reference Member State for the mutual recognition

procedure’), and

(b) the competent authorities of the Member States concerned by the mutual recognition

procedure, namely those in which the applicant seeks to obtain a national marketing

authorisation under the mutual recognition procedure.

2. The application shall include a list of the Member States concerned by the mutual

recognition procedure.

3. For a period of one year from the granting of a national marketing authorisation, the

competent authority of the reference Member State for the mutual recognition procedure

shall refuse applications for mutual recognition of that national marketing authorisation.

However, where the competent authority of the reference Member State for the mutual

recognition procedure is informed by the competent authority of another Member State that

that Member State has an interest in that medicinal product, the first subparagraph shall not

apply.

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4. The marketing authorisation applicant shall inform all the competent authorities of all

Member States when submitting an application pursuant to paragraph 1.

If necessary to meet the needs of patients in a Member State, the competent authority of

that Member State may request that its Member State become a Member State concerned

by the mutual recognition procedure and shall, within 30 days of the date of submission of

the marketing authorisation application, inform the marketing authorisation applicant and

the competent authority of the reference Member State for the mutual recognition

procedure of that request. The applicant shall provide the competent authority of that

Member State with the application for mutual recognition without undue delay, on receipt

of which that Member State shall be considered as a Member State concerned by the

mutual recognition procedure.

5. The competent authority of the reference Member State for the mutual recognition

procedure shall send the assessment report together with the approved summary of product

characteristics, labelling and package leaflet to the Member States concerned by the mutual

recognition procedure and to the applicant within 30 days of the date of validation of the

application for mutual recognition. Where a Member State concerned by the mutual

recognition procedure requests that the assessment report be updated, the procedure may

be extended to 90 days.

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6. Within 60 days of receipt of the assessment report, the summary of product characteristics,

the labelling and the package leaflet, and unless Article 41 applies, the competent

authorities of the Member States concerned by the mutual recognition procedure shall

approve the assessment report, the summary of product characteristics, the labelling and

the package leaflet and shall inform the competent authority of the reference Member State

for the mutual recognition procedure accordingly.

7. The competent authority of the reference Member State for the mutual recognition

procedure shall acknowledge the agreement between the reference Member State for the

mutual recognition procedure and the Member States concerned by the mutual recognition

procedure, close the procedure and inform the applicant accordingly.

8. Within seven days of receipt of the information under paragraph 7, the applicant shall

provide high quality translations of the summary of product characteristics, the labelling

and the package leaflet to each of the competent authorities of the Member States

concerned by the mutual recognition procedure.

9. Within 30 days of acknowledgement of the agreement referred to in paragraph 7 of this

Article, the competent authorities of the Member States concerned by the mutual

recognition procedure shall adopt a decision in accordance with Articles 46, 47 and 48 and

in conformity with the approved assessment report, summary of product characteristics,

labelling and package leaflet.

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SECTION 5

COORDINATION OF NATIONAL MARKETING AUTHORISATIONS

Article 40

Coordination group for decentralised and mutual recognition procedures

1. A coordination group for decentralised and mutual recognition procedures (the

‘coordination group’) shall be set up for the following purposes:

(a) to examine any question relating to a national marketing authorisation for a

medicinal product in two or more Member States in accordance with the procedures

laid down in Sections 3 and 4 and in this Section of this Chapter, and in Article 98;

(b) to examine questions related to the pharmacovigilance of medicinal products covered

by national marketing authorisations, in accordance with Articles 112, 114, 116, 120

and 125;

(c) to examine questions relating to variations of national marketing authorisations, in

accordance with Article 95(1).

(d) to establish and publish a list of medicinal products for which a harmonised summary

of product characteristics is to be drawn up, in accordance with Article 43;

(e) to harmonise the summary of product characteristics, in accordance with Article 43.

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For the purpose of carrying out its pharmacovigilance tasks referred to in the first

subparagraph, point (b), such as approving risk management systems and monitoring their

effectiveness, the coordination group shall rely on the scientific assessment and

recommendations of the Pharmacovigilance Risk Assessment Committee referred to in

Article 156 of Regulation (EU) 2026/…+ (the ‘Pharmacovigilance Risk Assessment

Committee’).

2. The coordination group shall be composed of one representative per Member State,

appointed for a renewable period of three years. Member States may appoint an alternate

for a renewable period of three years. Members of the coordination group may arrange to

be accompanied by experts.

For the purpose of carrying out their tasks, members of the coordination group and experts

shall rely on the scientific and regulatory resources available to competent authorities of

the Member States. Each competent authority of the Member State shall monitor the level

of expertise of the evaluations carried out and facilitate the activities of appointed

coordination group members and experts.

Article 154 of Regulation (EU) 2026/…+ shall apply to the coordination group as regards

transparency and the independence of its members.

+ OJ: please insert in the text the number of the Regulation in document ST 7105/26

(2023/0131(COD)).

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3. The Agency shall provide the secretariat of the coordination group. The coordination

group shall draw up its own rules of procedure, which shall enter into force after a

favourable opinion has been given by the Commission. Those rules of procedure shall be

made publicly available.

4. The Executive Director of the Agency or the representative of the Executive Director and

representatives of the Commission shall be entitled to attend all meetings of the

coordination group.

5. The members of the coordination group shall ensure that there is appropriate coordination

between the tasks of that group and the work of competent authorities of the

Member States, including the consultative bodies concerned with national marketing

authorisations.

6. Unless otherwise provided for in this Directive, within the coordination group, all

Member States representatives shall use their best endeavours to reach a position by

consensus on the action to be taken. If such a consensus cannot be reached, the position of

the majority of the Member States represented within the coordination group shall prevail.

7. Members of the coordination group shall be required, even after their duties have ceased,

not to disclose information of the kind covered by the obligation of professional secrecy.

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Article 41

Divergent positions of Member States in a decentralised or mutual recognition procedure

1. If, at the end of the period laid down in Article 37(7) or in Article 39(6), there is

disagreement between Member States on whether the national marketing authorisation can

be granted, on the grounds of potential serious risk to public health, the Member State

concerned shall provide a detailed explanation of the points of disagreement and the

reasons for its position to the reference Member State for the decentralised procedure or for

the mutual recognition procedure (the ‘reference Member State’), to the Member States

concerned by the decentralised procedure or by the mutual recognition procedure (the

‘Member States concerned’) and to the applicant. The points of disagreement shall be

referred to the coordination group without undue delay.

2. Guidelines to be adopted by the Commission shall define a potential serious risk to public

health.

3. Within the coordination group, Member States shall use their best endeavours to reach an

agreement on the action to be taken. They shall provide the marketing authorisation

applicant with an opportunity to make its point of view known orally or in writing. If,

within 60 days of the communication of the points of disagreement, the Member States

reach an agreement by consensus, the reference Member State shall acknowledge the

agreement, close the procedure and inform the marketing authorisation applicant

accordingly. The procedure laid down in Article 37(9) or in Article 39(9) shall apply.

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4. If within the 60-day period laid down in paragraph 3 of this Article, an agreement by

consensus cannot be reached, the position of the majority of the Member States represented

within the coordination group, with a detailed description of the matters on which the other

Member States have been unable to reach an agreement and of all the divergent positions

of Member States presented, shall be forwarded to the Commission. The coordination

group may recommend that the Commission refers the matter to the Committee for

Medicinal Products for Human Use. The Commission shall apply the procedure laid down

in Article 45. Where the Commission, on its own initiative or based on the

recommendation of the coordination group, considers that the matter is to be referred to the

Committee for Medicinal Products for Human Use, Article 44 shall also apply.

5. In the circumstances referred to in paragraph 4 of this Article, Member States that have

approved the assessment report, the summary of product characteristics, the labelling and

the package leaflet of the reference Member State may, at the request of the applicant,

authorise the medicinal product without waiting for the outcome of the procedure laid

down in Article 45. In that event, the national marketing authorisation shall be granted

without prejudice to the outcome of that procedure.

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Article 42

Referral procedure for divergent decisions by Member States

Where applications for a national marketing authorisation have been submitted in accordance with

Articles 7 and 10 to 15 for a particular medicinal product and Member States have adopted

divergent decisions concerning the national marketing authorisation, its variation, suspension or

revocation or the summary of product characteristics, the competent authority of the Member State

or the Commission may refer the matter to the Committee for Medicinal Products for Human Use

for the application of the procedure laid down in Articles 44 and 45.

Article 43

Harmonisation of summary of product characteristics

1. In order to promote the harmonisation of national marketing authorisations for medicinal

products throughout the Union, the competent authorities of the Member States may, each

year, propose to the coordination group a list of medicinal products for which a

harmonised summary of product characteristics is to be drawn up.

2. The coordination group may establish a list of medicinal products for which a harmonised

summary of product characteristics is to be drawn up, taking into account the proposals

from the competent authorities of all Member States, and shall decide on the harmonisation

of summary of product characteristics for those medicinal products and shall inform

the Commission.

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3. If, within the coordination group, the Member States represented reach an agreement by

consensus on the action to be taken, the chairman shall acknowledge the agreement and

send it to the marketing authorisation holder and the Member States. The Member States

shall adopt necessary measures to vary the marketing authorisations concerned in

accordance with the timetable for implementation determined in the agreement. The

marketing authorisation holder shall submit to the competent authorities of the

Member States an appropriate application for a variation of the marketing authorisation,

including an updated summary of product characteristics and an updated package leaflet

within the determined timetable for implementation.

4. If, within the coordination group, the Member States represented cannot reach an

agreement by consensus, the position of the majority of the Member States represented

together with a detailed description of the matters on which the other Member States have

been unable to reach agreement and of all the divergent positions of Member States

presented, shall be forwarded to the Commission. The Commission shall apply the

procedure laid down in Article 45. Where the Commission, on its own initiative or based

on the recommendation of the coordination group, considers that the matter is to be

referred to the Committee for Medicinal Products for Human Use, Article 44 shall also

apply.

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Article 44

Referral to the Committee for Medicinal Products for Human Use

1. Where a matter is referred to the Committee for Medicinal Products for Human Use, the

Committee for Medicinal Products for Human Use shall consider the matter and shall issue

a reasoned opinion within 60 days of the date when the matter was referred to it.

However, as regards matters referred to the Committee for Medicinal Products for Human

Use in accordance with Article 42, Article 43(4) or Article 98, the period referred to in the

first subparagraph of this paragraph may be extended by the Committee for Medicinal

Products for Human Use for a further period of up to 90 days.

On a proposal from its chairperson, the Committee for Medicinal Products for Human Use

may agree to a shorter deadline than that provided for in the first subparagraph of this

paragraph.

2. In order to consider the matter, the Committee for Medicinal Products for Human Use shall

appoint one of its members to act as rapporteur. The Committee for Medicinal Products for

Human Use may also appoint individual experts to advise it on specific questions. When

appointing experts, the Committee for Medicinal Products for Human Use shall define

their tasks and specify the time limit for the completion of those tasks.

3. Before issuing its opinion, the Committee for Medicinal Products for Human Use shall

provide the marketing authorisation applicant or the marketing authorisation holder with an

opportunity to present written or oral explanations within a time limit which it shall

specify.

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The opinion of the Committee for Medicinal Products for Human Use shall be

accompanied by a summary of product characteristics, the labelling and the package

leaflet.

If necessary, the Committee for Medicinal Products for Human Use may call upon any

other person to provide information relating to the matter and may convene a public

hearing in accordance with Article 153(1) of Regulation (EU) 2026/…+.

The Agency shall, in consultation with the parties concerned, draw up rules of procedure

on the organisation and conduct of public hearings, in accordance with Article 153(1)

of Regulation (EU) 2026/…+.

The Committee for Medicinal Products for Human Use may suspend the time limits

referred to in paragraph 1 of this Article in order to allow the marketing authorisation

applicant or the marketing authorisation holder to prepare explanations.

4. The Agency shall without undue delay inform the marketing authorisation applicant or the

marketing authorisation holder where the opinion of the Committee for Medicinal Products

for Human Use concludes that:

(a) the marketing authorisation application does not satisfy the criteria for a national

marketing authorisation;

(b) the summary of product characteristics proposed by the marketing authorisation

applicant or the marketing authorisation holder in accordance with Article 65 is to be

amended;

+ OJ: please insert in the text the number of the Regulation in document ST 7105/26

(2023/0131(COD)).

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(c) the national marketing authorisation is to be granted subject to certain conditions,

that are considered essential for the safe and effective use of the medicinal product,

including pharmacovigilance;

(d) a national marketing authorisation is to be suspended, varied or revoked;

(e) the medicinal product satisfies the conditions set out in Article 85 regarding

medicinal products addressing an unmet medical need.

Where the marketing authorisation applicant or the marketing authorisation holder intends

to request a re-examination of the opinion of the Committee for Medicinal Products for

Human Use, the marketing authorisation applicant or the marketing authorisation holder

shall notify the Agency in writing of its intention within 12 days of receipt of the opinion

of the Committee for Medicinal Products for Human Use and shall forward the detailed

grounds for the request to the Agency within 60 days of receipt of the opinion.

Within 60 days of receipt of the grounds for the request, the Committee for Medicinal

Products for Human Use shall re-examine its opinion in accordance with Article 13(2),

third subparagraph, of Regulation (EU) 2026/…+. The reasons for the conclusion reached

in its final opinion following that re-examination shall be annexed to the assessment report

referred to in Article 13(3) of Regulation (EU) 2026/…+.

+ OJ: please insert in the text the number of the Regulation in document ST 7105/26

(2023/0131(COD)).

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5. Within 12 days of the issuance by the Committee for Medicinal Products for Human Use

of its final opinion, the Agency shall forward it to the competent authorities of the

Member States, to the Commission and to the marketing authorisation applicant or the

marketing authorisation holder, together with a report describing the assessment of the

medicinal product and stating the reasons for its conclusions.

In the event of an opinion in favour of granting or maintaining a marketing authorisation to

place the medicinal product concerned on the market, the following documents shall be

annexed to the final opinion:

(a) a summary of product characteristics, as referred to in Article 65;

(b) the details of any conditions affecting the marketing authorisation within the

meaning of paragraph 4, first subparagraph, point (c);

(c) the details of any recommended conditions or restrictions with regard to the safe and

effective use of the medicinal product;

(d) the labelling and the package leaflet.

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Article 45

Commission decision

1. Within 12 days of receipt of the opinion of the Committee for Medicinal Products for

Human Use or the position of the majority of the Member States represented within the

coordination group, as set out in Article 41(4), the Commission shall submit to the

Standing Committee on Medicinal Products for Human Use referred to in Article 217(1) a

draft of the decision on the application concerned (‘draft decision’), on the basis of the

requirements set out in this Directive.

In duly justified cases, the Commission may refer the opinion of the Committee for

Medicinal Products for Human Use or the position of the majority of the Member States

represented within the coordination group, back to the Agency or to the coordination

group, as applicable, for further consideration.

Where a draft decision envisages the granting of a marketing authorisation, it shall include

or make reference to the documents referred to in Article 41(5) or 44(5), second

subparagraph.

Where a draft decision diverges from the opinion of the Committee for Medicinal Products

for Human Use or from the position of the majority of the Member States represented

within the coordination group, the Commission shall provide a detailed explanation of the

reasons for that divergence.

The Commission shall send the draft decision to the competent authorities of the

Member States and to the marketing authorisation applicant or the marketing authorisation

holder.

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2. The Commission shall, by means of implementing acts, adopt a final decision

within 12 days after obtaining the opinion of the Standing Committee on Medicinal

Products for Human Use.

Those implementing acts shall be adopted in accordance with the examination procedure

referred to in Article 217(2) and (3).

3. Where a Member State raises important new questions of a scientific or technical nature

that have not been addressed in the opinion issued by the Committee for Medicinal

Products for Human Use or in the position of the majority of the Member States

represented within the coordination group, the Commission may refer the marketing

authorisation application back to the Agency or to the coordination group, as applicable,

for further consideration. In that case, the procedures set out in paragraphs 1 and 2 shall

start again upon reception of the reply of the Agency or of the coordination group.

4. The decision referred to in paragraph 2 shall be addressed to all Member States and

forwarded for information to the marketing authorisation applicant or to the marketing

authorisation holder. The Member States concerned and the reference Member State shall

adopt a decision to either grant, suspend, refuse or revoke the marketing authorisation, or

vary its terms as necessary to comply with the decision referred to in paragraph 2 within 30

days of its notification. In the decision to grant, suspend, refuse, revoke or vary the

marketing authorisation, the Member States shall refer to the decision adopted pursuant to

paragraph 2. They shall inform the Agency or the coordination group accordingly, as

applicable.

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5. Where the procedure laid down in Article 44 and in this Article is initiated pursuant to

Article 98 and the scope thereof includes medicinal products covered by a centralised

marketing authorisation pursuant to Article 98(2), second subparagraph, the Commission

shall, where necessary, adopt decisions to vary, suspend or revoke the marketing

authorisations or to refuse the renewal of the marketing authorisations concerned in

accordance with this Article.

SECTION 6

RESULTS OF EXAMINATION OF A NATIONAL

MARKETING AUTHORISATION APPLICATION

Article 46

Granting of a national marketing authorisation

1. When the competent authority of a Member State grants a national marketing

authorisation, it shall inform the marketing authorisation applicant of the summary of

product characteristics, the package leaflet, the labelling as well as any conditions

established in accordance with Articles 47 and 48 together with any deadlines for the

fulfilment of those conditions.

2. The competent authorities of the Member States shall take all necessary measures to ensure

that the information given in the summary of product characteristics complies with that

accepted when the national marketing authorisation is granted or subsequently.

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3. The competent authorities of the Member States shall draw up an assessment report and

make comments on the file as regards the results of the pharmaceutical and non-clinical

tests, the clinical studies, the risk management system, the ERA and the pharmacovigilance

system of the medicinal product concerned.

4. The competent authorities of the Member States shall make the assessment report publicly

available without undue delay, together with the reasons for their opinion, after deletion of

any information of a commercially confidential nature. Reasons shall be provided

separately for each therapeutic indication applied for.

5. The public assessment report referred to in paragraph 3 and 4 shall include a summary

written in a manner that is understandable to the public. The summary shall contain, in

particular, a section relating to the conditions of use of the medicinal product.

6. The competent authorities of the Member States shall, without undue delay, make publicly

available the national marketing authorisation together with the summary of product

characteristics, the package leaflet, the antimicrobial stewardship plan and special

information requirements referred to in Article 18(1), points (a) and (b), as well as any

conditions established in accordance with Articles 47 and 48 and any obligations imposed

subsequently in accordance with Article 89, together with any deadlines for the fulfilment

of those conditions and obligations for each medicinal product that they have authorised.

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Article 47

National marketing authorisation subject to conditions

1. A national marketing authorisation for a medicinal product may be granted subject to one

or more of the following conditions:

(a) to take certain measures to ensure the safe use of the medicinal product to be

included in the risk management system;

(b) to conduct post-authorisation safety studies;

(c) to comply with obligations regarding the recording or reporting of suspected adverse

reactions that are stricter than those referred to in Chapter IX;

(d) to comply with any other conditions or restrictions with regard to the safe and

effective use of the medicinal product;

(e) to have an adequate pharmacovigilance system in place;

(f) to conduct post-authorisation efficacy studies where concerns relating to some

aspects of the efficacy of the medicinal product are identified and can be resolved

only after the medicinal product has been marketed;

(g) in the case of medicinal products for which there is substantial uncertainty as to the

surrogate endpoint in relation to the expected health outcome, to impose, where

appropriate and relevant for the benefit-risk balance, a post-authorisation obligation

to substantiate the clinical benefit;

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(h) to conduct post-authorisation ERA studies, to collect monitoring data or information

on use, or to implement appropriate risk mitigation measures, where identified or

potential concerns about risks to the environment or public health, including

antimicrobial resistance, need to be further investigated or mitigated after the

medicinal product has been marketed;

(i) to conduct post-authorisation studies in order to improve the safe and effective use of

the medicinal product;

(j) where appropriate, to carry out medicinal product-specific validation studies to

replace animal-based control methods with non-animal-based control methods.

An obligation to conduct post-authorisation efficacy studies referred to in the first

subparagraph, point (f), shall be based on the delegated acts adopted pursuant to Article 90.

2. The national marketing authorisation shall lay down deadlines for the fulfilment of the

conditions referred to in paragraph 1, first subparagraph, where necessary.

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Article 48

National marketing authorisation under exceptional circumstances

1. In exceptional circumstances where, with regard to a marketing authorisation application

under Article 7 for a medicinal product or an application for a variation of an existing

marketing authorisation under Article 94 for a new therapeutic indication, an applicant is

unable to provide comprehensive data on the efficacy and safety of the medicinal product

under normal conditions of use, the competent authority of the Member State may, by way

of derogation from Article 7, grant a national marketing authorisation under Article 46,

subject to specific conditions, where the following requirements are met:

(a) the applicant has demonstrated, in accordance with Annex II, that there are objective

and verifiable reasons why it is unable to submit comprehensive data on the efficacy

and safety of the medicinal product under normal conditions of use;

(b) except for the data referred to in point (a), the application is complete and satisfies all

the requirements of this Directive;

(c) specific conditions are included in the decision of the competent authorities of the

Member States, in particular to ensure the safety of the medicinal product as well to

ensure that the marketing authorisation holder notifies to the competent authorities of

the Member States any incident relating to its use and takes appropriate action where

necessary.

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2. The maintenance of the authorised new therapeutic indication and of the validity of the

national marketing authorisation under exceptional circumstances shall be subject to a

reassessment of the conditions set out in paragraph 1, carried out in accordance with

paragraph 3.

3. The competent authorities of the Member States shall reassess the conditions set out in

paragraph 1 two years after the date when the new therapeutic indication was authorised or

the national marketing authorisation was granted, or within a shorter deadline specified by

the competent authorities of the Member States, and thereafter at a risk-based frequency to

be determined by the competent authorities of the Member States and specified in the

national marketing authorisation.

The reassessment of the conditions shall be conducted on the basis of an application by the

marketing authorisation holder to maintain the authorised new therapeutic indication or to

maintain the validity of the national marketing authorisation under exceptional

circumstances.

Article 49

Validity and renewal of national marketing authorisations

1. Without prejudice to paragraph 4, the national marketing authorisation for a medicinal

product shall be valid for an unlimited period.

By way of derogation from the first subparagraph, a national marketing authorisation

granted in accordance with Article 48(1) shall be valid for five years.

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By way of derogation from the first subparagraph, the competent authority of the

Member State may decide at the time of granting the national marketing authorisation, on

objectively and duly justified grounds relating to safety of the medicinal product, to limit

the validity of the national marketing authorisation to five years.

2. The marketing authorisation holder may submit an application for a renewal of a national

marketing authorisation as referred to in paragraph 1, second or third subparagraph. Such

application shall be submitted at least nine months before the validity of the national

marketing authorisation expires.

3. Once the application for a renewal has been submitted within the time limit provided for in

paragraph 2, the national marketing authorisation shall remain valid until the competent

authority of the Member State adopts a decision on the renewal.

4. The competent authority of the Member State may renew the national marketing

authorisation on the basis of a re-evaluation of the benefit-risk balance. Once renewed, the

national marketing authorisation shall be valid for an unlimited period.

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Article 50

Refusal of a national marketing authorisation

1. The competent authority of the Member State shall refuse to grant a national marketing

authorisation where, after verification of the particulars and documents referred to in

Article 7 and subject to the specific requirements laid down in Articles 10 to 15, it

considers that:

(a) any of the particulars or documents submitted in support of the application does not

comply with Article 7, paragraphs 1 to 6, or Articles 10 to 15;

(b) the benefit-risk balance is not favourable;

(c) the applicant has not properly or sufficiently demonstrated the quality, safety or

efficacy of the medicinal product;

(d) the qualitative and quantitative composition of the medicinal product is not as

declared;

(e) the ERA is incomplete or insufficiently substantiated or the risks identified in the

ERA have not been sufficiently addressed by the applicant, including through risk

mitigation measures, unless the applicant has duly justified and substantiated the

reasons for the incomplete or insufficiently substantiated ERA, and the competent

authority of the Member State considers that the marketing authorisation can be

granted subject to the condition that post-authorisation ERA studies be conducted

or risk mitigation measures be implemented, as referred to in Article 47(1), point (h).

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(f) the labelling and the package leaflet proposed by the applicant do not comply with

Chapter VI or they are not in accordance with the particulars listed in the summary of

product characteristics.

2. The marketing authorisation applicant or the marketing authorisation holder shall be

responsible for the accuracy of the particulars and documents submitted.

SECTION 7

SPECIFIC REQUIREMENTS FOR PAEDIATRIC MEDICINAL PRODUCTS

Article 51

Compliance with the agreed paediatric investigation plan

1. The competent authority of the Member State in which a marketing authorisation

application or an application for a variation of a marketing authorisation is submitted under

this Chapter or Chapter VIII, shall verify whether it complies with the requirements laid

down in Article 7(5).

2. Where a marketing authorisation application or an application for a variation of a

marketing authorisation is submitted in accordance with the procedure set out in this

Chapter, Section 3 or 4, the verification of compliance, including, as appropriate,

requesting an opinion of the Agency in accordance with paragraph 3, point (b), shall be

conducted by the reference Member State.

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3. The Committee for Medicinal Products for Human Use may, in the following cases, be

requested to provide its opinion as to whether studies conducted by the applicant are in

compliance with the paediatric investigation plan agreed in accordance with Article 79

of Regulation (EU) 2026/…+:

(a) by the applicant, prior to submitting a marketing authorisation application or an

application for a variation of a marketing authorisation;

(b) by the competent authority of the Member State, when validating a marketing

authorisation application or an application for a variation of a marketing

authorisation that does not already include such an opinion.

4. In the case of a request in accordance with paragraph 3, point (a), the applicant shall not

submit its application until the Committee for Medicinal Products for Human Use has

provided its opinion, and a copy thereof shall be annexed to the application.

5. Member States shall take due account of any opinion provided in accordance with

paragraph 3.

6. When the competent authority of the Member State, during the scientific assessment of a

valid application for a marketing authorisation or for a variation of a marketing

authorisation, concludes that the studies are not in conformity with the agreed paediatric

investigation plan, the medicinal product shall not be eligible for the rewards and

incentives provided for in Article 88.

+ OJ: please insert in the text the number of the Regulation in document ST 7105/26

(2023/0131(COD)).

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Article 52

Data deriving from a paediatric investigation plan

1. Where a marketing authorisation or a variation of a marketing authorisation is granted in

accordance with this Chapter or Chapter VIII:

(a) the results of all studies conducted in compliance with an agreed paediatric

investigation plan as referred to in Article 7(5), point (a), shall be included in the

summary of product characteristics and, if appropriate, in the package leaflet of the

medicinal product concerned; or

(b) any waiver as referred to in Article 7(5), point (b), shall be recorded in the summary

of product characteristics and, if appropriate, in the package leaflet of the medicinal

product concerned.

2. If the application complies with all the measures contained in the agreed completed

paediatric investigation plan and if the summary of product characteristics reflects the

results of studies conducted in compliance with that agreed paediatric investigation plan,

the competent authority of the Member State shall include within the marketing

authorisation a statement indicating compliance of the application with the agreed

completed paediatric investigation plan. The competent authority of the Member State

shall make the conclusions of the assessment regarding compliance with the agreed

completed paediatric investigation plan publicly available.

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3. An application for new therapeutic indications, including paediatric indications, new

pharmaceutical forms, new strengths and new routes of administration of medicinal

products authorised in accordance with this Chapter or Chapter VIII and which are

protected either by a supplementary protection certificate under Regulation

(EC) No 469/2009, or by a patent which qualifies for the granting of a supplementary

protection certificate, may be referred to the Committee for Medicinal Products for Human

Use under the procedure laid down in Articles 44 and 45.

4. The procedure referred to in paragraph 3 shall be limited to the assessment of the specific

section of the summary of product characteristics to be varied.

Chapter IV

Prescription status

Article 53

Prescription status of medicinal products

1. When a marketing authorisation is granted, the competent authorities shall, by applying the

criteria laid down in Article 54, specify the prescription status of the medicinal product as:

(a) a medicinal product subject to medical prescription; or

(b) a medicinal product not subject to medical prescription.

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2. The competent authorities of the Member States may provide for sub-categories of

medicinal products that are subject to the following prescription status:

(a) medicinal products subject to medical prescription for renewable or non-renewable

delivery;

(b) medicinal products subject to special medical prescription;

(c) medicinal products subject to restricted medical prescription, reserved for use in

specific specialised areas.

Article 54

Medicinal products subject to medical prescription

1. A medicinal product shall be subject to medical prescription pursuant to Article 53(1),

point (a), where it:

(a) is likely to present a danger either directly or indirectly, even when used correctly, if

used without medical supervision;

(b) is frequently and to a very wide extent used incorrectly, and as a result is likely to

present a direct or indirect danger to human health;

(c) contains substances or preparations thereof, the activity or adverse reactions of which

require further investigation;

(d) is normally prescribed by a doctor to be administered parenterally;

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(e) is an antimicrobial; or

(f) contains an active substance which is persistent, bioaccumulative and toxic; very

persistent and very bioaccumulative; persistent, mobile and toxic; or very persistent

and very mobile, and for which medical prescription is required as a risk

minimisation measure with regard to the environment, unless other circumstances of

use justify otherwise.

2. Member States may set one or more of the following conditions to the prescription of

medicinal products referred to in paragraph 1, point (e), or to the prescription of medicinal

products containing active substances referred to in paragraph 1, point (f):

(a) limiting the quantities prescribed to the amount required for the treatment or

therapy concerned;

(b) restricting the validity of the medical prescription; or

(c) subjecting certain antimicrobials to special medical prescription or restricted medical

prescription.

3. Where the Member State provides for a sub-category of medicinal products to be subject to

special medical prescription, it shall take account of whether:

(a) the medicinal product contains, in a non-exempt quantity, a substance classified as a

narcotic or a psychotropic substance within the meaning of international

conventions;

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(b) the medicinal product is likely, if incorrectly used, to present a substantial risk of

abuse of medicinal products, to lead to addiction or be misused for illegal purposes;

or

(c) the medicinal product contains a substance that, by reason of its novelty or

properties, could, as a precautionary measure, be considered as belonging to the

group set out in point (b).

4. Where the Member State provides for a sub-category of medicinal products to be subject to

restricted medical prescription, it shall take account of whether:

(a) the medicinal product, because of its pharmaceutical characteristics or novelty or in

the interests of public health, is reserved for treatments that can only be followed in a

hospital environment;

(b) the medicinal product is used in the treatment of conditions that can only be

diagnosed in a hospital environment or in institutions with adequate diagnostic

facilities, irrespective of where the medicinal product is administered and of where

follow-up takes place;

(c) the medicinal product is intended for outpatients but its use may produce very serious

adverse reactions requiring a medical prescription drawn up as required by a

specialist and special supervision throughout the treatment.

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5. The competent authority of a Member State may waive application of paragraphs 1, 3

and 4, taking into account:

(a) the maximum single dose, the maximum daily dose, the strength, the pharmaceutical

form, certain types of packaging; or

(b) except for medicinal products referred to in paragraph 1, point (e), other

circumstances of use that it has specified.

6. The competent authority of a Member State may waive application of paragraphs 1, 3

and 4 for medicinal products referred to in paragraph 1, point (e), for topical use.

7. If a Member State does not provide for sub-categories of medicinal products, the

competent authority of that Member State shall nevertheless take into account the criteria

laid down in paragraphs 3 and 4 of this Article in determining whether a given medicinal

product is a medicinal product subject to medical prescription.

Article 55

Medicinal products not subject to medical prescription

A medicinal product shall not be subject to medical prescription if the medicinal product does not

meet the criteria in Article 54(1), (3) and (4) or if Article 54(5) or (6) is applicable.

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Article 56

Amendment of prescription status

When new facts are brought to their attention, the competent authorities shall examine and, as

appropriate, amend the prescription status of a medicinal product by applying the criteria listed

in Article 54.

In the case of a potential, expected or actual shortage of a medicinal product that puts patients’

needs or public health at risk, the competent authorities of the Member States may temporarily

amend the prescription status of a medicinal product from ‘not subject to medical prescription’ to

‘subject to medical prescription’ or from ‘subject to medical prescription’ to ‘subject to restricted

medical prescription’. The amendment shall be withdrawn as soon as the shortage or risk of

shortage ceases.

Article 57

Data protection of evidence for the change of prescription status

Where a change of prescription status of a medicinal product has been authorised on the basis of

significant non-clinical tests or clinical studies, the competent authority of the Member State, or the

Agency, as applicable, shall not refer to the results of those tests or studies when examining an

application by another marketing authorisation applicant for or marketing authorisation holder for a

change of prescription status of the same substance for one year after the initial change was

authorised.

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Chapter V

Obligations and liability of the marketing authorisation holder

Article 58

General obligations

1. Where a marketing authorisation has been granted, the marketing authorisation holder shall

be responsible for making the medicinal product that is covered by the marketing

authorisation available on the market. The designation of a marketing authorisation holder

representative shall not relieve the marketing authorisation holder of its legal

responsibility.

2. The holder of a marketing authorisation for a medicinal product placed on the market in a

Member State shall notify the competent authority of that Member State of the date of

placing on the market in that Member State, taking into account the various presentations

authorised.

3. Where a marketing authorisation is withdrawn, all relevant provisions of this Directive and

of Regulation (EU) 2026/…+ shall continue to apply to the medicinal product that was

placed on the market under that marketing authorisation before the date of the withdrawal

for an appropriate period. That period shall be approved by the competent authority prior

to the withdrawal of the marketing authorisation.

+ OJ: please insert in the text the number of the Regulation in document ST 7105/26

(2023/0131(COD)).

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4. The holder of a marketing authorisation for a medicinal product placed on the market in a

Member State shall, within the limits of its responsibility, ensure appropriate and continued

supplies of that medicinal product to wholesale distributors, pharmacies or other persons

authorised to supply medicinal products so that the needs of patients in that Member State

are met.

The arrangements for implementing the first subparagraph shall be justified on grounds of

public health protection and be proportionate in relation to the objective of such protection,

in accordance with the TFEU, particularly as regards the free movement of goods and

competition.

5. The marketing authorisation holder shall, at all stages of manufacturing and distribution,

ensure and verify that the starting materials, the ingredients of the medicinal products and

the medicinal products themselves are in compliance with the requirements of this

Directive and, where relevant, Regulation (EU) 2026/…+ and other Union law.

6. For integral combinations of a medicinal product with a medical device and for

combinations of a medicinal product with a product other than a medical device, the

marketing authorisation holder shall be responsible for the whole product in terms of

compliance of the medicinal product with the requirements of this Directive and

Regulation (EU) 2026/…+.

+ OJ: please insert in the text the number of the Regulation in document ST 7105/26

(2023/0131(COD)).

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7. The marketing authorisation holder shall be established in the Union.

8. Where the marketing authorisation holder considers, or has reason to believe, that the

medicinal product it has made available on the market is not in compliance with the

marketing authorisation or this Directive or Regulation (EU) 2026/…+ it shall

immediately:

(a) take the corrective action necessary to bring the medicinal product into conformity,

or to withdraw or recall it, as appropriate; and

(b) inform the competent authorities of the Member States or the Agency, as applicable,

and the distributors concerned to that effect.

9. Upon request, the marketing authorisation holder shall provide the competent authorities of

the Member States or the Agency, as applicable, with free samples in sufficient quantities

to enable controls to be carried out on the medicinal products that it has placed on the

market.

10. Upon request, the marketing authorisation holder shall provide the competent authority of

the Member State or the Agency, as applicable, with all data relating to the volume of sales

of the medicinal product and any data in its possession relating to the volume of medical

prescriptions for the medicinal product.

+ OJ: please insert in the text the number of the Regulation in document ST 7105/26

(2023/0131(COD)).

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Article 59

Specific requirements on the making available and supply

of a medicinal product in a Member State

1. With a view to facilitating access to a medicinal product that is covered by a valid

marketing authorisation within the territory of a Member State and that is subject to

regulatory protection under Article 83 or, if applicable, market exclusivity in accordance

with Article 73 of Regulation (EU) 2026/…+, a Member State may request the marketing

authorisation holder to place the medicinal product on the market of that Member State and

to supply it so that the needs of patients in the Member State in question are met as

specified by that Member State.

2. For the purposes of paragraph 1, a Member State may require the marketing authorisation

holder to do one or more of the following:

(a) submit a valid pricing and reimbursement application, in accordance with national

law;

(b) fulfil specific requirements for marketing authorisation holders in procurement

procedures, in accordance with national and Union law;

(c) establish a roll-out plan, in accordance with paragraph 3.

The practical arrangements to implement the requirements referred to in this

paragraph shall be proportionate to the objective pursued and in accordance with Union

law.

+ OJ: please insert in the text the number of the Regulation in document ST 7105/26

(2023/0131(COD)).

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3. For the purposes of paragraph 2, point (c), the roll-out plan shall include information about

the supply of the medicinal product by the marketing authorisation holder over a given

period in the Member State concerned. The roll-out plan shall be prepared by the

marketing authorisation holder and be agreed by the Member State concerned. The

Member State may, where justified, require the marketing authorisation holder to update

the roll-out plan.

4. Requests pursuant to paragraph 1, together with the practical arrangements referred to in

paragraph 2, shall be communicated to the marketing authorisation holder, within one year

of the granting of the marketing authorisation for the medicinal product concerned. The

communication under this paragraph shall contain explicit reference to this Article.

For the purposes of implementing this Article, the Member State and the marketing

authorisation holder shall cooperate in good faith and make best efforts to ensure, within

the limits of their responsibility, the availability and supply of the medicinal product

concerned.

5. Where, within three years of the date on which a Member State submitted its request

pursuant to paragraph 2 of this Article, the marketing authorisation holder has not, within

the limits of its responsibilities, made the medicinal product available and has not supplied

it continuously within that period so that the needs of patients in the requesting

Member State are met, the regulatory market protection for that medicinal product

provided for in Article 83(2) of this Directive, and, if applicable, the extension of market

exclusivity provided for in Article 74(1) of Regulation (EU) 2026/…+ shall not apply

within that Member State. In such cases, Article 169(5) of this Directive shall apply.

+ OJ: please insert in the text the number of the Regulation in document ST 7105/26

(2023/0131(COD)).

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6. The Member State shall make the information referred to in paragraph 5 publicly available

without undue delay. For medicinal products authorised in accordance with Regulation

(EU) 2026/…+, the Member State shall also notify the Agency.

7. By way of derogation from Article 83(1), a marketing authorisation application may be

validated and assessed by the competent authorities of the Member States or the Agency

six years after the start of the regulatory data protection period of the reference medicinal

product, where the medicinal product is a generic medicinal product or a biosimilar

medicinal product and where a Member State has made information publicly available with

regard to that reference medicinal product in accordance with paragraph 6.

Marketing authorisations validated and assessed in accordance with the first subparagraph

shall not be granted prior to the expiry of the regulatory data protection period.

8. This Article shall not affect the application of national legislation or procedural rules,

including with regard to pricing and reimbursement, public procurement or any other

procedures, that aim at making available and supplying the medicinal product concerned

within the territory of the Member States at any time following the granting of the

marketing authorisation.

This Article shall also not affect the right of marketing authorisation holders to make

available and supply the medicinal product concerned in a Member State by following the

relevant procedures under national law, regardless of whether a request in accordance with

paragraph 1 has been made by that Member State.

+ OJ: please insert in the text the number of the Regulation in document ST 7105/26

(2023/0131(COD)).

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9. Member States’ representatives may request the Commission to discuss issues related to

the practical application of this Article in the Committee established by Council

Decision 75/320/EEC50 (‘Pharmaceutical Committee’). The Commission may invite bodies

responsible for health technology assessments as referred to in Regulation (EU) 2021/2282

of the European Parliament and of the Council51 or national bodies responsible for pricing

and reimbursement, as required, to participate in the deliberations of the Pharmaceutical

Committee.

The Pharmaceutical Committee may exchange views on national measures envisaged in

the event that the obligations under this Article are not met.

10. Marketing authorisation holders shall comply with the obligations set out in this Article,

except in exceptional and unforeseeable circumstances, such as those related to disruptions

of supply, or in duly justified circumstances that are entirely outside the marketing

authorisation holder’s control, the consequences of which could not have been avoided

even if all best and reasonable measures had been taken. In such cases the marketing

authorisation holder shall provide an explanation of the case and circumstances and justify

the reasons for non-compliance.

50 Council Decision 75/320/EEC of 20 May 1975 setting up a pharmaceutical committee

(OJ L 147, 9.6.1975, p. 23, ELI: http://data.europa.eu/eli/dec/1975/320/oj). 51 Regulation (EU) 2021/2282 of the European Parliament and of the Council

of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU

(OJ L 458, 22.12.2021, p. 1, ELI: http://data.europa.eu/eli/reg/2021/2282/oj).

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Article 60

Responsibility to report public financial support

1. Marketing authorisation holders shall publicly declare any direct financial support received

from any public authority, publicly funded body, philanthropic organisation or

not-for-profit organisation or fund, in relation to any activities for the research and

development of a medicinal product covered by a national or centralised marketing

authorisation, irrespective of the legal entity that received that support.

2. Within 30 days of the granting of the marketing authorisation, the marketing authorisation

holder shall:

(a) draw up an electronic report listing:

(i) the amount of financial support received and the date thereof;

(ii) the entity that provided the financial support referred to in point (i);

(iii) the legal entity that received the support referred to in point (i);

(b) ensure that the electronic report is accurate and that it has been audited by an

independent external auditor;

(c) make the electronic report accessible to the public via a dedicated webpage;

(d) communicate the electronic link to such webpage to the competent authority of the

Member State or, where appropriate, to the Agency.

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3. For the medicinal products authorised under this Directive, the competent authority of the

Member State shall communicate in a timely manner the electronic link to the Agency.

4. Marketing authorisation holders shall keep the electronic link up to date and, as necessary,

update the report annually.

5. The Member States shall take appropriate measures to ensure that paragraphs 1, 2 and 4 are

complied with by the marketing authorisation holders established within their territory.

6. The Commission shall adopt implementing acts to lay down the principles and format for

the information to be reported pursuant to paragraph 2, by … [18 months from the date of

entry into force of this Directive]. Those implementing acts shall be adopted in accordance

with the examination procedure referred to in Article 217(2).

Article 61

Traceability of substances used in the manufacture of medicinal products

1. The marketing authorisation holder shall, when necessary, ensure the traceability of an

active substance, starting material, excipient or any other substance intended or expected to

be present in a medicinal product at all stages of manufacturing and distribution.

2. The marketing authorisation holder shall be able to identify any natural or legal person

from whom it has been supplied with an active substance, starting material, excipient or

any other substance intended or expected to be present in a medicinal product.

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3. The marketing authorisation holder and its suppliers of an active substance, starting

material, excipient or any other substance used in the manufacture of a medicinal product

shall have in place systems and procedures that allow for the information referred to in

paragraph 2 to be made available, upon request, to the competent authorities of the

Member States or the Agency, as applicable.

4. The marketing authorisation holder and its suppliers shall have in place systems and

procedures to identify the other natural or legal persons to whom an active substance,

starting material, excipient or any other substance used in the manufacture of a medicinal

product referred to in paragraph 2 have been supplied. This information shall, upon

request, be made available to the competent authorities of the Member States or the

Agency, as applicable.

Article 62

Placing on the market of products with paediatric indications

Where a medicinal product is authorised for a paediatric indication following completion of an

agreed paediatric investigation plan and that medicinal product has already been marketed with

other therapeutic indications, the marketing authorisation holder shall, within two years of the date

on which the medicinal product is authorised for that paediatric indication, place the medicinal

product on the market taking into account that paediatric indication in all Member States where the

medicinal product is already placed on the market.

A register, coordinated by the Agency, and made publicly available, shall mention deadlines that

apply pursuant to this Article.

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Article 63

Discontinuation of the placing on the market of paediatric medicinal products

If a medicinal product is authorised for a paediatric indication and the marketing authorisation

holder has benefited from rewards or incentives under Article 88 of this Directive or Article 95 of

Regulation (EU) 2026/…+, and those periods of protection have expired, and if the marketing

authorisation holder intends to discontinue placing the medicinal product on the market, the

marketing authorisation holder shall transfer the marketing authorisation to a third party or allow a

third party, which has declared its intention to continue to place the medicinal product in question

on the market, to use the pharmaceutical, non-clinical and clinical documentation contained in the

file of the medicinal product on the basis of Article 15 of this Directive.

The marketing authorisation holder shall inform the competent authorities of the Member States or

the Agency, as applicable, of its intention to discontinue the placing on the market of the medicinal

product no less than twelve months before the discontinuation. The competent authorities of the

Member States or the Agency, as applicable, shall make this fact publicly available.

Article 64

Liability of the marketing authorisation holder

The granting of a marketing authorisation shall not affect the civil and criminal liability of the

marketing authorisation holder.

+ OJ: please insert in the text the number of the Regulation in document ST 7105/26

(2023/0131(COD)).

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Chapter VI

Product information

Article 65

Summary of product characteristics

1. The summary of product characteristics shall contain the particulars listed in Annex V.

2. For marketing authorisations under Articles 10 to 13 and subsequent variations of such

marketing authorisations, if one or more of the therapeutic indications, posologies,

pharmaceutical forms, methods or routes of administration or any other way in which the

medicinal product may be used and that are part of the summary of product characteristics

of the reference medicinal product are still covered by a patent or a supplementary

protection certificate for medicinal products at the time when the generic, biosimilar,

hybrid or biohybrid medicinal product is marketed, the applicant for a marketing

authorisation or a variation of a marketing authorisation for a generic, biosimilar, hybrid or

biohybrid medicinal product can request that such information not be included in its

marketing authorisation. In such cases, however, all relevant safety information related to

the safe use of the medicinal product shall be included in the summary of product

characteristics.

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Article 66

General principles for package leaflets

1. A package leaflet shall be mandatory for medicinal products. The package leaflet shall be

made available by the marketing authorisation holder in the packaging in paper format and

electronically in accordance with the specifications, standards and format specified by the

implementing acts adopted pursuant to paragraph 6.

2. The package leaflet shall be written and designed in a clear and understandable way,

enabling users to act appropriately, when necessary with the help of healthcare

professionals.

3. By derogation from paragraph 1, Member States may decide, for specific categories of

medicinal products or for all medicinal products, following a consultation of patients,

healthcare professionals and other relevant stakeholders, that marketing authorisation

holders are only required to make available an electronic version of the package leaflet.

If a Member State decides that marketing authorisation holders are only required to make

available an electronic version of the package leaflet:

(a) the patient’s right to a printed copy of the package leaflet shall be guaranteed upon

request and free of charge;

(b) it shall not preclude the marketing authorisation holder from providing the package

leaflet in paper format in addition to the electronic version on a voluntary basis.

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It shall be ensured that the information in digital format is easily accessible to all patients.

The marketing authorisation holder shall be responsible for preparing the electronic

version of the package leaflet and ensuring that the electronic and printed versions of the

package leaflet are made readily available to the patient.

4. The obligation to make available the package leaflet in paper format in the packaging in a

Member State shall not constitute a reason justifying a refusal by the marketing

authorisation holder to supply the medicinal product on the market in that Member State.

5. By derogation from paragraphs 1 and 2 of this Article, where the information required

under Articles 67 and 76 appears on the outer packaging or on the immediate packaging, a

package leaflet shall not be required.

6. The Commission shall by … [18 months from the date of entry into force of the Directive]

adopt implementing acts to:

(a) establish common standards and formats for the electronic version of the package

leaflet, the summary of product characteristics and the labelling, taking into account

available technologies;

(b) establish criteria for the provision of the product information referred to in point (a)

by the marketing authorisation holder through secure digital platforms and digital

services and for the provision, establishment, management and accessibility of such

digital platforms and services;

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(c) establish the necessary procedures to validate the electronic version of the package

leaflet and to make them available to patients;

(d) specify information on the packaging on how to access the electronic version of the

package leaflet;

(e) specify the details on how to include the commonly recognised global antimicrobial

resistance symbol as referred to in Article 72(2) in the section of the package leaflet

that contains specific information about the medicinal product concerned and

information on antimicrobial resistance and on the importance of appropriate use and

disposal of antimicrobials.

Those implementing acts shall be adopted in accordance with the examination procedure

referred to in Article 217(2).

7. The Agency shall make a system available to accommodate the electronic product

information after consultation with Member States and the relevant stakeholders. The

system shall be available by … [18 months from the date of entry into force of

this Directive].

8. When accessing the package leaflet electronically, the protection of personal data shall be

ensured. Any technology giving access to the information shall ensure the protection of

personal data in accordance with Regulation (EU) 2016/679 and Directive 2002/58/EC and

shall not allow the identification, profiling or tracking of individuals, nor shall it be used

for commercial purposes, including for advertising or marketing activities.

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Article 67

Content of package leaflet

1. The package leaflet shall be drawn up in accordance with the summary of product

characteristics referred to in Article 65(1) and shall include the particulars listed

in Annex VI.

2. The package leaflet shall reflect the results of consultations with target patient groups to

ensure that it is legible, clear and easy to use.

Article 68

Labelling on the outer or immediate packaging

1. Labelling particulars listed in Annex IV shall appear on the outer packaging of medicinal

products or, where there is no outer packaging, the immediate packaging, with the

exception of the packaging referred to in Article 69, paragraphs 2 and 3.

2. The Commission is empowered to adopt delegated acts in accordance with Article 218 to:

(a) amend the list of labelling particulars set out in Annex IV in order to take account of

scientific progress or patients’ needs;

(b) supplement Annex IV by setting out a reduced list of mandatory labelling particulars

that shall appear on the outer packaging of multi-country packages that are also

multilingual.

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Article 69

Labelling on blister packs or small immediate packaging

1. The labelling particulars listed in Annex IV shall appear on immediate packaging other

than immediate packaging referred to in paragraphs 2 and 3.

2. On immediate packaging that takes the form of blister packs and that is placed in an outer

packaging that complies with the requirements laid down in Articles 68 and 76, at least the

following particulars shall appear:

(a) the name of the medicinal product;

(b) the name of the marketing authorisation holder placing the product on the market;

(c) the expiry date;

(d) the batch number.

3. On small immediate packaging units on which the particulars laid down in Articles 68

and 76 cannot be displayed, at least the following particulars shall appear:

(a) the name of the medicinal product and, if necessary, the route of administration;

(b) the method of administration, if not already evident from the name of the medicinal

product or from the route of administration of the medicinal product, as referred to in

point (a);

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(c) the expiry date;

(d) the batch number;

(e) the contents by weight, by volume or by unit.

Article 70

Safety features

1. Medicinal products subject to medical prescription shall bear the safety features referred to

in point (p) of Annex IV unless they have been listed in accordance with paragraph 2,

second subparagraph, point (b).

Medicinal products not subject to medical prescription shall not be required to bear the

safety features referred to in point (p) of Annex IV unless they have been listed in

accordance with paragraph 2, second subparagraph, point (b), or where the marketing

authorisation holder chooses to so display those features.

2. The Commission shall adopt delegated acts in accordance with Article 218 to supplement

Annex IV by laying down detailed rules for the safety features.

Those delegated acts shall set out:

(a) the characteristics and technical specifications of the unique identifier of the safety

features referred to in point (p) (ii) of Annex IV that enables the authenticity of

medicinal products to be verified and individual packs to be identified;

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(b) the lists containing the medicinal products or product categories that, in the case of

medicinal products subject to medical prescription shall not bear the safety features,

and in the case of medicinal products not subject to medical prescription shall bear

the safety features referred to in point (p) of Annex IV;

(c) the procedures for the notification to the Commission provided for in paragraph 4

and a rapid system for evaluating and deciding on such notification for the purpose

of applying point (b);

(d) the modalities for the verification of the safety features referred to in point (p) of

Annex IV by the manufacturers, wholesale distributors, pharmacists and other

natural or legal persons authorised or entitled to supply medicinal products to the

public and by the competent authorities of the Member States or the Agency, as

applicable;

(e) provisions on the establishment, management and accessibility of a repositories

system in which information on the safety features, enabling the verification of the

authenticity and identification of medicinal products, as provided for in point (p) of

Annex IV shall be contained.

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In establishing the lists referred to in the second subparagraph, point (b), the Commission

shall take into consideration the risk of falsification relating to the medicinal products or

categories of medicinal products concerned. To this end, at least the following criteria shall

be applied:

(a) the price and sales volume of the medicinal product;

(b) the number and frequency of previous cases of falsified medicinal products being

reported within the Union and in third countries and the evolution of the number and

frequency of such cases to date;

(c) the specific characteristics of the medicinal products concerned;

(d) the severity of the conditions intended to be treated;

(e) other potential risks to public health.

The modalities referred to in the second subparagraph, point (d), shall allow the

verification of the authenticity of each supplied pack of the medicinal products bearing the

safety features referred to in point (p) of Annex IV and determine the extent of such

verification. When establishing those modalities, the particular characteristics of the supply

chains in Member States, and the need to ensure that the impact of verification measures

on particular actors in the supply chains is proportionate, shall be taken into account.

For the purposes of the second subparagraph, point (e), the costs of the repositories system

shall be borne by the marketing authorisation holder or manufacturing authorisation holder

of the medicinal product bearing the safety features, as relevant.

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3. When adopting delegated acts referred to in paragraph 2, the Commission shall take due

account of at least the following:

(a) the protection of personal data as provided for in Union law;

(b) the legitimate interests to protect information of a commercially confidential nature;

(c) the ownership and confidentiality of the data generated by the use of the safety

features; and

(d) the cost-effectiveness of the measures.

4. The competent authorities of the Member States shall notify the Commission of medicinal

products not subject to medical prescription that they consider to be at risk of falsification

and may inform the Commission of medicinal products that they consider not to be at risk

of falsification in accordance with the criteria set out in paragraph 2, third subparagraph.

5. Member States may, for the purposes of reimbursement or pharmacovigilance, extend the

scope of application of the unique identifier of the safety features referred to in

point (p) (ii) of Annex IV to any medicinal product subject to medical prescription or

subject to reimbursement.

6. The competent authorities of the Member States or the Agency, as applicable, may, for the

purposes of reimbursement, pharmacovigilance or pharmacoepidemiology or to monitor

any potential, expected or actual shortage of a medicinal product, as well as to assess the

general supply situation to avoid shortages, use the information contained in the

repositories system referred to in paragraph 2, second subparagraph, point (e).

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7. Member States may, for the purposes of patient safety, extend the scope of application of

the anti-tampering device referred to in point (p) of Annex IV to any medicinal product.

Article 71

Labelling and instruction leaflet of radionuclides and radiopharmaceuticals

1. In addition to the rules laid down in this Chapter, the outer carton and the container of

medicinal products containing radionuclides shall be labelled in accordance with the

regulations for the safe transport of radioactive materials laid down by the International

Atomic Energy Agency. Moreover, the labelling shall comply with the provisions set out

in paragraphs 2 and 3.

2. The label on the shielding shall include the particulars laid down in Article 68. In addition,

the label on the shielding shall explain in full, the codes used on the vial and shall indicate,

where necessary, for a given time and date, the amount of radioactivity per dose or per vial

and the number of capsules, or, for liquids, the number of millilitres in the container.

3. In addition to the requirements of Article 68, the vial shall be labelled with the following

information:

(a) the name of the medicinal product or code of the medicinal product, including the

name or chemical symbol of the radionuclide;

(b) the batch identification and expiry date;

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(c) the international symbol for radioactivity;

(d) the name and address of the manufacturer;

(e) the amount of radioactivity as specified in paragraph 2.

4. The marketing authorisation holder shall ensure that a detailed instruction leaflet is

enclosed with the packaging of radiopharmaceuticals, radionuclide generators,

radionuclide kits or radionuclide precursors. The text of this leaflet shall be established in

accordance with Article 67(1). In addition, the leaflet shall include any precautions to be

taken by the user and the patient during the preparation and administration of the medicinal

product and special precautions for the disposal of the packaging and its unused contents.

Article 72

Special information requirements for antimicrobials

1. The marketing authorisation holder shall ensure that educational material is available to

healthcare professionals, including through medical sales representatives as referred to in

Article 178(1), point (c), regarding the appropriate use of diagnostic tools, testing or other

diagnostic approaches related to antimicrobial-resistant pathogens, that provides

information on the use of the antimicrobial. Any such educational material shall be

compatible and in accordance with the summary of product characteristics.

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2. The marketing authorisation holder shall include a section in the beginning of the package

leaflet of antimicrobials that contains the global antimicrobial resistance symbol, specific

information about the medicinal product concerned and information on antimicrobial

resistance and on the importance of the appropriate use and disposal of antimicrobials.

Where a Member State decides, in accordance with Article 66(3), first subparagraph, that

marketing authorisation holders are only required to make available an electronic version

of the package leaflet, the information referred to in the first subparagraph of this

paragraph is made available to patients also in paper format (‘awareness card’). The

awareness card shall be presented in a distinct and immediately visible way. However, in

duly justified cases referred to in Article 78, a Member State may decide to exempt

marketing authorisation holders from the obligation to make the awareness card available

to patients in paper format.

3. The text of the information referred to in paragraph 2 shall be aligned with Annex VI.

Article 73

Legibility

The package leaflet, labelling particulars and the awareness card referred to in this Chapter shall be

easily legible and comprehensible, and indelible.

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Article 74

Accessibility for persons with disabilities

The name of the medicinal product, followed by its strength, if appropriate, and pharmaceutical

form, if appropriate, shall also be expressed in Braille format on the outer packaging. The marketing

authorisation holder shall ensure that the package leaflet referred to in Article 66 is made available

free of charge upon request from patients’ organisations in formats appropriate for persons with

disabilities, including blind and partially-sighted persons.

Article 75

Member States labelling requirements

1. Notwithstanding Article 81, Member States may require the use of certain forms of

labelling of the medicinal product making it possible to ascertain:

(a) the price of the medicinal product;

(b) the reimbursement conditions;

(c) the prescription status of the medicinal product, in accordance with Chapter IV;

(d) authenticity and identification of medicinal products in accordance

with Article 70(5).

(e) the identity of the medicinal product in accordance with national requirements,

including for statistical reasons.

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2. For medicinal products for which a centralised marketing authorisation as referred to in

Article 6 has been granted, Member States shall, when applying this Article, consider the

detailed guidance published pursuant to Article 80.

Article 76

Symbols and pictograms

The outer packaging or, where there is no outer packaging, the immediate packaging, and the

package leaflet may include symbols or pictograms designed to clarify certain particulars or

information set out in Article 67(1), and Articles 68 and 72 and other information compatible with

the summary of product characteristics that is useful for the patient, to the exclusion of any element

of a promotional nature.

Article 77

Requirements on languages

1. The package leaflet and labelling particulars referred to in Article 67(1) and in

Article 68(1) shall appear in one or more official languages of the Member State where the

medicinal product is placed on the market, as specified by that Member State for the

purposes of this Directive.

The electronic version of the package leaflet shall also appear in the English language.

2. Paragraph 1 shall not prevent the package leaflet and labelling particulars from appearing

in several languages, provided that the same particulars appear in all the languages used.

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3. The awareness card referred to in Article 72(2) shall appear in one or more official

languages of the Member State where the medicinal product is placed on the market, as

specified by that Member State for the purposes of this Directive.

4. A Member State may grant a full or partial exemption from the obligation that the package

leaflet, the labelling particulars and the awareness card be in one or more official

languages of the Member State where the medicinal product is placed on the market, as

specified by that Member State for the purposes of this Directive.

5. By way of derogation from paragraph 1, 3 or 4, in the case of multi-language packages or

multi-country packages that are also multilingual, Member States may allow that the

package leaflet, the labelling particulars and the awareness card only be in an official

language of the Union that is commonly understood in the Member States where the multi-

language package or multi-country package that is also multilingual is marketed.

Article 78

Member States exemptions from requirements for labelling and package leaflet

The competent authorities of the Member States may, subject to measures they consider necessary

to safeguard public health, grant an exemption to the obligation that the particulars required

pursuant to Articles 67, 68 and 69 are to appear in the labelling and in the package leaflet in the

following cases:

(a) where the medicinal product is not intended to be delivered directly to the patient;

(b) where there are problems in respect of the availability of the medicinal product;

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(c) where there are space constraints due to the size of the packaging or of the package leaflet

or in the case of multi-language or multi-country packages or package leaflets;

(d) in the context of a public health emergency;

(e) to facilitate access to medicines in Member States.

Article 79

Approval of the labelling and package leaflet

1. One or more mock-ups of the outer packaging and the immediate packaging of a medicinal

product, together with the package leaflet, shall be submitted to the competent authorities

of the Member States or the Agency, as applicable, when the marketing authorisation

application is submitted. The results of assessments carried out in cooperation with target

patient groups shall also be provided to the competent authorities of the Member States or

to the Agency, as applicable.

2. The competent authorities shall refuse the marketing authorisation if the labelling or the

package leaflet does not comply with this Chapter or if it is not in accordance with the

particulars listed in the summary of product characteristics.

3. Any proposed change to an aspect of the labelling or the package leaflet covered by this

Chapter that is not connected with the summary of product characteristics shall be

submitted to the competent authorities of the Member States or the Agency, as applicable.

If the competent authorities of the Member States or the Agency, as applicable, have not

opposed a proposed change within 90 days of the submission of the request, the applicant

may put the change into effect.

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4. The fact that the competent authorities do not refuse a marketing authorisation pursuant to

paragraph 2 or a change to the labelling or the package leaflet pursuant to paragraph 3 does

not alter the general legal liability of the manufacturer and the marketing authorisation

holder.

Article 80

Guidance on labelling particulars

In consultation with the Member States and the parties concerned, the Commission shall draw

up and publish detailed guidance concerning in particular:

(a) the wording of certain special warnings for certain categories of medicinal products;

(b) the wording on prudent use of antimicrobials;

(c) the particular information needs relating to medicinal products not subject to medical

prescription;

(d) the legibility of labelling particulars and particulars in the package leaflet;

(e) the methods for the identification and authentication of medicinal products;

(f) the information for specific excipients that feature in the labelling of medicinal products;

(g) harmonised provisions for the implementation of Article 75;

(h) use of symbols, pictograms and abbreviations.

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Article 81

Placing on the market of labelled medicinal products

Member States may not prohibit or impede the placing on the market of medicinal products within

their territory on grounds connected with labelling or the package leaflet where these comply with

the requirements of this Chapter.

Article 82

Non-compliance with the requirements for labelling and package leaflet

Where the provisions of this Chapter are not complied with, and a notice served on the marketing

authorisation holder concerned has remained without effect, the competent authorities of the

Member States may suspend the marketing authorisation, until the labelling and the package leaflet

of the medicinal product in question have been made to comply with this Chapter.

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Chapter VII

Regulatory data protection and regulatory market protection,

unmet medical need and rewards

for paediatric medicinal products

Article 83

Regulatory data protection and regulatory market protection

1. Where a marketing authorisation has been granted for a medicinal product in accordance

with Article 7(2) of this Directive, the data referred to in Annex I that were submitted with

a view to obtaining that marketing authorisation shall not be referred to by another

marketing authorisation applicant for a subsequent marketing authorisation for a period of

eight years from the date when the marketing authorisation for that medicinal product was

granted, or nine years from that date in cases where one additional year of data protection

is granted in accordance with Article 41(1) of Regulation (EU) 2026/…+ (‘regulatory data

protection period’). For marketing authorisations that belong to the same global marketing

authorisation in accordance with Article 6(2) of this Directive, the regulatory data

protection period shall start from the date when the initial marketing authorisation was

granted in the Union.

+ OJ: please insert in the text the number of the Regulation in document ST 7105/26

(2023/0131(COD)).

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2. A medicinal product covered by a subsequent marketing authorisation referred to in

paragraph 1 shall not be placed on the market for a period of one year after the expiry of

regulatory data protection period (‘regulatory market protection period’). The regulatory

market protection period may be extended in accordance with Article 84.

3. By way of derogation from paragraph 1, the marketing authorisation holder concerned may

grant the marketing authorisation applicant for another marketing authorisation access to

its data submitted in accordance with Annex I by means of a letter of access in accordance

with Article 15.

4. By way of derogation from paragraphs 1 and 2, when a compulsory licence has been

granted by a relevant authority in the Union pursuant to Regulation (EU) 2025/2645 or to

national compulsory licensing frameworks, the regulatory data protection and regulatory

market protection with regard to that licensee shall be suspended to the extent required by

the compulsory licence and for the duration and territory of the Member States for which

the compulsory licence has been granted.

5. The regulatory data protection period shall also apply in Member States where the

medicinal product is not authorised or is no longer authorised.

6. The competent authorities of the Member States shall make available on their website the

list of medicinal products for which they have granted a national marketing authorisation

and that are protected by regulatory data protection and regulatory market protection,

indicating the applicable extension in accordance with Article 84. The Agency shall

compile and publish a list of hyperlinks to the websites referred to in this paragraph.

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Article 84

Additional regulatory market protection periods

1. The regulatory market protection period referred to in Article 83(2) shall be extended

by 12 months:

(a) where, at the time of the initial marketing authorisation application, the marketing

authorisation applicant demonstrates that the medicinal product addresses an unmet

medical need as referred to in Article 85; or

(b) for medicinal products containing a new active substance, where the marketing

authorisation applicant demonstrates that:

(i) the clinical trials supporting the initial marketing authorisation application use

a relevant and evidence-based comparator in accordance with the scientific

advice provided by the Agency; and

(ii) the marketing authorisation application has been submitted first to the

competent authority in the Union or has been submitted no later than 90 days

of the submission of the application for the first marketing authorisation

outside the Union; or

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(c) for medicinal products containing a new active substance, where the marketing

authorisation applicant demonstrates that:

(i) the clinical trials supporting the initial marketing authorisation application use

a relevant and evidence-based comparator in accordance with the scientific

advice provided by the Agency; and

(ii) clinical trials evaluating the efficacy of the medicinal product and used for the

marketing authorisation were conducted in more than one Member State; or

(d) for medicinal products containing a new active substance, where the marketing

authorisation applicant justifies that a clinical trial as referred to in points (b)(i)

and (c)(i) is not possible or appropriate and demonstrates that:

(i) clinical trials evaluating the efficacy of the medicinal product and used for the

marketing authorisation were conducted in more than one Member State; and

(ii) the marketing authorisation application has been submitted first to the

competent authority in the Union or has been submitted no later than 90 days

of the submission of the application for the first marketing authorisation

outside the Union.

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In the case of a conditional marketing authorisation granted in accordance with Article 20

of Regulation (EU) 2026/…+, the extension referred to in the first subparagraph, point (a),

shall only apply if:

– within four years of the granting of the conditional marketing authorisation, the

medicinal product has been granted a marketing authorisation in accordance with

Article 20(7) of Regulation (EU) 2026/…+; and

– in the case of medicinal products referred to in Article 85(1), point (b), of this

Directive, the studies referred to in Article 20(4) of Regulation (EU) 2026/…+

include clinical trials that use, where possible and appropriate, a relevant and

evidence-based comparator.

2. The regulatory market protection period shall be extended by an additional year if, during

the regulatory data protection period referred to in Article 83(1), the marketing

authorisation holder obtains an authorisation for one or more new therapeutic indications

which, during the scientific evaluation prior to their authorisation and based on supporting

data submitted by the marketing authorisation holder, are held to bring a significant clinical

benefit in comparison with existing therapies. This extension may only be granted once.

3. The cumulative duration of the regulatory market protection for a medicinal product shall

not exceed two years from the date when the regulatory data protection expires,

except when one additional year of the regulatory market protection is granted in

accordance with paragraph 2.

+ OJ: please insert in the text the number of the Regulation in document ST 7105/26

(2023/0131(COD)).

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4. The Agency shall set scientific guidelines on criteria for proposing a relevant and

evidence-based comparator for clinical trials, as referred to in paragraph 1, points (b)(i)

and (c)(i), taking into account the results of the consultation of the Commission and the

authorities or bodies involved in the consultation process referred to in Article 169

of Regulation (EU) 2026/…+.

Article 85

Medicinal products addressing an unmet medical need

1. A medicinal product shall be considered as addressing an unmet medical need if at least

one of its therapeutic indications relates to a life threatening or severely debilitating disease

and either of the following conditions are met:

(a) there is no medicinal product authorised in the Union for such disease;

(b) the use of that medicinal product for such a disease results in clinically relevant

improvement in efficacy, or in safety with at least comparable efficacy, in

comparison with existing medicinal products or other methods of prevention,

diagnosis or treatment authorised in the Union.

2. Designated orphan medicinal products referred to in Article 69 of Regulation

(EU) 2026/…+ shall be considered as addressing an unmet medical need.

3. The Agency shall adopt scientific guidelines to support the application of this Article. To

this end, it shall consult the Commission and the authorities or bodies involved in the

consultation process referred to in Article 169 of Regulation (EU) 2026/…+.

+ OJ: please insert in the text the number of the Regulation in document ST 7105/26

(2023/0131(COD)).

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Article 86

Regulatory data protection for repurposed medicinal products

1. A regulatory data protection period of four years shall be granted for a medicinal product

with respect to a new therapeutic indication not previously authorised in the Union for the

active substance(s), provided that:

(a) adequate clinical studies and, where relevant, non-clinical studies or tests were

carried out in relation to the new therapeutic indication demonstrating that it is of

significant clinical benefit; and

(b) the medicinal product is authorised in accordance with Articles 10 to 13 and has not

previously benefitted from regulatory data protection or 25 years have passed since

the granting of the initial marketing authorisation for the medicinal product

concerned.

2. The regulatory data protection period referred to in paragraph 1 may only be granted once

for any given medicinal product.

3. During the regulatory data protection period referred to in paragraph 1, the marketing

authorisation shall indicate that the medicinal product is an existing medicinal product

authorised in the Union that has been authorised with an additional therapeutic indication.

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Article 87

Exception relating to intellectual property rights

1. The protection provided by patent rights or supplementary protection certificates for

medicinal products shall not be regarded as infringed when the necessary studies, trials and

other activities are conducted for the purposes of:

(a) obtaining marketing authorisations, in particular for generic, biosimilar, hybrid or

bio-hybrid medicinal products and for subsequent variations;

(b) conducting health technology assessments as defined in Article 2, point (5),

of Regulation (EU) 2021/2282;

(c) obtaining pricing and reimbursement approvals;

(d) complying with subsequent practical requirements associated with activities referred

to in points (a), (b) and (c);

(e) submitting an application on procurement tenders, in compliance with Union and

national law, to the extent that it does not entail the sale or offering for sale or

marketing of the medicinal product concerned during the protection period provided

by patent rights or supplementary protection certificates.

The activities conducted exclusively for the purposes set out in the first subparagraph may

cover, where relevant, the submission of a marketing authorisation application and the

offer, manufacture, sale, supply, storage, import, use and purchase of medicinal products or

processes, including by third party suppliers and service providers.

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2. Decisions adopted concerning the activities referred to in paragraph 1 shall not be

considered as infringing intellectual property rights, within the meaning of that paragraph.

The intellectual property rights on the reference medicinal product shall not represent a

valid ground to refuse, revoke or suspend decisions adopted concerning the activities

referred to in paragraph 1.

3. The exception provided for in this Article shall not cover the placing on the market of the

medicinal products resulting from such activities.

Article 88

Rewards for paediatric medicinal products

1. Where a marketing authorisation application includes the results of all studies conducted in

compliance with an agreed paediatric investigation plan, the holder of the patent or

supplementary protection certificate shall be entitled to a six-month extension of the period

referred to in Article 13(1) and (2) of Regulation (EC) No 469/2009.

The first subparagraph shall also apply where completion of the agreed paediatric

investigation plan fails to lead to the authorisation of a paediatric indication, but the results

of the studies conducted are reflected in the summary of product characteristics and, if

appropriate, in the package leaflet of the medicinal product concerned.

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2. The inclusion in a marketing authorisation of the statement referred to in Article 52(2) of

this Directive or in Article 92(2) of Regulation (EU) 2026/…+ shall be used for the

purposes of applying paragraph 1.

3. Where the procedures laid down in Chapter III, Sections 3 and 4, have been used, the

six-month extension of the period referred to in paragraph 1 shall be granted only if the

medicinal product is authorised in all Member States.

4. In the case of an application for new therapeutic indications, which leads to the

authorisation of a new paediatric indication for a medicinal product which is protected

either by a supplementary protection certificate under Regulation (EC) No 469/2009, or by

a patent which qualifies for the granting of a supplementary protection certificate,

paragraphs 1, 2 and 3 shall not apply if the applicant applies for, and obtains, a one-year

extension of the market protection period for the medicinal product concerned, on the

grounds that this new paediatric indication brings a significant clinical benefit in

comparison with existing therapies, in accordance with Article 84(2).

+ OJ: please insert in the text the number of the Regulation in document ST 7105/26

(2023/0131(COD)).

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Chapter VIII

Post-marketing authorisation measures

Article 89

Imposed post-authorisation studies

1. After the granting of a national marketing authorisation, the competent authority of the

Member State may impose an obligation on the marketing authorisation holder:

(a) to conduct a post-authorisation safety study if there are concerns about the risks of an

authorised medicinal product. If the same concerns apply to more than one medicinal

product, the competent authority of the Member State shall, following consultation

with the Pharmacovigilance Risk Assessment Committee, encourage the marketing

authorisation holders concerned to conduct a joint post-authorisation safety study;

(b) to conduct a post-authorisation efficacy study when the understanding of the disease

or the clinical methodology indicate that previous efficacy evaluations might have to

be revised significantly. The obligation to conduct the post-authorisation efficacy

study shall be based on the delegated acts adopted pursuant to Article 90 while

taking into account the scientific guidance referred to in Article 127;

(c) to conduct any other post-authorisation studies to improve the safe and effective use

of the medicinal product, including treatment optimisation based on clinical

experience;

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(d) to conduct a post-authorisation ERA study or to collect monitoring data or

information on use, if there are concerns about the risks to the environment or public

health, including antimicrobial resistance, due to an authorised medicinal product, or

other medicinal products containing the same active substance.

If the same concerns apply to more than one medicinal product, and post­authorisation

studies are considered necessary, the competent authority of the Member State shall,

following consultation with the Agency, encourage the marketing authorisation holders

concerned to conduct a joint post-authorisation ERA study.

The imposition of an obligation as referred to in this paragraph shall be duly justified,

notified in writing, and shall include the objectives and timeframe for submission and

conduct of the study.

2. The competent authority of the Member State shall provide the marketing authorisation

holder with an opportunity to present written observations in response to the imposition of

an obligation in accordance with paragraph 1 within a time limit which it shall specify, if

the marketing authorisation holder so requests within 30 days of receipt of the written

notification of the obligation.

3. On the basis of the written observations presented by the marketing authorisation holder,

the competent authority of the Member State shall withdraw or confirm the obligation

imposed in accordance with paragraph 1. Where the competent authority of the

Member State confirms the obligation, the national marketing authorisation shall be varied

to include the obligation as a condition of the national marketing authorisation and, where

appropriate, the risk management system shall be updated accordingly.

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Article 90

Delegated acts on post-authorisation efficacy studies

In order to determine the situations in which post-authorisation efficacy studies may be required

under Articles 47 and 89, the Commission is empowered to adopt delegated acts in accordance with

Article 218, to specify measures supplementing the provisions in Articles 47 and 89.

Article 91

Recording of conditions related to national marketing authorisations

The marketing authorisation holder shall incorporate any safety or efficacy conditions referred to in

Article 47(1), points (a) to (g) and (i), Article 48 and Article 89(1), points (a), (b) and (c), in the risk

management system.

Article 92

Update of marketing authorisation related to

scientific and technological developments

1. After a national marketing authorisation has been granted in accordance with Chapter III,

the marketing authorisation holder shall, in respect of the methods of manufacture and

control stated in the application for that marketing authorisation, take account of scientific

and technical progress and introduce, by means of a variation, any changes that may be

required to enable the medicinal product to be manufactured and controlled by means of

generally accepted scientific methods.

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Those changes shall be subject to the approval of the competent authority of the

Member State.

2. The marketing authorisation holder shall without undue delay provide the competent

authority of the Member State with any new information that might entail the amendment

of the particulars or documents referred to in Articles 7 and 10 to 14, Article 44(5),

Article 65, Annex I or Annex II.

In particular, the marketing authorisation holder shall without undue delay inform the

competent authority of the Member State of any prohibition or restriction imposed on the

marketing authorisation holder or any entity in contractual relationship with the marketing

authorisation holder by the competent authorities of any country in which the medicinal

product is marketed and of any other new information that might influence the evaluation

of the benefits and risks of the medicinal product concerned. The information shall include

both positive and negative results of clinical trials or other studies in all therapeutic

indications and populations, whether or not included in the national marketing

authorisation, as well as data on the use of the medicinal product where such use is outside

the terms of the marketing authorisation.

3. The marketing authorisation holder shall ensure that the terms of the national marketing

authorisation including the summary of product characteristics, the labelling and the

package leaflet are kept up to date with current scientific knowledge, including the

conclusions of the assessment and recommendations made publicly available by means of

the European medicines web-portal set up in accordance with Article 106

of Regulation (EU) 2026/…+.

+ OJ: please insert in the text the number of the Regulation in document ST 7105/26

(2023/0131(COD)).

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4. The competent authority of the Member State may at any time request the marketing

authorisation holder to submit data demonstrating that the benefit-risk balance remains

favourable. The marketing authorisation holder shall answer fully and within the time limit

set any such request. The marketing authorisation holder shall also respond fully and

within the time limit set to any request of the competent authority of the Member State

regarding the implementation of any measures previously imposed, including risk

minimisation measures.

5. The competent authority of the Member State may at any time ask the marketing

authorisation holder to submit a copy of the pharmacovigilance system master file. The

marketing authorisation holder shall submit that copy at the latest seven days after

receipt of the request.

6. The marketing authorisation holder shall also respond fully and within the time limit set to

any request of the competent authority of the Member State regarding the implementation

of any measures previously imposed with regard to risks to the environment or public

health, including antimicrobial resistance.

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Article 93

Update of risk management plans

1. The holder of a national marketing authorisation for a medicinal product referred to in

Articles 10 and 12, who did not submit a risk management plan in accordance with

Article 22 shall submit to the competent authorities of the Member States concerned a risk

management plan and a summary thereof, where the marketing authorisation for the

reference medicinal product is withdrawn but the marketing authorisation for the medicinal

product referred to in Articles 10 and 12 is maintained.

The risk management plan and the summary thereof shall be submitted to the competent

authorities of the Member States concerned within 60 days of the withdrawal of the

marketing authorisation for the reference medicinal product by means of a variation.

2. The competent authority of the Member State may impose an obligation on the holder of a

national marketing authorisation for a medicinal product referred to in Articles 10 and 12

to submit a risk management plan and summary thereof where:

(a) additional risk minimisation measures have been imposed concerning the reference

medicinal product; or

(b) it is justified on pharmacovigilance grounds.

3. In the cases referred to in paragraph 1 and paragraph 2, point (a), the risk management plan

shall be aligned with the risk management plan for the reference medicinal product.

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4. The imposition of the obligation referred to in paragraph 2 shall be duly justified in

writing, notified to the marketing authorisation holder and shall include the deadline for

submission of the risk management plan and the summary thereof by means of a variation.

Article 94

Variation of national marketing authorisations

1. An application for a variation of a national marketing authorisation by the marketing

authorisation holder shall be made electronically in the formats made available by the

Agency, unless the variation is an update by the marketing authorisation holder of their

information held in a database.

2. Variations shall be classified in different categories depending on the level of risk to public

health and the potential impact on the quality, safety and efficacy of the medicinal product

concerned. Those categories shall range from changes to terms of the national marketing

authorisation that have the highest potential impact on the quality, safety or efficacy of the

medicinal product, to changes that have no or minimal impact thereon and to

administrative changes.

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3. The procedures for examination of applications for variations shall be proportionate to the

risk and impact involved. Those procedures shall range from procedures that allow

implementation only after approval based on a complete scientific assessment to

procedures that allow immediate implementation and subsequent notification by the

marketing authorisation holder to the competent authority of the Member State. Such

procedures may also include updates by the marketing authorisation holder of their

information held in a database.

4. The Commission is empowered to adopt delegated acts in accordance with Article 218 to

supplement this Directive by establishing the following:

(a) the categories referred to in paragraph 2 in which variations shall be classified;

(b) rules for the examination of applications for variations of the terms of national

marketing authorisations, including procedures for updates through a database;

(c) the conditions for submission of a single application for more than one change to the

terms of the same national marketing authorisation and for the same change to the

terms of several national marketing authorisations;

(d) specifying exemptions from the variation procedures where the update of

information in the national marketing authorisation referred to in Annex I may be

directly implemented;

(e) the conditions and procedures for cooperation with competent authorities of third

countries or international organisations on examination of applications for variations

of the terms of national marketing authorisations.

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Article 95

Variation of marketing authorisations

under the decentralised or mutual recognition procedure

1. Any application by the marketing authorisation holder to vary a marketing authorisation

that has been granted in accordance with the Chapter III, Sections 3 and 4, shall be

submitted to all the Member States that have previously authorised the medicinal product

concerned under the procedure set out in Article 37 or 39. The same shall apply where the

initial marketing authorisations were granted through separate procedures.

2. In the case of arbitration submitted to the Commission, the procedure laid down in

Articles 44 and 45 shall apply by analogy to variations made to marketing authorisations.

Article 96

Variation based on additional evidence

The competent authority of the Member State may consider and after having informed the

marketing authorisation holder decide upon additional evidence available, independently from the

data submitted by the marketing authorisation holder. On that basis, if the additional evidence has

an impact on the benefit-risk balance of a medicinal product, the competent authority of the

Member State may recommend that the summary of product characteristics is updated. In this case

the marketing authorisation holder shall submit to the competent authority of the Member State an

appropriate application for a variation, including an updated summary of product characteristics.

For medicinal products authorised in accordance with Article 37 or 39, the reference Member State

and all Member States concerned shall be involved.

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Article 97

Variation based on paediatric studies

1. On the basis of relevant paediatric studies received in accordance with Article 45(1) of

Regulation (EC) No 1901/2006 of the European Parliament and of the Council52, the

competent authorities of the Member States may, following a consultation of the marketing

authorisation holder, vary the national marketing authorisation for the medicinal product

concerned accordingly and consequently the marketing authorisation holder shall update

the summary of product characteristics and package leaflet of the medicinal product

concerned.

2. The activities pursuant to paragraph 1 shall be concluded by … [seven years from the date

of entry into force of this Directive].

3. When a medicinal product has been authorised under Chapter III, on the basis of the

information received in accordance with Article 93 of Regulation (EU) 2026/…+, the

competent authorities of the Member States may vary the marketing authorisation of the

medicinal product concerned accordingly and consequently the marketing authorisation

holder shall update the summary of product characteristics and package leaflet of the

medicinal product concerned.

52 Regulation (EC) No 1901/2006 of the European Parliament and of the Council

of 12 December 2006 on medicinal products for paediatric use and amending Regulation

(EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation

(EC) No 726/2004 (OJ L 378, 27.12.2006, p. 1,

ELI: http://data.europa.eu/eli/reg/2006/1901/oj). + OJ: please insert in the text the number of the Regulation in document ST 7105/26

(2023/0131(COD)).

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4. The Member States shall exchange information regarding the paediatric studies submitted

and, as appropriate, their implications for any national marketing authorisations concerned.

5. The Agency shall coordinate the exchange of information under this Article.

Article 98

Union interest referral

1. The Member States or the Commission shall, in specific cases where the interests of the

Union are involved, refer the matter to the Committee for Medicinal Products for Human

Use under the procedure laid down in Articles 44 and 45 before any decision is reached on

an application for a marketing authorisation or on the suspension or revocation of a

marketing authorisation, or on any variation of the marketing authorisation that appears

necessary. The Member States and the Commission shall consider any requests by the

applicant or the marketing authorisation holder to make such a referral.

Where the referral results from the evaluation of data relating to pharmacovigilance of an

authorised medicinal product, the matter shall be referred to the Pharmacovigilance Risk

Assessment Committee and Article 119(2) may apply. The Pharmacovigilance Risk

Assessment Committee shall issue a recommendation in accordance with the procedure

laid down in Article 44. The final recommendation shall be forwarded to the Committee

for Medicinal Products for Human Use or to the coordination group, as appropriate, and

the procedure laid down in Article 120 shall apply.

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However, where one of the criteria listed in Article 118(1) is met, the procedure laid down

in Articles 118, 119 and 120 shall apply.

The Member State concerned or the Commission shall clearly identify the question that is

referred to the Committee for Medicinal Products for Human Use or to the

Pharmacovigilance Risk Assessment Committee for consideration and shall inform the

applicant or the marketing authorisation holder.

The Member States and the applicant or the marketing authorisation holder shall supply the

Committee for Medicinal Products for Human Use or the Pharmacovigilance Risk

Assessment Committee with all available information relating to the matter in question.

2. Where the referral to the Committee for Medicinal Products for Human Use or to the

Pharmacovigilance Risk Assessment Committee concerns a range of medicinal products or

a therapeutic class, the Agency may limit the procedure to certain specific parts of the

marketing authorisation. In that event, Article 95 shall apply to those medicinal products

only if they were covered by the marketing authorisation procedures referred to in

Chapter III, Sections 3 and 4.

Where the scope of the procedure initiated under this Article concerns a range of medicinal

products or a therapeutic class, medicinal products that are covered by a centralised

marketing authorisation and that belong to that range or therapeutic class shall also be

included in the procedure.

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3. Without prejudice to paragraph 1, a Member State may, where urgent action is necessary to

protect public health, at any stage of the procedure, suspend the marketing authorisation

and prohibit the use of the medicinal product concerned on its territory until a definitive

decision is adopted. It shall inform the Commission, the Agency and the other

Member States, no later than the following working day, of the reasons for its action.

4. Where the scope of the procedure initiated under this Article, as determined in accordance

with paragraph 2, includes medicinal products covered by a centralised marketing

authorisation, the Commission may, where urgent action is necessary to protect public

health, at any stage of the procedure, suspend the marketing authorisation and prohibit the

use of the medicinal products concerned or take risk minimisation measures, until a

definitive decision is adopted. The Commission shall inform the Agency and the

Member States no later than the following working day of the reasons for its action.

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Chapter IX

Pharmacovigilance

SECTION 1

GENERAL PROVISIONS

Article 99

Member State pharmacovigilance systems

1. Member States shall operate a pharmacovigilance system for the fulfilment of their

pharmacovigilance tasks and their participation in Union pharmacovigilance activities.

The Member State pharmacovigilance systems shall be used to collect information on the

risks of medicinal products as regards patients’ or public health. That information shall in

particular refer to adverse reactions in human beings, arising from use of the medicinal

product within the terms of the marketing authorisation as well as from use outside the

terms of the marketing authorisation, and to adverse reactions associated with occupational

exposure.

2. Member States shall, by means of their pharmacovigilance system, evaluate all information

scientifically, consider options for risk minimisation and prevention and take regulatory

action concerning marketing authorisations as necessary. They shall perform a regular

audit of their pharmacovigilance system and take corrective actions if necessary.

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3. Each Member State shall designate a competent authority for the performance of

pharmacovigilance tasks.

4. The Commission may request the Member States to participate, under the coordination of

the Agency, in international harmonisation and standardisation of technical measures in

relation to pharmacovigilance.

Article 100

Member State responsibilities regarding pharmacovigilance activities

1. The Member States shall:

(a) take all appropriate measures to encourage patients, doctors, pharmacists and other

healthcare professionals to report suspected adverse reactions to the competent

authority of the Member State and involve, where appropriate, organisations

representing consumers, patients and healthcare professionals in those tasks;

(b) facilitate patient reporting through the provision of alternative reporting formats in

addition to web-based formats;

(c) take all appropriate measures to obtain accurate and verifiable data for the scientific

evaluation of suspected adverse reaction reports;

(d) ensure that the public is given important information on pharmacovigilance concerns

relating to the use of a medicinal product in a timely manner through publication on

the web-portal and through other means of publicly available information as

necessary;

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(e) ensure, through the methods for collecting information and where necessary through

the follow-up of suspected adverse reaction reports, that all appropriate measures are

taken to identify clearly any biological medicinal product prescribed, dispensed, or

sold in their territory that is the subject of a suspected adverse reaction report, with

due regard to the name of the medicinal product, and the batch number.

2. For the purposes of paragraph 1, points (a) and (e), the Member States may impose specific

obligations on doctors, pharmacists and other healthcare professionals.

Article 101

Member State delegation of pharmacovigilance tasks

1. A Member State may delegate any of the tasks entrusted to it under this Chapter to another

Member State subject to a written agreement of the latter. Each Member State may

represent no more than one other Member State.

2. The delegating Member State shall inform the Commission, the Agency and all other

Member States of the delegation in writing. The delegating Member State and the Agency

shall make that information publicly available.

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Article 102

Marketing authorisation holder pharmacovigilance system

1. Marketing authorisation holders shall operate a pharmacovigilance system for the

fulfilment of their pharmacovigilance tasks that is equivalent to the relevant

Member State’s pharmacovigilance system referred to in Article 99(1).

2. Marketing authorisation holders shall, by means of their pharmacovigilance system,

evaluate all information scientifically, consider options for risk minimisation and

prevention and take appropriate measures as necessary.

3. Marketing authorisation holders shall perform a regular audit of their pharmacovigilance

system. They shall place a note concerning the main findings of the audit on the

pharmacovigilance system master file and, based on the audit findings, ensure that an

appropriate corrective action plan is prepared and implemented. Once the corrective

actions have been fully implemented, the note may be removed.

4. As part of their pharmacovigilance system, marketing authorisation holders shall:

(a) have permanently and continuously at their disposal an appropriately qualified

person responsible for pharmacovigilance;

(b) maintain and make available on request by the competent authority of a

Member State or the Agency, as applicable, a pharmacovigilance system master file;

(c) operate a risk management system for each medicinal product;

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(d) monitor the outcome of risk minimisation measures that are contained in the risk

management plan or that are laid down as conditions of the marketing authorisation

pursuant to Article 47(1), points (a) to (g) and (i), and Article 48 and any obligations

imposed in accordance with Article 89(1) points (a), (b) and (c);

(e) update the risk management system and monitor pharmacovigilance data to

determine whether there are new risks or whether risks have changed or whether

there are changes to the benefit-risk balance of medicinal products.

5. The qualified person referred to in paragraph 4, point (a), shall reside and operate in the

Union and shall be responsible for the establishment and maintenance of the marketing

authorisation holder pharmacovigilance system. The marketing authorisation holder shall

submit the name and contact details of the qualified person to the competent authority of

the Member State and the Agency.

6. The marketing authorisation holder shall, upon request from the competent authority of the

Member State or the Agency, as applicable, nominate a contact person for

pharmacovigilance issues in that Member State who shall report to the qualified person

referred to in paragraph 4, point (a).

7. To ensure patient safety, marketing authorisation holders shall have procedures in place to

ensure continued fulfilment of their pharmacovigilance tasks for an appropriate period

after the marketing authorisation has been withdrawn or revoked. The period shall be

approved by the competent authority of the Member State or the Agency, as applicable,

prior to the withdrawal or revocation of the marketing authorisation.

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Article 103

Risk management system

1. Without prejudice to paragraphs 2, 3 and 4 of this Article, holders of national marketing

authorisations granted before 21 July 2012 shall, by way of derogation from

Article 102(4), point (c), not be required to operate a risk management system for the

medicinal product covered by those national marketing authorisations.

2. The competent authority of a Member State may impose an obligation on the holder of a

national marketing authorisation to operate a risk management system, as referred to in

Article 102(4), point (c), if there are concerns about the risks affecting the benefit-risk

balance of an authorised medicinal product. In that context, the competent authority of a

Member State shall also oblige the holder of a national marketing authorisation to submit a

risk management plan for the risk management system that they intend to introduce for the

medicinal product concerned.

3. The obligation referred to in paragraph 2 shall be duly justified, notified in writing, and

shall include the timeframe for submission of the risk management plan.

4. The competent authority of a Member State shall provide the holder of a national

marketing authorisation with an opportunity to submit written observations in response to

the imposition of the obligation within a time limit which it shall specify, if the marketing

authorisation holder so requests within 30 days of receipt of the written notification of the

obligation.

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5. On the basis of the written observations submitted by the holder of a national marketing

authorisation, the competent authority of a Member State shall withdraw or confirm the

obligation referred to in paragraph 2. Where the competent authority of a Member State

confirms that obligation, the marketing authorisation shall be varied accordingly to include

that obligation and the measures to be taken as part of the risk management system as

conditions of the national marketing authorisation referred to in Article 47(1), point (a).

Article 104

Funds for pharmacovigilance activities

1. The management of funds intended for activities connected with pharmacovigilance, the

operation of communication networks and market surveillance shall be under the

permanent control of the competent authorities of the Member States in order to guarantee

their independence in the performance of those pharmacovigilance activities.

2. Paragraph 1 shall not preclude the competent authorities of the Member States from

charging fees to marketing authorisation holders for performing pharmacovigilance

activities on the condition that independence in the performance of those

pharmacovigilance activities is strictly guaranteed.

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SECTION 2

TRANSPARENCY AND COMMUNICATIONS

Article 105

National medicines web-portal

1. Each Member State shall set up and maintain a national medicines web-portal which shall

be linked to the European medicines web-portal established in accordance with Article 106

of Regulation (EU) 2026/…+. By means of the national medicines web­portals, the

Member States shall make publicly available at least the following:

(a) public assessment reports, together with a summary thereof;

(b) summaries of product characteristics and package leaflets;

(c) summaries of risk management plans for medicinal products covered by a national

marketing authorisation in accordance with Chapter III;

(d) information on the different ways of reporting suspected adverse reactions to

medicinal products to competent authorities of the Member States by healthcare

professionals and patients, including the standard web-based structured forms

referred to in Article 104 of Regulation (EU) 2026/…+;

(e) information on prescription status of medicinal products authorised in their territory;

+ OJ: please insert in the text the number of the Regulation in document ST 7105/26

(2023/0131(COD)).

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(f) information on the shortage status of medicinal products as referred to in

Article 125(1), point (c), and Article 126 of Regulation (EU) 2026/…+.

2. The summaries referred to in paragraph 1, point (c), shall include, where relevant, a

description of additional risk minimisation measures.

Article 106

Publication of assessments

The Agency shall make the final assessments, conclusions, recommendations, opinions and

decisions referred to in Articles 111 to 120 publicly available by means of the European medicines

web-portal.

Article 107

Public announcements

1. As soon as the marketing authorisation holder intends to make a public announcement

relating to information on pharmacovigilance concerns in relation to the use of a medicinal

product, and in any event at the same time or before the public announcement is made, it

shall be required to inform the competent authorities of the Member States, the Agency

and the Commission.

+ OJ: please insert in the text the number of the Regulation in document ST 7105/26

(2023/0131(COD)).

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2. The marketing authorisation holder shall ensure that information to the public is presented

objectively and is not misleading.

3. Unless urgent public announcements are required for the protection of public health, the

Member States, the Agency and the Commission shall inform each other not less

than 24 hours prior to a public announcement relating to information on pharmacovigilance

concerns.

4. For active substances contained in medicinal products authorised in more than one

Member State, the Agency shall be responsible for the coordination between competent

authorities of the Member States of safety announcements and shall provide timetables for

the information being made publicly available.

5. Under the coordination of the Agency, the Member States shall make all reasonable efforts

to agree on a common message in relation to the safety of the medicinal product concerned

and the timetable for its dissemination. The Pharmacovigilance Risk Assessment

Committee shall, at the request of the Agency, provide advice on those safety

announcements.

6. Where the competent authorities of the Member States or the Agency, as applicable, make

information referred to in paragraphs 2 and 3 publicly available, any personal data or data

of a commercially confidential nature shall be deleted unless its public disclosure is

necessary for the protection of public health.

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SECTION 3

RECORDING AND REPORTING OF SUSPECTED ADVERSE REACTIONS

Article 108

Recording and reporting of suspected adverse reactions

by the marketing authorisation holder

1. Marketing authorisation holders shall record all suspected adverse reactions in the Union

or in third countries that are brought to their attention, whether reported spontaneously by

patients or healthcare professionals, or occurring in the context of a post-authorisation

study including data relating to suspected adverse reactions occurring where the product is

used outside the terms of the marketing authorisation.

Marketing authorisation holders shall ensure that those reports are accessible at a single

point within the Union.

By way of derogation from the first subparagraph, suspected adverse reactions occurring in

the context of a clinical trial shall be recorded and reported in accordance

with Regulation (EU) No 536/2014.

2. Marketing authorisation holders shall not refuse to consider reports of suspected adverse

reactions received electronically or by any other appropriate means from patients, who

may be assisted by other persons, or healthcare professionals, including reports received in

accordance with Article 109.

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3. Marketing authorisation holders shall submit electronically to the database and data-

processing network referred to in Article 103 of Regulation (EU) 2026/…+

(‘Eudravigilance database’) information on all serious suspected adverse reactions that

occur in the Union and in third countries within 15 days following the day on which the

marketing authorisation holder concerned gained knowledge of the event.

Marketing authorisation holders shall submit electronically to the Eudravigilance database

information on all non-serious suspected adverse reactions that occur in the Union,

within 90 days following the day on which the marketing authorisation holder concerned

gained knowledge of the event.

For medicinal products containing active substances referred to in the list of medical

literature monitored by the Agency pursuant to Article 108 of Regulation (EU) 2026/…+,

marketing authorisation holders shall not be required to submit to the Eudravigilance

database the suspected adverse reactions recorded in that listed medical literature, but they

shall monitor all other medical literature and report any suspected adverse reactions

recorded therein.

4. Marketing authorisation holders shall establish procedures in order to obtain accurate and

verifiable data for the scientific evaluation of suspected adverse reaction reports. They

shall also collect follow-up information and submit the updates electronically to the

Eudravigilance database. Reports obtained from the Eudravigilance database shall not be

re-submitted by the marketing authorisation holders to the Eudravigilance database, unless

they contain additional information.

+ OJ: please insert in the text the number of the Regulation in document ST 7105/26

(2023/0131(COD)).

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5. Marketing authorisation holders shall collaborate with the competent authorities of the

Member States and the Agency in the detection of duplicates of suspected adverse reaction

reports.

6. This Article shall apply mutatis mutandis to undertakings supplying medicinal products

used in accordance with Article 4, paragraph 1 or 4.

Article 109

Recording and reporting of suspected adverse reactions by wholesale distributors

Wholesale distributors that distribute medicinal products in accordance with Article 165(3) to (6)

shall record all suspected adverse reactions with regard to those medicinal products which are

brought to their attention, whether reported spontaneously by patients or by healthcare

professionals, including suspected adverse reactions occurring where the product is used outside the

terms of the marketing authorisation. They shall transmit those reports immediately to the

marketing authorisation holder holding the marketing authorisation in the source Member State

referred to in Article 165(3).

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Article 110

Recording and reporting of suspected adverse reactions by Member States

1. Each Member State shall record all suspected adverse reactions that occur in its territory

which are brought to its attention by healthcare professionals and patients. This shall

include all authorised medicinal products and medicinal products used in accordance with

Article 4, paragraph 1 or 4. Member States shall involve patients and healthcare

professionals, as appropriate, in the follow-up of any reports they receive in order to

comply with Article 100(1), points (c) and (e).

Member States shall ensure that reports of such reactions may be submitted by means of

the national medicines web-portals or by other means.

2. For reports submitted by a marketing authorisation holder, Member States on whose

territory the suspected adverse reaction occurred may involve the marketing authorisation

holder in the follow-up of the reports.

3. Member States shall collaborate with the Agency and the marketing authorisation holders

in the detection of duplicates of suspected adverse reaction reports.

4. Member States shall, within 15 days of the receipt of the reports of serious suspected

adverse reactions referred to in paragraph 1, submit the reports electronically to the

Eudravigilance database.

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Member States shall, within 90 days of the receipt of the reports referred to in paragraph 1,

submit reports of non-serious suspected adverse reactions electronically to the

Eudravigilance database.

Marketing authorisation holders and marketing authorisation applicants to the extent

necessary shall have access to the reports referred to in this paragraph through the

Eudravigilance database.

5. Member States shall ensure that reports of suspected adverse reactions arising from an

error associated with the use of a medicinal product that are brought to their attention are

submitted electronically to the Eudravigilance database and made available to any

authorities, bodies, organisations or institutions responsible for patient safety within the

Member State concerned. They shall also ensure that the authorities responsible for

medicinal products within that Member State are informed of any suspected adverse

reactions brought to the attention of any other authority within that Member State. These

reports shall be appropriately identified in the forms referred to in Article 104

of Regulation (EU) 2026/…+.

6. Unless there are justifiable grounds resulting from pharmacovigilance activities,

Member States shall not impose any additional obligations on marketing authorisation

holders for the reporting of suspected adverse reactions.

+ OJ: please insert in the text the number of the Regulation in document ST 7105/26

(2023/0131(COD)).

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SECTION 4

PERIODIC SAFETY UPDATE REPORTS

Article 111

Periodic safety update reports

1. Marketing authorisation holders shall submit electronically to the Agency periodic safety

update reports containing:

(a) summaries of data relevant to the benefit-risk balance of the medicinal product,

including results of all studies with a consideration of their potential impact on the

marketing authorisation;

(b) a scientific evaluation of the benefit-risk balance of the medicinal product;

(c) all data relating to the volume of sales of the medicinal product and any data in

possession of the marketing authorisation holder relating to the volume of medical

prescriptions, including an estimate of the population exposed to the medicinal

product.

The data provided in accordance with the first subparagraph, point (c), shall differentiate

between sales and volumes generated within the Union and those generated outside

the Union.

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2. The evaluation referred to in paragraph 1, first subparagraph, point (b), shall be based on

all available data, including data from clinical trials in unauthorised therapeutic indications

and populations.

3. The Agency shall make available the periodic safety update reports referred to in

paragraph 1 to the competent authorities of the Member States, the members of the

Pharmacovigilance Risk Assessment Committee, the Committee for Medicinal Products

for Human Use and the coordination group by means of the repository for periodic safety

update reports set up under Article 105 of Regulation (EU) 2026/…+.

4. By way of derogation from paragraph 1, the marketing authorisation holders for medicinal

products referred to in Article 10 or 14 shall only be required to submit periodic safety

update reports for such medicinal products to the competent authority of the Member State

or the Agency, as applicable, in the following cases:

(a) where such obligation has been laid down as a condition in the marketing

authorisation in accordance with Article 47 or 48; or

(b) when requested by the competent authority of a Member State or the Agency, as

applicable, on the basis of concerns relating to pharmacovigilance data or due to the

lack of periodic safety update reports relating to an active substance after the

marketing authorisation has been granted.

+ OJ: please insert in the text the number of the Regulation in document ST 7105/26

(2023/0131(COD)).

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By way of derogation from paragraph 1, the registration holders for medicinal products

referred to in Article 130 or Article 138(1), shall only be required to submit periodic safety

update reports for such medicinal products when requested by the competent authority of a

Member State on the basis of concerns relating to pharmacovigilance data.

The assessment reports of the periodic safety update reports referred to in the first

subparagraph of this paragraph shall be communicated by the competent authority of a

Member State or the Agency, as applicable, to the Pharmacovigilance Risk Assessment

Committee, which shall consider whether there is a need for a single assessment report for

all marketing authorisations for medicinal products containing the same active substance

and which shall inform the coordination group or the Committee for Medicinal Products

for Human Use accordingly, in order to apply the procedures laid down in Article 112(4)

and Article 114.

Article 112

Frequency of periodic safety update reports

1. The frequency with which the periodic safety update reports referred to in Article 111 are

to be submitted shall be specified in the marketing authorisation.

The dates of submission of the periodic safety update reports according to the specified

frequency shall be calculated from the date when then marketing authorisation was

granted.

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2. Holders of marketing authorisations which have been granted before 21 July 2012, and for

which the frequency and dates of submission of the periodic safety update reports are not

laid down as a condition to the marketing authorisation, shall submit the periodic safety

update reports in accordance with the second subparagraph of this paragraph unless

another frequency or other dates of submission of the reports are set in the marketing

authorisation or determined in accordance with paragraphs 4, 5 and 6.

Periodic safety update reports shall be submitted to the competent authorities of the

Member States or the Agency, as applicable, immediately upon request or in accordance

with the following:

(a) where a medicinal product has not yet been placed on the market, at least every six

months following the granting of the marketing authorisation and until the placing on

the market;

(b) where a medicinal product has been placed on the market, once a year during the first

five years following the initial placing on the market, and at three-yearly intervals for

the subsequent six years and with a five-year interval thereafter.

3. Paragraph 2 shall also apply to medicinal products that are authorised only in one

Member State and for which paragraph 4 does not apply.

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4. Where medicinal products that are subject to different marketing authorisations contain the

same active substance or the same combination of active substances, the frequency and

dates of submission of the periodic safety update reports resulting from the application of

paragraphs 1 and 2 may be amended and harmonised to enable a single assessment to be

made in the context of a periodic safety update report work-sharing procedure and to set a

Union reference date from which the dates of submission of the reports are calculated.

The harmonised frequency for the submission of the reports and the Union reference date

may be determined, after consultation of the Pharmacovigilance Risk Assessment

Committee, by one of the following:

(a) the Committee for Medicinal Products for Human Use, where at least one of the

marketing authorisations for the medicinal products containing the active substance

concerned has been granted in accordance with the centralised procedure provided

for in Article 3 of Regulation (EU) 2026/…+;

(b) the coordination group, in other cases than those referred to in point (a).

The harmonised frequency for the submission of the reports determined pursuant to this

paragraph shall be made publicly available by the Agency. Marketing authorisation holders

shall submit an application for a variation of the marketing authorisation accordingly.

+ OJ: please insert in the text the number of the Regulation in document ST 7105/26

(2023/0131(COD)).

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5. For the purposes of paragraph 4, the Union reference date for medicinal products

containing the same active substance or the same combination of active substances shall be

one of the following:

(a) the date when the first marketing authorisation was granted in the Union for a

medicinal product containing that active substance or that combination of active

substances;

(b) if the date referred to in point (a) cannot be ascertained, the earliest of the known

dates of the marketing authorisations for a medicinal product containing that active

substance or that combination of active substances.

6. Marketing authorisation holders shall be allowed to submit requests to the Committee for

Medicinal Products for Human Use or the coordination group, as appropriate, to determine

Union reference dates or to change the frequency of submission of periodic safety update

reports on one of the following grounds:

(a) for reasons relating to public health;

(b) in order to avoid a duplication of the assessment;

(c) in order to achieve international harmonisation.

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Such requests shall be submitted in writing and shall be duly justified. The Committee for

Medicinal Products for Human Use or the coordination group shall, following the

consultation with the Pharmacovigilance Risk Assessment Committee, either approve or

deny such requests. Any change to the Union reference dates or the frequency of

submission of periodic safety update reports shall be made publicly available by the

Agency. The marketing authorisation holders shall submit an application for a variation of

the marketing authorisation accordingly.

7. The Agency shall make public a list of Union reference dates and frequency of submission

of periodic safety update reports by means of the European medicines web-portal.

Any change to the frequency or dates of submission of periodic safety update reports

specified in the marketing authorisation as a result of the application of paragraphs 4, 5

and 6 shall take effect four months from the date of the publication referred to in the first

subparagraph.

Article 113

Assessment of periodic safety update reports

The competent authorities of the Member State shall assess periodic safety update reports to

determine whether there are new risks or whether risks have changed or whether there are changes

to the benefit-risk balance of medicinal products.

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Article 114

Single assessment of periodic safety update reports

1. A single assessment of periodic safety update reports shall be performed for medicinal

products authorised in more than one Member State and, in the cases referred to in

Article 112, paragraphs 4, 5 and 6, for all medicinal products containing the same active

substance or the same combination of active substances and for which a Union reference

date and a frequency for the submission of periodic safety update reports have been

established.

The single assessment shall be conducted by either of the following:

(a) a Member State appointed by the coordination group where none of the marketing

authorisations concerned has been granted in accordance with the centralised

procedure provided for in Article 3 of Regulation (EU) 2026/…+;

(b) a rapporteur appointed by the Pharmacovigilance Risk Assessment Committee,

where at least one of the marketing authorisations concerned has been granted in

accordance with the centralised procedure provided for in Article 3

of Regulation (EU) 2026/…+.

When selecting the Member State in accordance with the second subparagraph, point (a),

the coordination group shall take into account whether any Member State is acting as a

reference Member State, in accordance with Chapter III, Sections 3 and 4.

+ OJ: please insert in the text the number of the Regulation in document ST 7105/26

(2023/0131(COD)).

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2. The Member State or rapporteur, as applicable, shall draw up an assessment report

within 60 days of receipt of the periodic safety update report and send it to the Agency and

to the Member States concerned. The Agency shall send the report to the marketing

authorisation holder.

Within 30 days of receipt of the assessment report, the Member States and the marketing

authorisation holder may submit comments to the Agency and to the Member State or

rapporteur. Where the report includes questions addressed to the marketing authorisation

holder, the marketing authorisation holder shall provide answers within those 30 days.

3. Within 15 days of receipt of the comments referred to in paragraph 2, second

subparagraph, the Member State or rapporteur shall update the assessment report, taking

into account any comments submitted, and forward it to the Pharmacovigilance Risk

Assessment Committee. The Pharmacovigilance Risk Assessment Committee shall

adopt the assessment report with or without further changes at its next meeting and issue a

recommendation. The recommendation shall mention any divergent positions and the

grounds on which they are based.

The Agency shall include the adopted assessment report and the recommendation in the

repository for periodic safety update reports set up under Article 105 of Regulation

(EU) 2026/…+ and forward them to the marketing authorisation holder.

+ OJ: please insert in the text the number of the Regulation in document ST 7105/26

(2023/0131(COD)).

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Article 115

Regulatory action on periodic safety update reports

Following the assessment of periodic safety update reports referred to in Article 113, the competent

authorities of the Member States shall consider whether any action concerning the marketing

authorisation for the medicinal product concerned is necessary and shall maintain, vary, suspend or

revoke the marketing authorisation as appropriate.

Article 116

Procedure for regulatory action on periodic safety update reports

1. In the case of a single assessment of periodic safety update reports in accordance with

Article 114(1) which recommends action concerning more than one marketing

authorisation that does not include any centralised marketing authorisation, the

coordination group shall, within 30 days of receipt of the assessment report of the

Pharmacovigilance Risk Assessment Committee, consider the assessment report and reach

a position on the maintenance, variation, suspension or revocation of the marketing

authorisations concerned, including a timetable for the implementation of the agreed

position.

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2. If, within the coordination group, the Member States represented reach an agreement by

consensus on the action to be taken, the chairperson shall acknowledge the agreement and

send it to the marketing authorisation holder and the Member States. The Member States

shall adopt necessary measures to maintain, vary, suspend or revoke the marketing

authorisations concerned in accordance with the timetable for implementation determined

in the agreement.

In the event a variation is agreed upon, the marketing authorisation holder shall submit to

the competent authorities of the Member States an appropriate application for a variation,

including an updated summary of product characteristics and an updated package leaflet

within the determined timetable for implementation.

If an agreement by consensus cannot be reached, the position of the majority of the

Member States represented within the coordination group shall be forwarded to the

Commission which shall apply the procedure laid down in Article 45.

Where the agreement reached by the Member States represented within the coordination

group or the position of the majority of Member States differs from the recommendation of

the Pharmacovigilance Risk Assessment Committee referred to in Article 114(3), the

coordination group shall attach to the agreement or the majority position a detailed

explanation of the scientific grounds for the differences together with the recommendation.

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3. In the case of a single assessment of periodic safety update reports in accordance with

Article 114(1) that recommends action concerning more than one marketing authorisation

that includes at least one centralised marketing authorisation, the Committee for Medicinal

Products for Human Use shall, within 30 days of receipt of the assessment report of the

Pharmacovigilance Risk Assessment Committee, consider the assessment report and

adopt an opinion on the maintenance, variation, suspension or revocation of the marketing

authorisations concerned, including a timetable for the implementation of the opinion.

4. Where the opinion of the Committee for Medicinal Products for Human Use referred to in

paragraph 3 differs from the recommendation of the Pharmacovigilance Risk Assessment

Committee referred to in Article 114(3), the Committee for Medicinal Products for Human

Use shall attach to its opinion a detailed explanation of the scientific grounds for the

differences together with the recommendation.

5. On the basis of the opinion of the Committee for Medicinal Products for Human Use

referred to in paragraph 3, the Commission shall, by means of implementing acts:

(a) adopt a decision addressed to the Member States concerning the measures to be taken

in respect of marketing authorisations granted by the Member States and concerned

by the procedure provided for in this section; and

(b) where the opinion states that regulatory action concerning the marketing

authorisation is necessary, adopt a decision to vary, suspend or revoke the centralised

marketing authorisations concerned by the procedure provided for in this section.

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6. Article 45 shall apply to the adoption of the decision referred to in paragraph 5, point (a),

of this Article and to its implementation by the Member States.

7. Article 14 of Regulation (EU) 2026/…+ shall apply to the decision referred to in

paragraph 5, point (b), of this Article. Where the Commission adopts such decision, it may

also adopt a decision addressed to the Member States pursuant to Article 59

of Regulation (EU) 2026/…+.

SECTION 5

SIGNAL DETECTION

Article 117

Signal monitoring and detection

1. Regarding medicinal products authorised in accordance with Chapter III, the competent

authorities of the Member States shall, in collaboration with the Agency, take the

following measures:

(a) monitor the outcome of risk minimisation measures contained in risk management

plans and of the conditions referred to in Article 47(1), points (a) to (g) and (i), and

in Article 48 and any obligations imposed in accordance with Article 89(1)

points (a), (b) and (c);

(b) assess updates of the risk management system;

+ OJ: please insert in the text the number of the Regulation in document ST 7105/26

(2023/0131(COD)).

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(c) monitor the data in the Eudravigilance database to determine whether there are new

risks or whether risks have changed and whether those risks have an impact on the

benefit-risk balance.

2. The Pharmacovigilance Risk Assessment Committee shall perform the initial analysis and

prioritisation of signals of new risks or risks that have changed or changes to the benefit-

risk balance. Where it considers that follow-up action may be necessary, the assessment of

those signals and agreement on any subsequent action concerning the marketing

authorisation shall be conducted in a timescale commensurate with the extent and

seriousness of the issue. Where appropriate, the assessment of those signals may be

included in a pending assessment of a periodic safety update report or a pending procedure

in accordance with Articles 94 to 98 and 118 to 120 of this Directive or Article 57

of Regulation (EU) 2026/…+.

3. The Agency and competent authorities of the Member States and the marketing

authorisation holder shall inform each other in the event of new risks or risks that have

changed or changes to the benefit-risk balance being detected.

4. Member States shall ensure that marketing authorisation holders inform the Agency and

competent authorities of the Member State in the event of new risks or risks that have

changed or changes to the benefit-risk balance being detected.

+ OJ: please insert in the text the number of the Regulation in document ST 7105/26

(2023/0131(COD)).

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SECTION 6

URGENT UNION PROCEDURE

Article 118

Initiation of an urgent Union procedure

1. A Member State or the Commission, as appropriate, shall, on the basis of concerns

resulting from the evaluation of data from pharmacovigilance activities, initiate the

procedure provided for in this Section (the ‘urgent Union procedure’) by informing the

other Member States, the Agency and the Commission where:

(a) it considers suspending or revoking a marketing authorisation;

(b) it considers prohibiting the supply of a medicinal product;

(c) it considers refusing the renewal of a marketing authorisation; or

(d) it is informed by the marketing authorisation holder that, on the basis of safety

concerns, the marketing authorisation holder has interrupted the placing on the

market of a medicinal product or has taken action to have a marketing authorisation

withdrawn, or intends to take such action or has not applied for the renewal of a

marketing authorisation.

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2. A Member State or the Commission, as appropriate, shall, on the basis of concerns

resulting from the evaluation of data from pharmacovigilance activities, inform the other

Member States, the Agency and the Commission where it considers that a new

contraindication, a reduction in the recommended dose or a restriction to the therapeutic

indications of a medicinal product is necessary. The information shall outline the action

considered and the reasons therefor.

Any Member State or the Commission, as appropriate, shall, when urgent action is

considered necessary in any of the cases referred to in the first subparagraph, initiate the

urgent Union procedure.

Where the urgent Union procedure is not initiated, for medicinal products authorised in

accordance with Chapter III, Sections 3 and 4, the matter shall be brought to the attention

of the coordination group.

Article 98 shall apply where the interests of the Union are involved.

3. Where the urgent Union procedure is initiated, the Agency shall verify whether the safety

concern relates to medicinal products other than the one covered by the information

referred to in paragraphs 1 and 2, or whether the safety concern is common to all medicinal

products belonging to the same range or therapeutic class.

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Where the medicinal product involved is authorised in more than one Member State, the

Agency shall without undue delay inform the initiator of the urgent Union procedure

referred to in paragraph 2, second subparagraph, of the outcome of the verification, and the

procedures laid down in Articles 119 and 120 shall apply. Otherwise, the safety concern

shall be addressed by the Member State concerned. The Agency or the Member State, as

applicable, shall make the information that the urgent Union procedure has been initiated

available to marketing authorisation holders.

4. Without prejudice to paragraphs 1 and 2 of this Article and Articles 119 and 120, a

Member State may, where urgent action is necessary to protect public health, suspend the

marketing authorisation and prohibit the use of the medicinal product concerned on its

territory until a definitive decision is adopted in the urgent Union procedure. It shall inform

the Commission, the Agency and the other Member States no later than the following

working day of the reasons for its action.

5. At any stage of the procedure laid down in Articles 119 and 120, the Commission may

request a Member State in which the medicinal product is authorised to take temporary

measures immediately.

Where the scope of the procedure, as determined in accordance with paragraphs 1 and 2,

includes medicinal products covered by centralised marketing authorisations, the

Commission may, at any stage of the urgent Union procedure, take temporary measures

immediately in relation to those marketing authorisations.

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6. The information referred to in paragraphs 1 and 2 may relate to individual medicinal

products or to a range of medicinal products or a therapeutic class.

If the Agency identifies that the safety concern relates to more medicinal products than

those that are covered by the information referred to in paragraphs 1 and 2 or that the

safety concern is common to all medicinal products belonging to the same range or

therapeutic class, it shall extend the scope of the procedure accordingly.

Where the scope of the urgent Union procedure concerns a range of medicinal products or

a therapeutic class, medicinal products covered by the centralised marketing authorisation

that belong to that range of medicinal products or therapeutic class shall also be included in

the procedure.

7. At the time the information referred to in paragraphs 1 and 2 is provided, the Member State

shall make available to the Agency all relevant scientific information that it has at its

disposal and any assessment by the Member State.

Article 119

Urgent Union procedure scientific assessment

1. Following receipt of the information referred to in Article 118, paragraphs 1 and 2, the

Agency shall publicly announce the initiation of the urgent Union procedure by means of

the European medicines web-portal. In parallel, Member States may publicly announce the

initiation of the urgent Union procedure on their national medicines web-portals.

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The announcement shall specify the matter submitted to the Agency in accordance with

Article 118, and the medicinal products and, where applicable, the active substances

concerned. It shall contain information on the right of the marketing authorisation holders,

healthcare professionals and the public to submit to the Agency information relevant to the

procedure and it shall state how such information may be submitted.

2. The Pharmacovigilance Risk Assessment Committee shall assess the matter that has been

submitted to the Agency in accordance with Article 118. The rapporteur appointed by the

Pharmacovigilance Risk Assessment Committee in accordance with Article 159 of

Regulation (EU) 2026/…+, shall closely collaborate with the rapporteur appointed by the

Committee for Medicinal Products for Human Use in accordance with Article 159 of

Regulation (EU) 2026/…+ and with the reference Member State for the medicinal products

concerned.

For the purposes of the assessment referred to in the first subparagraph, the marketing

authorisation holder may submit comments in writing.

Where the urgency of the matter permits, the Pharmacovigilance Risk Assessment

Committee may hold public hearings, where it considers that this is appropriate on justified

grounds particularly with regard to the extent and seriousness of the safety concern. The

hearings shall be held in accordance with the modalities specified by the Agency and shall

be announced by means of the European medicines web-portal. In the hearing, the

Pharmacovigilance Risk Assessment Committee shall also give due regard to the

therapeutic effect and clinical context of the medicinal product. The announcement shall

specify the modalities of participation.

+ OJ: please insert in the text the number of the Regulation in document ST 7105/26

(2023/0131(COD)).

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The Agency shall, in consultation with the parties concerned, draw up rules of procedure

on the organisation and conduct of public hearings, in accordance with Article 153(1)

of Regulation (EU) 2026/…+.

Where a marketing authorisation holder or another person intending to submit information,

has confidential data relevant to the subject matter of the procedure, they may request

permission to present those data to the Pharmacovigilance Risk Assessment Committee in

a non-public hearing.

3. Within 60 days of the submission of the information, the Pharmacovigilance Risk

Assessment Committee shall make a recommendation, stating the reasons on which it is

based, having due regard to the therapeutic effect of the medicinal product. The

recommendation shall mention any divergent positions and the grounds on which they are

based. In the case of urgency, and on the basis of a proposal by its chairperson, the

Pharmacovigilance Risk Assessment Committee may agree to a shorter deadline. The

recommendation shall include any or a combination of the following conclusions:

(a) no further evaluation or action is required at Union level;

(b) the marketing authorisation holder should conduct further evaluation of data and

carry out a follow-up of the results of that evaluation;

(c) the marketing authorisation holder should sponsor a post-authorisation safety study

and carry out a follow up evaluation of the results of that study;

+ OJ: please insert in the text the number of the Regulation in document ST 7105/26

(2023/0131(COD)).

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(d) the Member States or marketing authorisation holder should implement risk

minimisation measures;

(e) the marketing authorisation should be suspended, revoked or not renewed;

(f) the marketing authorisation should be varied.

4. For the purposes of paragraph 3, point (d), the recommendation shall specify the risk

minimisation measures recommended and any conditions or restrictions to which the

marketing authorisation should be made subject, including the timeline for implementation.

5. For the purposes of paragraph 3, point (f), where it is recommended to change or add

information in the summary of product characteristics or the labelling or package leaflet,

the recommendation shall suggest the wording of such changed or added information and

shall indicate where in the summary of product characteristics, the labelling or package

leaflet such wording should be placed.

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Article 120

Follow-up of recommendation made in the framework of the urgent Union procedure

1. Where the scope of the urgent Union procedure, as determined in accordance with

Article 118(6), does not include any centralised marketing authorisation, the coordination

group shall, within 30 days of receipt of the recommendation of the Pharmacovigilance

Risk Assessment Committee referred to in Article 119(3), consider the recommendation

and reach a position on the maintenance, variation, suspension, revocation or refusal of the

renewal of the marketing authorisation concerned, including a timetable for the

implementation of the agreed position. Where an urgent adoption of the position is

necessary, the coordination group may, on the basis of a proposal by its chairperson, agree

to a shorter deadline.

2. If, within the coordination group, the Member States represented reach an agreement on

the action to be taken by consensus, the chairperson shall record the agreement and send it

to the marketing authorisation holder and the Member States. The Member States shall

adopt necessary measures to maintain, vary, suspend, revoke or refuse renewal of the

marketing authorisation concerned in accordance with the implementation timetable

determined in the agreement.

In the event that a variation is agreed upon, the marketing authorisation holder shall submit

to the competent authorities of the Member States an appropriate application for a

variation, including an updated summary of product characteristics and an updated package

leaflet within the determined timetable for implementation.

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If an agreement by consensus cannot be reached, the position of the majority of the

Member States represented within the coordination group shall be forwarded to the

Commission which shall apply the procedure laid down in Article 45.

Where the agreement reached by the Member States represented within the coordination

group or the position of the majority of the Member States represented within the

coordination group differs from the recommendation of the Pharmacovigilance Risk

Assessment Committee referred to in Article 119(3), the coordination group shall attach to

the agreement or the majority position a detailed explanation of the scientific grounds for

the differences together with the recommendation.

3. Where the scope of the procedure, as determined in accordance with Article 118(6),

includes at least one centralised marketing authorisation, the Committee for Medicinal

Products for Human Use shall, within 30 days of receipt of the recommendation of the

Pharmacovigilance Risk Assessment Committee referred to in Article 119(3), consider the

recommendation and adopt an opinion on the maintenance, variation, suspension,

revocation or refusal of the renewal of the marketing authorisations concerned. Where an

urgent adoption of the opinion is necessary, the Committee for Medicinal Products for

Human Use may, on the basis of a proposal by its chairperson, agree to a shorter deadline.

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Where the opinion of the Committee for Medicinal Products for Human Use referred to in

the first subparagraph of this paragraph differs from the recommendation of the

Pharmacovigilance Risk Assessment Committee referred to in Article 119(3), the

Committee for Medicinal Products for Human Use shall attach to its opinion a detailed

explanation of the scientific grounds for the differences together with the recommendation.

4. On the basis of the opinion of the Committee for Medicinal Products for Human Use

referred to in paragraph 3, the Commission shall, by means of implementing acts:

(a) adopt a decision addressed to the Member States concerning the measures to be taken

in respect of marketing authorisations that are granted by the Member States and that

are subject to the urgent Union procedure;

(b) where the opinion states that regulatory action concerning the marketing

authorisation is necessary, adopt a decision to vary, suspend, revoke or refuse the

renewal of the centralised marketing authorisations concerned by the Union urgent

procedure.

5. Article 45 shall apply to the adoption of the decision referred to in paragraph 4, point (a),

of this Article and to its implementation by the Member States.

6. Article 14 of Regulation (EU) 2026/…+ shall apply to the decision referred to in

paragraph 4, point (b), of this Article. Where the Commission adopts such decision, it may

also adopt a decision addressed to the Member States pursuant to Article 59

of Regulation (EU) 2026/…+.

+ OJ: please insert in the text the number of the Regulation in document ST 7105/26

(2023/0131(COD)).

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SECTION 7

SUPERVISION OF NON-INTERVENTIONAL POST-AUTHORISATION SAFETY STUDIES

Article 121

Non-interventional post-authorisation safety studies

1. This Section applies to non-interventional post-authorisation safety studies that are

initiated, managed or financed by the marketing authorisation holder voluntarily or

pursuant to obligations imposed in accordance with Article 47 or 89, and that involve the

collection of safety data from patients or healthcare professionals.

2. This Section is without prejudice to Member States and Union requirements for ensuring

the well-being and rights of participants in non-interventional post-authorisation safety

studies.

3. The studies shall not be performed where the act of conducting the study promotes the use

of a medicinal product.

4. Payments to healthcare professionals for participating in non-interventional post-

authorisation safety studies shall be restricted to the compensation for time and expenses

incurred.

5. The competent authority of the Member State may require the marketing authorisation

holder to submit the protocol and the progress reports to the competent authorities of the

Member States in which the study is conducted.

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6. The marketing authorisation holder shall send the final report of the study to the competent

authorities of the Member States in which the study was conducted within 12 months of

the end of data collection.

7. While a study is being conducted, the marketing authorisation holder shall monitor the data

generated and consider its implications for the benefit-risk balance of the medicinal

product concerned.

Any new information that might influence the evaluation of the benefit-risk balance of the

medicinal product shall be communicated to the competent authorities of the

Member States in which the medicinal product has been authorised in accordance

with Article 92.

The obligation laid down in the second subparagraph of this paragraph is without prejudice

to the information on the results of studies that the marketing authorisation holder shall

make available by means of the periodic safety update reports as laid down in Article 111.

8. Articles 122 to 125 shall apply exclusively to studies referred to in paragraph 1 of this

Article that are conducted pursuant to an obligation imposed in accordance with Article 47

or 89.

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Article 122

Agreement of a protocol for a non-interventional post-authorisation safety study

1. Before a study is conducted, the marketing authorisation holder shall submit a draft

protocol to the Pharmacovigilance Risk Assessment Committee, except for studies to be

conducted in only one Member State that requires the study in accordance with Article 89.

For such studies, the marketing authorisation holder shall submit a draft protocol to the

competent authority of the Member State in which the study is conducted.

2. Within 60 days of the submission of the draft protocol referred to in paragraph 1, the

competent authority of the Member State or the Pharmacovigilance Risk Assessment

Committee, as appropriate, shall issue:

(a) a letter endorsing the draft protocol;

(b) a letter of objection, which shall set out in detail the grounds for the objection,

where:

(i) it considers that the conduct of the study promotes the use of a medicinal

product;

(ii) it considers that the design of the study does not fulfil the study objectives; or

(c) a letter notifying the marketing authorisation holder that the study is a clinical trial

falling under the scope of Regulation (EU) No 536/2014.

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3. The study may commence only when the written endorsement from the competent

authority of the Member State or the Pharmacovigilance Risk Assessment Committee, as

appropriate, has been issued.

Where a letter of endorsement of the draft protocol as referred to in paragraph 2, point (a),

has been issued, the marketing authorisation holder shall forward the protocol to the

competent authorities of the Member States in which the study is to be conducted and may

thereafter commence the study according to the endorsed protocol.

Article 123

Update of a protocol for a non-interventional post-authorisation safety study

After a study has been commenced, any substantial amendments to the protocol shall be submitted,

before their implementation, to the competent authority of the Member State or to the

Pharmacovigilance Risk Assessment Committee, as appropriate. The competent authority of the

Member State or the Pharmacovigilance Risk Assessment Committee, as appropriate, shall assess

the amendments and inform the marketing authorisation holder of its endorsement or objection.

Where applicable, the marketing authorisation holder shall inform the Member States in which the

study is conducted.

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