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Council of the European Union

Brussels, 28 September 2026 (OR. en)

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SAN 132 PHARM 31 MI 219 COMPET 289 VETER 30 ENV 203 RECH 109 PI 30 CODEC 400

PARLNAT

Interinstitutional File: 2023/0131(COD)

LEGISLATIVE ACTS AND OTHER INSTRUMENTS

Subject: Position of the Council at first reading with a view to the adoption of a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 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 – Adopted by the Council on 28 September 2026

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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

(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 Article 114

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,

After consulting 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/2025/1329, 13.3.2025,

ELI: http://data.europa.eu/eli/C/2025/1329/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 pharmaceutical legislation for centrally authorised medicinal products, laid

down in, inter alia, Regulations (EC) No 141/20003, (EC) No 726/20044 and

(EC) No 1901/20065 of the European Parliament and of the Council, has enabled the

authorisation of high-quality, safe and efficacious medicinal products in the Union,

contributing to a high level of public health and the smooth functioning of the internal

market for those products.

(2) The ‘Pharmaceutical Strategy for Europe’ adopted by the Commission in its

communication of 25 November 2020 marks a turning point, with the addition of further

key objectives. It aims to create an attractive environment for research, development and

production of medicinal products in the Union, together with a modern framework that

makes innovative and established medicinal products available to patients and healthcare

systems at affordable prices. It also aims to strengthen the fight against shortages of

medicinal products, ensure security of supply and address environmental concerns.

3 Regulation (EC) No 141/2000 of the European Parliament and of the Council

of 16 December 1999 on orphan medicinal products (OJ L 18, 22.1.2000, p. 1,

ELI: http://data.europa.eu/eli/reg/2000/141/oj). 4 Regulation (EC) No 726/2004 of the European Parliament and of the Council

of 31 March 2004 laying down Union procedures for the authorisation and supervision of

medicinal products for human use and establishing a European Medicines Agency

(OJ L 136, 30.4.2004, p. 1, ELI: http://data.europa.eu/eli/reg/2004/726/oj). 5 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).

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(3) Ensuring that patients receive the medicinal products they need, when they need them,

regardless of where they live in the Union, is a central objective of the Commission’s

approach as set out in its communication of 22 May 2024 entitled ‘The European Health

Union: acting together for people’s health’. Ensuring the competitiveness of the European

pharmaceutical industry, whilst providing better availability of medicinal products and

more equal and timely access for patients, is a key objective of the Union pharmaceutical

reform, as proposed by the Commission in April 2023.

(4) Commission communication of 24 October 2023 entitled ‘Addressing medicine shortages

in the EU’ outlined key measures aimed at addressing critical shortages of medicinal

products and strengthening security of supply in the Union in anticipation of the measures

provided for in a revised pharmaceutical regulation. Among other things, that

communication envisaged a first informal Union list of critical medicinal products and the

launch of a European voluntary solidarity mechanism for medicinal products allowing

Member States to request support from another Member State and redistribution of

available stocks in the event of shortage.

(5) Addressing unequal patient access to medicinal products has become a key priority of the

Pharmaceutical Strategy for Europe as has been highlighted by the Council and the

European Parliament. Member States and the European Parliament have called for revised

mechanisms and incentives for development of medicinal products tailored to the level of

unmet medical need, while ensuring a transparent process, patient access to medicinal

products, and availability as well as affordability of medicinal products in all

Member States.

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(6) Previous amendments to the Union pharmaceutical legislation have addressed access to

medicinal products by providing for accelerated assessment of marketing authorisation

applications or by allowing conditional marketing authorisation for medicinal products to

meet unmet medical needs. While these measures accelerated the authorisation of

innovative and promising therapies in some areas, the medicinal products do not always

reach the patient and patients in the Union still have different levels of access to medicinal

products. In addition, many unaddressed public health priorities remain.

(7) The COVID-19 pandemic further underlined critical issues, which require a reform of the

Union pharmaceutical legislation to strengthen its resilience, while improving the

availability of medicinal products and ensuring that it contributes to public health needs

and serves the people under all circumstances.

(8) For the sake of legal clarity and simplification, and having regard to the need to reform the

Union pharmaceutical legislation, the legal provisions applicable to centrally authorised

medicinal products should be integrated into a new Regulation.

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(9) Veterinary medicinal products are governed by Regulation (EU) 2019/6 of the European

Parliament and of the Council6. Those medicinal products fall outside the scope of this

Regulation, except for certain provisions on the governance and general tasks of the

European Medicines Agency (the ‘Agency’) set out in this Regulation that still apply to

them. The Agency’s specific tasks concerning veterinary medicinal products are laid down

in Regulation (EU) 2019/6 and Regulation (EC) No 470/2009 of the European Parliament

and of the Council7.

(10) Without prejudice to the provisions laid down in Regulation (EU) 2019/6, which remain

applicable for veterinary medicinal products, in order to create greater legal certainty, this

Regulation should set certain conditions for placing on the market medicinal products

authorised by the Union, confer on the Agency powers to monitor the distribution of

medicinal products authorised by the Union, define the responsibilities regarding the

transparency rules for the Agency’s work and, in the event of failure to observe this

Regulation and the conditions contained in the marketing authorisations granted under the

procedures it establishes, specify the sanctions and the procedures for implementing them.

6 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). 7 Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009

laying down Community procedures for the establishment of residue limits of

pharmacologically active substances in foodstuffs of animal origin, repealing Council

Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European

Parliament and of the Council and Regulation (EC) No 726/2004 of the European

Parliament and of the Council (OJ L 152, 16.6.2009, p. 11,

ELI: http://data.europa.eu/eli/reg/2009/470/oj).

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(11) It is necessary to provide for the coordinated implementation of Union procedures for the

marketing authorisation of medicinal products, and of Member States procedures for the

marketing authorisation which have already been harmonised to a considerable degree by

Directive (EU) 2026/… of the European Parliament and of the Council8+.

(12) The scope of this Regulation with regard to centrally authorised medicinal products needs

to be adapted to the realities of the market and technological development as well as to the

need to ensure a centralised evaluation of certain categories of medicinal products. In the

light of the Commission’s report of 31 August 2021, addressed to the European Parliament

and the Council, on the experience acquired with the procedures for authorising and

supervising medicinal products for human use, it has proved necessary to improve the

functioning of the marketing authorisation procedures for the placing of medicinal

products on the internal market and to amend certain administrative aspects of the Agency.

In addition, the regulatory framework should be adapted to the current market conditions

and economic reality, while continuing to safeguard a high level of protection of public

health and the environment. It emerges from the report that certain operating procedures

need to be corrected and adapted in order to take account of scientific and technological

development. It also emerges from the report that the previously established general

principles which govern the centralised marketing authorisation procedure (‘centralised

procedure’) should be maintained.

8 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 (OJ L, …, ELI: …). + OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)) and in the corresponding footnote the number, date of adoption and

publication reference of that Directive, including its ELI number.

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(13) As regards the scope of this Regulation, the authorisation of antimicrobials at Union level

is in the interest of patients’ health and therefore it should be made possible to authorise

them through the centralised procedure.

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

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

example as regards the marketing authorisation procedures and the pharmacovigilance,

quality and environmental risk assessment requirements. However, specific requirements

also apply to them. Such requirements, which are currently laid down in separate

legislative acts, should be integrated into this Regulation in order to ensure the clarity and

coherence of all the measures applicable to such medicinal products.

(15) With a view to maintaining a high level of scientific evaluation for new medicinal products

and medicinal products that will serve the entire Union population, the centralised

procedure should be mandatory for high-technological medicinal products, particularly

those resulting from biotechnological processes, and for advanced therapy medicinal

products, priority antimicrobials, orphan medicinal products, medicinal products

authorised in accordance with paediatric use marketing authorisation and any medicinal

product containing a new active substance. In addition, the mandatory scope of the

centralised procedure should be aligned with that provided for in Regulation

(EC) No 726/2004. Accordingly, it should continue to apply to medicinal products

containing a new active substance authorised between 20 May 2004 and the date of

application of this Regulation, for the indications listed in Annex I to this Regulation.

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(16) For medicinal products for human use, optional access to the centralised procedure should

also be provided for where a single procedure offers added value for patients. The

centralised procedure should remain optional for medicinal products that do not fall within

categories subject to centralised marketing authorisation but are nonetheless

therapeutically innovative. It is appropriate to extend access to that procedure to medicinal

products that, while not necessarily innovative, could still provide benefits to society or to

patients, including paediatric patients, especially if they are authorised at Union level from

the outset, such as certain medicinal products which can be dispensed without a medical

prescription. This option could be extended to generic medicinal products and biosimilar

medicinal products authorised by the Union, provided that this does not undermine

harmonisation achieved when the reference medicinal product was evaluated nor the

results of that evaluation. At the same time, to ensure wide availability of generic

medicinal products, it is possible for those medicinal products to be authorised by the

competent authorities of the Member States, even if they are based on a centrally

authorised reference medicinal product.

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(17) The Court of Justice of the European Union (hereafter ‘the Court’) has on numerous

occasions held that the health and life of humans rank foremost among the assets and

interests protected by the Treaties. According to the Charter of Fundamental Rights of the

European Union (the ‘Charter’), a high level of human health protection is to be ensured in

the definition and implementation of all the Union’s policies and activities. The centralised

procedure ensures a high standard of scientific evaluation and delivers significant benefits

to the Union’s patient population, particularly regarding innovative medicinal products that

can improve prevention, diagnosis and treatment of diseases and patients’ lives. In addition

to its objective of guaranteeing a high level of protection of public health at Union level,

the centralised procedure also brings greater clarity and efficiency to the Union’s

authorisation system. This allows the marketing authorisation applicant (the ‘applicant’) of

such medicinal products to benefit from easier and harmonised access to the internal

market. However, these innovative medicinal products are often unevenly available across

the Union. This results in different levels of patient access depending on the Member State

in which patients live. While fully respecting fundamental rights and without prejudice to

the provisions of the Treaties, including provisions on the free movement of goods and

common rules on competition, it is essential that marketing authorisation holders who

obtain a centralised marketing authorisation for such medicinal products make every effort

to place them on the market in all Member States.

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In light of the fact that medicinal products are key for a broad and good therapeutic offer to

patients in the Union, this is necessary to maintain a high level of public health protection

across the Union, remove obstacles within the internal market and to strengthen Union-

wide access to these products. Marketing authorisation holders should, in addition to

complying with national legislation and procedures aiming at placing on the market and

supplying medicinal products at national level, also make their best efforts in complying

with the specific requirements on placing on the market and supplying a medicinal product

in a Member State provided for by Directive (EU) 2026/…+ that allow Member States to

signal directly to companies their interest to have supply of a specific new medicinal

product. Accordingly, a marketing authorisation holder for a medicinal product authorised

through the centralised procedure which is subject to regulatory protection or intellectual

property rights, should ensure that the medicinal product is placed on the market and

supplied in accordance with the needs of patient populations across all Member States.

This obligation, however, is neither to compromise the financial viability of the company

nor to be considered breached where external factors beyond the company’s control make

supply in all Member States impossible.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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(18) The establishment of the Agency by means of Council Regulation (EEC) No 2309/939,

which was repealed by Regulation (EC) No 726/2004, has made it possible to reinforce the

scientific evaluation and monitoring of medicinal products in the Union, in particular

through its scientific bodies and committees for which competent authorities of the

Member States provide experts and expertise, ensuring a high quality and independent

assessment. As this Regulation serves to replace Regulation (EC) No 726/2004, the

Agency, previously established under Regulation (EC) No 726/2004, should continue to

function under this Regulation.

(19) Experience with the functioning of the regulatory system has shown that the existing

Agency multi-scientific committee structure often creates complexity in the scientific

assessment process among committees, duplication of work and non-optimised use of

expertise and resources. In addition, the Agency and the competent authorities of the

Member States are confronted with challenges related to limited capacity and appropriate

expertise to deal with increasing number of procedures related to existing medicinal

products and assessment of new ones, in particular cutting edge innovative and complex

medicinal products.

(20) Scientific committees, such as the Committee for Advanced Therapies, have been

instrumental to ensure expertise and capacity building in an emerging technological field.

However, after more than 15 years, advanced therapy medicinal products are now more

common. The integration of their assessment in the work of the Committee for Medicinal

Products for Human Use will facilitate the scientific evaluation of medicinal products

within the same therapeutic class, regardless of the technology on which they are based.

9 Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures

for the authorization and supervision of medicinal products for human and veterinary use

and establishing a European Agency for the Evaluation of Medic inal Products (OJ L 214,

24.8.1993, p. 1, ELI: http://data.europa.eu/eli/reg/1993/2309/oj).

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(21) To optimise the functioning and efficiency of the regulatory system, the structure of the

Agency’s scientific committees is simplified and reduced to two main committees for

medicinal products for human use, namely the Committee for Medicinal Products for

Human Use and Pharmacovigilance Risk Assessment Committee.

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

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

of medicinal products. It should also allow for the reduction of the scientific evaluation

period from 210 days to 180 days.

(23) The Agency’s scientific committees should be supported, in relation to their evaluation

duties, by working parties, whilst retaining complete responsibility for the scientific

opinions issued by them. Those working parties should be open to experts from the

scientific world appointed for that purpose.

(24) The Agency and its committees should, where necessary, establish the appropriate working

parties to ensure the appropriate expertise for the evaluation of medicinal products,

including an Environmental Risk Assessment working party. That working party should

have the scientific expertise necessary to characterise and assess the environmental risks,

and the mitigation measures for such risks, related to the use and disposal of medicinal

products.

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(25) The expertise of the Committee for Advanced Therapies, the Committee for Orphan

Medicinal Products, the Paediatric Committee and Committee for Herbal Medicinal

Products is retained through working groups, working parties, advisory groups, and a pool

of experts who are organised based on different areas of expertise and who are giving input

to the Committee for Medicinal Products for Human Use and the Pharmacovigilance Risk

Assessment Committee. This structure gives the possibility for the Committee for

Medicinal Products for Human Use and the Pharmacovigilance Risk Assessment

Committee to call upon additional scientific experts to provide specific input and advice on

specific aspects raised during the evaluation. In addition, patients and healthcare

professionals can be part of the pool of experts based on their expertise. The Committee for

Medicinal Products for Human Use and the Pharmacovigilance Risk Assessment

Committee consist of experts from all Member States while working parties and expert

groups consist in majority of experts appointed by the Member States, based on their

expertise, and, if necessary, of external experts. The model of rapporteurs remains

unchanged. The efficiency gain, involvement of appropriate scientific expertise and broad

geographic representation of experts in the scientific committees, working parties and

working groups will be ensured as part of the strategy for the organisational management

and internal control systems. Representation of patients and health-care professionals, with

expertise in a wide range of areas, including rare and paediatric diseases, is assured at the

Committee for Medicinal Products for Human Use and the Pharmacovigilance Risk

Assessment Committee, in addition to the dedicated working groups representing patients

and health-care professionals. Information regarding the composition and work of the

committees, working parties and working groups, should be publicly available.

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(26) It is crucial not only that the expertise of experts be preserved within working groups,

working parties and a pool of experts, but also that the relevant expertise be expanded to

cover emerging technologies, incorporate expertise from a broader range of Member States

and enable the Agency to continue fulfilling its obligations at the highest scientific level. It

is also essential for experts to be able to share knowledge, expand their skills through

training programmes, such as those offered by the EU Network Training Centre, and

engage in on-the-job learning activities, including through shadowing rapporteurs,

mentoring, and participating in discussions on topics of interest in working parties,

European scientific expert groups, and other relevant fora.

(27) The Agency’s scientific committees field of activity should be enlarged and their operating

methods and composition modernised. Therefore it is important to ensure patient and

healthcare professional representation in the Committee for Medicinal Products for Human

Use as it is the main evaluation committee of the Agency.

(28) The Committee for Medicinal Products for Human Use should be exclusively responsible

for preparing the Agency’s opinions on all questions concerning medicinal products for

human use.

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(29) The patients and healthcare professionals representatives, for both the Committee for

Medicinal Products for Human Use and the Pharmacovigilance Risk Assessment

Committee, should be selected by the Commission, based on a public call for expressions

of interest. Healthcare professionals can be represented by doctors and pharmacists. The

appointment of such representatives should ensure there is a well-balanced representation

of medical specialties and diseases amongst appointed members and alternates, and there

are robust rules on the prevention of conflicts of interest including financial or other

interests in the pharmaceutical or medical devices industry which could affect their

impartiality.

(30) The structure and functioning of the Agency’s various bodies should be designed in such a

way as to ensure the continuous renewal of scientific expertise, foster cooperation between

Union and national bodies and ensure the adequate involvement of civil society, as well as

to be able to accommodate a future enlargement of the Union. The Agency’s various

bodies should establish and develop appropriate contacts with the parties concerned, in

particular with representatives of patients, consumers and healthcare professionals.

(31) The Agency’s primary task should be to provide Member States and Union institutions

with the best possible scientific opinions, enabling them to exercise the powers of

authorisation and supervision of medicinal products conferred on them by Union legal acts

in this field. Marketing authorisation should be granted by the Commission after

completion of a single scientific evaluation procedure, conducted by the Agency, applying

the highest possible standards, addressing the quality, safety and efficacy of

high-technology medicinal products.

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(32) When examining the marketing authorisation application of the medicinal product, the

Agency should draw up the European public assessment report (EPAR) on the quality,

safety, efficacy, and the environmental risk assessment of the medicinal product and state

the reasons for its opinion. The Agency should make publicly available a summary of the

EPAR and a summary of the environmental risk assessment, after the deletion of any

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

understandable to the public.

(33) To ensure close cooperation between the Agency and the experts operating in Member

States, the composition of the Management Board should be such as to guarantee that the

competent authorities of the Member States are closely involved in the overall

management of the system for authorising medicinal products in the Union.

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(34) The independence and impartiality of the members of the Management Board, the

committees, rapporteurs and experts who participate in meetings or working groups of the

Agency is crucial to avoid any conflict of interest and to preserve the scientific integrity of

the work and activities of the Agency. In implementing this objective, the Agency faces the

challenge of balancing the need for specific expert input within tight time -limits with the

necessity of safeguarding the credibility of its decisions from being compromised by

conflicts of interest. In certain fields, such as rare diseases, special populations, niche

therapeutic indications and highly innovative technologies, the pool of experts is limited,

and many are involved in clinical research on medicinal products. In situations where

specific expertise is required and can be provided only by individuals with competing

interests, which would normally disqualify or limit their involvement in the Agency’s

activities as a member or expert, it might still be in the interest of public health to allow

such individuals to provide observations before a scientific evaluation is finalised, while

excluding them from direct involvement in discussions or decision-making.

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(35) The Agency’s budget should be transparent and composed of fees and charges paid by the

private sector and contributions from the Union budget to implement Union policies as

well as contributions paid from third countries, and comply, where applicable, with

Regulation (EU) 2024/568 of the European Parliament and of the Council10. Although the

majority of its funding comes from fees, the Agency is a public authority. It is of utmost

importance to safeguard Agency’s integrity and impartiality in order to maintain public

trust in its work and the Union regulatory framework.

(36) It is important that Member States ensure adequate funding of competent authorities to

carry out their tasks under this Regulation and under Directive (EU) 2026/…+. In addition,

in line with the Joint Statement of the European Parliament, the Council and the

Commission on decentralised agencies of 19 July 2012, Member States ensure that

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

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

based remuneration they receive from the Agency.

10 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). + OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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(37) The staff of the Agency, including the Executive Director and the Deputy Executive

Director of the Agency, as officials or other servants of the Union, are bound by the

principles of independence, impartiality, integrity, as well as by the obligations provided

for in the Staff Regulations of Officials of the European Union and the Conditions of

Employment of Other Servants of the Union laid down in Council Regulation

(EEC, Euratom, ECSC) No 259/6811 (‘the Staff Regulations’ and ‘Conditions of

Employment of Other Servants’) and the rules agreed upon by the Union’s institutions.

These obligations should continue after leaving the service such as engaging in lobbying or

advocacy vis-à-vis staff of their former institution for their business, clients or employers

on matters for which they were responsible. The Staff Regulations also lay down rules for

those intending to engage in an occupational activity, whether gainful or not, after leaving

the service and provides for the possibility for the Agency, having regard to the interests of

the service, either forbid them from undertaking it or give its approval subject to any

conditions it thinks fit.

11 OJ L 56, 4.3.1968, p. 1, ELI: http://data.europa.eu/eli/reg/1968/259(1)/oj.

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(38) Scientific advice for future applicants seeking a marketing authorisation should be

provided more generally and in greater depth and should be adapted to the specificities of

the medicinal product concerned. Similarly, structures allowing the development of advice

for companies, in particular micro, small and medium-sized enterprises (‘SMEs’) within

the meaning of Commission Recommendation 2003/361/EC12, and for not-for-profit

entities, should be put in place. The Agency should also promote open and public

exchanges about the latest scientific developments and updates of scientific guidelines.

12 Commission Recommendation 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).

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(39) In order to allow for scientific advice for future applicants that is more informative and an

exchange of information between different bodies, scientific advice provided by the

Agency should sometimes take place in parallel to scientific advice provided by other

bodies. This should be the case for the joint scientific consultation carried out by the

Member State Coordination Group on Health Technology Assessment established by

Regulation (EU) 2021/2282 of the European Parliament and of the Council13 and for the

consultation of the expert panels, in cases of medicinal products involving a medical

device, as provided for in Regulation (EU) 2017/745 of the European Parliament and of the

Council14. Where parallel scientific advice consultation mechanisms are established under

other relevant Union legal acts, a similar mechanism should apply.

(40) Promising medicinal products that have the potential to significantly address patients’

unmet medical needs and are expected to be of major public health interest, particularly

regarding their level of therapeutical innovation, or are priority antimicrobials or are likely

to target a neglected tropical disease, should benefit from early and enhanced scientific

support. Such support will ultimately help patients benefit from new therapies as early as

possible.

13 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). 14 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).

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(41) It is important to recognise that unmet medical needs also exist in the area of mental

health, and that promising medicinal products to address such unmet medical needs should

also benefit from early and enhanced scientific support.

(42) The Agency should deliver on request scientific recommendations on whether a product

under development, which could potentially fall under the mandatory scope of the

centralised procedure, meets the scientific criteria to be a medicinal product. Such an

advisory mechanism would address, as early as possible, questions related to borderline

cases with other areas, such as substances of human origin, cosmetics or medical devices,

which could arise as science develops. To ensure that recommendations given by the

Agency take into account the views of equivalent advisory mechanisms in other legal

frameworks, the Agency should consult the relevant advisory or regulatory bodies.

(43) Pharmaceutical research plays a decisive role in the continuing improvement in public

health and in ensuring the Union’s competitiveness. Medicinal products, in particular those

that are the result of long, costly research will not continue to be developed in the Union

unless they are covered by favourable rules that provide for sufficient protection to

encourage such research. While such rules can contribute to the attractiveness of the

internal market, they are however agnostic to the medicinal products’ geographical origin

and medicinal products from third countries authorised in the Union are equally eligible to

receive Union incentives.

7105/2/26 REV 2 23

EN

(44) To promote innovation and the development of new medicinal products by SMEs and to

reduce the cost of the placing on the market of medicinal products for human use

authorised via the centralised procedure, these undertakings should benefit from a support

scheme from the Agency.

(45) The support scheme should be composed of regulatory, procedural and administrative

support, and of a reduction, deferral or waiver of fees. The scheme should cover the

various steps involved in pre-authorisation procedures, such as scientific advice, the

submission of the marketing authorisation application, and post-authorisation procedures.

(46) Not-for-profit entities, such as universities, public bodies, research centres or not-for-profit

organisations, represent an important source of research in the area of unmet medical

needs, research in different subpopulations, repurposing and treatment optimisation and

should also benefit from this support scheme. Whereas it should be possible to take

account of the particular situation of these entities on an individual basis, such support can

best be achieved by means of a dedicated support scheme, including administrative support

and through the reduction, deferral and waiver of fees.

(47) To increase transparency of scientific assessments and all other activities, a European

medicines web-portal should be created and maintained by the Agency.

7105/2/26 REV 2 24

EN

(48) The Union Register of Medicinal Products lists all medicinal products for human use as

well as orphan medicinal products that have been granted a marketing authorisation by the

Commission through the centralised procedure. The information provided in the Union

Register can be used to search for pertinent information on the medicinal product in

question, including the active substance, and any post-authorisation requirements as well

as applicable prolongations to regulatory protection periods.

(49) To allow for more informative advice on clinical trial applications and therefore a more

integrated development advice in view of future data requirements for marketing

authorisation applications, the Agency can engage in consultation with representatives

from Member States having clinical trial expertise. Nevertheless, decisions on clinical trial

applications should remain within the competence of the Member States, in accordance

with Regulation (EU) No 536/2014 of the European Parliament and of the Council15.

15 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).

7105/2/26 REV 2 25

EN

(50) To allow for a more informative decision making and for exchange of information and

pooling of knowledge on general issues of scientific or technical nature related to the tasks

of the Agency regarding medicinal products for human use, in particular to scientific

guidelines on unmet medical needs and the design of clinical trials, or other studies and the

generation of evidence along the life cycle of medicinal product, the Agency should be

able to have recourse to a consultation process of authorities or bodies active along the life

cycle of medicinal products. These authorities or bodies could be, as appropriate,

representatives from Heads of Medicines Agencies, the Clinical Trial Coordination and

Advisory Group, the substances of human origin (SoHO) Coordination Board, the

Coordination Group on Health Technology Assessment, the Medical Devices Coordination

Group, medical devices competent authorities of Member States, competent authorities of

Member States for pricing and reimbursement of medicinal products, national insurance

funds or healthcare payers. The Agency should also be able to extend the consultation

mechanism to consumers, patients, healthcare professionals, industry, associations

representing payers, or other stakeholders, as relevant.

(51) It is also necessary to reinforce the role of the Agency’s scientific committees in such a

way as to enable it to participate actively in international scientific dialogue and to develop

certain activities that will be necessary, in particular regarding international scientific

harmonisation and technical cooperation with the World Health Organization (‘WHO’).

7105/2/26 REV 2 26

EN

(52) In the context of cooperation with international organisations to support global public

health, it is important to leverage the scientific assessment performed by the Union and to

promote reliance by third-country regulatory authorities based on the use of certificates of

medicinal products for authorised medicinal products in the Union. An applicant should be

able to request independently or as part of an application under the centralised procedure a

scientific opinion from the Agency for the use of the medicinal product for markets outside

the Union. The Agency should cooperate with the WHO and relevant third-country

regulatory authorities and bodies to issue such scientific opinions.

(53) The Agency should be able to cooperate with competent authorities of third countries in

the context of performing its tasks. Such regulatory cooperation should be consistent with

the broader economic relationship of the Union with the third country concerned, taking

account of the relevant international agreements between the Union and that third country.

7105/2/26 REV 2 27

EN

(54) The Union is required, pursuant to Article 208 of the Treaty on the Functioning of the

European Union (TFEU), to take account of the objectives of development cooperation in

the policies that it implements which are likely to have an impact on low- and middle-

income countries. Union pharmaceutical legislation has a role to play in the realisation of

global public health objectives by promoting the development of efficacious, safe,

accessible, and affordable innovations for antimicrobial resistance, poverty-related,

emerging and re-emerging health threats, and neglected diseases, and other conditions of

global public health interest. For example, as part of its Priority Medicines scheme, the

Agency will offer dedicated support to medicinal product developments in the area of

neglected tropical diseases. The Commission needs to continue encouraging research,

development and innovation in areas of major global health interest, in line with its

international commitments.

(55) In the interest of public health, marketing authorisation decisions under the centralised

procedure should be taken on the basis of the scientific criteria of quality, safety and

efficacy of the medicinal product concerned, to the exclusion of economic and other

considerations. However, Member States should be able, exceptionally and temporarily, to

prohibit the use in their territory of certain medicinal products. Member States should

provide justification for such prohibition of use to the Commission and the Agency.

7105/2/26 REV 2 28

EN

(56) The quality, safety and efficacy principles of Directive (EU) 2026/…+ should apply to

medicinal products authorised by the Union under the centralised procedure. The benefit-

risk balance of all medicinal products should be assessed when they are placed on the

market, and at any other time the competent authority deems appropriate.

(57) To avoid unnecessary administrative and financial burden both for the pharmaceutical

industry and the competent authorities of the Member States or the Agency, certain

streamlining measures should be introduced. Marketing authorisation applications, like any

other application submitted to the Agency, should follow the ‘digital by default’ principle

and hence be sent to the Agency in electronic form. Electronic applications for marketing

authorisations and for variations to the terms of the marketing authorisation should be

made possible.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

7105/2/26 REV 2 29

EN

(58) Applications should be examined on the basis of the file submitted by the applicant in

accordance with the provisions of Directive (EU) 2026/…+ on different types of

applications. At the same time, the Agency and its relevant committees should be able to

take into account any information that is in their possession. Applicants should be

requested to generally submit raw data, in particular with regard to the clinical trials

conducted by the applicant in order to ensure a full scientific evaluation of the quality,

safety and efficacy of the medicinal product. However, the obligation to submit raw data

should not be construed as obliging the Agency and the relevant committees to examine or

make use of all such data during their scientific assessment. They should retain the

discretion to determine in which cases such data are relevant and necessary for the purpose

of examining the application.

(59) To optimise the use of resources for both applicants and competent authorities of the

Member States or the Agency assessing such applications, a single assessment of an active

substance master file should be introduced. The outcome of the single assessment should

be issued through a certificate. To avoid duplication of assessment, the use of an active

substance master file certificate should be mandatory for subsequent applications for

marketing authorisations for medicinal products for human use containing that active

substance from an active substance master file certification holder.

(60) In the context of the development and authorisation of medicinal products, it is crucial that

particular attention be given to the composition of clinical trials in order to ensure

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

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

7105/2/26 REV 2 30

EN

(61) Directive 2010/63/EU of the European Parliament and of the Council16 lays down

provisions on the protection of animals used for scientific purposes based on the principle

of replacement, reduction and refinement. Any study involving the use of live animals,

which provides essential information on the quality, safety and efficacy of a medicinal

product, should take into account that principle of replacement, reduction and refinement,

where it concerns the care and use of live animals for scientific purposes, and should be

optimised in order to provide the most satisfactory results whilst using the minimum

number of animals. The procedures of such testing should be only used where necessary

and 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. In particular, the applicant and the marketing authorisation holder should take into

account the principle of replacement, reduction and refinement laid down in

Directive 2010/63/EU, giving priority to new approach methodologies in place of animal

testing. These can include: 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, in chemico technologies and any combination thereof or read-

across models. Ultimately, efforts should be made to fully replace procedures on live

animals for scientific purposes.

16 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).

7105/2/26 REV 2 31

EN

(62) This Regulation 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 of, humans and animals. In

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

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

public health globally.

(63) Procedures are to be in place to facilitate joint animal testing, wherever possible, in order

to avoid unnecessary testing using live animals covered by Directive 2010/63/EU.

Applicants and marketing authorisation holders should make all efforts to reuse animal

study results and make the results obtained from animal studies publicly available. In line

with Directive (EU) 2026/…+, abridged applications are to refer to the relevant studies

conducted for the reference medicinal product.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

7105/2/26 REV 2 32

EN

(64) The summary of product characteristics and the package leaflet should reflect the scientific

evaluation of the Agency and be part of its scientific opinion. The opinion could

recommend certain conditions that should be part of the marketing authorisation, for

example on the safe and efficacious use of the medicinal product or on post-authorisation

obligations that have to be complied with by the marketing authorisation holder. Those

conditions could include the requirement to conduct post-authorisation safety or efficacy

studies or other studies that are considered necessary to optimise the treatment, for

example where the dose scheme proposed by the applicant, whilst acceptable and

justifying a favourable benefit-risk balance, could be further optimised after the

authorisation has been granted. Where the applicant disagrees with parts of the opinion, the

applicant should be able to submit a request for its re-examination.

(65) Due to the need to reduce overall approval times for medicinal products, the time between

the opinion of the Committee for Medicinal Products for Human Use and the final decision

on the application for a marketing authorisation should in principle be no longer

than 46 days.

7105/2/26 REV 2 33

EN

(66) On the basis of the opinion of the Agency, the Commission should adopt a decision on the

application for a marketing authorisation by means of implementing acts. In justified cases,

the Commission should be able to refer back the opinion for further examination or deviate

in its decision from the opinion of the Agency. 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 will use the

available mechanisms under Regulation (EU) No 182/2011 of the European Parliament

and of the Council17 and in particular the possibility to obtain the committee’s opinion by

written procedure and within expeditious time limits which, in principle, will not

exceed 10 calendar days.

(67) As a general rule, a marketing authorisation should be granted for an unlimited time.

However, one renewal may be decided only on justified grounds related to the safety of the

medicinal product.

17 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).

7105/2/26 REV 2 34

EN

(68) There is a need to ensure that the ethical requirements of Regulation (EU) No 536/2014

apply to medicinal products authorised by the Union. In particular, with respect to clinical

trials conducted outside the Union on medicinal products to be authorised within the

Union, at the time of the examination of the application for authorisation, it should be

verified that those trials were conducted in accordance with the principles of good clinical

practice and the ethical requirements that are equivalent to those set out in Regulation

(EU) No 536/2014 as regards the rights and safety of the subject and the reliability and

robustness of the data generated in the clinical trial.

(69) Environmental risks can arise from medicinal products consisting of, or containing,

genetically modified organisms (GMOs). It is thus necessary to subject such medicinal

products to an environmental risk-assessment procedure similar to the procedure under

Directive 2001/18/EC of the European Parliament and of the Council18, to be conducted in

parallel with the evaluation, under a single Union procedure, of the quality, safety and

efficacy of the medicinal product concerned. The environmental risk-assessment should be

conducted in accordance with the requirements laid down in this Regulation and in

Directive (EU) 2026/…+ which are based on the principles set out in Directive 2001/18/EC

but taking into account the specificities of medicinal products.

18 Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on

the deliberate release into the environment of genetically modified organisms and repealing

Council Directive 90/220/EEC (OJ L 106, 17.4.2001, p. 1,

ELI: http://data.europa.eu/eli/dir/2001/18/oj). + OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

7105/2/26 REV 2 35

EN

(70) Directive (EU) 2026/…+ permits Member States to temporarily allow the use and supply of

unauthorised medicinal products for public health reasons or individual patient needs and

that includes medicinal products to be authorised under this Regulation. It is also

necessary, that Member States are allowed under this Regulation to make a medicinal

product available for compassionate use prior to its marketing authorisation. In those

exceptional and urgent situations, where there is a lack of a suitable authorised medicinal

product, the need to protect public health or the health of individual patients must prevail

over other considerations, in particular the need to obtain a marketing authorisation and

consequently, to have available complete information about the risks posed by the

medicinal product, including any risks to the environment from medicinal products

consisting of, or containing, GMOs. To avoid delays in making these products available or

uncertainties as regards their status in certain Member States, it is appropriate, in those

exceptional and urgent situations, that for a medicinal product consisting of, or containing,

GMOs, an environmental risk assessment or consent in accordance with

Directive 2001/18/EC or Directive 2009/41/EC of the European Parliament and of the

Council19 should not be a prerequisite. Nevertheless, in those cases, Member States should

implement appropriate measures in line with the precautionary principle to minimise

foreseeable negative environmental impacts resulting from the intended or unintended

release of the medicinal products consisting of, or containing, GMOs into the environment.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)). 19 Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the

contained use of genetically modified micro-organisms (OJ L 125, 21.5.2009, p. 75,

ELI: http://data.europa.eu/eli/dir/2009/41/oj).

7105/2/26 REV 2 36

EN

(71) For medicinal products, the period for protection of data relating to non-clinical tests and

clinical trials should be the same as that provided for in Directive (EU) 2026/…+.

(72) In order to meet, in particular, the legitimate expectations of patients and to take account of

the increasingly rapid progress of science and therapies, accelerated assessment procedures

should be set up, reserved for medicinal products of major therapeutic interest, and

procedures for obtaining conditional marketing authorisations subject to certain regularly

reviewable conditions.

(73) Compassionate use programmes allow for an early access to medicinal products. Existing

provisions should be reinforced to ensure that a common approach is followed, whenever

possible, regarding the criteria and conditions for the compassionate use of new medicinal

products under national law. Moreover, it is important to allow for data on such use to be

collected to inform decisions regarding the benefit-risk balance of the medicinal products

concerned.

(74) It should be recognised that unmet medical needs also exist in the area of mental health.

Promising medicinal products to address serious mental health conditions should therefore

also be considered for compassionate use.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

7105/2/26 REV 2 37

EN

(75) 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. The legislation should allow under similar circumstances for

medicinal products with a standard marketing authorisation for new indications to be

authorised on a conditional basis or under exceptional 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 imposed specific conditions or obligations. The grounds for refusal of a

marketing authorisation should apply mutatis mutandis for such cases.

(76) Before a medicinal product for human use is authorised for placing on the market of one or

more Member States, it generally has to undergo extensive studies to ensure that it is of

high quality, safe and effective for use in the target population. However, in the case of

certain categories of medicinal products for human use, in order to meet unmet medical

needs of patients and in the interest of public health, it might be necessary to grant

marketing authorisation on the basis of less complete data than is normally the case. Such

marketing authorisation should be granted subject to specific obligations. The categories of

medicinal products for human use concerned should be the medicinal products that aim at

the prevention, diagnosis or treatment of seriously debilitating or life-threatening diseases,

or that are intended to be used in emergency situations in response to public health threats.

7105/2/26 REV 2 38

EN

(77) In principle, it should not be possible for more than one marketing authorisation to be

granted to an applicant for a medicinal product. Duplicate marketing authorisations should

be granted only in exceptional circumstances. When those exceptional circumstances are

no longer present, in particular as regards the protection by a patent or a supplementary

protection certificate in one or more Member States, any potentially negative effects on

markets from the existence of duplicate marketing authorisations should be minimised

through a withdrawal of the initial or the duplicate marketing authorisation.

(78) Regulatory decision-making on the development, authorisation and supervision of

medicinal products can be supported by access and analysis of health data, including

real-world data, where appropriate, i.e. health data generated outside of clinical studies,

and data generated via in silico methods, such as computational modelling and simulation,

digital molecular representation and mechanistic modelling, digital twin technology and

artificial intelligence (AI). The Agency should be able to use such data, including via the

Data Analysis and Real World Interrogation Network and the European Health Data Space

interoperable infrastructure. Through the use of those possibilities, the Agency can take

advantage of all the potential of supercomputing, AI and big-data science to fulfil its

mandate, without compromising privacy rights. The Agency should put in place sufficient,

effective and specific technical and organisational measures to safeguard the fundamental

rights and interests of data subjects in accordance with Union law. It is appropriate for the

Agency to cooperate with the competent authorities of the Member States, where

necessary, with a view to achieving that objective.

7105/2/26 REV 2 39

EN

(79) The handling of health data requires a high level of protection against cyber attacks. It is

necessary for the Agency to be equipped with a high level of security controls and

processes against cyber attacks to ensure that the Agency operates normally at all times. To

that end, the Agency should establish a plan to prevent, detect, mitigate and respond to

cyber attacks so that its operations are secure at all times, while preventing any illegal

access to documentation held by the Agency.

(80) Due to the sensitive nature of health data, the Agency 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 Regulation, such processing should be done in accordance with

Union law on the protection of personal data. Any processing of personal data under this

Regulation should take place in accordance with Regulations (EU) 2016/67920 and

(EU) 2018/172521 of the European Parliament and of the Council.

20 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). 21 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).

7105/2/26 REV 2 40

EN

(81) Access to individual patient data from clinical studies in structured format allowing for

statistical analyses is valuable to assist regulators in understanding the submitted evidence

and to inform regulatory decision-making on the benefit-risk balance of a medicinal

product. The introduction of such possibility in the legislation is important to further

enable data-driven benefit-risk assessments at all stages of the life cycle of a medicinal

product. This Regulation therefore empowers the Agency to receive and use such data as

part of the assessment of initial and post-authorisation applications.

(82) In a situation of public health emergency, it is of major interest for the Union that safe and

efficacious medicinal products can be developed and made available within the Union as

soon as possible. Agile, fast and streamlined processes are of the essence. A range of

measures already exists at Union level to facilitate, support and speed up the development

of and granting marketing authorisations for treatments and vaccines during a public health

emergency.

7105/2/26 REV 2 41

EN

(83) It is also considered appropriate for the Commission to have the possibility to grant

temporary emergency marketing authorisations to address public health emergencies.

Temporary emergency marketing authorisations can be granted provided that, having

regard to the circumstances of the public health emergency, the benefit of the immediate

availability on the market of the medicinal product concerned outweighs the risk inherent

to the fact that additional comprehensive quality, non-clinical and clinical data might still

be required. A temporary emergency marketing authorisation should be valid only during

the public health emergency. The Commission should be given the possibility to vary,

suspend or revoke such marketing authorisations in order to protect public health or when

the marketing authorisation holder has not complied with the conditions and obligations

laid down in the temporary emergency marketing authorisation.

(84) It is appropriate to have in place transparency measures and standards regarding the

Agency’s regulatory activities in relation to medicinal products, in particular those that are

granted a temporary emergency marketing authorisation. Those measures should include

the timely publication of all relevant information on centrally approved medicinal

products.

7105/2/26 REV 2 42

EN

(85) In the event of a risk to public health, the marketing authorisation holder or the competent

authorities of the Member States or the Agency should be able to implement urgent safety

or efficacy restrictions on their own initiative to ensure a swift adaption of the marketing

authorisation to maintain the safe and efficacious use of the medicinal product by

healthcare professionals and patients. If a review is launched by a competent authority

regarding the same safety or efficacy concern as one which has been covered by urgent

restrictions, any written observations by the marketing authorisation holder should be

considered in that review to avoid duplication of assessment.

(86) The terms of a marketing authorisation for a medicinal product for human use can be

varied. While the core elements of a variation to the marketing authorisation are laid down

in this Regulation, the Commission should be empowered by means of delegated acts to

complement those core elements by laying down further necessary elements, to adapt the

system to technical and scientific progress, and to employ digitalisation measures to ensure

that unnecessary administrative burden is avoided for marketing authorisation holders and

competent authorities of the Member States or the Agency.

(87) Competent authorities of the Member States or the Agency should have the power to

evaluate additional evidence that could affect the benefit-risk balance of medicinal

products, beyond the evidence provided by marketing authorisation holders. Where

justified, competent authorities of the Member States or the Agency should be able to

recommend that the marketing authorisation holder vary the terms of its marketing

authorisation.

7105/2/26 REV 2 43

EN

(88) For generic medicinal products and biosimilar medicinal products, as a general rule, risk

management plans should not be developed and submitted, also considering that the

reference medicinal product has such a plan. However, in specific cases, a risk

management plan for generic medicinal products and biosimilar medicinal products should

be developed and submitted to the competent authorities of the Member States or

the Agency.

(89) It is appropriate to entrust the Commission, in close cooperation with the Agency and after

consultations with the Member States, with the task of coordinating the execution of the

various supervisory responsibilities vested in the Member States, and in particular with the

tasks of providing information on medicinal products and of checking the observance of

good manufacturing, laboratory and clinical practices.

7105/2/26 REV 2 44

EN

(90) Without prejudice to the powers of the competent authorities of Member States and

without undermining their national inspection resources, the Agency should be provided

with the targeted inspection capacity to contribute to the strengthening of the supervision

of the manufacturing of the medicinal products worldwide, in the interest of the Union.

This could be the case in situations where, to ensure faster access to medicinal products,

challenges with inspection capacities at national level have to be addressed in a timely

manner or where a response to a public health emergency or a major event requires

immediate action. Therefore, the Agency should be empowered and given the capacity to

support Member States with regard to carrying out inspections in third countries. In

particular, where the competent authorities of the Member States request support in

carrying out their tasks under Directive (EU) 2026/…+, the Agency should be able to

participate in inspections. Where the competent authority of a Member State cannot carry

out an inspection, the Agency should facilitate the delegation of the inspection to another

competent authority of a Member State. As a last resort, where no other competent

authority of a Member State is able to accept the delegation to carry out an inspection, the

competent authority concerned should be able to request the Agency to carry out the

inspection.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

7105/2/26 REV 2 45

EN

(91) To ensure consistency in supervision of inspected activities and enforcement of good

manufacturing and distribution practices in the Union, harmonised inspection standards

should be ensured through the establishment of a joint audit programme (‘JAP’) within the

Agency. This JAP will also further harmonise the interpretation of good manufacturing and

distribution practices on the basis of Union legislative requirements. As regards the

implementation of the JAP by the competent authorities of the Member States or the

Agency, this Regulation takes into account the specific constitutional and administrative

structures of each Member State pursuant to Article 4(2) of the Treaty on the European

Union (TEU), while ensuring the effectiveness of such implementation, in accordance with

Article 4(3) TEU. Moreover, it will support further mutual recognition of inspection

outcomes between Member States and with strategic partners. Within the JAP, the

competent authorities of the Member States or the Agency are subject to regular audits

conducted by other Member States to maintain an equivalent and harmonised quality

system and to ensure an appropriate implementation of relevant good manufacturing and

distribution practices in national law and their equivalence with those of other Member

States.

7105/2/26 REV 2 46

EN

(92) The inspection working groups, which provide input and recommendations on all matters

relating, directly or indirectly, to good clinical practice, good manufacturing practice, good

distribution practice and good pharmacovigilance practice, irrespective of the marketing

authorisation procedure through different reporting lines, should be established within the

Agency. In particular, the working group in charge of good manufacturing and good

distribution practices should be responsible for the establishment, development and overall

supervision of the JAP.

(93) The Union should have the means to carry out a scientific assessment of a medicinal

product authorised in accordance with the decentralised marketing authorisation

procedures. Moreover, with a view to ensuring the effective harmonisation of

administrative decisions taken by Member States with regard to a medicinal product

authorised in accordance with decentralised marketing authorisation procedures, it is

necessary to endow the Union with the means to resolve disagreements between Member

States concerning the quality, safety and efficacy of medicinal products in accordance with

the referral procedure.

7105/2/26 REV 2 47

EN

(94) The development of antimicrobial resistance is a growing concern. However, antimicrobial

research and development is being hampered by the low commercial value of the

antimicrobial medicinal product market. It is therefore necessary to maintain the efficacy

of existing antimicrobials for as long as possible and to consider a number of new

measures to promote the development of priority antimicrobials that are effective against

antimicrobial resistance and to support companies, often SMEs, and not-for-profit entities

which choose to invest in this area. It is equally necessary to support research and

development of novel antimicrobials including through the establishment of subscription

models. Such models delink the volume of antimicrobial sales from the reward received, in

particular through voluntary joint procurement and can help overcome such market

failures. Such measures should facilitate the development of alternative treatments, such as

bacteriophages, which can be effective against multi-drug resistant bacteria and can be

used as an alternative treatment or together with antibiotics.

7105/2/26 REV 2 48

EN

(95) Reluctance to invest in the development of antimicrobials exists in part because the

development of antimicrobials is costly and many developers, often SMEs, cannot afford

to proceed to the next stage of development. Additionally, when an antimicrobial is

developed, there is a limited market for it by virtue of the inherent need to use

antimicrobials prudently, which typically limits the sales of such products. Therefore, it is

necessary to consider further Union level action to support the development of

antimicrobials and address existing market failures. Accordingly, a voluntary subscription

model for the joint procurement of antimicrobials should be developed to ensure that a

market exists for developers that delinks volumes sold from payment received.

(96) To be considered a ‘priority antimicrobial’, a medicinal product should represent a real

advancement against antimicrobial resistance and therefore its developer should provide

non-clinical and clinical data that underpin a significant clinical benefit with respect to

antimicrobial resistance. When assessing the conditions for antimicrobials, the Agency

should take into account the prioritisation of pathogens as regards the risk of antimicrobial

resistance set out in the ‘WHO Bacterial Priority Pathogens List: Bacterial pathogens of

public health importance to guide research, development and strategies to prevent and

control antimicrobial resistance’ (‘WHO bacterial priority pathogens list’), specifically

those listed in the ‘critical group’ or in the ‘high group’. Where there is an equivalent list

of priority pathogens established at Union level, it would be appropriate for the Agency to

give precedence to that Union list.

7105/2/26 REV 2 49

EN

(97) The creation of a transferable data exclusivity voucher (‘data exclusivity voucher’) as an

incentive rewarding the development of priority antimicrobials through an additional year

of regulatory data protection has the capacity to provide the needed financial support to

developers of priority antimicrobials. However, in order to ensure that the financial reward

which is ultimately borne by health systems is mostly absorbed by the developer of the

priority antimicrobial and not the buyer of the data exclusivity voucher, the number of

available data exclusivity vouchers on the market should be kept to a minimum. It is

therefore necessary to establish strict conditions of granting, transfer and use of the data

exclusivity voucher and to further give the possibility to the Commission to revoke the data

exclusivity voucher under certain circumstances.

(98) A data exclusivity voucher should only be available to those antimicrobials that bring a

significant clinical benefit with respect to antimicrobial resistance, and which have the

characteristics described in this Regulation. It is also necessary to ensure that an

undertaking which receives this incentive is in turn capable to supply the antimicrobial to

patients across the Union in sufficient quantities and to provide information on all funding

received for research related to its development in order to provide a full account of the

direct financial support given to those antimicrobials.

7105/2/26 REV 2 50

EN

(99) To ensure a high level of transparency and complete information on the economic effect of

a data exclusivity voucher, in particular as regards the risk of overcompensation of

investment, a developer of a priority antimicrobial is required to provide in a declaration

information on all direct financial support received for research related to the development

of the priority antimicrobial. The declaration should include direct financial support

received from any source worldwide.

(100) It should be possible for the transfer of a data exclusivity voucher for a priority

antimicrobial to be conducted by sale. It should not be possible for such a voucher to be

transferred more than once. The value of the transaction, which can be monetary or

otherwise agreed between the buyer and the seller, should be made public so as to inform

regulators and the public. The identity of the holder of a data exclusivity voucher that has

been granted and not yet used should be publicly known at all times so as to ensure a

maximum level of transparency and trust.

7105/2/26 REV 2 51

EN

(101) The provisions related to data exclusivity vouchers should be applicable for a specified

period from the entry into force of this Regulation or until a maximum number of those

vouchers are granted by the Commission in order to limit the total cost of the measure to

Member State health systems. The limited application of the measure will also provide the

possibility to assess the effect of the measure in addressing the market failure in the

development of new antimicrobials tackling antimicrobial resistance and assess the cost on

national health systems. That assessment will provide the knowledge necessary to decide

whether to extend the application of the measure. On the basis of that assessment, the

Commission should, where appropriate, submit a proposal to the European Parliament and

to the Council to extend the period of application of the provisions on data exclusivity

vouchers for priority antimicrobials and the total number of those vouchers.

(102) Through the Priority Medicines (PRIME) scheme, the Agency has gained experience of the

provision of early scientific and regulatory support to developers of certain medicinal

products that, based on preliminary evidence, are likely to address an unmet medical need

and are considered promising at an early stage of development. It is appropriate to

recognise this early support mechanism for medicinal products that have the potential to

significantly address patients’ unmet medical needs and are expected to be of major

interest from the point of view of public health, in particular as regards therapeutic

innovation, or are antimicrobials addressing antimicrobial resistance or target a neglected

tropical disease when they fulfil the criteria for the scheme. The Agency, in consultation

with the Member States and the Commission, should establish selection criteria for

promising medicinal products.

7105/2/26 REV 2 52

EN

(103) The Agency, in consultation with the Member States and the Commission, should set the

scientific selection criteria for medicinal products that receive pre-authorisation support

with priority to be given to the most promising developments in therapies. In the case of

medicinal products for unmet medical needs, based on the scientific selection criteria set

by the Agency, any interested developer can submit preliminary evidence to demonstrate

that the medicinal product has the potential to address an identified unmet medical need

and be of major public health interest particularly regarding its therapeutic innovation.

(104) In the preparation of scientific advice and in duly justified cases, the Agency should also

be able to consult authorities established in other relevant Union legal acts or other public

bodies established in the Union, as applicable. These could include experts in clinical

trials, medical devices, substances of human origin or any other as required for the

provision of the scientific advice in question.

(105) Some conditions occur so infrequently that the cost of developing and bringing to the

market a medicinal product to diagnose, prevent or treat the condition cannot be recovered

by the expected sales of the medicinal product. However, patients suffering from such rare

conditions should be entitled to the same quality of treatment as other patients. It is

therefore necessary to stimulate the research, development and placing on the market of

appropriate medicinal products by the pharmaceutical industry.

7105/2/26 REV 2 53

EN

(106) Regulation (EC) No 141/2000 has proved to be successful in boosting developments of

orphan medicinal products in the Union, although more progress is needed, as a majority of

rare diseases are still without an authorised treatment. Action at Union level therefore

remains preferable to uncoordinated measures by the Member States, which could result in

distortions of competition and barriers to intra-Union trade.

(107) The open and transparent centralised procedure for the designation of potential medicinal

products as orphan medicinal products established by Regulation (EC) No 141/2000

should be maintained. To increase legal clarity and simplification, the specific legal

provisions applicable to those medicinal products should be integrated in this Regulation.

(108) Objective criteria for the orphan designation based on the prevalence of the life-threatening

or chronically debilitating condition for which prevention, diagnosis, or treatment is sought

and the existence of no satisfactory method of prevention, diagnosis or treatment of the

condition in question that has been authorised in the Union should be maintained. A

prevalence of not more than five affected persons per 10 000 is generally regarded as

appropriate for orphan designation. The orphan designation criterion on the basis of return

on investment has been abolished, since it has never been used.

7105/2/26 REV 2 54

EN

(109) The criterion for orphan designation based on prevalence of a disease might not be

appropriate to identify rare diseases in all cases. For example, for conditions which have a

short duration and high mortality, measuring the number of people that acquired the

disease during a specific time period would better reflect if it is rare within the meaning of

this Regulation than measuring the number of people who are ‘affected by it’ in a specific

moment of time.

(110) With the aim to better identify only those diseases which are rare, the Commission should

be empowered to supplement the designation criteria by a delegated act if they are not

appropriate for certain conditions due to scientific reasons and on the recommendation of

the Agency. In addition, the designation criteria require implementing acts to be adopted

by the Commission.

7105/2/26 REV 2 55

EN

(111) If a satisfactory method of prevention, diagnosis or treatment of the condition in question

has already been authorised in the Union, the orphan medicinal product will have to be of

significant benefit to those affected by that condition. In this context, a medicinal product

authorised in one Member State is generally deemed as being authorised in the Union. It is

not necessary for it to have Union authorisation or to be authorised in all Member States to

be considered a satisfactory method. In addition, commonly used methods of prevention,

diagnosis, or treatment that are not subject to a marketing authorisation can be considered

to be satisfactory if there is scientific evidence of their safety and efficacy. In certain cases,

medicinal products prepared for an individual patient in a pharmacy according to a medical

prescription, or according to the prescriptions of a pharmacopoeia and intended to be

supplied directly to patients served by the pharmacy, may be considered to be satisfactory

treatment if they are well known and safe and this is a general practice for the relevant

patient population in the Union.

(112) The competence to designate a medicinal product as an orphan medicinal product, in the

form of a decision, is accorded to the Agency. This is expected to facilitate and expedite

the designation procedure, while ensuring high level of scientific expertise.

7105/2/26 REV 2 56

EN

(113) In order to incite faster authorisation of designated orphan medicinal products, the validity

of orphan designation has been set at seven years, with the possibility of extension by the

Agency under certain specified conditions. The orphan designation can be withdrawn at

the request of the orphan medicinal product sponsor, who provides a reasoned justification

for the withdrawal request. The Agency should make the reasoned justification for the

withdrawal request publicly available, when that justification is provided by the orphan

medicinal product sponsor.

(114) The Agency is responsible for designation of an orphan medicinal product as well as for

the setting up and management of a register of designated orphan medicinal products. That

register should be publicly available. The minimum data which should be included in the

register have been specified in this Regulation and the Commission is empowered to

amend or supplement those minimum data by a delegated act.

(115) Sponsors of orphan medicinal products designated under this Regulation should be entitled

to the full benefit of incentives granted by the Union or by the Member States to support

the research and development of medicinal products for the prevention, diagnosis or

treatment of orphan conditions, including rare diseases.

7105/2/26 REV 2 57

EN

(116) Patients suffering from rare diseases deserve medicinal products of the same quality, safety

and efficacy as other patients. Designated orphan medicinal products should therefore be

submitted to the normal evaluation process carried out by the Committee of Medicinal

Products for Human Use for the applicant to obtain a marketing authorisation for those

indications which meet the criteria for orphan designation, while a separate marketing

authorisation can be granted for indications not meeting the criteria of an orphan medicinal

product. Those marketing authorisations should be considered as belonging to the same

global marketing authorisation.

(117) A vast percentage of rare diseases remains without treatment with research and

development clustered in the areas where profit is better assured. Therefore, there is a need

to target those areas where research is mostly needed and where investments are

most risky.

(118) Orphan medicinal products are considered to be breakthrough orphan medicinal products if

they prevent, diagnose or treat conditions where no other method of prevention, diagnosis

or treatment exists and they result in a clinically relevant reduction in disease morbidity or

mortality for the relevant patient population.

7105/2/26 REV 2 58

EN

(119) Experience since the adoption of Regulation (EC) No 141/2000 shows that the strongest

incentive for industry to invest in the development and making available of orphan

medicinal products is where there is a prospect of obtaining market exclusivity for a certain

number of years during which part of the investment might be recovered. In addition to the

periods of market exclusivity, orphan medicinal products will benefit from the periods of

regulatory data and market protection set out in Directive (EU) 2026/…+, as well as from

one additional year of regulatory data protection provided for in this Regulation by using a

data exclusivity voucher. However, where an orphan medicinal product obtains an

additional therapeutic indication, it should only benefit from the prolongation of market

exclusivity in accordance with this Regulation.

(120) In order to incentivise research and development of breakthrough orphan medicinal

products, to ensure market predictability and to ensure a fair distribution of incentives, a

modulation of market exclusivity has been introduced. Breakthrough orphan medicinal

products benefit from the longest market exclusivity, while market exclusivity for

well-established-use orphan medicinal products, requiring less investment, is the shortest.

In order to ensure increased predictability for developers, the possibility to review the

eligibility criteria for market exclusivity six years after the marketing authorisation has

been abolished.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

7105/2/26 REV 2 59

EN

(121) To maximise the potential benefit of clinical research, continued exploration of new

therapeutic indications for orphan medicinal products should be encouraged. To reward

research into and development of new therapeutic indications, an additional period of one

year of market exclusivity is provided for a new therapeutic indication (with a maximum of

two indications).

(122) This Regulation aims to avoid unjustified benefits being derived from market exclusivity

and to improve the accessibility of medicinal products by ensuring faster entry on the

market of generic medicinal products, biosimilar medicinal products and similar medicinal

products. It also clarifies the concurrence of market exclusivity with regulatory data

protection periods and sets out situations in which a similar medicinal product can be

granted a marketing authorisation despite ongoing market exclusivity.

7105/2/26 REV 2 60

EN

(123) The EU Health Strategy developed by the Commission has identified rare diseases as a

priority for action with the aim to improve patient access to diagnosis, information and

care. Programmes for Union action in this field build on a supportive policy framework at

Union level that encourages national plans and collaborative efforts among Member States.

Under Directive 2011/24/EU of the European Parliament and of the Council22, the

Commission has supported the continued development of European Reference Networks

connecting healthcare providers across the Union to share expertise and provide

consultations for patients suffering from rare diseases. Funding is provided through

programmes like Horizon Europe to support research on rare diseases. Moreover, efforts

are made to enhance patient registries and data collection to support research and improve

knowledge on rare diseases. Additionally, the European Health Data Space is set to have a

transformative impact on research, particularly for rare diseases. It will draw on the work

of the European Platform on Rare Diseases Registration, to address the issue of

fragmentation of patient data across the Union. In 2024 the Commission launched a

new 7-year research partnership, the European Rare Diseases Research Alliance for better

prevention, better diagnosis, and better treatment of rare diseases. With these

comprehensive set of actions, the Union aims to improve diagnosis, treatment, and quality

of life and to better meet the unmet needs of people living with rare diseases and

their carers.

22 Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on

the application of patients’ rights in cross-border healthcare (OJ L 88, 4.4.2011, p. 45,

ELI: http://data.europa.eu/eli/dir/2011/24/oj).

7105/2/26 REV 2 61

EN

(124) Before a medicinal product for human use is placed on the market in one or more Member

States, it has to have undergone extensive studies, including non-clinical tests and clinical

trials, to ensure that it is safe, of high quality and effective for use in the target population.

It is important that such studies are undertaken also in the paediatric population in order to

ensure that medicinal products are appropriately authorised for use in the paediatric

population, and to improve the information available on the use of medicinal products in

the various paediatric population. It is also important that medicinal products be presented

in dosages and formulations that are suitable for children.

(125) Therefore, the development of medicinal products that could potentially be used for the

paediatric population should become an integral part of the development of medicinal

products, integrated into the development programme for adults. Thus, paediatric

investigation plans should be submitted early during medicinal product development, in

time for studies to be conducted in the paediatric population, where appropriate, before

marketing authorisation applications are submitted.

(126) As the development of medicinal products is a dynamic process dependent on the result of

ongoing studies, in certain cases, for example when limited information on the medicinal

products are available because the medicinal products are tested for the first time in the

paediatric population, a specific procedure allowing to progressively build up a paediatric

investigation plan should be put in place.

7105/2/26 REV 2 62

EN

(127) During public health emergencies, in order not to delay a prompt authorisation of a

medicinal product intended for the prevention or treatment of a condition related to the

public health emergency, there should be a possibility to temporarily waive the

requirements concerning paediatric studies to be submitted at the moment of marketing

authorisation.

(128) In order to not endanger the health of children and to avoid exposing them to unnecessary

clinical trials, the obligation to agree and conduct studies in children should be waived

when the medicinal product is likely to be ineffective or unsafe in part or all of the

paediatric population, the specific medicinal product does not represent a significant

therapeutic benefit over existing methods of prevention, diagnosis or treatment for children

or the disease for which the medicinal product is intended occurs only in the adult

population. Nevertheless, if on the basis of existing scientific evidence, the medicinal

product due to its mechanism of action is relevant for a different disease or condition in

children in the same therapeutic area, the obligation should be maintained.

(129) To ensure that research in the paediatric population is only conducted to meet their

therapeutic needs, the Agency should agree and make public lists of waivers for specific

medicinal products or for classes or part of classes of medicinal products. As knowledge of

science and medicine evolves over time, provision should be made for the lists of waivers

to be amended. However, if a waiver is revoked, the requirement for a paediatric

investigation plan should not apply for a given period in order to allow time for such a plan

to be agreed and for studies in the paediatric population to be initiated before an

application for marketing authorisation is submitted.

7105/2/26 REV 2 63

EN

(130) With a view to ensuring that research is conducted only when safe and ethical and that the

requirement for study data in the paediatric population does not block or delay the

authorisation of medicinal products for other populations, the Agency should be able to

defer, on scientific or technical grounds or on the basis of considerations related to public

health, the initiation or completion of some or all of the measures contained in a paediatric

investigation plan for a limited period. Such deferral should be extended only in duly

justified cases.

(131) The possibility to modify an agreed paediatric investigation plan should be provided for in

cases where the applicant encounters such difficulties with its implementation as to render

the plan unworkable or no longer appropriate.

(132) The Agency, after consultation of the Commission and of interested parties, should draw

up the details of the content of an application for agreement of a paediatric investigation

plan, for its modification, for waivers and for deferral requests.

(133) Where it is intended to develop medicinal products for use only in children, simplified

details of the paediatric investigation plan should be sufficient.

(134) To ensure that the data supporting the marketing authorisation concerning the use of a

medicinal product in children to be authorised under this Regulation have been correctly

developed, the Committee for Medicinal Products for Human Use should check

compliance with the agreed paediatric investigation plan and any waivers and deferrals at

the validation step for marketing authorisation applications.

7105/2/26 REV 2 64

EN

(135) Scientific advice, free of charge, should be provided by the Agency as an incentive to

sponsors developing medicinal products for the paediatric population.

(136) To provide healthcare professionals and patients with information on the safe and

efficacious use of medicinal products in the paediatric population, the results of the studies

conducted in compliance with an agreed paediatric investigation plan, independently from

the fact that they support or not the use of the medicinal product in children, should be

included in the summary of product characteristics and, if appropriate, in the

package leaflet.

(137) To sustain the development of novel, paediatric only indications from authorised medicinal

products no longer covered by intellectual property rights, it is necessary to establish a

specific type of marketing authorisation, the paediatric use marketing authorisation. A

paediatric use marketing authorisation should be granted through existing marketing

authorisation procedures but should apply specifically for medicinal products developed

exclusively for use in the paediatric population. It should be possible for the name of the

medicinal product that has been granted a paediatric use marketing authorisation to retain

the existing name of the corresponding medicinal product authorised for adults, in order to

capitalise on existing brand recognition, while benefiting from the regulatory protection

associated with a new marketing authorisation.

7105/2/26 REV 2 65

EN

(138) An application for a paediatric use marketing authorisation should include the submission

of data concerning use of the medicinal product in the paediatric population, collected in

accordance with an agreed paediatric investigation plan. Such data could be derived from

the published literature or from new studies. An application for a paediatric use marketing

authorisation should also be able to refer to data contained in the dossier of a medicinal

product which is or has been authorised in the Union. This is intended to provide an

additional incentive to encourage SMEs, including companies manufacturing generic

medicinal products, to develop off-patent medicinal products for the paediatric population.

(139) Some paediatric investigation plans might be discontinued for various reasons despite

possible positive results for the treatment of children obtained from the studies already

conducted. The information of such discontinuations and their reasons should be collected

by the Agency and made public in order to inform eventual third parties who might be

interested in continuing those studies.

(140) To increase the transparency on clinical trials conducted in children in third countries and

referred to in a paediatric investigation plan or conducted from a marketing authorisation

holder independently from a paediatric investigation plan, information on these clinical

trials should be included in the European clinical trial database (‘EU database’) created

pursuant to Regulation (EU) No 536/2014.

7105/2/26 REV 2 66

EN

(141) The summary of the results of all the paediatric clinical trials included in the EU database

created by Regulation (EU) No 536/2014 should be made publicly available within

six months of the end of the clinical trials unless this is not possible for justified scientific

reasons.

(142) To discuss priority in medicinal product development, in particular in areas of unmet

medical need for children and to coordinate studies relating to paediatric medicinal

products, the Agency should set up a European network for paediatric research composed

of patient representatives, academics, medicinal products developers, investigators and

research centres based in the Union or in the European Economic Area.

(143) Union funding should be provided to cover all aspects of the work of the Agency resulting

from paediatric related activities, such as the assessment of paediatric investigation plans,

fee waivers for scientific advice, and information and transparency measures, including the

database of paediatric studies and the European network for paediatric research.

(144) It is necessary to take measures for the supervision of medicinal products authorised by the

Union, and in particular for the intensive supervision of undesirable effects of these

medicinal products, and the collection of real-world data within the framework of Union

pharmacovigilance activities, so as to ensure the rapid withdrawal from the market of any

medicinal product presenting a negative benefit-risk balance under normal conditions

of use.

7105/2/26 REV 2 67

EN

(145) The main tasks of the Agency in the area of pharmacovigilance laid down in Regulation

(EC) No 726/2004 should be maintained. They include the management of the Union

pharmacovigilance database and data-processing network (the ‘Eudravigilance database’),

the coordination of safety announcements by the Member States and the provision to the

public of information regarding safety issues. The Eudravigilance database should be the

single point of receipt of pharmacovigilance information. Member States should therefore

not impose any additional reporting requirements on marketing authorisation holders. The

database should be fully and permanently accessible to the Member States, the Agency and

the Commission, and accessible to an appropriate extent to marketing authorisation holders

and the public.

7105/2/26 REV 2 68

EN

(146) 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 medicinal products 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.

7105/2/26 REV 2 69

EN

(147) Where the Commission considers that there are reasons to believe that a medicinal product

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

medicinal product should be undertaken by the Agency, leading to a decision whether to

maintain, vary, suspend or revoke the marketing authorisation, and taken on the basis of an

overall evaluation of the benefit-risk balance. It should also be possible for the

Commission to act on a centralised marketing authorisation where the conditions attached

to it are not complied with.

7105/2/26 REV 2 70

EN

(148) It is recognised that improved access to information contributes to public awareness and

increases public trust, gives the public the opportunity to express its observations and

enables authorities to take due account of those observations. The general public should

therefore have access to information in the Union Register of Medicinal Products, the

Eudravigilance database and the Union database referred to in Article 191(15) of Directive

(EU) 2026/…+, after the deletion of any commercially confidential information by the

competent authority, unless there is an overriding public interest in disclosure, in

accordance with Regulation (EC) No 1049/2001 of the European Parliament and of the

Council23. Regulation (EC) No 1049/2001 gives the fullest possible effect to the right of

public access to documents and lays down the general principles and limits on such access.

The Agency should therefore give the widest possible access to the documents while

carefully balancing the right to information with existing data protection requirements.

Certain public and private interests, such as personal data and commercially confidential

information, should be protected by way of exception in accordance with Regulation

(EC) No 1049/2001.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)). 23 Regulation (EC) No 1049/2001 of the European Parliament and of the Council

of 30 May 2001 regarding public access to European Parliament, Council and Commission

documents (OJ L 145, 31.5.2001, p. 43, ELI: http://data.europa.eu/eli/reg/2001/1049/oj).

7105/2/26 REV 2 71

EN

(149) To enhance the efficiency of market surveillance, the Agency should be responsible for

coordinating Member States’ pharmacovigilance activities. A number of provisions are

required to put in place stringent and efficient pharmacovigilance procedures, to allow the

competent authority of the Member State to take provisional emergency measures,

including the introduction of amendments to the marketing authorisation and, finally, to

permit a reassessment to be made at any time of the benefit-risk balance of a

medicinal product.

(150) Scientific and technological progresses in data analytics and data infrastructure are

essential for the development, authorisation and supervision of medicinal products. The

digital transformation has affected regulatory decision-making, making it more data-driven

and multiplying the possibilities to access evidence and real-world data, across the life

cycle of a medicinal product. This Regulation recognises the Agency’s experience and

capacity to access and analyse data submitted independently from the applicant or

marketing authorisation holder. On this basis, the Agency should take the initiative to

recommend the marketing authorisation holder to vary the summary of product

characteristics in cases where new safety or efficacy data have an impact on the benefit-

risk balance of a medicinal product, without excluding other actions that the competent

authority might take.

7105/2/26 REV 2 72

EN

(151) The Union and Member States have developed an evidence-based scientific evaluation

process that allows competent authorities of the Member States to determine the relative

effectiveness of new or existing medicinal products. This process focuses specifically on

the added value of a medicinal product in comparison with other new or existing medicinal

products and health technologies. However, such process should not be conducted in the

context of a marketing authorisation for which it is agreed that the fundamental criteria of

quality, safety and efficacy should be retained. It is useful in this respect to allow the

Agency for the possibility of gathering information on the methods used by the Member

States to determine the therapeutic benefit obtained by each new medicinal product.

(152) In the area of medicinal products, a high level of protection of health of, inter alia, citizens

and consumers, as well as legal certainty and a level playing field and fair competition,

always need to be ensured and existing levels of protection need to be respected.

(153) Regulatory sandboxes can provide a structured context for experimentation under a

controlled framework, to enable where appropriate in a real-world environment the testing

of innovative technologies, products, services or approaches – at the moment especially in

the context of digitalisation or the use of AI and machine learning in the life cycle of

medicinal products from drug discovery, through the development to the administration of

medicinal products – for a limited time and in a limited part of a sector or area under

regulatory supervision ensuring that appropriate safeguards are in place. In particular,

SMEs and startups should have the possibility to participate in regulatory sandboxes to

which they can, as relevant contribute with their knowhow and experience.

7105/2/26 REV 2 73

EN

(154) Implementing powers should be conferred on the Commission to establish a regulatory

sandbox, based on the recommendation of the Agency, when the development and

authorisation of an innovative medicinal product or innovative category of medicinal

products cannot be achieved under the requirements applicable to medicinal products, due

to methods related to those innovative medicinal products or innovative categories of

medicinal products or their inherent scientific or technical characteristics. A regulatory

sandbox facilitates the development, validation and testing of the innovative element of the

medicinal products or categories of medicinal products under the supervision of the

Agency and national regulators while allowing, where necessary and justified, the

adaptation of the regulatory requirements for those medicinal products or categories of

medicinal products. However, such adaptation should ensure that the principles of quality,

safety and efficacy of medicinal products laid down in Union legislation are respected.

Regulatory sandboxes can also benefit patients’ access to groundbreaking new therapies

without compromising the standards of quality, safety and efficacy. The outcome of

regulatory sandboxes should guide the Commission in assessing if an adapted framework

for the medicinal products in question is appropriate and should be pursued.

7105/2/26 REV 2 74

EN

(155) The establishment of a regulatory sandbox by means of a Commission implementing

Decision, following a recommendation of the Agency, should be based on a detailed and

comprehensive plan outlining the particularities of the sandbox as well as describing the

products to be covered. A regulatory sandbox should be limited in duration and could be

terminated at any time based on public health considerations. The learnings stemming from

a regulatory sandbox are capable of informing future changes to the legal framework to

fully integrate the particular innovative aspects into the medicinal product regulation.

Where appropriate, adapted frameworks could be developed by the Commission on the

basis of the results of a regulatory sandbox. Marketing authorisations under a sandbox

should ensure that the principles of quality, safety and efficacy under this Regulation and

Directive (EU) 2026/…+ are respected. The regulatory sandbox should not affect the

supervisory and corrective powers of the competent authorities of the Member States or the

Agency and the liability of the participants, such as clinical trial sponsors, marketing

authorisation holders, applicants, or any entities involved in the lifecycle of the

medicinal product.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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(156) Shortages of medicinal products represent a growing threat to public health, with potential

serious risks to the smooth functioning of the internal market, as well as the health of

patients in the Union and impacts on their right to access appropriate medical treatment,

including longer delays or interruptions in care or therapy, longer periods of

hospitalisation, increased risks of exposure to falsified medicinal products, medication

errors, adverse events following the substitution of unavailable medicinal products with

alternative ones, significant psychological distress for patients and increased costs for

healthcare systems. The root causes of shortages are multifactorial, with challenges

identified along the entire pharmaceutical value chain, and can range from quality to

manufacturing problems. In particular, shortages of medicinal products can result from

supply chain disruptions and vulnerabilities affecting the supply of key ingredients and

components. Member States, depending on their situation, have addressed this in different

ways. Due to a lack of coordination of measures taken at national level, these efforts have

resulted in a fragmented response jeopardising the availability of medicinal products across

the Union. Increased coordination is therefore required at Union level.

(157) More often than in the past, Member States experience critical shortages of various

medicinal products, including certain antimicrobials, endangering the health of patients and

risking the development of antimicrobial resistance. Those critical shortages of

antimicrobials are the result of a multiplicity of factors, including changing infection

patterns, which strongly increases demand. On the supply side, the long lead times needed

to boost production make it difficult to respond quickly. This experience underlines the

need for a dedicated effort from all actors to address the issue of critical shortages.

7105/2/26 REV 2 76

EN

(158) To achieve a better security of supply for medicinal products in the internal market and to

contribute thereby to a high level of public health protection, it is appropriate to

approximate the rules on reporting of supply disruptions and monitoring of expected or

actual shortages of medicinal products, including the procedures and the respective roles

and obligations of concerned entities in this Regulation. It is important to ensure continued

supply of medicinal products, which is often taken for granted in the Union. This is

especially true for the most critical medicinal products which are essential to ensure the

continuity of care, the provision of quality healthcare and guarantee a high level of public

health protection within the Union.

(159) A Member State should be able to decide to exempt a marketing authorisation holder from

complying with certain obligations under Chapter X where the medicinal product is

authorised by that Member State based on public health grounds.

7105/2/26 REV 2 77

EN

(160) Without prejudice to this Regulation, Member States remain the sole responsible for their

own national security. They are responsible for 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 exempt marketing authorisation holders and other

relevant actors from some of the obligations applicable to them only when the medicinal

products are manufactured for military and defence purposes and insofar as the application

of such requirements imply a risk to national security and defence. For medicinal products

that are supplied for military and defence purposes but also to cover the needs of patients,

such exemptions should only target the specific batches that are supplied for military and

defence purposes. Furthermore, Member States should be able to also exempt national

authorities from communicating information where such a requirement would imply a risk

to national security and defence.

7105/2/26 REV 2 78

EN

(161) To prevent or mitigate future shortages of medicinal products, marketing authorisation

holders should notify the concerned competent authorities of the Member States and,

where applicable, the Agency of any future withdrawal of a marketing authorisation,

permanent market cessation or temporary suspension of the marketing of a medicinal

product and any supply disruption exceeding two weeks. Supply disruptions should be

notified as soon as the marketing authorisation holder becomes aware of the situation, and

at the latest six months in advance of the interruption, unless there are duly justified

exceptional circumstances, to allow competent authorities of the Member States or the

Agency to engage with relevant stakeholders and take the necessary mitigation measures.

Furthermore, shortage prevention plans are key tools for the prevention of shortages given

that they require marketing authorisation holders to identify risks in their supply chains and

take the necessary mitigation measures to avoid shortages. Therefore, marketing

authorisation holders should have shortage prevention plans in place for medicinal

products subject to medical prescription and, where applicable, additional medicinal

products identified by the Commission, taking into account recommendations from the

Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), to

prevent or mitigate shortages. The Agency should provide guidance to marketing

authorisation holders on approaches to streamline the implementation of those plans. A

documented risk assessment of supply chain risks should be required for other medicinal

products. The Commission should be able to request the information of the shortage

prevention plans of medical countermeasures in the context of crisis preparedness.

7105/2/26 REV 2 79

EN

(162) To ensure continuity of supply and availability of medicinal products identified as critical

at national level and other specific medicinal products on the market of any Member State

where the medicinal product is authorised, rules for the transfer of the marketing

authorisation or for the offer of a letter of access prior to the withdrawal of the marketing

authorisation or the permanent market cessation, respectively, in Member States where the

marketing authorisation is valid, should be laid down. Such transfer should not be

considered to be a variation. Rules on wholesale distribution of medicinal products,

marketed as a result of a marketing authorisation, whose data have been shared via a letter

of access, do not affect the contractual arrangements between the marketing authorisation

holders or wholesalers concerned.

7105/2/26 REV 2 80

EN

(163) The competent authorities of the Member States should monitor shortages of medicinal

products that are authorised through both national and centralised procedures, based on

notifications of marketing authorisation holders. The Agency should monitor shortages of

centrally authorised medicinal products, also based on notifications of marketing

authorisation holders. When critical shortages of Union concern are identified, both

competent authorities of the Member States and the Agency should work in a coordinated

manner to manage those critical shortages, whether the medicinal product concerned by the

critical shortage is covered by a centralised marketing authorisation or a national marketing

authorisation and communicate the necessary information to patients, consumers and

healthcare professionals. Marketing authorisation holders and other relevant entities should

provide the relevant information to inform the monitoring. Wholesale distributors and

other entities, including natural and legal persons, such as patient organisations or health-

care professionals, should also be able to report a shortage of a given medicinal product

marketed in the Member State concerned to the competent authority. The Agency, with the

support of MSSG already established within the Agency pursuant to Regulation

(EU) 2022/123 of the European Parliament and of the Council24, should establish and,

where necessary, update a list of critical shortages of Union concern. The Agency, in

coordination with the competent authority of the Member State concerned should ensure

monitoring of those shortages.

24 Regulation (EU) 2022/123 of the European Parliament and of the Council

of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis

preparedness and management for medicinal products and medical devices (OJ L 20,

31.1.2022, p. 1, ELI: http://data.europa.eu/eli/reg/2022/123/oj).

7105/2/26 REV 2 81

EN

(164) Parallel trade of medicinal products concerns medicinal products traded from one Member

State to another Member State. Parallel trade facilitates the free movement of medicinal

products due to the fact that the medicinal products are authorised in more Member States

on the basis of the Union legislation. This situation is different from export, where the

harmonised system of authorising and making medicinal products available on the market

does not exist. While the Court has ruled that parallel trade fosters the free movement of

medicinal products and is therefore beneficial to the internal market, it has also recognised

the need to ensure that a Member State has reliable supplies for essential medical purposes,

in particular a supply of medicinal products to the public that is reliable and of good

quality. Therefore, it should be possible for a Member State to require, for certain

medicinal products, wholesale distributors to inform it whenever such a product leaves the

Member State in question to be distributed in another Member State.

7105/2/26 REV 2 82

EN

On the basis of that information and other information at its disposal, including shortage

prevention plans, the Member State should be able to take measures to prevent or mitigate

shortages and should notify them to the Agency. Those measures should also be

appropriate and proportionate to such objectives and take into account that the principle of

the free movement of goods is restricted only for the purpose of safeguarding public

health, thus respecting the case law of the Court and the Treaties, in particular the

provisions on free movement of goods and competition. The information requirements laid

down in this Regulation do not affect existing obligations under Union law for the

notification of technical regulations and technical barriers to the internal market, including

those laid down in Directive (EU) 2015/1535 of the European Parliament and of the

Council25. It is important to recognise that parallel import can contribute to the objective of

access to medicinal products, especially in smaller or vulnerable markets.

25 Directive (EU) 2015/1535 of the European Parliament and of the Council

of 9 September 2015 laying down a procedure for the provision of information in the field of

technical regulations and of rules on Information Society services (OJ L 241, 17.9.2015,

p. 1, ELI: http://data.europa.eu/eli/dir/2015/1535/oj).

7105/2/26 REV 2 83

EN

(165) A voluntary mechanism can foster solidarity between Member States in the context of

critical shortages that require urgent collective action. The voluntary solidarity mechanism

for medicinal products can be activated as a last resort mechanism and should aim to

support Member States experiencing critical shortages that cannot be resolved at national

level despite exhaustive short-term measures. Activation of that Mechanism should be

contingent upon specific conditions, including the lack of therapeutic alternatives and

insufficient quantities to cover critical indications and an imminent risk of stockout which

underline the urgency of the situation. The Agency should facilitate communication and

coordinate support responses, thereby also offering assistance in liaising with marketing

authorisation holders when necessary. The MSSG should be responsible for establishing

procedural rules to ensure the efficient operationalisation of that Mechanism.

7105/2/26 REV 2 84

EN

(166) Competent authorities of the Member States should identify, on the basis of a common

Union methodology, medicinal products they consider to be critical at national level. The

resulting list of critical medicinal products identified by Member States (‘Union long list’)

should be adopted and published by the Commission. The MSSG should also propose a

Union list of critical medicinal products authorised in accordance with Directive

(EU) 2026/…+ or in accordance with this Regulation to ensure monitoring of the supply of

those products, to be adopted by the Commission. The MSSG, supported by the Agency,

should undertake the vulnerability evaluation of critical medicinal products on the Union

list of critical medicinal products following a defined prioritisation. The Commission

should gradually, taking into account the outcome of the vulnerability evaluation, specify

the critical medicinal product for which a vulnerability is established. Among those

medicinal products the Commission should also specify those critical medicinal products,

including their active substances, which are vulnerable due to a high level of dependency

on a single or limited number of countries outside the Union. The MSSG should be able to

provide recommendations on measures to be taken by marketing authorisation holders, the

Member States, the Commission and other entities to resolve any critical shortage or to

ensure the security of supply of those critical medicinal products to the market. Where

appropriate, those security of supply measures should also comprise the use of regulatory

flexibilities such as on packaging and labelling requirements. However, such flexibility

should not undermine the quality, safety, and efficacy standards.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

7105/2/26 REV 2 85

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(167) Monitoring and prevention activities, together with targeted actions at national level, have

at times proven to be insufficient to prevent disruption of supply within the Union of

critical medicinal products. Experience has shown that difficulties in the supply chain have

led to uncoordinated approaches at company and governmental level, such as imposing

contingency stocks requirements on actors in the supply chain, which led to restrictions in

the internal market. Such restrictions are also likely to result in a suboptimal level of

availability of critical medicinal products, due to the fact that a fragmented approach is

jeopardising the availability throughout the Union. It is necessary to ensure that tools for a

Union approach are available to address such situations which are likely to lead to such

restrictions, in specific circumstances, to ensure the free movement of medicinal products

by safeguarding security of a safe and stable supply of them at Union level. The

Commission should therefore be able to draw up recommendations on national measures,

after having duly identified a serious risk of disruptions, to improve security of supply

within the Union.

7105/2/26 REV 2 86

EN

(168) To ensure the enforcement of certain obligations relating to the marketing authorisation for

medicinal products for human use granted in accordance with this Regulation, the

Commission should be able to impose financial penalties. When assessing the

responsibility for failures to comply with those obligations and imposing such penalties, it

is important that means exist to address the fact that marketing authorisation holders could

be part of a wider economic entity. Otherwise, there is a clear and identifiable risk that the

responsibility for a failure to comply with those obligations could be evaded, which might

have an impact on the ability to impose effective, proportional and dissuasive penalties.

The penalties imposed should be effective, proportionate and dissuasive, having regard to

the circumstances of the specific case. For the purpose of ensuring legal certainty in the

conduct of the infringement procedure, it is necessary to set maximum amounts for

penalties. Those maximum amounts should not be linked to the turnover of a particular

medicinal product but the economic entity involved.

7105/2/26 REV 2 87

EN

(169) To supplement or amend certain non-essential elements of this Regulation, the power to

adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in

respect of determining the situations in which post-authorisation efficacy studies could be

required; specifying the categories of medicinal products to which a marketing

authorisation subject to specific obligations could be granted and specifying the procedures

and requirements for granting such a marketing authorisation and for its renewal;

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; establishing procedures for the examination of

applications for the transfer of marketing authorisations; laying down the procedure and

rules for the imposition of fines or periodic penalty payments for a failure to comply with

the obligations under this Regulation as well as the conditions and methods for their

collection. The Commission should be empowered to adopt supplementary measures

laying down the situations in which post-authorisation efficacy studies could be required.

7105/2/26 REV 2 88

EN

It is of particular importance that the Commission carries 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

between the European Parliament, the Council of the European Union and the European

Commission of 13 April 2016 on Better Law-Making26. 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.

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

7105/2/26 REV 2 89

EN

(170) In order to ensure uniform conditions for the implementation of this Regulation in relation

to marketing authorisations for medicinal products for human use, implementing powers

should be conferred on the Commission. The implementing powers related to the granting

of centralised marketing authorisations and for suspending, revoking or withdrawing those

authorisations, for granting data exclusivity vouchers, establishing and modifying

regulatory sandboxes and adopting decisions on the regulatory status of medicinal products

should be exercised in accordance with Regulation (EU) No 182/2011.

(171) Article 91 of Regulation (EU) No 536/2014 currently stipulates, amongst others, that it

applies without prejudice to Directives 2001/18/EC and 2009/41/EC.

(172) Experience shows that, in clinical trials with investigational medicinal products consisting

of, or containing, GMOs, the procedure to achieve compliance with the requirements of

Directives 2001/18/EC and 2009/41/EC as regards the environmental risk assessment and

consent by the competent authority of a Member State is complex and can take a

significant amount of time.

7105/2/26 REV 2 90

EN

(173) The complexity of that procedure increases greatly in the case of multi-centre clinical trials

conducted in several Member States, as sponsors of clinical trials need to submit multiple

requests for authorisation to multiple competent authorities in different Member States in

parallel. In addition, national requirements and procedures for the environmental risk

assessment (ERA) and written consent by competent authorities under GMO legislation

vary greatly from one Member State to another as some Member States apply

Directive 2001/18/EC, others apply Directive 2009/41/EC and there are Member States

that apply either Directive 2009/41/EC or 2001/18/EC depending on the specific

circumstances of a clinical trial. It is therefore not possible to determine a priori the

national procedure that is to be followed.

(174) Consequently, it is particularly difficult to conduct multi-centre clinical trials with

investigational medicinal products that consist of, or contain, GMOs involving several

Member States.

(175) One of the objectives of Regulation (EU) No 536/2014 is that there will be a single

coordinated and harmonised assessment of the clinical trial application between the

involved Member States, with one country leading the coordination of the assessment (the

‘reporting Member State’).

7105/2/26 REV 2 91

EN

(176) It is therefore appropriate to envisage a centralised assessment of the ERA involving

experts from the competent authorities of the Member States and where relevant the

Environmental Risk Assessment working party.

(177) Article 5 of Directive 2001/18/EC provides that the authorisation procedures for the

deliberate release into the environment of GMOs for any other purpose than for placing on

the market and related provisions in Articles 6 to 11 do not apply to medicinal substances

and compounds for human use if such release is authorised by Union legal acts that meet

the requirements listed in that Article.

(178) The requirement for the holding of authorisation of manufacturing and import of

investigational medicinal products in the Union in accordance with Article 61(2), point (a),

of Regulation (EU) No 536/2014 should be extended to investigational medicinal products

consisting of, or containing, GMOs in Directive 2009/41/EC.

(179) It is thus judicious, in order to ensure an efficient functioning of Regulation

(EU) No 536/2014, to define a specific authorisation procedure for the deliberate release of

medicinal substances and compounds for human use consisting of, or containing, GMOs

that meet requirements of Article 5 of Directive 2001/18/EC and taking into account the

specific characteristics of medicinal substances and compounds.

7105/2/26 REV 2 92

EN

(180) Detailed rules concerning financial penalties for failure to comply with certain obligations

laid down in this Regulation are specified in Commission Regulation (EC) No 658/200727.

Those rules should be maintained, but it is appropriate to consolidate them by moving their

core elements and the list specifying those obligations into this Regulation, while

maintaining a delegation of powers that allows the Commission to supplement this

Regulation by laying down procedures for imposing such financial penalties. It is

appropriate, in order to provide for legal certainty, to clarify that Commission Regulation

(EC) No 2141/9628 remains in force and continues to apply unless and until repealed. For

the same reason, it should be clarified that Commission Regulations (EC) No 2049/200529,

(EC) No 507/200630, (EC) No 658/2007 and (EC) No 1234/200831 remain in force and

continue to apply unless and until repealed.

27 Commission Regulation (EC) No 658/2007 of 14 June 2007 concerning financial penalties

for infringement of certain obligations in connection with marketing authorisations granted

under Regulation (EC) No 726/2004 of the European Parliament and of the Council

(OJ L 155, 15.6.2007, p. 10, ELI: http://data.europa.eu/eli/reg/2007/658/oj). 28 Commission Regulation (EC) No 2141/96 of 7 November 1996 concerning the examination

of an application for the transfer of a marketing authorization for a medicinal product falling

within the scope of Council Regulation (EC) No 2309/93 (OJ L 286, 8.11.1996, p. 6,

ELI: http://data.europa.eu/eli/reg/1996/2141/oj). 29 Commission Regulation (EC) No 2049/2005 of 15 December 2005 laying down, pursuant to

Regulation (EC) No 726/2004 of the European Parliament and of the Council, rules

regarding the payment of fees to, and the receipt of administrative assistance from, the

European Medicines Agency by micro, small and medium-sized enterprises (OJ L 329,

16.12.2005, p. 4, ELI: http://data.europa.eu/eli/reg/2005/2049/oj). 30 Commission Regulation (EC) No 507/2006 of 29 March 2006 on the conditional marketing

authorisation for medicinal products for human use falling within the scope of Regulation

(EC) No 726/2004 of the European Parliament and of the Council (OJ L 92, 30.3.2006, p. 6,

ELI: http://data.europa.eu/eli/reg/2006/507/oj). 31 Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the

examination of variations to the terms of marketing authorisations for medicinal products for

human use (OJ L 334, 12.12.2008, p. 7, ELI: http://data.europa.eu/eli/reg/2008/1234/oj).

7105/2/26 REV 2 93

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(181) This Regulation is based on the double legal basis of Article 114 and Article 168(4),

point (c), TFEU. It aims at achieving an internal market as regards medicinal products for

human use, based on a high level of protection of health. At the same time, this Regulation

sets high standards of quality and safety for medicinal products in order to meet common

safety concerns as regards those products. Both objectives are being pursued

simultaneously. Those two objectives are inseparably linked and one is not secondary to

another. Regarding Article 114 TFEU, this Regulation establishes a European Medicines

Agency and provides specific provision with regard to the central authorisation of

medicinal products, therefore ensuring the functioning of the internal market and the free

movement of medicinal products. Regarding Article 168(4), point (c), TFEU, this

Regulation sets high standards of quality and safety for medicinal products.

(182) Since provisions on the centralised procedure for the authorisation and supervision of

medicinal products for human use, including orphan medicinal products and paediatric

medicinal products, and on the European Medicines Agency, are integrated into this

Regulation, it is necessary to repeal Regulations (EC) No 141/2000, (EC) No 726/2004 and

(EC) No 1901/2006.

(183) This Regulation respects the fundamental rights and observes the principles recognised by

the Charter and in particular human dignity, the integrity of the person, the rights of the

child, respect for private and family life, the protection of personal data and the freedom of

art and science. Similarly this regulation integrates a high level of protection of the

environment.

7105/2/26 REV 2 94

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(184) Since the objective of this Regulation, namely to ensure the authorisation of high quality

medicinal products, including for paediatric patients and patients suffering from rare

diseases throughout the Union, cannot be sufficiently achieved by the Member States but

can rather, by reason of the scale of the action needed, 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 Regulation does not go beyond what is

necessary in order to achieve that objective.

(185) 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 202332,

HAVE ADOPTED THIS REGULATION:

32 OJ C, C/2023/712, 14.11.2023, ELI: http://data.europa.eu/eli/C/2023/712/oj.

7105/2/26 REV 2 95

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Chapter I

Subject matter, scope and definitions

Article 1

Subject matter and scope

1. This Regulation lays down Union procedures for the authorisation, supervision and

pharmacovigilance of medicinal products for human use at Union level.

2. This Regulation also establishes rules and procedures, at both Union and Member State

level, relating to the monitoring and management of shortages and critical shortages and

the security of supply of medicinal products.

3. Furthermore, this Regulation establishes the European Medicines Agency (the ‘Agency’),

previously established by Regulation (EC) No 726/2004, and lays down provisions

concerning its governance, as well as provisions concerning its tasks relating to medicinal

products for human use laid down in this Regulation, and concerning other tasks laid down

in Regulation (EU) 2019/6 and in other relevant Union legal acts.

7105/2/26 REV 2 96

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4. This Regulation shall not affect the powers of Member States’ authorities as regards setting

the prices of medicinal products for human use, or the inclusion of medicinal products

within national health systems or social security schemes on the basis of health, economic

and social conditions. Member States may choose from the particulars contained in the

marketing authorisation those therapeutic indications and pack sizes which will be covered

by their social security bodies.

Article 2

Definitions

For the purposes of this Regulation, the following definitions apply:

(1) ‘medicinal product’ or ‘medicinal product for human use’ means a medicinal product as

defined in Article 5(1), point (1), of Directive (EU) 2026/…+;

(2) ‘antimicrobial’ means an antimicrobial as defined in Article 5(1), point (23), of Directive

(EU) 2026/…+;

(3) ‘antimicrobial resistance’ means antimicrobial resistance as defined in Article 5(1),

point (24), of Directive (EU) 2026/…+;

(4) ‘substance’ means a substance as defined in Article 5(1), point (2), of Directive

(EU) 2026/…+;

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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(5) ‘active substance’ means an active substance as defined in Article 5(1), point (3), of

Directive (EU) 2026/…+;

(6) ‘active substance master file’ means an active substance master file as defined in

Article 5(1), point (42), of Directive (EU) 2026/…+;

(7) ‘radiopharmaceutical’ means radiopharmaceutical as defined in Article 5(1), point (19), of

Directive (EU) 2026/…+;

(8) ‘reference medicinal product’ means a reference medicinal product as defined in

Article 5(1), point (12), of Directive (EU) 2026/…+;

(9) ‘homeopathic medicinal product’ means a homeopathic medicinal product as defined in

Article 5(1), point (67), of Directive (EU) 2026/…+;

(10) ‘package leaflet’ means package leaflet as defined in Article 5(1), point (49), of Directive

(EU) 2026/…+;

(11) ‘labelling’ means labelling as defined in Article 5(1), point (52), of Directive

(EU) 2026/…+;

(12) ‘environmental risk assessment’ or ‘ERA’ means an environmental risk assessment as

defined in Article 5(1), point (40), of Directive (EU) 2026/…+;

(13) ‘starting material’ means starting material as defined in Article 5(1), point (4), of Directive

(EU) 2026/…+;

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

7105/2/26 REV 2 98

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(14) ‘intermediate product’ means an intermediate product as defined in Article 5(1), point (5),

of Directive (EU) 2026/…+;

(15) ‘excipient’ means an excipient as defined in Article 5(1), point (6), of Directive

(EU) 2026/…+;

(16) ‘post-authorisation safety study’ means a post-authorisation safety study as defined in

Article 5(1), point (61), of Directive (EU) 2026/…+;

(17) ‘adverse reaction’ means an adverse reaction as defined in Article 5(1), point (64), of

Directive (EU) 2026/…+;

(18) ‘non-clinical’, with respect to a study or test, means non-clinical as defined in Article 5(1),

point (11), of Directive (EU) 2026/…+;

(19) ‘benefit-risk balance’ means benefit-risk balance as defined in Article 5(1), point (47), of

Directive (EU) 2026/…+;

(20) ‘risk management plan’ means a risk management plan as defined in Article 5(1),

point (38), of Directive (EU) 2026/…+;

(21) ‘risk management system’ means a risk management system as defined in Article 5(1),

point (39), of Directive (EU) 2026/…+;

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

7105/2/26 REV 2 99

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(22) ‘pharmacovigilance system’ means a pharmacovigilance system as defined in Article 5(1),

point (62), of Directive (EU) 2026/…+;

(23) ‘pharmacovigilance system master file’ means a pharmacovigilance system master file as

defined in Article 5(1), point (63), of Directive (EU) 2026/…+;

(24) ‘medical prescription’ means a medical prescription as defined in Article 5(1), point (45),

of Directive (EU) 2026/…+;

(25) ‘variation’ or ‘variation of the terms of a marketing authorisation’ means a variation or a

variation of the terms of a marketing authorisation as defined in Article 5(1), point (60), of

Directive (EU) 2026/…+;

(26) ‘critical medicinal product’ means a medicinal product whose insufficient supply would

result in serious harm or risk of serious harm to patients, and identified using the

methodology set out in Article 136(1), point (a);

(27) ‘not-for-profit entity’ means a not-for-profit entity as defined in Article 5(1), point (58), of

Directive (EU) 2026/…+;

(28) ‘micro, small and medium-sized enterprise’ means a micro, small and medium-sized

enterprise as defined in Article 2 of the Annex to Commission

Recommendation 2003/361/EC;

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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(29) ‘medical device’ means a medical device as defined in Article 2, point (1), of Regulation

(EU) 2017/745;

(30) ‘in vitro diagnostic medical device’ means an in vitro diagnostic medical device as defined

in Article 2, point (2), of Regulation (EU) 2017/746;

(31) ‘advanced therapy medicinal product’ means an advanced therapy medicinal product as

defined in Article 2(1), point (a), of Regulation (EC) No 1394/2007 of the European

Parliament and of the Council33;

(32) ‘allergen medicinal product’ means an allergen medicinal product as defined in

Article 5(1), point (10), of Directive (EU) 2026/…+;

(33) ‘substance of human origin’ or ‘SoHO’ means a substance of human origin as defined in

Article 3, point (1), of Regulation (EU) 2024/1938 of the European Parliament and of the

Council34;

33 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 Directive in document ST 7106/26

(2023/0132(COD)). 34 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,

17.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1938/oj).

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(34) ‘orphan condition’ means a life-threatening or chronically debilitating condition that meets

the rarity criteria set out in Article 65(1), point (a), and Article 65(2);

(35) ‘designated orphan medicinal product’ means a medicinal product under development

which has been granted an orphan designation by a decision pursuant to Article 66(4);

(36) ‘orphan medicinal product’ means a medicinal product which has been granted an orphan

marketing authorisation pursuant to Article 71;

(37) ‘orphan medicinal product sponsor’ means any legal or natural person, established in the

Union, who has submitted an application for or been granted an orphan designation for a

medicinal product by a decision pursuant to Article 66(4);

(38) ‘significant benefit’ means a clinically relevant advantage or a major contribution to

patient care of an orphan medicinal product if such an advantage or contribution benefits

the relevant part of the target population;

(39) ‘clinically superior’, with respect to a medicinal product, means that a medicinal product is

shown to provide a significant therapeutic or diagnostic advantage above that provided by

an orphan medicinal product in one or more of the following ways:

(a) greater efficacy in the relevant part of the target population than an orphan medicinal

product which has market exclusivity;

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(b) greater safety in the relevant part of the target population than an orphan medicinal

product which has market exclusivity;

(c) in exceptional cases, where neither greater safety nor greater efficacy as referred to

in points (a) and (b) has been shown, demonstration that the medicinal product

otherwise makes a major contribution to diagnosis or to patient care;

(40) ‘similar active substance’ means an identical active substance, or an active substance,

which has the same principal molecular structural features (but not necessarily all of the

same molecular structural features) and which acts via the same mechanism; for advanced

therapy medicinal products, for which the principal molecular structural features cannot be

fully determined, the similarity between two active substances shall be assessed based on

the biological and functional characteristics;

(41) ‘similar medicinal product’ means a medicinal product which contains a similar active

substance or similar active substances as contained in an orphan medicinal product for the

same therapeutic indication;

(42) ‘generic medicinal product’ means a generic medicinal product as defined in Article 5(1),

point (13), of Directive (EU) 2026/…+;

(43) ‘biosimilar medicinal product’ means a biosimilar medicinal product as defined in

Article 5(1), point (15), of Directive (EU) 2026/…+;

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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(44) ‘paediatric investigation plan’ means a paediatric investigation plan as defined in

Article 5(1), point (43), of Directive (EU) 2026/…+;

(45) ‘paediatric population’ means paediatric population as defined in Article 5(1), point (44),

of Directive (EU) 2026/…+;

(46) ‘strength’ as regards a medicinal product means strength as defined in Article 5(1),

point (55), of Directive (EU) 2026/…+;

(47) ‘paediatric use marketing authorisation’ means a marketing authorisation granted for a

medicinal product for human use which is not protected by a supplementary protection

certificate under Regulation (EC) No 469/2009 of the European Parliament and of the

Council35 or by a patent which qualifies for the granting of the supplementary protection

certificate, and which covers exclusively therapeutic indications which are relevant for use

in the paediatric population, or subsets thereof, including the appropriate strength,

pharmaceutical form or route of administration for that product;

(48) ‘public health emergency’ means a public health emergency as defined in Article 5(1),

point (57), of Directive (EU) 2026/…+;

(49) ‘vaccine’ means a vaccine as defined in Article 5(1), point (31), of Directive

(EU) 2026/…+;

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)). 35 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. 1, ELI: http://data.europa.eu/eli/reg/2009/469/oj).

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(50) ‘name of the medicinal product’ means the name of the medicinal product as defined in

Article 5(1), point (53), of Directive (EU) 2026/…+;

(51) ‘abuse of medicinal products’ means abuse of medicinal products as defined in

Article 5(1), point (46), of Directive (EU) 2026/…+;

(52) ‘regulatory sandbox’ means a regulatory framework within which it is possible to develop,

validate and test innovative or adapted regulatory solutions in a controlled environment,

thereby facilitating the development and authorisation of innovative medicinal products

which are likely to fall within the scope of this Regulation, according to a specific plan and

for a limited time under regulatory supervision;

(53) ‘letter of access’ means a letter of access as defined in Article 5(1), point (16), of Directive

(EU) 2026/…+;

(54) ‘shortage’ means a situation in which the supply (as defined in Annex IV) of a medicinal

product that is authorised and placed on the market in a Member State does not meet the

demand (as defined in Annex IV) for that medicinal product in that Member State

whatever the cause;

(55) ‘critical shortage in the Member State’ means a shortage of a medicinal product for which

there is no appropriate alternative medicinal product available in sufficient quantities on

the market in a Member State and which could result in a significant impact on the

healthcare system of that Member State, or result in harm or risk of harm to patients;

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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(56) ‘critical shortage of Union concern’ means a critical shortage in the Member State that

cannot be resolved at Member State level and for which coordinated Union level action is

necessary to resolve it in accordance with this Regulation;

(57) ‘wholesale distribution’, with respect to medicinal products, means wholesale distribution

as defined in Article 5(1), point (76), of Directive (EU) 2026/…+;

(58) ‘falsified medicinal product’ means a falsified medicinal product as defined in Article 5(1),

point (56), of Directive (EU) 2026/…+;

(59) ‘veterinary medicinal product’ means a medicinal product as defined in Article 4, point (1),

of Regulation (EU) 2019/6;

(60) ‘herbal medicinal product’ means a herbal medicinal product as defined in Article 5(1),

point (69), of Directive (EU) 2026/…+;

(61) ‘biological medicinal product’ means a biological medicinal product as defined in

Article 5(1), point (14), of Directive (EU) 2026/…+;

(62) ‘manufacture of medicinal products’ means manufacture of medicinal products as defined

in Article 5(1), point (73), of Directive (EU) 2026/…+;

(63) ‘decentralised manufacturing’ means decentralised manufacturing as defined in

Article 5(1), point (74), of Directive (EU) 2026/…+.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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Article 3

Centrally authorised medicinal products

1. A medicinal product listed in Annex I shall be placed on the market in the Union only if it

has been granted a marketing authorisation by the Union in accordance with this

Regulation (‘centralised marketing authorisation’ or ’marketing authorisation’).

2. A medicinal product not listed in Annex I may be granted a centralised marketing

authorisation, if it meets at least one of the following requirements:

(a) the applicant shows that the medicinal product constitutes a significant therapeutic,

scientific or technical innovation or that the granting of a centralised marketing

authorisation is in the interest of patients’ health at Union level, including in relation

to antimicrobial resistance and medicinal products for public health emergencies;

(b) it is a medicinal product intended solely for paediatric use;

(c) the applicant refers in the marketing authorisation application to a reference

medicinal product that has been authorised through the centralised marketing

authorisation procedure (‘centralised procedure’);

(d) the medicinal product contains a new active substance which, on 20 May 2004, was

not authorised in the Union.

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3. Homeopathic medicinal products shall not be granted a centralised marketing

authorisation.

4. The Commission shall grant and supervise centralised marketing authorisations for

medicinal products for human use in accordance with Chapter II.

5. The Commission is empowered to adopt delegated acts in accordance with Article 181 to

amend Annex I, in order to adapt it to scientific and technological progress. When

preparing and drawing up a delegated act, the Commission shall:

(a) justify the appropriateness of updating the description of the biotechnological

processes referred to in point 1 of Annex I on the basis of scientific and technological

evidence;

(b) base the delegated act on an up-to-date scientific literature review as regards the

types and extent of developments that have occurred, including, where applicable,

international guidelines and comparative standards;

(c) where applicable, take into account any relevant new or updated scientific opinions

from the WHO or medicines agencies.

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Article 4

National marketing authorisation of medicinal products

that refer to centrally authorised reference medicinal products

By way of derogation from Article 3 of this Regulation, the competent authorities of the Member

States may authorise, in accordance with Directive (EU) 2026/…+, a medicinal product that refers

to a centrally authorised reference medicinal product where the following conditions are met:

(a) the application for marketing authorisation is submitted in accordance with Article 10

or 12 of Directive (EU) 2026/…+ or, in duly justified cases, in accordance with Article 11

or 13 of that Directive;

(b) the summary of product characteristics and the package leaflet are in all relevant respects

consistent with that of the medicinal product authorised by the Union, including its

indications;

(c) the reference medicinal product is not a medicinal product referred to in Annex I, point 1

or 2.

Where the application for marketing authorisation is submitted in accordance with Article 11 or 13

of Directive (EU) 2026/…+, the applicant shall demonstrate that all the indications covered by the

application have been centrally authorised for the active substance concerned.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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Point (b) of the first paragraph shall not apply to those parts of the summary of product

characteristics or the package leaflet that refer to indications, posologies, pharmaceutical forms,

methods or routes of administration or any other ways in which the medicinal product can be used

that were protected by a patent or a supplementary protection certificate for medicinal products at

the time of the placing on the market of the medicinal product for which a marketing authorisation

has been applied for under this Article where the applicant has requested not to include that

information in the marketing authorisation.

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Chapter II

General provisions and rules on applications

SECTION 1

APPLICATION FOR CENTRALISED MARKETING AUTHORISATIONS

Article 5

Submission of applications for centralised marketing authorisations

1. The marketing authorisation holder for medicinal products covered by this Regulation shall

be established in the Union. The marketing authorisation holder shall be responsible for the

placing on the market of those medicinal products, whether done by that marketing

authorisation holder or by one or more persons designated to that effect.

2. The marketing authorisation applicant (the ‘applicant’) and the Agency shall agree on the

submission date for a marketing authorisation application.

3. The applicant shall submit an application for a marketing authorisation electronically to the

Agency, using the format made available by the Agency.

4. The applicant shall be responsible for the accuracy and completeness of the information

and documents submitted with respect to its application.

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5. Within 20 days of receipt of an application, the Agency shall check whether all particulars

and documents required under Article 7 have been submitted and whether the application

contains any critical deficiencies that might prevent the evaluation of the medicinal

product. The Agency shall then decide on the validity of the application.

6. If the Agency considers that the application is incomplete, or contains critical deficiencies

that may prevent the evaluation of the medicinal product, it shall notify the applicant

accordingly and set a time limit for submitting the missing information and documents.

The Agency may extend that time limit once.

Upon receiving the applicant’s responses to the request for missing information and

documents, the Agency shall determine whether the application can be considered valid. If

the Agency refuses to validate an application, it shall notify the applicant and provide the

reasons for such a refusal.

If the applicant fails to provide the missing information and documents within the time

limit referred to in the first subparagraph, the application shall be considered to have been

withdrawn.

7. The Agency shall draw up scientific guidelines for the identification of critical deficiencies

that might prevent the evaluation of a medicinal product, in consultation with the

Commission and the Member States.

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Article 6

Requirements to place on the market and supply

centrally authorised medicinal products

1. With a view to facilitating access to a centrally authorised medicinal product, and where

such product is subject, as applicable, to regulatory data protection or regulatory market

protection pursuant to Article 83 of Directive (EU) 2026/…+, market exclusivity pursuant

to Article 73 of this Regulation, patent or a supplementary protection certificate, a Member

State may request the marketing authorisation holder to place that medicinal product on the

market of that Member State and to supply it, either in accordance with the requirements

laid down in Article 59 of Directive (EU) 2026/…+, including the requirements referred to

in paragraph 2 of that Article, or independently from the provisions of that Article. The

marketing authorisation holder shall ensure, upon agreement with the respective Member

State and within the limits of its responsibility, that such medicinal product is placed on the

market and supplied so that the needs of patients in that Member State are met.

The practical arrangements between the marketing authorisation holder and the respective

Member State to implement the requirements laid down in the first subparagraph shall be

proportionate to the objective pursued.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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A marketing authorisation holder shall comply with the requirements laid down in the first

subparagraph, unless there are exceptional and unforeseeable circumstances, including

those related to disruptions of supply, or other circumstances fully outside the marketing

authorisation holder’s control, the consequences of which could not have been avoided

even if all best reasonable measures had been taken. In such a case, the marketing

authorisation holder shall provide an explanation of the circumstances of the case and

provide duly justified reasons for non-compliance.

2. Where a Member State considers that a marketing authorisation holder has consistently

failed to place on the market and supply a medicinal product to meet the needs of patients

in that Member State, it may inform the Commission. The Member State shall provide the

Commission with a detailed description of the facts of the case and substantiate the

marketing authorisation holder’s failure to place on the market and supply a

medicinal product.

Prior to informing the Commission, the Member State shall notify the marketing

authorisation holder concerned and invite it to provide written observations within four

weeks of the notification. This period may be extended once. The written observations

shall be attached to the information provided to the Commission in accordance with the

first subparagraph. When informing the Commission, the Member State shall duly consider

the explanations provided by the marketing authorisation holder in its written observations.

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3. Whenever more than one Member State invokes non-compliance pursuant to the

first subparagraph of paragraph 2 in relation to the same medicinal product, the

Commission shall require the marketing authorisation holder to enter into negotiations in

good faith with those Member States and make best efforts to ensure supply in order to

meet the needs of patients in those Member States.

4. By … [four years from the date of application of this Regulation], the Commission shall

present a report to the European Parliament and the Council on the application of this

Article. That report shall be based on, inter alia, information provided by Member States,

and it shall include an assessment of whether the rules provided for in this Article ensure

that the medicinal products concerned are placed on the market and supplied for use in

patients in all Member States that have applied this Article. The Commission shall, where

appropriate, submit legislative proposals based on that assessment, in particular with

regard to remedial actions in the case of non-compliance, including the possibility to

impose penalties in accordance with Article 178.

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Article 7

Centralised marketing authorisation applications

1. Applications for a centralised marketing authorisation of a medicinal product for human

use, submitted to the Agency in accordance with Article 5 of this Regulation, shall

specifically and completely include the particulars and documents required pursuant to

Chapter II of Directive (EU) 2026/…+. In the case of applications in accordance with

Article 7(2) and Articles 11 and 13 of Directive (EU) 2026/…+, those particulars and

documents shall be accompanied by raw data submitted electronically, in accordance with

Annex II to that Directive.

The particulars and documents referred to in the first subparagraph of this paragraph shall

include a declaration to the effect that clinical trials carried out outside the Union meet the

ethical requirements of Regulation (EU) No 536/2014. Those particulars and documents

shall take account of the Union nature of the authorisation requested and, in cases other

than exceptional cases relating to the application of the law on trademarks pursuant to

Regulation (EU) 2017/1001 of the European Parliament and of the Council36, shall include

the use of a single name for the medicinal product. The use of a single name shall not

exclude the use of additional qualifiers where necessary to identify different presentations

of the medicinal product concerned.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)). 36 Regulation (EU) 2017/1001 of the European Parliament and of the Council of 14 June 2017

on the European Union trade mark (OJ L 154, 16.6.2017, p. 1,

ELI: http://data.europa.eu/eli/reg/2017/1001/oj).

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2. The Agency may offer to the applicant a phased review of complete data packages for

individual modules of particulars and documents as referred to in paragraph 1 for

medicinal products which:

(a) are likely to address an unmet medical need as referred to in Article 85(1) of

Directive (EU) 2026/…+ and are expected to be of major interest from the point of

view of public health, particularly regarding its therapeutic innovation;

(b) are antimicrobials with any of the characteristics mentioned in Article 41(3) or are

antimicrobials targeting pathogens included in the ‘WHO bacterial priority pathogens

list’, specifically those listed in the ‘critical group’ or ‘high group’, or included in

any equivalent list of priority pathogens established at Union level; or

(c) are intended to be used in relation to a potential or recognised public health

emergency.

The Agency shall apply the first subparagraph following the advice of the Committee for

Medicinal Products for Human Use regarding the fulfilment of the criteria listed in

points (a) to (c) of the first subparagraph, and the maturity of the data concerning the

development of those medicinal products.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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The Agency may at any stage suspend or cancel the phased review, where the Committee

for Medicinal Products for Human Use considers that the submitted data are not of

sufficient maturity or where it considers that the medicinal product no longer fulfils the

criteria set out in the first subparagraph. The Agency shall inform the applicant

accordingly.

3. A fee shall apply for a centralised marketing authorisation application and shall be payable

to the Agency for the examination of the application.

4. Where appropriate, the application for a centralised marketing authorisation may include

summary documents, certificates, protocols or master files in accordance with Chapter II,

Section 4, and Annex II to Directive (EU) 2026/…+.

5. The 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.

The applicant shall not carry out animal testing where scientifically satisfactory non-

animal testing methods are available.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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6. The Agency shall ensure that the opinion of the Committee for Medicinal Products for

Human Use is issued within 180 days of receipt of a valid application. In the case of a

medicinal product for human use that consists of, or contains, genetically modified

organisms (GMOs) the opinion of that Committee shall take into account the evaluation of

the environmental risk assessment in accordance with Article 8(1).

On the basis of a duly justified request, the Committee for Medicinal Products for Human

Use may extend the duration of the analysis of the scientific data related to an application

for a centralised marketing authorisation.

7. When an application for a centralised marketing authorisation is submitted for a medicinal

product for human use which is of major interest from the point of view of public health

and in particular from the viewpoint of therapeutic innovation, the applicant may request

an accelerated assessment procedure. That shall also apply to medicinal products referred

to in Article 62. The request shall be duly substantiated.

If the Committee for Medicinal Products for Human Use accepts the request referred to in

the first subparagraph of this paragraph, the time limit specified in paragraph 6, first

subparagraph, shall be reduced to 150 days.

8. The adapted frameworks established in accordance with Article 31 of Directive

(EU) 2026/…+ may also apply for the purpose of obtaining a centralised marketing

authorisation in accordance with this Regulation.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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Article 8

Environmental risk assessment for medicinal products

consisting of, or containing, GMOs

1. Without prejudice to Article 23 of Directive (EU) 2026/…+, the marketing authorisation

application of a medicinal product for human use consisting of, or containing, GMOs as

defined in Article 2(2) of Directive 2001/18/EC shall be accompanied by an environmental

risk assessment identifying and evaluating potential adverse effects of the GMOs on

human or animal health, and the environment.

2. The environmental risk assessment for the medicinal products referred to in paragraph 1 of

this Article shall be conducted in accordance with the elements listed in Article 9 of this

Regulation and the specific requirements set out in Annex II to Directive (EU) 2026/…+

which are based on the principles laid down in Annex II to Directive 2001/18/EC taking

into account the specificities of medicinal products.

3. Articles 13 to 24 of Directive 2001/18/EC shall not apply to medicinal products for human

use consisting of, or containing, GMOs.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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4. Articles 6 to 11 of Directive 2001/18/EC as well as Articles 4 to 13 of

Directive 2009/41/EC shall not apply to operations related to the supply and clinical use,

including the packaging and labelling, distribution, storage, transport, preparation for

administration, administration, destruction or disposal of medicinal products consisting of,

or containing, GMOs, with the exception of their manufacture, in any of the following

cases:

(a) where such medicinal products have been exempted from the requirements of

Directive (EU) 2026/…+ by a Member State pursuant to Article 4(1) of that

Directive;

(b) where the use and distribution of such medicinal products have been temporarily

authorised by a Member State pursuant to Article 4(4) of Directive (EU) 2026/…+; or

(c) where such medicinal products are made available by a Member State pursuant to

Article 27(1).

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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5. In the cases referred to in paragraph 4, Member States shall implement appropriate

measures to minimise foreseeable negative environmental impacts resulting from the

intended or unintended release of the medicinal products consisting of, or containing,

GMOs into the environment.

The competent authorities of the Member States shall ensure that information related to the

use of medicinal products referred to in paragraph 4 of this Article is available and

provided to the competent authorities under Directive 2009/41/EC, when necessary and in

particular in the event of an accident referred to in Articles 14 and 15 of

Directive 2009/41/EC.

Article 9

Content of the environmental risk assessment for medicinal products

consisting of, or containing, GMOs

The environmental risk assessment referred to in Article 8(2) shall contain the following elements:

(a) a description of the GMO and the modifications introduced as well as characterisation of

the finished product;

(b) an identification and characterisation of hazards for the environment, animals and

human health;

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(c) an exposure characterisation, which assesses the likelihood or probability that the

identified hazards materialise;

(d) a risk characterisation, which takes into account the magnitude of each possible hazard and

the likelihood or probability that an adverse effect occurs;

(e) risk minimisation and mitigation strategies proposed to address identified risks including

specific containment measures to limit contact of the medicinal product with human beings

other than the intended patient and its dissemination in the environment;

(f) an overall risk evaluation and conclusions.

Article 10

Procedure for the environmental risk assessment for medicinal products

consisting of, or containing, GMOs

1. The applicant shall submit an environmental risk assessment as provided for in Article 8(1)

to the Agency.

The Committee for Medicinal Products for Human Use shall assess the environmental risk

assessment.

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2. In the case of first-in-class medicinal products or when a novel question is raised during

the assessment of the submitted environmental risk assessment, the Committee for

Medicinal Products for Human Use, or the rapporteur appointed by that Committee, shall,

as necessary, carry out consultations with bodies established by Member States in

accordance with Directive 2001/18/EC. They shall, as necessary, consult the relevant

Union bodies. Details on the consultation procedure shall be published by the Agency at

the latest by … [12 months from the date of entry into force of this Regulation].

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Article 11

Assessment by the Committee for Medicinal Products for Human Use

of applications for marketing authorisation

1. When preparing its opinion pursuant to Article 13, the Committee for Medicinal Products

for Human Use shall verify that the particulars and documents submitted in accordance

with Article 7 comply with the requirements of Directive (EU) 2026/…+, and shall assess

whether the conditions specified in this Regulation for granting a centralised marketing

authorisation are satisfied. When preparing its opinion, the Committee for Medicinal

Products for Human Use may request:

(a) that an official medicines control laboratory or a laboratory that a Member State has

designated for that purpose tests the medicinal product for human use, its starting

materials, ingredients and, where necessary, its intermediate products or other

constituents in order to ensure that the control methods employed by the

manufacturer and described in the particulars and documents accompanying the

centralised marketing authorisation application are satisfactory;

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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(b) that the applicant supplements the particulars and documents accompanying the

application within a specific time -limit; in the event of such a request, the time limit

specified in Article 7(6), first subparagraph, shall be suspended until the

supplementary information requested is provided; likewise, this time limit shall be

suspended for the time allowed for the applicant to prepare oral or written

explanations.

2. Where within 90 days of the date of validation of the centralised marketing authorisation

application and during its assessment, the Committee for Medicinal Products for Human

Use considers that the submitted data are not of sufficient quality or maturity to complete

the assessment, the assessment may be terminated. Prior to the termination, the Committee

for Medicinal Products for Human Use shall summarise the deficiencies in writing. On that

basis, the Agency shall inform the applicant accordingly and set a time limit for the

applicant to address the deficiencies. The application shall be suspended until the applicant

addresses the deficiencies. If the applicant fails to address those deficiencies within the

time limit set by the Agency, the assessment shall be terminated and the application shall

be considered to have been withdrawn.

3. The Committee for Medicinal Products for Human Use may consider additional evidence

that is available to the Agency, independently from the data submitted by the applicant,

and adopt its opinion pursuant to Article 13 based on that evidence.

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Article 12

Certification of manufacturer and importer and inspection of the manufacturing site

1. Upon receipt of a written request from the Committee for Medicinal Products for Human

Use, a Member State shall provide the information demonstrating that the manufacturer of

a medicinal product or the importer from a third country is able to manufacture the

medicinal product concerned or carry out the necessary control tests, or both, in

accordance with the particulars and documents submitted by the applicant pursuant to

Article 7.

2. The Committee for Medicinal Products for Human Use may, if it considers it necessary in

order to complete its assessment, require the applicant to undergo a specific inspection of

the manufacturing site of the medicinal product concerned.

The inspection shall be carried out within the time limit specified in Article 7(6),

first subparagraph, by inspectors from the Member State holding the appropriate

qualifications. Those inspectors may be accompanied by a rapporteur or an expert

appointed by the Committee for Medicinal Products for Human Use, or by one or more

inspectors of the Agency. The inspection may be carried out unannounced.

For manufacturing sites located in third countries, the inspection may be carried out by the

Agency, following a request by the Member States and based on the procedure laid down

in Article 54.

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Article 13

Committee for Medicinal Products for Human Use opinion

1. The Agency shall without undue delay inform the applicant if the opinion of the

Committee for Medicinal Products for Human Use is that the application:

(a) does not satisfy the criteria for centralised marketing authorisation set out in this

Regulation;

(b) satisfies the criteria set out in this Regulation provided that changes required by the

Agency to the summary of product characteristics are made;

(c) satisfies the criteria set out in this Regulation provided that changes required by the

Agency to the labelling or package leaflet of the medicinal product are made to

ensure compliance with Chapter VI of Directive (EU) 2026/…+; or

(d) where applicable, satisfies the criteria set out in Articles 19 and 20 subject to specific

conditions set out in those Articles.

2. Within 12 days of receipt of the opinion referred to in paragraph 1, the applicant may

request by written notice to the Agency a re-examination of the opinion. In that case, the

applicant shall provide the Agency with the detailed grounds for the request within 60 days

of receipt of the opinion.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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The re-examination procedure shall address only the points of the opinion initially

identified by the applicant and shall be based only on the scientific data available at the

time the Committee for Medicinal Products for Human Use adopted its initial 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. The reasons for the conclusion

reached shall be annexed to the final opinion.

3. Within 12 days of the adoption of the final opinion of the Committee for Medicinal

Products for Human Use, the Agency shall send it to the Commission, to the Member

States and to the applicant, together with a report describing the assessment of the

medicinal product by the Committee for Medicinal Products for Human Use and stating

the reasons for its conclusions (the ‘assessment report’).

4. If an opinion is favourable to the granting of the relevant marketing authorisation, the

following documents shall be annexed to the opinion:

(a) a summary of product characteristics referred to in Article 65 of Directive

(EU) 2026/…+ which corresponds to the assessment of the medicinal product and to

the opinion referred to in paragraph 1;

(b) a recommendation on the frequency of submission of periodic safety update reports;

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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(c) details of any conditions or restrictions to be imposed on the supply or use of the

medicinal product concerned, including the conditions under which the medicinal

product may be made available to patients, in accordance with the criteria set out in

Chapter XII of Directive (EU) 2026/…+;

(d) details of any recommended conditions or restrictions with regard to the safe and

effective use of the medicinal product;

(e) details of any recommended measures for ensuring the safe use of the medicinal

product to be included in the risk management system;

(f) where appropriate, details of any recommended obligation to conduct post-

authorisation safety studies or to comply with obligations on the recording or

reporting of suspected adverse reactions which are stricter than those referred to in

Chapter VIII of this Regulation;

(g) where appropriate, details of any recommended obligation 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 placed on the market. Such an obligation to conduct such studies

shall be based on the delegated acts adopted pursuant to Article 22 of this Regulation

while taking into account the scientific guidance referred to in Article 127 of

Directive (EU) 2026/…+;

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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(h) where appropriate, details of any recommended obligation to conduct any other post-

authorisation studies to improve the safe and effective use of the medicinal product,

including treatment optimisation studies;

(i) in the case of medicinal products for which there is substantial uncertainty as to the

surrogate endpoint relation to the expected health outcome, where appropriate and

relevant for the benefit-risk balance, details of any post-authorisation obligation to

substantiate the clinical benefit;

(j) where appropriate, details of any recommended obligation to conduct additional

post-authorisation environmental risk assessment studies or the collection of

monitoring data or information on use, or to implement appropriate risk mitigation

measures, where 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 placed on the market;

(k) the text of the labelling and package leaflet, presented in accordance with Chapter VI

of Directive (EU) 2026/…+;

(l) the assessment report as regards the results of the pharmaceutical and non-clinical

tests and of the clinical trials, and as regards the risk management system and the

pharmacovigilance system for the medicinal product concerned;

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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(m) where appropriate, details of any recommended obligations to carry out medicinal

product-specific validation studies to replace animal-based control methods with

non-animal-based control methods;

(n) where applicable, reasoning as to whether the medicinal product satisfies the criteria

of Article 85 of Directive (EU) 2026/…+ regarding medicinal products addressing an

unmet medical need.

5. When adopting its opinion, the Committee for Medicinal Products for Human Use shall

include the criteria for the medical prescription or for use of the medicinal product, in

accordance with Article 53 of Directive (EU) 2026/…+.

SECTION 2

CENTRALISED MARKETING AUTHORISATION DECISIONS

Article 14

Commission decision on the marketing authorisation

1. Within 12 days of receipt of the opinion of the Committee for Medicinal products for

Human Use, the Commission shall submit to the Standing Committee on Medicinal

Products for Human Use referred to in Article 179(1) a draft decision on the application for

centralised marketing authorisation (‘draft decision’).

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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In duly justified cases, the Commission may refer the opinion of the Committee for

Medicinal Products for Human Use back to the Agency for further consideration.

Where a draft decision envisages the granting of a centralised marketing authorisation, it

shall include or make reference to the documents referred to in Article 13(4).

Where a draft decision envisages the granting of a centralised marketing authorisation

subject to the conditions referred to in Article 13(4), points (c) to (j), it shall lay down

deadlines for the fulfilment of the conditions, where necessary.

Where the draft decision differs from the opinion of the Agency, the Commission shall

provide a detailed explanation of the reasons for the differences.

The Commission shall send the draft decision to the Member States and the applicant.

2. The Commission shall, by means of implementing acts, take a final decision

within 12 days of 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 179(2) and (3).

3. Where a Member State raises, within the Standing Committee on Medicinal Products for

Human Use, important new questions of a scientific or technical nature that have not been

addressed in the opinion issued by the Agency, the Commission may refer the application

back to the Agency for further consideration. In that case, the procedures laid down in

paragraphs 1 and 2 shall start again upon receipt of the reply of the Agency.

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4. The Agency shall publish the documents referred to in Article 13(4), points (a) to (e), and,

where relevant, the documents referred to in Article 13(4), points (f) to (n), together with

any deadlines laid down pursuant to paragraph 1, first subparagraph of this Article.

Article 15

Withdrawal of a centralised marketing authorisation application

If an applicant withdraws an application for a marketing authorisation submitted to the Agency

before an opinion has been issued by the Committee for Medicinal Products for Human Use on the

application, the applicant shall communicate its reasons for doing so to the Agency. The Agency

shall make this information publicly available and shall publish the assessment report, if available,

after deletion of all information of a commercially confidential nature.

After the opinion has been issued on the application, the applicant is no longer in the position to

withdraw an application on its own initiative.

Article 16

Refusal to grant a centralised marketing authorisation

1. The Commission shall refuse to grant the centralised marketing authorisation where, after

verification of the particulars and documents submitted by the applicant in accordance with

Article 7, it appears that:

(a) the benefit-risk balance of the medicinal product is not favourable;

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(b) the applicant has not properly or sufficiently demonstrated the quality, safety or

efficacy of the medicinal product;

(c) the qualitative and quantitative composition of the medicinal product is not as

declared;

(d) the environmental risk assessment is incomplete or insufficiently substantiated, or the

risks identified in the environmental risk assessment 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 environmental risk assessment and the Agency considers

that the marketing authorisation can be granted subject to the condition that post-

authorisation environmental risk assessment studies be conducted or risk mitigation

measures be implemented, as referred to in Article 13(4), point (j);

(e) particulars or documents provided by the applicant in accordance with Article 7(1)

to (4) are incorrect;

(f) the labelling and package leaflet proposed by the applicant are not in accordance

with Chapter VI of Directive (EU) 2026/…+.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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2. The Commission decision to refuse to grant a centralised marketing authorisation shall

constitute a prohibition on the placing on the market of the medicinal product concerned

throughout the Union.

3. Information about all refusals and the reasons for them shall be made publicly available.

Article 17

Marketing authorisations

1. Without prejudice to Article 1(7) and (8) of Directive (EU) 2026/…+, a marketing

authorisation which has been granted in accordance with this Regulation shall be valid

throughout the Union. It shall confer to the marketing authorisation holder the same rights

and obligations in each of the Member States as a marketing authorisation granted by that

Member State in accordance with Article 6 of Directive (EU) 2026/…+.

The Commission shall ensure that authorised medicinal products for human use are added

to the Union Register of Medicinal Products and that they are given a number, which shall

appear on the packaging.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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2. A summary table of decisions on marketing authorisation shall be published in the Official

Journal of the European Union, quoting the date of notification of the marketing

authorisation and the registration number in the Union Register of Medicinal Products, any

International Non-proprietary Name of the active substance of the medicinal product, its

pharmaceutical form, and any Anatomical Therapeutic Chemical Code.

3. The Agency shall immediately publish the European public assessment report (EPAR) on

the medicinal product for human use and the reasons for its opinion in favour of granting

marketing authorisation, after deletion of any information of a commercially confidential

nature. The justification for a marketing authorisation granted under Articles 19, 20 and 31

shall be included in the assessment report.

The EPAR shall include:

(a) a summary of the assessment report 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;

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(b) a summary of environmental risk assessment studies and their results as submitted by

the marketing authorisation holder and the evaluation of the environmental risk

assessment and of the information submitted on the basis of the scientific guidelines

referred to in Article 23(5) of Directive (EU) 2026/…+ by the Agency;

(c) for antimicrobials, the information referred to in Article 18(1), point (a), of Directive

(EU) 2026/…+ and paragraph 21, point (a), of Annex I to that Directive, as well as

any other obligations imposed on the marketing authorisation holder.

4. After a marketing authorisation has been granted, the marketing authorisation holder shall

inform the Agency of the dates of placing on the market of the medicinal product for

human use in the Member States, taking into account the various presentations authorised.

Upon request by the Agency, particularly in the context of pharmacovigilance under

Chapter VIII, the marketing authorisation holder shall provide the Agency with all data

relating to the volume of sales of the medicinal product at Union level, broken down by

Member State, and any data in the marketing authorisation holder’s possession relating to

the volume of medical prescriptions in the Union and its Member States.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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Article 18

Validity and renewal of marketing authorisations

1. Without prejudice to paragraph 2, a marketing authorisation for a medicinal product shall

be valid for an unlimited period.

2. By way of derogation from paragraph 1, the Commission may decide when granting an

authorisation, on the basis of a scientific opinion by the Agency concerning the safety of

the medicinal product, to limit the validity of the marketing authorisation to five years.

Where the validity of the marketing authorisation is limited to five years, the marketing

authorisation holder shall apply to the Agency for a renewal of the marketing authorisation

at least nine months before the marketing authorisation ceases to be valid.

Where a renewal application has been submitted in accordance with the second

subparagraph of this paragraph, the marketing authorisation shall remain valid until a

decision is adopted by the Commission in accordance with Article 14.

The marketing authorisation may be renewed on the basis of a re-evaluation by the Agency

of the benefit-risk balance. Once renewed, the marketing authorisation shall be valid for an

unlimited period.

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Article 19

Marketing authorisation granted in exceptional circumstances

1. In exceptional circumstances where, in an application under Article 7 of Directive

(EU) 2026/…+ for a marketing authorisation of a medicinal product or a new therapeutic

indication of an existing marketing authorisation under this Regulation, an applicant is

unable to provide comprehensive data on the safety and efficacy of the medicinal product

under normal conditions of use, the Commission may, by way of derogation from Article 7

of this Regulation, grant an authorisation under Article 14 of this Regulation, subject to

specific conditions, where the following requirements are met:

(a) the applicant has demonstrated, in the application file, that there are objective and

verifiable reasons not to be able to submit comprehensive data on the safety and

efficacy of the medicinal product under normal conditions of use based on one of the

grounds set out in Annex II to Directive (EU) 2026/…+;

(b) except for the data referred to in point (a), the application file is complete and

satisfies all the requirements of this Regulation.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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The specific conditions referred to in the first subparagraph shall be included in the

Commission decision granting the marketing authorisation, in particular to ensure the

safety of the medicinal product as well as to ensure that the marketing authorisation holder

notifies to the competent authorities of the Member States and the Agency any incident

relating to its use and takes appropriate action where necessary.

2. The maintenance of the authorised new therapeutic indication and the validity of the

marketing authorisation granted in accordance with paragraph 1 shall be linked to the

reassessment by the Agency of the conditions referred to in paragraph 1 after two years, or

a shorter period as set out in the marketing authorisation, from the date when the new

therapeutic indication was authorised or the marketing authorisation was granted, and

thereafter at a risk-based frequency to be determined by the Agency and specified by the

Commission in the marketing authorisation.

This reassessment shall be conducted on the basis of an application by the marketing

authorisation holder to maintain the authorised new therapeutic indication or renew the

marketing authorisation under exceptional circumstances.

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Article 20

Conditional marketing authorisation

1. In duly justified cases, to meet an unmet medical need of patients, a conditional marketing

authorisation or a new conditional therapeutic indication in an existing marketing

authorisation granted in accordance with Article 14 of this Regulation may be granted by

the Commission to a medicinal product that is likely to address the unmet medical need in

accordance with Article 85(1), of Directive (EU) 2026/…+, prior to the submission of

comprehensive clinical data, provided that the benefit of the immediate availability on the

market of that medicinal product outweighs the risk inherent in the fact that additional data

are still required.

In emergency situations, a conditional marketing authorisation or a new conditional

therapeutic indication referred to in the first subparagraph may be granted also where

comprehensive non-clinical or pharmaceutical data have not been supplied.

2. Conditional marketing authorisations or a new conditional therapeutic indication referred

to in paragraph 1 may be granted only if the benefit-risk balance of the medicinal product

is favourable and the applicant is likely to be able to provide comprehensive data.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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3. Conditional marketing authorisations or a new conditional therapeutic indication granted

pursuant to this Article shall be subject to specific obligations. Those specific obligations

and, where appropriate, the time limit for compliance shall be specified in the conditions to

the marketing authorisation. Those specific obligations shall be reviewed annually by

the Agency.

4. As part of the specific obligations referred to in paragraph 3, the marketing authorisation

holder of a conditional marketing authorisation granted pursuant to this Article shall be

required to complete ongoing studies, or to conduct new studies, with a view to confirming

that the benefit-risk balance is favourable.

5. The summary of product characteristics and the package leaflet shall clearly mention that

the conditional marketing authorisation for the medicinal product has been granted subject

to specific obligations as referred to in paragraph 3.

6. By way of derogation from Article 18(1), an initial conditional marketing authorisation

granted pursuant to this Article shall be valid for one year on a renewable basis.

7. When the specific obligations referred to in paragraph 3 of this Article have been fulfilled

for a conditional marketing authorisation granted pursuant to this Article, the Commission

may, following an application by the marketing authorisation holder pursuant to Article 7,

and after having received a favourable opinion from the Agency, grant a marketing

authorisation pursuant to Article 14.

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8. The Commission is empowered to adopt delegated acts in accordance with Article 181 to

supplement this Regulation by establishing the following:

(a) the categories of medicinal products to which paragraph 1 of this Article applies;

(b) the procedures and requirements for granting a conditional marketing authorisation,

for its renewal, and for adding a new conditional therapeutic indication to an existing

marketing authorisation.

Article 21

Imposed post-authorisation studies

1. After the granting of a marketing authorisation, the Agency may consider that it is

necessary that the marketing authorisation holder:

(a) 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 Agency shall, following consultation with the Pharmacovigilance Risk

Assessment Committee, encourage the marketing authorisation holders concerned to

conduct a joint post-authorisation safety study;

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(b) 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 22 of this Regulation

while taking into account the scientific guidance referred to in Article 127 of

Directive (EU) 2026/…+;

(c) conduct any other post-authorisation studies to improve the safe and effective use of

the medicinal product, including treatment optimisation based on clinical experience;

(d) conduct a post-authorisation environmental risk assessment study to further

investigate the risks to the environment or public health, including antimicrobial

resistance, due to the release of the medicinal product in the environment, if new

concerns emerge on the authorised medicinal product, or other medicinal products

containing the same active substance.

If the same concerns apply to several medicinal products, the Agency shall encourage the

marketing authorisation holders concerned to conduct a joint post-authorisation

environmental risk assessment study.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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Where the Agency considers that any of the post-authorisation studies referred to in

points (a) to (d), of the first subparagraph is necessary, it shall inform the marketing

authorisation holder of its opinion in writing, stating the grounds for its assessment and

shall include the objectives and time limit for submission and conduct of the relevant

study.

2. The Agency shall provide the marketing authorisation holder with an opportunity to

present written observations in response to its opinion within a time limit which it shall

specify, if the marketing authorisation holder so requests within 30 days of receipt of

the opinion.

3. On the basis of the written observations presented by the marketing authorisation holder,

the Agency shall review its opinion.

4. Where the opinion of the Agency confirms the need for any of the post-authorisation

studies referred to in paragraph 1, first subparagraph, points (a) to (d), of this Article, to be

carried out, the Commission shall vary the marketing authorisation, by means of

implementing acts, adopted pursuant to Article 14 to include the obligation to conduct such

a study as a condition of the marketing authorisation unless the Commission refers the

opinion back to the Agency for further consideration. For obligations under paragraph 1,

first subparagraph, points (a), (b) and (c), of this Article, the marketing authorisation

holder shall update the risk management system accordingly.

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Article 22

Delegated acts on post authorisation efficacy studies

The Commission is empowered to adopt delegated acts in accordance with Article 181 to

supplement this Regulation by determining the situations in which post-authorisation efficacy

studies may be required under Article 13(4), point (g), and Article 21(1), first subparagraph,

point (b).

Article 23

Risk management system

The marketing authorisation holder shall incorporate any condition of authorisation reflecting the

elements referred to in Article 13(4), points (d) to (i), Article 21(1), first subparagraph, points (a),

(b) and (c), or in Article 19(1) and Article 20, in their risk management system.

Article 24

Liability of the marketing authorisation holder

The granting of a marketing authorisation shall not affect the civil or criminal liability of the

manufacturer or of the marketing authorisation holder pursuant to the applicable national law in

Member States.

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Article 25

Suspension of marketing, withdrawal from the market of a medicinal product,

withdrawal of a marketing authorisation by the marketing authorisation holder

1. The marketing authorisation holder shall notify the Agency without undue delay of any

action they take to suspend the marketing of a medicinal product, to withdraw a medicinal

product from the market, to request the withdrawal of a marketing authorisation or not to

apply for the renewal of a marketing authorisation, together with a detailed reasoning for

such action.

The marketing authorisation holder shall declare if such action is based on the following

grounds:

(a) the medicinal product is harmful;

(b) it lacks therapeutic efficacy;

(c) the benefit-risk balance is not favourable;

(d) its qualitative and quantitative composition is not as declared;

(e) the controls on the medicinal product or on the ingredients and the controls at an

intermediate stage of the manufacturing process have not been carried out, or any

other requirement or obligation relating to the grant of the manufacturing

authorisation has not been fulfilled;

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(f) a serious risk to the environment or to public health via the environment has been

identified and not sufficiently addressed by the marketing authorisation holder; or

(g) commercial reasons.

Where the action notified pursuant to the first subparagraph is to withdraw a medicinal

product from the market, the marketing authorisation holder shall provide information on

the impact of such withdrawal on patients who are already being treated.

The marketing authorisation holder shall make the notification electronically and in the

formats made available by the Agency. The Agency shall consult the Member States when

drawing up the formats.

2. The marketing authorisation holder shall make the notification pursuant to paragraph 1 if

the action is taken in a third country and such action is based on any of the grounds set out

in paragraph 1, second subparagraph, points (a) to (f).

3. In the cases referred to in paragraphs 1 and 2, the Agency shall forward the marketing

authorisation holder’s notification to the competent authorities of the Member States

without undue delay.

4. In the case referred to in paragraph 1, second subparagraph, point (f), the Agency shall

immediately inform the Commission, and the marketing authorisation holder shall inform

the relevant national and Union authorities without delay.

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Article 26

Duplicate marketing authorisations

1. Only one marketing authorisation may be granted to an applicant for a specific medicinal

product.

By way of derogation from the first subparagraph, the Commission shall authorise the

same applicant to submit more than one application to the Agency for that medicinal

product in either of the following cases:

(a) if one of its indications or pharmaceutical forms, posologies, methods or routes of

administration or any other way in which the medicinal product may be used is

protected by a patent or a supplementary protection certificate in one or more

Member States;

(b) for reasons of co-marketing with a different undertaking not belonging to the same

group as the marketing authorisation holder of the medicinal product for which a

duplicate marketing authorisation is requested.

As soon as the relevant patent or supplementary protection certificate referred to in the

second subparagraph, point (a), expires, the marketing authorisation holder shall withdraw

the initial or duplicate marketing authorisation as soon as possible.

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2. As regards medicinal products for human use, Article 190(3) of Directive (EU) 2026/…+

shall apply to medicinal products authorised under this Regulation.

3. Without prejudice to the Union nature of the content of the documents referred to in

Article 13(4), points (a) to (k), this Regulation shall not prohibit the use of two or more

commercial designs for a given medicinal product for human use covered by a single

marketing authorisation.

Article 27

Medicinal products for compassionate use

1. Member States may make available a medicinal product for human use belonging to the

categories referred to in Article 3(1) and (2) for compassionate use. Making available a

medicinal product for compassionate use may include new therapeutic uses of an

authorised medicinal product.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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2. For the purposes of this Article, ‘compassionate use’ shall mean making a medicinal

product belonging to the categories referred to in Article 3(1) and (2) available for

compassionate reasons to a single patient or group of patients with a chronically or

seriously debilitating disease, or whose disease is considered to be life-threatening, or is

impacting their mental health with severe psychological or emotional distress, leading to

worsening of clinical symptoms and severely compromising the ability to function in daily

life, and who cannot be treated satisfactorily by an authorised medicinal product. The

medicinal product for compassionate use shall either be the subject of an application for a

marketing authorisation that has been submitted in accordance with Article 7 or whose

submission is imminent, or be undergoing clinical trials for the same proposed therapeutic

indication.

3. When applying paragraph 1, Member States shall notify the Agency, which shall make that

notification publicly available.

4. When compassionate use is envisaged by a Member State, the Committee for Medicinal

Products for Human Use, after consulting the manufacturer or the applicant, may adopt an

opinion on the conditions for use, the conditions for distribution, the patients targeted and

the conditions of monitoring. The opinion shall be updated where necessary.

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In the preparation of its opinion, the Committee for Medicinal Products for Human Use

may request information and data from the marketing authorisation holder and from the

medicinal product developer and may engage with them in preliminary discussions. The

Committee for Medicinal Products for Human Use may also make use of health data

generated outside of clinical studies, including real-world data, where available, taking into

account the reliability of those data.

The Agency may also liaise with third-country agencies for medicinal products with

respect to additional information and data exchanges.

In the preparation of its opinion, the Committee for Medicinal Products for Human Use

may consult the Member State concerned and request it to provide any available

information or data that the Member State has in its possession relating to the medicinal

product concerned.

5. When applying paragraph 1, Member States shall take account of any available opinion

and notify the Agency of the making available of medicinal products on the basis of the

opinion in their territory. Member States shall ensure that pharmacovigilance requirements

as regards the recording and reporting of suspected adverse reactions and the submission of

safety reports are applied for those medicinal products.

6. The Agency shall keep an up-to-date list of the opinions adopted in accordance with

paragraph 4 and shall publish it on its website.

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7. The opinions referred to in paragraph 4 shall not affect the civil or criminal liability of the

manufacturer or of the applicant.

8. In cases where a Member State has a compassionate use programme in place, the applicant

shall ensure the supply of the medicinal product to patients taking part in that programme,

if necessary for the entire period, after the marketing authorisation has been granted, and

until the medicinal product is made available on the market of the Member State

concerned.

9. This Article shall be without prejudice to Regulation (EU) No 536/2014 and to Article 4 of

Directive (EU) 2026/…+.

10. The Agency shall adopt detailed guidelines laying down the format and content of

notifications referred to in paragraphs 3 and 5, and of any data exchange under this Article.

Article 28

Request for opinion on scientific matters

At the request of the Executive Director of the Agency or the Commission, the Committee for

Medicinal Products for Human Use shall draw up an opinion on any scientific matter concerning

the evaluation of medicinal products for human use. That Committee shall take due account of any

requests by Member States for such an opinion.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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The Agency shall publish the opinion referred to in the first paragraph after deletion of any

information of a commercially confidential nature.

Article 29

Regulatory scope concerning decisions on marketing authorisations

An authorisation to place on the market a medicinal product covered by this Regulation shall not be

granted, refused, varied, suspended, withdrawn or revoked except through the procedures and on

the grounds set out in this Regulation.

Article 30

Regulatory protection periods

Without prejudice to the law on the protection of industrial and commercial property, medicinal

products for human use which have been authorised in accordance with this Regulation shall benefit

from the periods of regulatory protection set out in Chapter VII of Directive (EU) 2026/…+.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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SECTION 3

TEMPORARY EMERGENCY MARKETING AUTHORISATION

Article 31

Temporary emergency marketing authorisation

During a public health emergency recognised at Union level, the Commission may grant a

temporary emergency marketing authorisation for medicinal products intended for prevention,

diagnosis or treatment of a serious or life-threatening disease or condition which is directly related

to that public health emergency, prior to the submission of the complete quality, non-clinical,

clinical and environmental data and information.

Where medicinal products consisting of, or containing, GMOs as defined in Article 2(2) of

Directive 2001/18/EC are concerned, Articles 13 to 24 of that Directive shall not apply.

An application for a temporary emergency marketing authorisation shall be submitted to the

Agency in accordance with Articles 5 and 7.

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Article 32

Requirements for granting a temporary emergency marketing authorisation

A temporary emergency marketing authorisation may be granted only after the recognition of a

public health emergency at Union level in accordance with Article 23 of Regulation

(EU) 2022/2371 of the European Parliament and of the Council37 and where the following

requirements are met:

(a) there is no other satisfactory method of prevention, diagnosis or treatment authorised or

sufficiently available in the Union or, if such method is already available, the temporary

emergency marketing authorisation of the medicinal product will contribute to address the

public health emergency;

(b) based on the scientific evidence available, the Agency issues an opinion concluding that

the medicinal product could be effective in preventing, diagnosing or treating the disease

or condition directly related to the public health emergency, and the known and potential

benefits of the product outweigh the known and potential risks of the product, taking into

consideration the threat posed by the public health emergency.

37 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).

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Article 33

Scientific opinion of the Agency

1. The Agency shall ensure that the Committee for Medicinal Products for Human Use

prepares a scientific opinion without undue delay, taking into account the recommendation

of the Emergency Task Force referred to in Article 39(1), second subparagraph. For the

purpose of issuing its opinion, the Agency may consider any relevant data on the medicinal

product concerned.

2. The Agency shall without undue delay review any new evidence provided by the medicinal

product developer, the Member States or the Commission, or any other evidence that

comes to its attention, in particular evidence that might influence the benefit-risk balance

of the medicinal product concerned.

The Agency shall update its scientific opinion as necessary.

3. The Agency shall transmit without undue delay to the Commission the scientific opinion

and its updates and any recommendations on the temporary emergency marketing

authorisation.

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Article 34

Commission decision for a temporary emergency marketing authorisation

1. On the basis of the scientific opinion of the Agency or its updates referred to in

Article 33(1) and (2), the Commission shall, by means of an implementing act, take a

decision without undue delay on the granting of a temporary emergency marketing

authorisation of the medicinal product subject to the specific conditions set in accordance

with paragraphs 2 and 3 of this Article. Such implementing act shall be adopted in

accordance with the examination procedure referred to in Article 179(2).

2. On the basis of the scientific opinion of the Agency referred to in paragraph 1, the

Commission shall set specific conditions with respect to the temporary emergency

marketing authorisation, in particular the conditions for manufacturing, use, supply and

safety monitoring and the compliance with related good manufacturing and

pharmacovigilance practices. Where necessary, those conditions may specify the batches

of the medicinal product concerned by the temporary emergency marketing authorisation.

3. Specific conditions may be set to require the completion of ongoing studies or to conduct

new studies to ensure the safe and effective use of the medicinal product or minimise its

impact on the environment. A time limit for the submission of those studies shall be set.

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4. The specific conditions set in accordance with paragraphs 2 and 3 and, where appropriate,

the time limit for the submission of the results of the studies referred to in paragraph 3

shall be specified in the conditions to the temporary emergency marketing authorisation

and shall be reviewed annually by the Agency.

5. The Agency shall immediately publish the assessment report on the medicinal product for

human use and the reasons for its opinion in favour of granting the temporary emergency

marketing authorisation, after deletion of any information of a commercially confidential

nature.

Article 35

Validity of a temporary emergency marketing authorisation

The temporary emergency marketing authorisation shall cease to be valid when the Commission

terminates the recognition of a public health emergency in accordance with Article 23(2) and (4) of

Regulation (EU) 2022/2371.

Article 36

Variation, suspension or revocation of a temporary emergency marketing authorisation

The Commission may vary, suspend or revoke the temporary emergency marketing authorisation by

means of implementing acts at any time in any of the following cases:

(a) the criteria set out in Article 32 are no longer met;

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(b) it is appropriate to protect public health;

(c) the marketing authorisation holder of a temporary emergency marketing authorisation has

not complied with the conditions and obligations laid down in the temporary emergency

marketing authorisation;

(d) the marketing authorisation holder of a temporary emergency marketing authorisation has

not complied with the specific conditions laid down in accordance with Article 34.

Those implementing acts shall be adopted in accordance with the examination procedure referred to

in Article 179(2).

Article 37

Granting of a marketing authorisation or a conditional marketing authorisation

after a temporary emergency marketing authorisation

As soon as sufficient data have been generated, the marketing authorisation holder of a temporary

emergency marketing authorisation in accordance with Article 34 shall submit an application in

accordance with Articles 5 and 7 in order to replace the temporary emergency marketing

authorisation by a marketing authorisation granted in accordance with Article 14, 19 or 20.

For the purposes of regulatory data protection, the temporary emergency marketing authorisation

and any subsequent marketing authorisation as referred to in the first paragraph shall be considered

to be part of the same global marketing authorisation.

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Article 38

Transitional period

Where a temporary emergency marketing authorisation of a medicinal product is suspended or

revoked for reasons other than the safety of the medicinal product, or if that temporary emergency

marketing authorisation ceases to be valid, Member States may, in exceptional circumstances, for a

transitional period, allow the supply of the medicinal product to patients who are already being

treated with it. In such cases, the Member State concerned shall inform the Agency about the

application of the transitional period. Conditions for manufacturing, use, supply and safety

monitoring and the compliance with the related good manufacturing and pharmacovigilance

practices shall continue to apply during that period.

Article 39

Relation with Article 18 of Regulation (EU) 2022/123

1. For medicinal products for which a temporary emergency marketing authorisation is being

considered by the Agency, Article 18(1) and (2) of Regulation (EU) 2022/123 shall apply.

The Emergency Task Force established pursuant to Article 15 of Regulation

(EU) 2022/123 shall provide a recommendation for a temporary emergency marketing

authorisation to the Committee for Medicinal Products for Human Use for an opinion in

accordance with Article 33 of this Regulation. To this purpose, the Emergency Task Force

may, where appropriate, perform the activities referred to in Article 18(2) of Regulation

(EU) 2022/123 prior to the recognition of a public health emergency.

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2. Where a request referred to in Article 18(3) of Regulation (EU) 2022/123 for a

recommendation has been made and there is an application for a temporary emergency

marketing authorisation for the medicinal product concerned, the procedure for a

recommendation under Article 18(3) of Regulation (EU) 2022/123 shall be stopped and the

procedure for a temporary emergency marketing authorisation shall prevail. Any available

data shall be considered under the temporary emergency marketing authorisation

application.

Article 40

Withdrawal of authorisations granted

in accordance with Article 4(4) of Directive (EU) 2026/…+

When the Commission has granted a temporary emergency marketing authorisation in accordance

with Article 34 of this Regulation, Member States shall, where possible and within a reasonable

time limit, withdraw any authorisation granted in accordance with Article 4(4) of Directive

(EU) 2026/…+ for the use of medicinal products containing the same active substance for any

therapeutic indications covered by the temporary marketing authorisation.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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Chapter III

Incentives for the development of antimicrobials

SECTION 1

TRANSFERABLE DATA EXCLUSIVITY VOUCHERS FOR PRIORITY ANTIMICROBIALS

Article 41

Granting of a transferable data exclusivity voucher

1. Following a request by the applicant when applying for a marketing authorisation, the

Commission may, by means of an implementing act, grant a transferable data exclusivity

voucher (‘data exclusivity voucher’) to a ‘priority antimicrobial’ referred to in paragraph 3,

under the conditions referred to in paragraph 4, based on a scientific assessment by the

Agency.

2. The data exclusivity voucher referred to in paragraph 1 shall give the right to its holder to

extend by 12 months the regulatory data protection period referred to in Article 83( 1) of

Directive (EU) 2026/…+ for one authorised medicinal product.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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3. An antimicrobial shall be considered a ‘priority antimicrobial’ if it addresses a multi-drug

resistant organism, if the preclinical and clinical data demonstrate a significant clinical

benefit with respect to antimicrobial resistance and if it has at least one of the following

characteristics:

(a) its mechanism of action is distinctly different from that of any authorised

antimicrobial in the Union;

(b) it contains a new active substance that, when used either alone or in combination

with other active substances, addresses a serious or life threatening infection.

In the scientific assessment of the criteria referred to in the first subparagraph, the Agency

shall take into account the ‘WHO bacterial priority pathogens list’, or an equivalent list of

priority pathogens established at Union level.

4. To be granted the data exclusivity voucher referred to in paragraph 1 by the Commission,

the applicant shall:

(a) demonstrate capacity to supply the priority antimicrobial in sufficient quantities for

the expected needs of the Union market;

(b) provide information on all direct financial support received for research related to the

development of the priority antimicrobial;

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(c) demonstrate that the application for a marketing authorisation of the priority

antimicrobial has been first submitted to the Agency or has been submitted no later

than 180 days after the submission of the application for the first marketing

authorisation outside the Union.

Within 30 days of the granting of the marketing authorisation, the marketing authorisation

holder shall make the information referred to in point (b) of the first subparagraph publicly

available via a dedicated webpage and shall communicate to the Agency, in a timely

manner, the electronic link to that webpage.

5. Once the marketing authorisation is granted, the Agency shall inform the Executive

Steering Group on Shortages and Safety of Medicinal Products (‘MSSG’) without undue

delay with a view to proposing the potential inclusion of the priority antimicrobial on the

Union list of critical medicinal products in accordance with Article 137(2).

6. A priority antimicrobial shall be reserved for exclusive use for the treatment of humans for

a period of 10 years to preserve the efficacy of those antimicrobials.

The period referred to in the first subparagraph may be prolonged based on an assessment

by the Agency on the basis of the criteria set in the Commission Delegated Regulation

(EU) 2021/176038.

38 Commission Delegated Regulation (EU) 2021/1760 of 26 May 2021 supplementing

Regulation (EU) 2019/6 of the European Parliament and of the Council by establishing the

criteria for the designation of antimicrobials to be reserved for the treatment of certain

infections in humans (OJ L 353, 6.10.2021, p. 1,

ELI: http://data.europa.eu/eli/reg_del/2021/1760/oj).

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7. The Commission shall inform the Member States of the granting of the marketing

authorisation and include a recommendation inviting Member States to make use of the

possibility of a voluntary subscription model for joint procurement referred to in

Article 45.

Article 42

Transfer and use of the data exclusivity voucher

1. A data exclusivity voucher referred to in Article 41 of this Regulation may be used to

extend by 12 months the regulatory data protection period referred to in Article 83(1) of

Directive (EU) 2026/…+ of the priority antimicrobial or of another medicinal product

authorised in accordance with this Regulation of the same or different marketing

authorisation holder.

A data exclusivity voucher may be used once and in relation to a single centrally

authorised medicinal product.

In the case of a medicinal product other than the priority antimicrobial concerned, the use

of the data exclusivity voucher shall take place only in the fifth or sixth year of the

regulatory data protection period and only if the marketing authorisation holder

demonstrates that the annual gross sales of that medicinal product in the Union during any

of the first four years after the granting of the marketing authorisation have not

exceeded EUR 490 000 000.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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2. The marketing authorisation holder shall demonstrate that information about the annual

gross sales referred to in paragraph 1 is accurate and complete and that it has been audited

by an independent external auditor.

A data exclusivity voucher may only be used if the marketing authorisation of the priority

antimicrobial for which the right was initially granted has not been withdrawn.

3. To use the data exclusivity voucher, its owner shall apply for a variation of the marketing

authorisation concerned in accordance with Article 49 to extend the regulatory data

protection period.

4. A data exclusivity voucher may be transferred to another marketing authorisation holder

and shall not be transferred further.

5. A marketing authorisation holder to whom a data exclusivity voucher is transferred shall

notify the Agency of the transfer within 30 days, stating the value of the transaction

between the two parties. The Agency shall make this information publicly available on its

webpage.

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Article 43

Validity of the data exclusivity voucher

1. A data exclusivity voucher shall cease to be valid in the following cases:

(a) where the Commission has adopted a decision in accordance with Article 49 to

extend the regulatory data protection period of the medicinal product in respect of

which the regulatory data protection extension was granted;

(b) where it is not used in accordance with Article 42(3) within five years of the date on

which it was granted.

2. The Commission may revoke the data exclusivity voucher prior to its transfer as referred to

in Article 42(4) if a request for supply by any Member State or the Commission, for

procurement or for purchase of the priority antimicrobial in the Union has not been

fulfilled.

3. Without prejudice to patent rights, or supplementary protection certificates, if a priority

antimicrobial is withdrawn from the internal market prior to the expiry of the periods of

regulatory data protection and regulatory market protection laid down in Articles 83 and 84

of Directive (EU) 2026/…+, those periods shall not prevent the validation of an application

for a marketing authorisation for a medicinal product that uses the priority antimicrobial as

a reference medicinal product, or the authorisation or placing on the market of such a

medicinal product, in accordance with Chapter II, Section 2, of Directive (EU) 2026/…+.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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Article 44

Duration of application of Section 1 of this Chapter

Section 1 shall apply, taking into account the outcome of the evaluation referred to in

Article 176(6), until … [15 years from the date of entry into force of this Regulation] or until the

date when the Commission has granted a total of five data exclusivity vouchers in accordance with

this Chapter, whichever date is the earliest.

SECTION 2

VOLUNTARY SUBSCRIPTION MODEL FOR ANTIMICROBIALS

Article 45

Voluntary subscription model for the joint procurement of antimicrobials

1. Contracting authorities from different Member States may act jointly in the award of

public contracts pursuant to Article 39 of Directive 2014/24/EU of the European

Parliament and of the Council39 with a view to purchasing antimicrobials.

2. For the purposes of paragraph 1, in addition to the elements set out in Article 39(4) of

Directive 2014/24/EU, the agreement between contracting authorities from different

Member States shall determine the practical arrangements governing the conditions for a

subscription model and other procedures, including the duration of the public contract to be

awarded and whether parallel procurement is allowed.

39 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).

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3. The public contract to be awarded shall take the form of a multi-year subscription and

include at least the following conditions:

(a) delinkage or partial delinkage of funding from the volume of sales of the

antimicrobial;

(b) arrangements regarding criteria to support continuous and sufficient supply in pre-

agreed quantities.

4. For the purpose of paragraphs 2 and 3, the Commission shall, in consultation with Member

States and relevant parties, draw up guidelines to identify the relevant components for a

subscription model, including the methodology for valuing and remunerating medicinal

products to ensure economic viability of their supply, and incentives to encourage

investment in the development of priority antimicrobials. Member States may take such

guidelines into account when they establish a subscription model under this Article.

5. The Commission shall upon request support Member States in the application of this

Article. Member States may, where necessary, request the Commission to organise joint

meetings between the competent authorities of the Member States, the Agency, and any

other relevant parties, as appropriate, including bodies responsible for pricing and

reimbursement, to discuss issues related to the practical application of this Article. Member

States shall notify the Commission when applying this Article.

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Chapter IV

Post-marketing authorisation measures

Article 46

Urgent safety or efficacy restrictions

1. If the marketing authorisation holder, in the event of a risk to public health, applies urgent

safety or efficacy restrictions on its own initiative, it shall immediately inform the Agency

and the competent authorities of the Member States in which the medicinal product is

placed on the market.

If the Agency has not raised objections within 24 hours of receipt of the information

referred to in first subparagraph, the urgent safety or efficacy restrictions shall be deemed

temporarily accepted. The marketing authorisation holder shall submit the corresponding

application for variation, in accordance with Article 49, within 12 days of the initiation of

the urgent safety or efficacy restriction.

2. In the event of a risk to public health, the Commission may vary the marketing

authorisation to impose urgent safety or efficacy restrictions on the marketing authorisation

holder.

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Where the Commission decision in accordance with this Article imposes restrictions with

regard to the safe and effective use of the medicinal product, the Commission may also

adopt a decision addressed to the Member States for the implementation of those

restrictions pursuant to Article 59.

Where the marketing authorisation holder disagrees with the Commission decision, it may

provide to the Agency written observations on the variation within 12 days of the receipt of

the Commission decision. The Agency shall, based on the written observations, issue an

opinion on whether an amendment of the variation is required.

If an amendment of the variation is required, the Commission shall take a final decision in

accordance with the examination procedure referred to in Article 179(2).

If a referral procedure under Article 57 of this Regulation or under Article 98 or 118 of

Directive (EU) 2026/…+ is launched on the same safety or efficacy concern covered by

this variation, any written observation provided by the marketing authorisation holder shall

be considered in that referral procedure.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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Article 47

Marketing authorisation update related to scientific and technological developments

1. After a marketing authorisation has been granted in accordance with this Regulation, the

marketing authorisation holder shall, in respect of the methods of manufacture and control

provided for in points (6) and (10) of Annex I to Directive (EU) 2026/…+, take account of

scientific and technical progress and introduce any changes that might be required to

enable the medicinal product to be manufactured and checked by means of generally

accepted scientific methods. The marketing authorisation holder shall apply for approval of

corresponding variations in accordance with Article 49 of this Regulation.

2. The marketing authorisation holder shall, without undue delay, provide the Agency, the

Commission and the Member States with any new information which might entail the

amendment of the particulars or documents referred to in Articles 12 and 31, Article 44(5)

or Article 65 of Directive (EU) 2026/…+, in Annex I or II to that Directive, or in

Article 13(4) of this Regulation.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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The marketing authorisation holder shall, without undue delay, inform the Agency, the

Commission and the competent authorities of the Member States of:

(a) 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 Member State or any third country in which the

medicinal product is made available on the market; and

(b) any other new information which might influence the evaluation of the benefits and

risks of the medicinal product concerned.

The information referred to in this paragraph shall include both positive and negative

results of clinical trials or other studies in all indications and populations, whether or not

included in the 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 marketing

authorisation, including the summary of product characteristics, the labelling and package

leaflet, are kept up to date with the current scientific knowledge, including the conclusions

of the assessments and recommendations made public by means of the European medicines

web portal set up in accordance with Article 106.

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4. The Agency 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 for any such request.

The marketing authorisation holder shall also respond fully and within the time limit set to

any such request of a competent authority regarding the implementation of any measures

previously imposed, including risk minimisation measures.

The Agency 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.

The marketing authorisation holder shall also respond fully and within the time limit set to

any request of a competent authority regarding the implementation of any measures

previously imposed with regard to risks to the environment or public health, including

antimicrobial resistance.

5. The Agency, through its scientific committees referred to in Article 148, points (d) and (e),

may consider additional evidence available, independently from the data submitted by the

marketing authorisation holder. If the additional evidence has an impact on the benefit-risk

balance of a medicinal product, the Agency may recommend that the summary of product

characteristics be updated, without excluding other actions that may be taken. In this case

the marketing authorisation holder shall submit to the Agency an appropriate application

for a variation, including an updated summary of product characteristics.

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Article 48

Update of risk management plans

1. The marketing authorisation holder for a medicinal product referred to in Articles 10

and 12 of Directive (EU) 2026/…+ who did not submit a risk management plan in

accordance with Article 22 of Directive (EU) 2026/…+ shall submit to the Agency 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 of Directive (EU) 2026/…+ is maintained.

The risk management plan and the summary thereof shall be submitted to the Agency

within 60 days of the withdrawal of the marketing authorisation for the reference medicinal

product by means of a variation in accordance with Article 49.

2. The Agency may impose an obligation on the marketing authorisation holder for a

medicinal product referred to in Articles 10 and 12 of Directive (EU) 2026/…+ 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.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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3. In the cases referred to in paragraph 1 and paragraph 2, point (a), the marketing

authorisation holder shall align the risk management plan referred to in paragraph 2 with

the risk management plan for the reference medicinal product.

4. The imposition of the obligation referred to in paragraph 2 of this Article 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 by means of a

variation in accordance with Article 49.

Article 49

Variation of a centralised marketing authorisation

1. An application for variation of a centralised 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 the

information held in the database referred to in point (b) of paragraph 5.

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 the terms of the 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 as referred to in paragraph 2. Those procedures shall range from

procedures that allow implementation only after approval based on a complete scientific

assessment to procedures that allow immediate implementation of the variation and

subsequent notification by the marketing authorisation holder to the Agency. Such

procedures may also allow updates by the marketing authorisation holder of the

information held in the database referred to in point (b) of paragraph 5.

4. Where necessary, depending on the category of variation as referred to in paragraph 2 and

the type of procedure as referred to in paragraph 3, the Commission shall take a decision to

vary the centralised marketing authorisation by means of an implementing act.

5. The Commission is empowered to adopt delegated acts in accordance with Article 181 to

supplement this Article by:

(a) establishing the categories referred to in paragraph 2 in which variations shall be

classified;

(b) establishing the procedures for the examination of applications for variations to the

terms of marketing authorisations, including procedures for updates of information,

through a database, by the marketing authorisation holder;

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(c) establishing the conditions for submission of a single application for more than one

change to the terms of the same marketing authorisation and for the same change to

the terms of several marketing authorisations;

(d) specifying exemptions to the variation procedures where the update of information in

the marketing authorisation referred to in Annex I to the Directive (EU) 2026/…+

may be directly implemented;

(e) establishing the conditions and procedures for cooperation with competent

authorities of third countries or international organisations on examination of

applications for variations to the terms of marketing authorisation.

Article 50

Scientific opinion on data submitted by not-for-profit entities

for repurposing of an authorised medicinal product

1. A not-for-profit entity may submit to the Agency or to a competent authority of the

Member State substantive non-clinical or clinical evidence for a new therapeutic indication

of an authorised medicinal product that is expected to fulfil an unmet medical need.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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The Agency may, at the request of a Member State, the Commission, or on its own

initiative and on the basis of all available evidence, including any additional evidence that

may be submitted by the marketing authorisation holder for the medicinal product

concerned, make a scientific evaluation of the benefit-risk of the use of a medicinal

product with a new therapeutic indication and deliver a scientific opinion. The Agency

shall draw up guidance on the consultation process.

The scientific opinion of the Agency shall be made publicly available and the competent

authorities of the Member States and the marketing authorisation holder shall be informed

thereof.

2. In cases where the scientific opinion is favourable and the new therapeutic indication

addresses an unmet medical need, at the request of the Agency, the marketing authorisation

holder of the medicinal product concerned shall submit an application for a variation to

update the product information with the new therapeutic indication.

3. Articles 84(2) and 86(1) of Directive (EU) 2026/…+ shall not apply for variations required

under paragraph 2 of this Article.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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Article 51

Transfer of a marketing authorisation

1. A marketing authorisation may be transferred to a new marketing authorisation holder.

Such a transfer shall not be considered to be a variation. The transfer shall be subject to

prior approval by the Commission, by means of an implementing act, following the

submission of an application to the Agency for the transfer of a marketing authorisation.

2. The Commission is empowered to adopt delegated acts in accordance with Article 181 to

supplement this Regulation by establishing procedures for the examination of an

application to the Agency for the transfer of a marketing authorisation.

Article 52

Supervisory authorities

1. In the case of medicinal products manufactured within the Union, the supervisory

authorities for manufacturing shall be the competent authorities of the Member State or

Member States which granted the manufacturing authorisation referred to in Article 146(1)

of Directive (EU) 2026/…+ in respect of the medicinal product concerned.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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2. In the case of medicinal products imported from third countries, the supervisory authorities

for imports shall be the competent authorities of the Member State or Member States that

granted the manufacturing authorisation to the holder responsible for certification of the

batches of the medicinal product concerned in accordance with Article 157(3) of Directive

(EU) 2026/…+.

A Member State may request assistance from another Member State or from the Agency.

3. The supervisory authority for pharmacovigilance shall be the competent authority of the

Member State in which the pharmacovigilance system master file is located.

Article 53

Responsibilities of the supervisory authorities

1. The supervisory authorities for manufacturing and import shall be responsible for verifying

on behalf of the Union that the marketing authorisation holder for the medicinal product or

the manufacturer or importer established within the Union satisfies the requirements

concerning manufacturing and import laid down in Chapters XI and XV of Directive

(EU) 2026/…+.

When carrying out the verification referred to in the first subparagraph, the supervisory

authorities may request to be accompanied by a rapporteur or expert appointed by the

Committee for Medicinal Products for Human Use or by an inspector of the Agency.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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The supervisory authorities for pharmacovigilance shall be responsible for verifying on

behalf of the Union that the marketing authorisation holder for the medicinal product

satisfies the pharmacovigilance requirements laid down in Chapters IX and XV of

Directive (EU) 2026/…+.

The supervisory authorities for pharmacovigilance may, if necessary, conduct pre-

authorisation inspections to verify the accuracy and successful implementation of the

pharmacovigilance system as it has been described by the applicant in support of the

application.

2. Where, in accordance with Article 205 of Directive (EU) 2026/…+, the Commission is

informed of serious differences of opinion between Member States as to whether the

marketing authorisation holder for the medicinal product for human use or a manufacturer

or importer established within the Union satisfies the requirements referred to in

paragraph 1, the Commission may, after consultation with the Member States concerned,

request an inspector from the supervisory authority to undertake a new inspection of the

marketing authorisation holder, the manufacturer or the importer.

The inspector in question may be accompanied by up to two inspectors from Member

States which are not party to the dispute or by two experts nominated by the Committee for

Medicinal Products for Human Use.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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3. Without prejudice to any agreements which may have been concluded between the Union

and third countries, the Commission may, following a request from a Member State or

from the Committee for Medicinal Products for Human Use, or on its own initiative,

require a manufacturer established in a third country to undergo an inspection.

The inspection shall be requested from the supervisory authority referred to in

Article 52(2). The inspection shall be carried out by appropriately qualified inspectors

from the Member States or, when requested, from the Agency. Inspectors may request to

be accompanied by a rapporteur or an expert appointed by the Committee for Medicinal

Products for Human Use or by an inspector from the Agency. The inspections reports shall

be made available electronically to the Commission, the Member States and the Agency.

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Article 54

Cooperation between competent authorities of the Member States

and the Agency for inspections in third countries

1. Without prejudice to the responsibilities of the competent authorities of Member States

under Article 191(1) of Directive (EU) 2026/…+, when an inspection is needed under

Article 191(1), second subparagraph, point (a) of Directive (EU) 2026/…+ or requested, as

referred to in Article 12(2) of this Regulation, for a site located in a third country, the

competent authority of the Member State concerned may:

(a) request the Agency to participate in the inspection; the Agency may provide its

assistance by participating in a joint inspection of the site with the requesting

competent authority of the Member State concerned; in that case the requesting

competent authority of the Member State shall lead the inspection and the follow-up

thereof; or

(b) request the Agency to facilitate cooperation among competent authorities of Member

States when a competent authority of a Member State intends to delegate the

inspection to a competent authority of another Member State as referred to in

Article 192(6) of Directive (EU) 2026/…+; or

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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(c) if no competent authority of a Member State accepts the delegation to carry out the

inspection as referred to in point (b) of this paragraph, request the Agency to carry

out the inspection and the follow-up thereof; if the inspection is in the interest of the

Union as defined in Annex III to this Regulation, the Agency shall accept the

delegation and carry out the inspection; if the outcome of that inspection shows that

the inspected entity complies with the principles of good manufacturing practice

(GMP), the Agency shall issue the relevant GMP certificate and shall enter that

certificate in the Union database referred to in Article 191(15) of Directive

(EU) 2026/…+.

Where the Agency carries out the inspection, the Agency may request the competent

authorities of Member States to participate in the inspection. Article 192 of Directive

(EU) 2026/…+ concerning joint inspections shall apply to any such request.

The Agency may also request to be accompanied by a rapporteur or expert appointed by

the Committee for Medicinal Products for Human Use.

Where the Agency has issued a GMP non-compliance statement and a follow-up

inspection is required, the Agency shall accept a request of a competent authority of a

Member State to perform that follow-up inspection.

2. Article 191(6) and Article 191(8) to (17) of Directive (EU) 2026/…+ shall apply

mutatis mutandis to the inspections referred to in paragraph 1, first subparagraph, point (c),

of this Article.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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3. Following a request by a competent authority of a Member State, the inspectors of the

Agency may provide support to that competent authority of a Member State when it

performs inspections under Regulation (EU) No 536/2014.

4. The Agency shall:

(a) ensure that appropriate resources are made available for the performance of

inspection tasks in accordance with paragraphs 1 and 3;

(b) ensure that the inspectors of the Agency possess expertise, technical knowledge, and

formal qualifications equivalent to those of the national inspectors as detailed in the

compilation, published by the Commission of Union procedures on inspections and

exchange of information;

(c) implement a quality system in accordance with the principles referred to in

Article 193(1), point (a), of Directive (EU) 2026/…+, to the extent applicable, and

participate as an inspectorate in the joint audit programme (‘JAP’) referred to in

Article 56 of this Regulation, which includes periodic audits;

(d) review its inspectorate regularly to ensure that its resources are providing appropriate

additional capacity to competent authorities of the Member States without

undermining their inspection resources and, where needed, take actions for

improvement.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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5. The cooperation between competent authorities of the Member States and the Agency for

the inspections in the interest of the Union shall be facilitated by the inspection working

group referred to in Article 148, point (k).

Article 55

International inspection programmes

1. The Agency shall, in consultation with the Commission and Member States, coordinate a

structured cooperation on inspections in third countries between Member States and, as

relevant, the European Directorate for the Quality of Medicines and Healthcare of the

Council of Europe, the World Health Organisation and trusted international authorities, by

means of international inspection programmes.

2. The Agency, in particular through its inspection working group referred to in Article 148,

point (k), in agreement with the Commission, shall draw up detailed guidelines laying

down the principles applicable to those international inspection programmes.

Article 56

Joint audit programme

1. The inspection working group referred to in Article 148, point (k), shall ensure the

following:

(a) the establishment and development of the JAP and the supervision thereof;

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(b) the monitoring of any measure taken by the Member State concerned or by the

Agency pursuant and limited to paragraph 4 of this Article, in cooperation with that

Member State or the Agency;

(c) cooperation with relevant international and Union level bodies to facilitate the work

of the JAP and to facilitate the recognition by international partners of the

inspections carried out by the competent authorities of the Member States or the

Agency.

For the purposes of the first subparagraph, the inspection working group may establish an

operational subgroup.

2. For the purposes of paragraph 1, first subparagraph, point (a), each Member State shall:

(a) provide trained auditors;

(b) accept that the competent authorities of Member States in charge of the

implementation of good manufacturing and good distribution practices and related

surveillance and enforcement activities applicable to medicinal products and active

substances are audited, regularly and where appropriate, in accordance with the JAP.

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3. The JAP shall be considered an integral part of the quality system of the inspectorates of

competent authorities of Members States and the Agency in accordance with the principles

referred to in Article 193(1), point (a), of Directive (EU) 2026/…+ and ensure that

adequate and equivalent quality standards are maintained within the Union network of

competent authorities.

4. Under the JAP, the auditors shall issue an audit report after each audit. The audit report

shall include, where relevant, appropriate recommendations on measures that the Member

State concerned or the Agency shall consider taking to ensure that its relevant quality

system and its enforcement activities are consistent with Union quality standards.

At the request of the Member State concerned, the Commission or the Agency may support

that Member State in taking the appropriate measures pursuant to the first subparagraph.

5. For the purposes of paragraph 4 of this Article, the Agency in particular through its

inspection working group referred to in Article 148, point (k), shall:

(a) ensure the harmonisation of the assessments during the JAP’s audits, and the quality

and consistency of audit reports;

(b) establish the criteria for the provision of the JAP’s recommendations.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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6. The Agency, in particular through its inspection working group referred to in Article 148,

point (k) of this Regulation, shall update the compilation of Union procedures on

inspections and exchange of information referred to in Article 3(1) of Commission

Directive (EU) 2017/157240 to cover rules applicable to the functioning, structure and tasks

of the JAP.

7. The Union shall provide the financing for activities that support the work of the JAP.

Article 57

Referral procedure

1. Where the supervisory authorities or the competent authorities of any other Member State

are of the opinion that the manufacturer or importer established within the Union territory

is no longer fulfilling the obligations laid down in Chapter XI of Directive (EU) 2026/…+,

they shall without undue delay inform the Agency and the Commission, stating their

reasons in detail and indicating the course of action proposed.

40 Commission Directive (EU) 2017/1572 of 15 September 2017 supplementing Directive

2001/83/EC of the European Parliament and of the Council as regards the principles and

guidelines of good manufacturing practice for medicinal products for human use (OJ L 238,

16.9.2017, p. 44, ELI: http://data.europa.eu/eli/dir/2017/1572/oj). + OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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Similarly, where a Member State or the Commission considers that one of the measures

envisaged in Chapters IX, XIV and XV of Directive (EU) 2026/…+ is to be applied in

respect of the medicinal product concerned or where the Committee for Medicinal

Products for Human Use has issued an opinion to that effect, they shall without undue

delay inform each other, as well as the Committee for Medicinal Products for Human Use,

stating their reasons in detail and indicating the course of action proposed.

2. In each of the situations referred to in paragraph 1, the Commission shall request the

opinion of the Agency within a time limit which it shall specify having regard to the

urgency of the matter, in order to examine the reasons advanced. Whenever practicable, the

marketing authorisation holder for placing the medicinal product for human use on the

market shall be invited to provide oral or written explanations.

3. At any stage of the procedure laid down in this Article, following appropriate consultation

of the Agency, the Commission may take temporary measures, by means of implementing

acts. Those temporary measures shall be applied immediately.

Without undue delay, the Commission shall, by means of implementing acts, adopt a final

decision concerning the measures to be taken in respect of the medicinal product

concerned. Those implementing acts shall be adopted in accordance with the examination

procedure referred to in Article 179(2).

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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The Commission may also, pursuant to Article 59, adopt a decision addressed to the

Member States.

4. Where urgent action is essential to protect public health or the environment, a Member

State may, on its own initiative or at the Commission’s request, suspend the use in its

territory of a medicinal product for human use which has been authorised in accordance

with this Regulation.

When a Member State takes suspensive measures on its own initiative, it shall inform the

Commission and the Agency of the reasons for its action at the latest on the next working

day following the suspension. The Agency shall inform thereon the other Member States

without delay. The Commission shall immediately initiate the procedure laid down in

paragraphs 2 and 3.

5. In cases referred to in paragraph 4, the Member State shall ensure that healthcare

professionals are rapidly informed of the action taken and the reasons for it. Networks set

up by professional associations may be used to this effect. The Member States shall inform

the Commission and the Agency of actions taken for this purpose.

6. The suspensive measures referred to in paragraph 4 may be maintained in force until such

time as a final decision has been adopted by the Commission in accordance with

paragraph 3.

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7. The Agency shall, upon request, inform any person concerned of the final decision and

make the decision publicly available immediately after it has been taken.

8. Where the procedure is initiated as a result of the evaluation of data relating to

pharmacovigilance, the opinion of the Agency, in accordance with paragraph 2 of this

Article, shall be adopted by the Committee for Medicinal Products for Human Use on the

basis of a recommendation from the Pharmacovigilance Risk Assessment Committee and

Article 119(2) of Directive (EU) 2026/…+ shall apply.

9. By way of derogation from paragraphs 1 to 7 of this Article, where a procedure under

Article 98 or Articles 118, 119 and 120 of Directive (EU) 2026/…+ concerns a range of

medicinal products or a therapeutic class, medicinal products that are authorised in

accordance with this Regulation and that belong to that range or class shall only be

included in the procedure under Article 98, or Articles 118, 119 and 120 of that Directive.

Article 58

Action on conditional marketing authorisation

and on marketing authorisations granted under exceptional circumstances

Where the Agency concludes that a holder of a marketing authorisation granted in accordance with

Articles 19 and 20, including a new therapeutic indication granted referred to Articles 19 and 20,

failed to comply with the conditions or obligations laid down in the marketing authorisation, the

Agency shall inform the Commission accordingly.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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The Commission shall adopt a decision to vary, suspend or revoke that marketing authorisation in

accordance with the procedure laid down in Article 14.

Article 59

Member States implementation of conditions or restrictions

on a centralised marketing authorisation

Where the Committee for Medicinal Products for Human Use refers in its opinion to recommended

conditions or restrictions as provided for in Article 13(4), points (d) to (g), the Commission may

adopt a decision addressed to the Member States, in accordance with Article 14, for the

implementation of those conditions or restrictions.

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Chapter V

Pre-authorisation regulatory support

Article 60

Scientific advice

1. Undertakings or, as relevant, not-for-profit entities may request scientific advice as

referred to in Article 144(1), second subparagraph, point (q), from the Agency.

Such an advice can also be requested for medicinal products referred to in Articles 85

and 86 of Directive (EU) 2026/…+.

2. In preparing the scientific advice referred to in paragraph 1 and upon request by

undertakings or, as relevant, not-for-profit entities that requested the scientific advice, the

Agency may consult experts of the Member States with clinical trials or medical devices

expertise or the expert panels designated in accordance with Article 106(1) of Regulation

(EU) 2017/745.

3. In preparing the scientific advice referred to in paragraph 1 the Agency may consult

authorities established under other Union legal acts, as relevant, for the provision of the

scientific advice in question, other public bodies established in the Union, as applicable,

and in duly justified cases public bodies established in third countries.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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4. The Agency shall include in the EPAR the key areas of the scientific advice once the

Commission has taken the corresponding marketing authorisation decision in relation to

the medicinal product concerned, after deletion of any information of a commercially

confidential nature. For priority medicinal products the EPAR shall include the key areas

of enhanced scientific and regulatory support provided by the Agency in accordance with

Article 62, together with explanations on how the conditions for that enhanced support

have been fulfilled and, if applicable, the reasons for stopping the enhanced support prior

to the granting of the marketing authorisation.

5. To support undertakings or, as relevant, not-for-profit entities, the Agency shall

develop guidelines on the design of studies in support of marketing authorisation

applications. When developing such guidelines, it shall use, where relevant, the

consultation process referred to in Article 169.

Article 61

Parallel scientific advice

1. Undertakings or, as relevant, not-for-profit entities established in the Union may request

that the scientific advice referred to in Article 60(1) of this Regulation takes place in

parallel to the joint scientific consultation carried out by the Member State Coordination

Group on Health Technology Assessment, in accordance with Article 16(5) of Regulation

(EU) 2021/2282.

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2. In the case of medicinal products involving a medical device or an in vitro diagnostic

medical device, undertakings or, as relevant, not-for profit entities may request scientific

advice as referred to in Article 60(1) of this Regulation in parallel to the consultation of the

expert panels referred to in Article 61(2) of Regulation (EU) 2017/745 and Article 48(6) of

Regulation (EU) 2017/746.

3. In the case of paragraph 2 of this Article, the scientific advice, as referred to in

Article 60(1), shall involve exchanges of information between the respective authorities or

bodies and, where applicable, have synchronised timing, while preserving the separation of

their respective remits.

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Article 62

Enhanced scientific and regulatory support for priority medicinal products (PRIME)

1. The Agency may offer enhanced scientific and regulatory support, including as applicable

consultation with other bodies as referred to in Articles 60 and 61 and accelerated

assessment mechanisms, for certain medicinal products that, based on preliminary

evidence submitted by the medicinal product developer, fulfil at least one of the following

conditions:

(a) are likely to address an unmet medical need as referred to in Article 85(1) of

Directive (EU) 2026/…+ and are expected to be of major interest from the point of

view of public health, in particular as regards therapeutic innovation, taking into

account the early stage of their development;

(b) are antimicrobials with any of the characteristics mentioned in Article 41(3), are

antimicrobials targeting pathogens included in the ‘WHO bacterial priority pathogens

list’, specifically those listed as ‘critical group’ or ‘high group’, or are antimicrobials

targeting pathogens included in any equivalent list of priority pathogens established

at Union level; or

(c) are likely to target a neglected tropical disease.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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2. The Agency, at the request of the Commission and after consulting the EMA Emergency

Task Force, may offer enhanced scientific and regulatory support to developers of a

medicinal product preventing, diagnosing or treating a disease resulting from serious cross

border threats to health if access to such product is considered necessary to ensure a high

level of Union preparedness and response to such health threats.

3. The Agency may stop the enhanced support if it is established that the medicinal product is

no longer a priority medicinal product in accordance with paragraphs 1 and 2, including

where it does not address the identified unmet medical need, or does not have the potential

to ensure a high level of Union preparedness and response to serious cross border health

threats to the anticipated extent.

4. The compliance of a medicinal product with the criteria set out in Article 85 of Directive

(EU) 2026/…+ to be considered as addressing an unmet medical need shall be assessed on

the basis of the relevant criteria, independently of whether it has received enhanced support

for priority medicinal products under this Article.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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Article 63

Scientific recommendation on regulatory status

1. For products under development which may fall within the categories of medicinal

products to be authorised by the Union listed in Annex I, a developer, a competent

authority of the Member States or the Commission on its own initiative may submit a duly

substantiated request to the Agency for a scientific recommendation with a view to

determining on scientific grounds whether the concerned product is potentially a

‘medicinal product’, including an ‘advanced therapy medicinal product’. The Agency may

rely on the relevant expertise of working parties and pools of experts when making its

recommendation.

The Agency shall deliver its recommendation within 60 days of receiving such a request,

which shall be extended by an additional 30 days where a consultation in accordance with

paragraph 2 is required.

2. When preparing the recommendation referred to in paragraph 1 of this Article, the Agency

shall consult, where appropriate and where there is a doubt as to the regulatory status of a

product under development, relevant advisory or regulatory bodies established under other

Union legal acts in related fields. In particular, in the case of products which are based on

substances of human origin, the Agency shall consult the substances of human origin

(SoHO) Coordination Board as established in Regulation (EU) 2024/1938.

The advisory or regulatory bodies consulted shall reply to the consultation within 30 days

of receipt of the request.

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The Agency shall annex to its scientific recommendations the opinions received from the

relevant advisory or regulatory bodies referred to in the first subparagraph and shall

publish summaries of the recommendations delivered in accordance with paragraph 1, after

deletion of all information of a commercially confidential nature.

Article 64

Decision on regulatory status

1. In the case of duly substantiated disagreement with the Agency’s scientific

recommendation, in accordance with Article 63(2), a Member State may request the

Commission to initiate a procedure in order to decide whether the product is a medicinal

product referred to in Article 63(1).

The Commission may initiate the procedure referred to in the first subparagraph on its own

initiative.

2. The Commission may ask the Agency for clarifications or refer the recommendation back

to the Agency for further consideration where a Member State’s substantiated request

raises new questions of a scientific or technical nature or on its own initiative.

3. The decision of the Commission referred to in paragraph 1 shall be adopted by means of

implementing acts, in accordance with the examination procedure referred to in

Article 179(2), taking into account the scientific recommendation of the Agency.

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Chapter VI

Orphan medicinal products

Article 65

Criteria for orphan designation

1. A medicinal product that is intended for the prevention, diagnosis or treatment of a life-

threatening or chronically debilitating condition shall be granted the status of designated

orphan medicinal product (‘orphan designation’) where the orphan medicinal product

sponsor can demonstrate that the following criteria are met:

(a) the condition affects not more than five in 10 000 persons in the Union when the

application for an orphan designation is submitted; and

(b) no satisfactory method of prevention, diagnosis or treatment of the condition has

been authorised in the Union or, if there is such a method of, prevention, diagnosis,

or treatment, the medicinal product would be of significant benefit to those affected

by that condition.

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2. On the basis of a recommendation from the Agency concluding that the criteria set out in

paragraph 1, point (a), of this Article are not appropriate to identify certain conditions as

being an orphan condition within the scope of rarity in paragraph 1, point (a), of this

Article due to the specific characteristics of those conditions or any other scientific

reasons, the Commission is empowered to adopt delegated acts in accordance with

Article 181 in order to supplement paragraph 1, point (a), of this Article, by setting specific

criteria for certain conditions.

3. The Commission shall adopt the necessary provisions for implementing this Article by

means of implementing acts in accordance with the procedure laid down in Article 179(2)

in order to further specify the criteria set out in paragraph 1 of this Article.

Article 66

Decision granting a medicinal product an orphan designation

1. The orphan medicinal product sponsor shall submit to the Agency an application for the

orphan designation of a medicinal product (‘application for an orphan designation’) at any

stage of the development of the medicinal product before the application for marketing

authorisation referred to in Articles 5 and 7 is submitted.

2. The application for an orphan designation shall be accompanied by the following

particulars and documents:

(a) the name or company name and permanent address of the orphan medicinal product

sponsor;

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(b) the information on the active substances of the medicinal product;

(c) proposed condition for which the medicinal product is intended or its proposed

therapeutic indication;

(d) justification that the criteria set out in Article 65(1) or in the relevant delegated acts

adopted in accordance with Article 65(2) are fulfilled and a description of the stage

of development of the medicinal product, including its expected therapeutic

indication.

The orphan medicinal product sponsor shall be responsible for the accuracy of the

particulars and documents submitted pursuant to the first subparagraph.

3. The Agency shall, in consultation with the Member States, the Commission and interested

parties, draw up detailed guidelines on the procedure, format and content of applications

for an orphan designation and for the transfer of the orphan designation pursuant to

Article 67.

4. Within 90 days of receipt of a valid application, the Agency shall adopt a decision granting

or refusing the orphan designation based on the criteria set out in Article 65(1) or in the

relevant delegated acts adopted in accordance with Article 65(2). The Agency shall verify

the validity of the application. The application shall be considered valid if it includes all

the particulars and documents referred to in paragraph 2 of this Article.

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For the purpose of establishing whether the orphan designation criteria set out in

Article 65(1) or in the relevant delegated acts adopted in accordance with Article 65(2) are

fulfilled, the Agency may ask the orphan medicinal product sponsor to provide

supplementary information, within the time limit set by the Agency.

For the purpose of establishing whether the orphan designation criteria are fulfilled, the

Agency shall consult the Committee for Medicinal Products for Human Use. The

Committee for Medicinal Products for Human Use shall ensure the appropriate

involvement of the relevant scientific expertise through the scientific working parties

referred to in Article 157 or may delegate this task to one of those working parties. The

outcome of such consultations, including information on the involvement of relevant

scientific expertise, shall be annexed to the Agency’s decision granting or refusing the

orphan designation, as part of the scientific conclusions of the Agency which justify the

decision.

The decision together with the Annexes referred to in the third subparagraph shall be

notified to the applicant.

By way of derogation from the third subparagraph, the Committee for Medicinal Products

for Human Use shall establish scientific principles to determine the situations where

consultation of that Committee is not required.

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5. When the scientific conclusions referred to in the third subparagraph of paragraph 4 of this

Article state that the application does not fulfil the criteria set out in Article 65(1), they

shall be transmitted without delay by the Agency to the orphan medicinal product sponsor

before the adoption of the decision referred to in paragraph 4 of this Article.

Within 15 days of receipt of the scientific conclusions, the orphan medicinal product

sponsor may submit to the Agency a duly reasoned request, in writing, for a re-

examination of the scientific conclusions.

Within 30 days of receipt of the request for re-examination referred to in second

subparagraph of this paragraph, the Agency shall reexamine its scientific conclusions. The

reasons for the conclusion reached following that re-examination shall be part of the final

scientific conclusions. The time limit referred to in paragraph 4 of this Article shall be

suspended until the scientific conclusions become final. For the purposes of this paragraph,

the Agency shall consult the Committee for Medicinal Products for Human Use.

If the orphan medicinal product sponsor does not submit a written justified request for

re-examination within 15 days of receipt of the scientific conclusions, they shall become

final.

6. Decisions of the Agency on granting or refusing the orphan designation shall be made

public after deletion of any information of a commercially confidential nature.

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Article 67

Transfer of an orphan designation

1. The orphan designation may be transferred from one orphan medicinal product sponsor

(the ‘current orphan medicinal product sponsor’) to another orphan medicinal product

sponsor (the ‘new orphan medicinal product sponsor’). Such transfers shall be subject to

prior approval by the Agency, following the submission of an application for transfer by

the current orphan medicinal product sponsor to the Agency.

2. The application for transfer of an orphan designation by the current orphan medicinal

product sponsor shall be accompanied by the following particulars and documents:

(a) name or company name and permanent address of the current and new orphan

medicinal product sponsor;

(b) decision of the Agency granting the orphan designation pursuant to Article 66(4);

(c) designation number as referred to in Article 69(1), point (e);

(d) reasons for the transfer of the orphan designation.

3. The Agency shall adopt a decision granting or refusing the transfer of the orphan

designation within 30 days of receipt of a valid application by the current orphan medicinal

product sponsor. The application shall be considered valid if it includes all the particulars

and documents referred to in paragraph 2. The Agency shall address its decision to the

current and new orphan medicinal product sponsor.

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Article 68

Validity of an orphan designation

1. An orphan designation shall be valid for seven years. During that period, the orphan

medicinal product sponsor shall be eligible for incentives referred to in Article 70.

2. By way of derogation from paragraph 1, on the basis of a reasoned request by the orphan

medicinal product sponsor, the Agency may extend the validity of the orphan designation,

where the orphan medicinal product sponsor provides evidence that the relevant studies

supporting the use of the designated orphan medicinal product to prevent, diagnose or treat

the condition specified in the application for an orphan designation are ongoing and

promising with regard to the filing of a future application. Any extension shall be limited

in time, taking into account the expected time remaining needed to file an application for

marketing authorisation.

3. By way of derogation from paragraph 1 of this Article, where an orphan designation is

valid at the time when a marketing authorisation application for an orphan medicinal

product has been submitted in accordance with Article 5, the orphan designation shall

remain valid until a decision is adopted by the Commission in accordance with

Article 14(2).

4. An orphan designation shall cease to be valid once an orphan medicinal product sponsor

has obtained a marketing authorisation for a therapeutic indication covered under the

orphan designation in accordance with Article 14(2).

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5. An orphan designation may be withdrawn at any time, at the request of the orphan

medicinal product sponsor. The orphan medicinal product sponsor shall provide the

Agency with the reasons for such request. The Agency shall make this information

publicly available.

Article 69

Register of designated orphan medicinal products

1. The Agency shall set up and manage a register of designated orphan medicinal products

and make it publicly available. The register of designated orphan medicinal products shall

list all designated orphan medicinal products and shall include at least the following

particulars and documents:

(a) the information on the active substance;

(b) the name or company name and permanent address of the orphan medicinal product

sponsor;

(c) the proposed condition for which the medicinal product is intended or its proposed

therapeutic indication;

(d) the designation date;

(e) the designation number;

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(f) the decision on granting the orphan designation;

(g) the decision on transfer of the orphan designation; and

(h) where applicable, the decision extending the validity of the orphan designation in

accordance with Article 68(2).

2. The Commission shall be empowered to adopt delegated acts in accordance with

Article 181 in order to amend the information to be included in the register of designated

orphan medicinal products referred to in paragraph 1 of this Article to ensure that users of

the register are sufficiently informed.

3. Where an orphan designation ceases to be valid or is withdrawn pursuant to Article 68, the

Agency shall make an entry in the register of designated orphan medicinal products.

Article 70

Protocol assistance and research support for designated orphan medicinal products

1. Prior to the submission of an application for marketing authorisation, the orphan medicinal

product sponsor may request advice from the Agency on the following:

(a) the conduct of the various tests and trials necessary to demonstrate the quality,

safety and efficacy of the medicinal product, as referred to Article 144(1),

second subparagraph, point (q);

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(b) the conduct of the various tests and trials necessary for the environmental risk

assessment of the medicinal product;

(c) the demonstration of significant benefit within the scope of the orphan condition as

set out in Article 65(1);

(d) the demonstration of similarity to, or clinical superiority over, other medicinal

products, which have market exclusivity for the same therapeutic indication.

2. Medicinal products designated as orphan medicinal products under this Regulation shall be

eligible for incentives made available by the Union and by the Member States to support

research into, and the development and availability of, orphan medicinal products and in

particular aid for research for SMEs and entities not engaged in economic activity provided

for in framework programmes for research and technological development.

Article 71

Marketing authorisation as an orphan medicinal product

1. An application for marketing authorisation as an orphan medicinal product shall be

submitted in accordance with Articles 5 and 7 and the related marketing authorisation shall

be obtained in accordance with Article 14(2).

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2. In addition, the applicant shall demonstrate that the medicinal product has been granted an

orphan designation and that the criteria set out in Article 65(1) or in the relevant delegated

acts adopted in accordance with Article 65(2) are fulfilled for the therapeutic indication

sought.

Where appropriate, the applicant shall provide relevant evidence to demonstrate that the

medicinal product meets the criteria laid down in Article 72(1).

3. The Committee for Medicinal Products for Human Use shall assess whether the medicinal

product fulfils the criteria set out in Article 65(1) or in the relevant delegated acts adopted

in accordance with Article 65(2). In the situation referred to in paragraph 2,

second subparagraph, of this Article that Committee shall also assess whether the

medicinal product is considered a breakthrough orphan medicinal product as provided for

in Article 72(1). The Committee for Medicinal Products for Human Use shall ensure the

appropriate involvement of scientific expertise regarding orphan medicinal products.

The assessment pursuant to the first subparagraph shall be subject to the same time limit as

the application for the marketing authorisation itself. The assessment and its detailed

conclusions shall be part of the opinion referred to in Article 13(1) and, where relevant, the

final opinion referred to in Article 13(3).

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4. The orphan marketing authorisation shall cover only those therapeutic indications which

fulfil the criteria set out in Article 65(1) or in the relevant delegated acts adopted in

accordance with Article 65(2) at the time when the orphan marketing authorisation is

granted.

5. If after the submission of an application for the orphan marketing authorisation and prior to

the opinion of the Committee for Medicinal Products for Human Use the orphan

designation is withdrawn pursuant to Article 68(5), the application for the orphan

marketing authorisation shall be treated as the application for a marketing authorisation in

accordance with Article 7.

6. An applicant may submit an application for a separate marketing authorisation for other

therapeutic indications which do not fulfil the criteria set out in Article 65(1) or in the

relevant delegated acts adopted in accordance with Article 65(2).

Article 72

Breakthrough orphan medicinal products

1. A medicinal product which meets the criteria referred to in Article 65 shall be considered a

breakthrough orphan medicinal product if it meets the following additional criteria:

(a) there is no medicinal product authorised in the Union for the orphan condition; and

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(b) the use of the medicinal product results in a clinically relevant reduction in disease

morbidity or mortality for the relevant patient population.

2. A medicinal product for which an application has been submitted in accordance with

Article 14 of Directive (EU) 2026/…+ shall not be considered to meet the criteria laid

down in paragraph 1 of this Article.

Article 73

Market exclusivity of orphan medicinal products

1. Where an orphan marketing authorisation is granted and without prejudice to intellectual

property law, the Union and the Member States shall not grant a centralised or national

marketing authorisation or extend an existing centralised or national marketing

authorisation, for the same therapeutic indication, in respect of a similar medicinal product

for the duration of market exclusivity set out in paragraph 2.

2. The duration of market exclusivity shall be as follows:

(a) nine years for orphan medicinal products other than those referred to in points (b)

and (c);

(b) eleven years for breakthrough orphan medicinal products referred to in Article 72;

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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(c) four years for orphan medicinal products which have been authorised in accordance

with Article 14 of Directive (EU) 2026/…+.

3. Where a marketing authorisation holder holds more than one orphan marketing

authorisation for the same active substance, those authorisations shall not benefit from

separate market exclusivity periods. The duration of the market exclusivity shall start from

the date when the first orphan marketing authorisation was granted in the Union.

4. By way of derogation from paragraph 1, and without prejudice to intellectual property law,

the centralised or national marketing authorisation may be granted, for the same

therapeutic indication, to a similar medicinal product if:

(a) the marketing authorisation holder for the original orphan medicinal product has

given consent to the second applicant;

(b) the marketing authorisation holder for the original orphan medicinal product is

unable to supply sufficient quantities of the medicinal product; or

(c) the second applicant can establish in the application that the second medicinal

product, although similar to the orphan medicinal product already authorised, is

safer, more effective or otherwise clinically superior.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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5. The submission, validation and assessment of the application for the centralised or national

marketing authorisation and the granting of the centralised or national marketing

authorisation for a generic medicinal product or biosimilar medicinal product to the

reference medicinal product, shall not be prevented by the market exclusivity of a similar

product to the reference medicinal product.

6. The market exclusivity of the orphan medicinal product shall not prevent the submission,

validation and assessment of an application for a centralised or national marketing

authorisation, including to extend an existing centralised or national marketing

authorisation for a new therapeutic indication, of a similar medicinal product, including

generic medicinal products and biosimilar medicinal products, where the remainder of the

duration of the market exclusivity is less than two years. This may include the adoption of

the corresponding decision provided that the decision granting or extending the centralised

or national marketing authorisation does not enter into force prior to the expiry of the

market exclusivity period.

7. Where the Agency adopts scientific guidelines for the application of paragraphs 1 and 4, it

shall consult the Commission.

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Article 74

Extension of market exclusivity

1. The period of market exclusivity shall be extended by an additional period of 12 months

for orphan medicinal products referred to in Article 73(2), points (a) and (b), if, at least two

years before the end of the exclusivity period, the orphan marketing authorisation holder

obtains a marketing authorisation for one or more new therapeutic indications for a

different orphan condition.

Such an extension may be granted twice, provided that each new therapeutic indication

concerns a different orphan condition.

2. The orphan medicinal products which benefit from the extension of market exclusivity

referred to in paragraph 1 of this Article shall not benefit from the additional period of

market protection referred to in Article 84(2) of Directive (EU) 2026/…+.

3. Article 73(3) equally applies to the extension of market exclusivity referred to in

paragraph 1 of this Article.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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Article 75

Union financial contribution related to orphan medicinal products

The working arrangements referred to in Article 8 of Regulation (EU) 2024/568 shall set out total or

partial reductions for the applicable fees and charges payable to the Agency as laid down in that

Regulation. Such reductions shall be covered by the Union contribution provided for in

Article 161(3), first subparagraph, point (a) of this Regulation.

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Chapter VII

Paediatric medicinal products

Article 76

Paediatric investigation plan

1. A paediatric investigation plan shall specify the timing and all the measures proposed to

evaluate the quality, safety and efficacy of the medicinal product in all subsets of the

paediatric population that might be concerned. In addition, the paediatric investigation plan

shall describe any measures to adapt the pharmaceutical form, the strength, route of

administration and any administration device for the medicinal product so as to make its

use more acceptable, easier, safer or more effective for different subsets of the paediatric

population.

2. By way of derogation from paragraph 1, an applicant may submit only an initial paediatric

investigation plan in the following cases:

(a) where the active substance is not yet authorised in any medicinal product in the

Union and is intended for diagnosis, prevention or treatment of a novel paediatric

condition or for the diagnosis, prevention or treatment of an existing paediatric

condition by means of a new mechanism of action; or

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(b) where the Agency has accepted a duly justified request from an applicant in

accordance with paragraph 3.

An initial paediatric investigation plan shall specify only the details and the timing of the

measures proposed to assess the quality, safety and efficacy of the medicinal product in all

subsets of the paediatric population that might be concerned, that are known at the moment

of the submission of the request for agreement referred to in Article 78(1).

The initial paediatric investigation plan shall also specify the timing for the submission to

the Agency of updated versions of that paediatric investigation plan and for the submission

of a final paediatric investigation plan complying with paragraph 1.

3. When it is not possible, on the basis of scientifically justified reasons, to have a complete

paediatric investigation plan in accordance with the timing referred to in Article 76(1) an

applicant may submit a duly justified request to the Agency to use the procedure

mentioned in paragraph 2 of this Article. The Agency has 20 days to accept or refuse the

request and shall immediately inform the applicant and state the reasons for refusal.

4. On the basis of the experience acquired as a result of the application of this Article or of

scientific knowledge, the Commission is empowered to adopt delegated acts in accordance

with Article 181 to amend the grounds for granting the possibility to derogate from

paragraph 1 of this Article pursuant to paragraph 2 of this Article.

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Article 77

Class or product-specific waivers

1. In accordance with the procedure laid down in Article 80 of this Regulation, the Agency

may decide that the production of the information referred to in Article 7(5),

first subparagraph, point (a), of Directive (EU) 2026/…+ shall be waived for specific

medicinal products or for classes of medicinal products, if there is evidence showing any

of the following:

(a) that the specific medicinal product or class of medicinal products is likely to be

ineffective or unsafe in part or all of the paediatric population;

(b) that the disease or condition for which the specific medicinal product or class of

medicinal products is intended occurs only in the adult population, except when the

specific medicinal product displays a mechanism of action, including where its

action is directed at a specific molecular target or biological pathway that, on the

basis of existing scientific data, is relevant for a different disease or condition in

children in the same therapeutic area as the one for which the specific medicinal

product or class of medicinal products is intended for in the adult population;

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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(c) that the specific medicinal product is likely to not represent a significant therapeutic

benefit over existing methods of diagnosis, prevention or treatment for paediatric

patients, except when the specific medicinal product displays a mechanism of action,

including where its action is directed at a specific molecular target or biological

pathway that, on the basis of existing scientific data, is relevant for a different

disease or condition in children in the same therapeutic area as the one for which the

specific medicinal product or class of medicinal products is intended for in the adult

population.

2. The waiver provided for in paragraph 1 may be granted with reference to one or more

specified subsets of the paediatric population, or to one or more specified therapeutic

indications, or to a combination of both.

3. On the basis of the experience acquired as a result of the application of this Article or of

scientific knowledge, the Commission is empowered to adopt delegated acts in accordance

with Article 181 to amend the grounds for granting a waiver provided for in paragraph 1 of

this Article.

4. The Agency shall, in consultation with the Commission, the competent authorities of the

Member States and relevant interested parties, draw up guidelines for the application of

this Article.

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Article 78

Validation of a proposed paediatric investigation plan or of a waiver

1. A paediatric investigation plan pursuant to Article 76 or an application for a

product-specific waiver pursuant to Article 77 shall be submitted to the Agency together

with a request for agreement, except in duly justified cases, before the initiation of safety

and efficacy clinical studies so as to ensure that a decision on use in the paediatric

population of the medicinal product concerned can be taken at the time of the marketing

authorisation or other application concerned.

2. Within 30 days of receipt of the request referred to in paragraph 1, the Agency shall verify

the validity of the request and inform the applicant of the result of that verification.

3. Where appropriate, the Agency may ask the applicant to submit additional particulars and

documents, in which case the time limit of 30 days referred to in paragraph 2 shall be

suspended until the supplementary information has been provided.

4. In consultation with the Commission, the competent authorities of the Member States and

with interested parties, the Agency shall draw up and publish guidelines for the practical

application of this Article.

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Article 79

Decisions agreeing a paediatric investigation plan

1. Within 90 days of the validation of the proposed paediatric investigation plan referred to in

Article 76(1) in accordance with Article 78(2), the Agency shall adopt a decision as to

whether the studies proposed will ensure the generation of the data necessary to determine

the conditions in which the medicinal product may be used to treat the paediatric

population or subsets of that population, and as to whether the expected therapeutic

benefits, where appropriate, including as compared to existing treatments, justify the

studies proposed. When adopting its decision, the Agency shall consider whether the

measures proposed to adapt the pharmaceutical form, the strength, route of administration

and any administration device for the medicinal product for use in different subsets of the

paediatric population are appropriate.

2. The Agency shall adopt a decision within 70 days of the validation of the proposed initial

paediatric investigation plan referred to in Article 76(2), first subparagraph, in accordance

with Article 78(2), as to whether the paediatric investigation plan is expected to ensure the

generation of the data necessary to determine the conditions in which the medicinal

product may be used to treat the paediatric population or subsets of that population, and as

to whether the expected therapeutic benefits, where relevant, including as compared to

existing treatments, justify the studies proposed.

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3. After receiving an updated version of the paediatric investigation plan referred to in

Article 76(2), third subparagraph, the Agency shall review it within 60 days.

After the expiry of the time limit specified in the first subparagraph of this paragraph, and

in the absence of any request from the Agency in accordance with paragraph 5, the updated

version of the paediatric investigation plan shall be considered to be agreed.

4. Within 60 days of receipt of the final paediatric investigation plan referred to in

Article 76(2), third subparagraph, the Agency shall adopt a final decision on the paediatric

investigation plan, considering the initial decision and any updated reviews conducted in

accordance with paragraphs 2 and 3 of this Article.

5. Within the time limits referred to in paragraph 1, 2, 3 or 4, the Agency may request the

applicant to propose modifications to the paediatric investigation plan or ask for

supplementary information, in which case the time limits referred to in paragraphs 1, 2, 3

and 4 shall be extended for a maximum of the same number of days. Those time limits

shall be suspended until the supplementary information has been provided.

6. The procedure laid down in Article 89 shall apply for the adoption of decisions by the

Agency under this Article.

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Article 80

Decisions granting, refusing, reviewing or revoking a class or product-specific waiver

1. An applicant may apply to the Agency for a product-specific waiver, on the grounds set out

in Article 77(1).

2. Within 90 days of receipt of a valid application, the Agency shall adopt a decision granting

or refusing a product-specific waiver.

Where appropriate, the Agency may request the applicant to supplement the particulars and

documents submitted. Where the Agency avails itself of this option, the 90-day time limit

shall be suspended until the supplementary information has been provided.

3. Where appropriate, the Agency may on its own motion adopt decisions, on the basis of the

grounds set out in Article 77(1), to the effect that a class or a product-specific waiver, as

referred to in Article 77(2), is granted.

4. The Agency may at any time adopt a decision reviewing a class or product-specific waiver.

5. If a particular class or product-specific waiver is revoked, the requirement laid down in

Article 7(5) of Directive (EU) 2026/…+ shall not apply for 36 months from the date of its

removal from the list of waivers referred to in Article 81 of this Regulation.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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6. The procedure laid down in Article 89 shall apply for the adoption of decisions by the

Agency under this Article.

7. In consultation with the Commission, the competent authorities of the Member States and

interested parties, the Agency shall draw up and publish guidelines for the practical

application of this Article.

Article 81

List of waivers

The Agency shall maintain a list of waivers. The list shall be updated regularly and publicly

available.

Article 82

Waivers granted following a negative decision on a paediatric investigation plan

If, having assessed a paediatric investigation plan, the Agency concludes that Article 77(1),

point (a), (b) or (c), applies to the medicinal product, it shall adopt, simultaneously:

(a) a negative decision under Article 79(1), (2) or (4); and

(b) a decision granting a class or a product-specific waiver under Article 80(3).

The procedure laid down in Article 89 shall apply for the adoption of decisions by the Agency

under this Article.

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Article 83

Decisions granting or refusing deferrals

1. At the same time as the request for agreement of a paediatric investigation plan is

submitted to the Agency pursuant Article 78(1) or during the assessment for a paediatric

investigation plan, the applicant may also make a request to the Agency for deferral of the

initiation or completion of some or all of the measures set out in that plan. Such deferral

shall be justified on scientific or technical grounds or on grounds related to public health.

In any event, a deferral shall be granted when it is appropriate to conduct studies in adults

prior to initiating studies in the paediatric population or when studies in the paediatric

population will take longer to conduct than studies in adults.

2. The Agency shall adopt a decision granting or refusing the deferral and inform the

applicant thereof. The Agency shall adopt that decision at the same time as it adopts a

positive decision under Article 79(1) or (2).

A decision granting the deferral shall specify the time limits for initiating or completing the

measures concerned.

3. The length of the deferral shall be specified in the decision of the Agency and shall be

substantiated by scientific or technical grounds or by considerations pertaining to public

health and shall not exceed five years.

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4. On the basis of the experience acquired as a result of the application of this Article, the

Commission is empowered to adopt delegated acts in accordance with Article 181 to

amend the grounds for granting a deferral referred to in paragraph 1 of this Article.

Article 84

Decisions on extension of deferrals

1. In duly justified cases, a request for an extension of the deferral, may be submitted, at least

six months before the expiry of the deferral period. An extension of the deferral shall not

exceed the duration of the deferral period given under Article 83(3).

The Agency shall decide on the extension within 60 days.

2. Where appropriate, the Agency may ask the applicant to submit, within the time limit

specified by the Agency, additional particulars and documents, in which case the time limit

of 60 days shall be suspended until the supplementary information has been provided.

3. The procedure laid down in Article 89 shall apply for the adoption of decisions by the

Agency under this Article.

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Article 85

Derogation during a public health emergency

1. The decision by the Agency referred to in Article 7(5), first subparagraph, point (e), of

Directive (EU) 2026/…+ shall concern only medicinal products intended for prevention,

diagnosis or treatment of a serious or life-threatening disease or condition which is directly

related to the public health emergency.

2. The decision referred to in paragraph 1 shall include the grounds for providing such

derogation and its duration.

3. At the latest at the date of expiry of the derogation referred to in paragraph 2 of this

Article, the applicant shall submit to the Agency a paediatric investigation plan or an

application for a waiver with a request for agreement in accordance with Article 78(1).

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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Article 86

Modification of a paediatric investigation plan

1. If, following the decision agreeing the paediatric investigation plan, the applicant

encounters such difficulties with its implementation as to render the plan unworkable or no

longer appropriate, the applicant may propose modifications to the plan or request the

Agency to grant a deferral in accordance with Article 83 or a waiver in accordance with

Article 77. The Agency shall, within 90 days, adopt a decision on the basis of the

procedure laid down in Article 89. If appropriate, the Agency may request the applicant to

supplement the particulars and documents submitted. Where the Agency avails itself of

this option, the time limit shall be suspended until such supplementary information has

been provided.

2. If, following the decision agreeing the paediatric investigation plan referred to in

Article 79(1), (2) and (4), or on the basis of the updated paediatric investigation plan

received in accordance with Article 79(3), the Agency, on the base of new scientific

information available, considers that the agreed plan or any of its elements are no longer

appropriate, it shall request, based on scientific grounds, that the applicant propose

modifications to the paediatric investigation plan.

The applicant shall submit the modifications requested within 60 days.

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Within 30 days, the Agency shall review those modifications and adopt a decision on their

refusal or acceptance.

3. Within the time limit referred to in paragraph 2, third subparagraph, the Agency may

request the applicant for additional modifications to the submitted modifications or to

provide supplementary information. In that case, the time limit referred to in that

subparagraph shall be extended by another 30 days. This time limit shall be suspended

until the additional modifications or the supplementary information have been provided.

4. The procedure laid down in Article 89 shall apply for the adoption of decisions by the

Agency under this Article.

Article 87

Detailed arrangements for applications

in relation to paediatric investigation plans, waivers and deferrals

1. In consultation with the Member States, the Commission and interested parties, the Agency

shall draw up the detailed arrangements concerning the format and content for applications

for agreement or modification of a paediatric investigation plan, and requests for waivers

or deferrals in order to be considered valid as well as concerning the operation of the

compliance verification referred to in Article 51 and Article 52(2) of Directive

(EU) 2026/…+, and Article 88 and Article 92(2) of this Regulation.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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2. The detailed arrangement concerning the format and content of applications for agreement

of a paediatric investigation plan mentioned in paragraph 1 shall:

(a) specify which information is to be included in an application for agreement or

modification of a paediatric investigation plan or requests for a waiver in the cases

referred to in Article 77(1);

(b) be adapted to take into account the specificities of:

(i) the adapted procedure for paediatric investigation plans as referred to in

Article 76(2);

(ii) products intended to be developed only for paediatric use;

(iii) products intended to be submitted under the procedure referred to in Article 94.

Article 88

Compliance with the paediatric investigation plan

Where an application for marketing authorisation or variation is submitted in accordance with this

Regulation, the Committee for Medicinal Products for Human Use shall verify whether the

application complies with the requirements laid down in Article 7(5) of Directive (EU) 2026/…+.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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Article 89

Procedure for adopting a decision

in relation to paediatric investigation plans, a waiver or a deferral

1. Decisions of the Agency adopted pursuant to Articles 79, 80, 82, 83, 84 and 86 shall be

supported by scientific conclusions which shall be annexed to those decisions.

2. The Agency shall consult the Committee for Medicinal Products for Human Use when

preparing the scientific conclusions referred to in paragraph 1 of this Article. The

Committee for Medicinal Products for Human Use shall ensure, as necessary, the

appropriate involvement of the relevant scientific expertise through at least one of the

working parties established under Article 157 or may delegate this task to one of those

working parties. The outcome of such consultations shall be annexed to the decisions

referred to in paragraph 1 of this Article, as part of the scientific conclusions of the Agency

which justify the relevant decision.

3. By way of derogation from paragraph 2, the Committee for Medicinal Products for Human

Use shall establish scientific principles to determine the situations where consultation of

that Committee is not required.

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4. The Agency shall transmit its scientific conclusions referred to in paragraph 1 of this

Article to the applicant without delay before the adoption of the decisions pursuant to

Articles 79, 80, 82, 83, 84 and 86. Within 15 days of receipt of the scientific conclusions,

the applicant may submit to the Agency a duly justified request, in writing, for the re-

examination of the scientific conclusions. Within 30 days of receipt of a request the

Agency shall reexamine its scientific conclusions. The reasons for the conclusion reached

following that re-examination shall be part of final scientific conclusions. The time limit

referred to in Articles 79, 80, 84 and 86 will be suspended until the scientific conclusions

become definitive. For the purposes of this paragraph, the Agency shall consult the

Committee for Medicinal Products for Human Use.

If the applicant does not submit a justified request for re-examination in writing

within 15 days of receipt of the scientific conclusions, they shall become definitive.

5. Decisions of the Agency pursuant to Articles 79, 80, 82, 83, 84 and 86 shall be made

public after deletion of any information of a commercially confidential nature.

Article 90

Discontinuation of a paediatric investigation plan

Where an applicant intends to discontinue a paediatric investigation plan that has been agreed in

accordance with Article 79(1), (2) and (4), the applicant shall notify its intention to the Agency. The

notification shall be sent without undue delay and in any case at least six months before the

intended discontinuation and shall include the reasons for discontinuation.

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The Agency shall publish the information contained in the notification after deleting any personal or

commercially sensitive information.

Article 91

Scientific advice for paediatric developments

Any legal or natural person who develops a medicinal product intended for paediatric use or in

utero treatment may, prior to the submission of a paediatric investigation plan and during its

implementation, request advice from the Agency on the design and conduct of the various tests and

studies necessary to demonstrate the quality, safety and efficacy of the medicinal product in the

paediatric population in accordance with Article 144(1), second subparagraph, point (zb).

The Agency shall provide advice under this Article free of charge.

Article 92

Data deriving from a paediatric investigation plan

1. Where a marketing authorisation or a variation of a marketing authorisation, is granted

under this Regulation:

(a) the results of all studies conducted in compliance with an agreed paediatric

investigation plan as referred to in Article 7(5), first subparagraph, point (a), of

Directive (EU) 2026/…+ shall be included in the summary of product characteristics

and, if appropriate, in the package leaflet; or

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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(b) any class or product-specific waiver granted as referred to in Article 7(5), first

subparagraph, points (b) and (c) of Directive (EU) 2026/…+ shall be recorded in the

summary of product characteristics and, if appropriate, in the package leaflet of the

medicinal product concerned.

2. The Commission shall include a statement in the marketing authorisation indicating that

the application complies with the agreed paediatric investigation plan if the following

conditions are met:

(a) the application complies with all the measures contained in the agreed completed

paediatric investigation plan; and

(b) the summary of product characteristics reflects the results of studies conducted in

compliance with that agreed paediatric investigation plan.

Article 93

Variation of marketing authorisations on the basis of paediatric studies

1. Any clinical study which involves the use in the paediatric population of a medicinal

product covered by a centralised or national marketing authorisation and is sponsored by

the marketing authorisation holder, whether or not it is conducted in compliance with an

agreed paediatric investigation plan, shall be submitted to the Agency or to the Member

States in which the medicinal product is authorised within six months of completion of the

studies concerned.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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2. Paragraph 1 shall apply irrespective of whether the marketing authorisation holder intends

to apply for a marketing authorisation of a paediatric indication.

3. When products are authorised in accordance with this Regulation, the Commission may

update the summary of product characteristics and package leaflet, and may vary the

marketing authorisation accordingly.

Article 94

Paediatric use marketing authorisation

1. An application for a paediatric use marketing authorisation shall be submitted in

accordance with Articles 5 and 7 and shall be accompanied by the particulars and

documents necessary to establish quality, safety and efficacy in the paediatric population,

including any specific data needed to support an appropriate formulation, pharmaceutical

form, strength, route of administration and eventual administration device for the

medicinal product, in accordance with the agreed paediatric investigation plan. The

application shall also include the decision of the Agency agreeing the paediatric

investigation plan concerned.

2. Where a medicinal product is or has been authorised in a Member State or in the Union,

data contained in the dossier on that product may, where appropriate, be referred to, in

accordance with Article 30 of this Regulation or Articles 10 and 12 of Directive

(EU) 2026/…+, in an application for a paediatric use marketing authorisation.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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3. The medicinal product in respect of which a paediatric use marketing authorisation is

granted may retain the name of any medicinal product which contains the same active

substance and in respect of which the same marketing authorisation holder has been

granted authorisation for use in adults.

4. Submission of an application for a paediatric use marketing authorisation shall in no way

preclude the right to apply for a marketing authorisation for other therapeutic indications.

Article 95

Rewards for products authorised under the paediatric use marketing authorisation procedure

Where a paediatric use marketing authorisation referred to in Article 94 of this Regulation is

granted and includes the results of all studies conducted in compliance with an agreed paediatric

investigation plan, the medicinal product shall benefit from independent regulatory data protection

and regulatory market protection periods referred to in Articles 83 and 84 of Directive

(EU) 2026/…+.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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Article 96

Paediatric clinical trials

1. The EU database set up pursuant to Article 81 of Regulation (EU) No 536/2014 (the ‘EU

database’) shall include clinical trials that are conducted in third countries and that are:

(a) contained in an agreed paediatric investigation plan;

(b) submitted in accordance with Article 93.

2. For the clinical trials referred to in paragraph 1 of this Article which are conducted in third

countries, the description of the following elements shall be entered into the EU database

referred to in paragraph 1 of this Article prior to the start of the trial by the clinical trial

sponsor, the addressee of the Agency’s decision on a paediatric investigation plan referred

to in Article 79, or by the marketing authorisation holder, as appropriate:

(a) the clinical trial protocol;

(b) the investigational medicinal products used;

(c) the therapeutic indications covered;

(d) details of the clinical trial population.

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Within six months of the end of the clinical trial, irrespective of the outcome thereof, the

clinical trial sponsor, the addressee of the Agency’s decision on a paediatric investigation

plan or the marketing authorisation holder, as appropriate, shall submit a summary of the

results of the clinical trial to the EU database. That summary shall be entered into the

EU database.

If for scientific reasons, it is not possible to submit the summary of the result of the clinical

trial within six months, it shall be submitted to the EU database at the latest

within 12 months of the end of the clinical trial, together with the reasons for the delay.

3. In consultation with the Commission, Member States and interested parties, the Agency

shall draw up guidance on the nature of the information referred to in paragraph 2.

4. On the basis of the experience acquired as a result of the application of this Article, the

Commission may adopt implementing acts in accordance with the examination procedure

referred to in Article 179(2) to amend the details concerning clinical trials conducted in

third countries to be submitted to the EU database pursuant to this Article.

Article 97

European network for paediatric research

1. The Agency shall develop a European network of patient representatives, academics,

medicinal product developers, investigators and centres with expertise in the performance

of studies in the paediatric population (‘European network for paediatric research’).

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2. The objectives of the European network for paediatric research shall be, inter alia, to

discuss priorities in the clinical development of medicinal products for children, in

particular in areas of unmet medical need, to coordinate studies relating to paediatric

medicinal products, to build up the necessary scientific and administrative competences at

Union level, and to avoid unnecessary duplication of studies or testing in the paediatric

population.

Article 98

Incentives for research in medicinal products for children

Paediatric medicinal products shall be eligible for incentives made available by the Union and by

the Member States to support research into, and the development and availability of, paediatric

medicinal products.

Article 99

Fees and Union contribution for paediatric activities

1. Where an application for a paediatric use marketing authorisation is submitted in

accordance with the procedure laid down in Article 94 of this Regulation, the amount of

the reduced fees for the assessment of the application and the maintenance of the

marketing authorisation shall be set in accordance with Article 6 of Regulation

(EU) 2024/568.

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2. The following assessments by the Agency shall be free of charge:

(a) applications for waivers;

(b) applications for deferrals;

(c) applications for paediatric investigation plans;

(d) compliance with the agreed paediatric investigation plan.

3. The Union contribution provided for in Article 161 shall cover the work of the Agency,

including the assessment of paediatric investigation plans, scientific advice and any fee

waivers provided for in this Chapter, and shall support the Agency’s activities under

Articles 96 and 97.

Article 100

Yearly reporting on paediatric activities

At least on an annual basis, the Agency shall make public:

(a) a list of the entities and of the medicinal products that have benefited from any of the

rewards and incentives in this Chapter;

(b) the entities that have failed to comply with any of the obligations in this Chapter;

(c) the number of paediatric investigation plans agreed in accordance with Article 76;

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(d) the number of waivers granted, providing also a summary of their reasons;

(e) a list of deferrals granted;

(f) the number of paediatric investigation plans completed;

(g) the prolongations of the deferrals beyond five years and the detailed reasons provided

referred to in Article 84;

(h) the scientific advice provided for the development of medicinal products intended for

paediatric use, requested in accordance with Article 91.

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Chapter VIII

Pharmacovigilance

Article 101

Pharmacovigilance

1. The obligations of marketing authorisation holders laid down in Article 102 and

Article 103(1), of Directive (EU) 2026/…+ shall apply to marketing authorisation holders

for medicinal products for human use centrally authorised in accordance with this

Regulation.

2. The Agency may impose an obligation on a holder of a centralised marketing authorisation

to operate a risk management system, as referred to in Article 102(4), point (c) of Directive

(EU) 2026/…+, if there are concerns about the risks affecting the benefit-risk balance of an

authorised medicinal product. In that context, the Agency shall also oblige the marketing

authorisation holder to submit a risk management plan for the risk-management system

that they intend to introduce for the medicinal product concerned.

The obligation shall be duly justified, notified in writing, and shall include the timeframe

for submission of the risk-management plan.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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3. The Agency shall provide the marketing authorisation holder with an opportunity to submit

written observations in response to the imposition of the obligation referred to in

paragraph 2 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.

On the basis of the written observations submitted by the marketing authorisation holder,

the Agency shall review its opinion.

4. Where the opinion of the Agency confirms the obligation referred to in paragraph 2 of this

Article, and unless the Commission refers the opinion back to the Agency for further

consideration, the Commission shall vary the marketing authorisation in accordance with

the procedure laid down in Article 14, to include:

(a) that obligation as a condition of the marketing authorisation;

(b) the measures to be taken as part of the risk management system as a condition of the

marketing authorisation referred to in Article 13(4), point (e).

In the case of point (a) of the first subparagraph, the marketing authorisation holder shall

update the risk management system accordingly.

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Article 102

Safety announcements

The obligations of marketing authorisation holders laid down in Article 107(1) and (2) of Directive

(EU) 2026/…+, and the obligations of the Member States, the Agency and the Commission laid

down in paragraphs 3 and 4 of that Article shall apply to the safety announcements referred to in

Article 144(1), second subparagraph, point (g), of this Regulation concerning medicinal products

for human use authorised in accordance with this Regulation.

Article 103

Eudravigilance database

1. The Agency shall, in collaboration with the Member States and the Commission, set up

and maintain a database and data processing network (‘Eudravigilance database’) to collate

pharmacovigilance information regarding medicinal products authorised in the Union and

to allow competent authorities of the Member States or the Agency to access that

information simultaneously and to share it.

The Eudravigilance database shall include pharmacovigilance information with regard to

medicinal products made available for compassionate use as referred to in Article 27 or

through early access schemes.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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The Eudravigilance database shall contain information on suspected adverse reactions in

human beings arising from use of the medicinal product within the terms of the marketing

authorisation, as well as from uses outside the terms of the marketing authorisation, and on

suspected adverse reactions occurring in the course of post-authorisation studies relating to

the medicinal product or to occupational exposure to that medicinal product.

2. The Agency shall, in collaboration with the Member States and the Commission, draw up

the functional specifications for the Eudravigilance database, together with a timeframe for

their implementation.

The Agency shall prepare an annual report on the Eudravigilance database and send it to

the European Parliament, the Council and the Commission.

Any substantial change to the Eudravigilance database and the functional specifications

shall take into account the recommendations of the Pharmacovigilance Risk Assessment

Committee.

The Eudravigilance database shall be fully accessible to the competent authorities of the

Member States and to the Agency and the Commission. It shall also be accessible to

marketing authorisation holders and applicants to the extent necessary for them to comply

with their pharmacovigilance obligations.

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The Agency shall ensure that healthcare professionals and the public have appropriate

levels of access to the Eudravigilance database, and that personal data are protected in

accordance with Union law. The Agency shall work together with all stakeholders,

including research institutions, healthcare professionals, as well as patient and consumer

organisations in order to define the ‘appropriate level of access’ for healthcare

professionals and the public to the Eudravigilance database.

The data held on the Eudravigilance database shall be made publicly available in an

aggregated and anonymised format together with an explanation of how to interpret the

data.

3. The Agency shall, in collaboration either with the marketing authorisation holder or with

the Member State that submitted an individual suspected adverse reaction report to the

Eudravigilance database, be responsible for operating procedures that ensure the quality

and integrity of the information collected in the Eudravigilance database.

4. Individual suspected adverse reaction reports and follow-ups submitted to the

Eudravigilance database by marketing authorisation holders and applicants shall be

transmitted electronically, upon receipt, to the competent authority of the Member State

where the reaction occurred.

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Article 104

Forms for reporting suspected adverse reactions

The Agency shall, in collaboration with the Member States, develop standard web-based structured

forms for the reporting of suspected adverse reactions by healthcare professionals and patients in

accordance with Article 110 of Directive (EU) 2026/…+.

Article 105

Periodic safety update reports repository

The Agency shall, in collaboration with the competent authorities of the Member States and the

Commission, set up and maintain a repository for periodic safety update reports (the ‘repository’)

and the corresponding assessment reports regarding medicinal products authorised in the Union so

that they are fully and permanently accessible to the Commission, the competent authorities of the

Member States, the Pharmacovigilance Risk Assessment Committee, the Committee for Medicinal

Products for Human Use and the coordination group for decentralised and mutual recognition

procedures referred to in Article 40 of Directive (EU) 2026/…+ (the ‘coordination group referred to

in Article 40 of Directive (EU) 2026/…+’).

The Agency shall, in collaboration with the competent authorities of the Member States and the

Commission, and after consultation with the Pharmacovigilance Risk Assessment Committee, draw

up the functional specifications for the repository.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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Any substantial change to the repository and the functional specifications shall always take into

account the recommendations of the Pharmacovigilance Risk Assessment Committee.

Article 106

European medicines web-portal

1. The Agency shall, in collaboration with the Member States and the Commission, set up

and maintain a European medicines web-portal for the dissemination of information on

medicinal products authorised or to be authorised in the Union. That web-portal shall be

easily accessible and user-friendly. By means of that portal, the Agency shall make public

the following:

(a) the names of members of the committees referred to in Article 148, points (d)

and (e), of this Regulation, and the members of the coordination group referred to in

Article 40 of Directive (EU) 2026/…+, together with their professional qualifications

and with the declarations referred to in Article 154(2) of this Regulation;

(b) agendas and minutes from each meeting of the committees referred to in Article 148,

points (d) and (e), of this Regulation, and of the coordination group referred to in

Article 40 of Directive (EU) 2026/…+ as regards pharmacovigilance activities;

(c) the risk management plans for medicinal products authorised in accordance with this

Regulation;

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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(d) information about how to report to competent authorities of the Member States

suspected adverse reactions to medicinal products and the standard structured forms

referred to in Article 104 for their web-based reporting by patients and healthcare

professionals, including links to national websites;

(e) Union reference dates and frequency of submission of periodic safety update reports

established in accordance with Article 112 of Directive (EU) 2026/…+;

(f) protocols and public abstracts of results of the post-authorisation safety studies

referred to in Articles 122 and 124 of Directive (EU) 2026/…+;

(g) the initiation of the procedure laid down in Article 57 of this Regulation, and

Articles 98, 118, 119 and 120 of Directive (EU) 2026/…+, the active substances or

medicinal products concerned and the issue being addressed, any public hearings

pursuant to that procedure and information on how to submit information and to

participate in public hearings;

(h) conclusions of assessments, recommendations, opinions, approvals and decisions

taken by the Agency and its scientific committees under this Regulation and

Directive (EU) 2026/…+;

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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(i) conclusions of assessments, recommendations, opinions, approvals and decisions

taken by the coordination group referred to in Article 40 of Directive (EU) 2026/…+,

the competent authorities of the Member States and the Commission in the

framework of the procedures set out in Articles 17, 109, 110 and 111 of this

Regulation and of Chapter IX, Sections 3 and 7, of Directive (EU) 2026/…+.

2. In the development and review of the European medicines web portal, the Agency shall

consult relevant stakeholders, including patient and consumer groups, healthcare

professionals, not-for-profit entities and industry representatives.

Article 107

European register of studies for environmental risk assessment

The Agency shall, in collaboration with the Member States and the Commission, set up and

maintain a register of results of environmental risk assessment studies conducted for the purpose of

supporting an environmental risk assessment for medicinal products authorised in the Union, unless

relevant data are made public in accordance with Regulation (EU) 2025/2455 of the European

Parliament and of the Council41.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)). 41 Regulation (EU) 2025/2455 of the European Parliament and of the Council

of 26 November 2025 establishing a common data platform on chemicals, laying down rules

to ensure that the data contained in it are findable, accessible, interoperable and reusable and

establishing a monitoring and outlook framework for chemicals (OJ L, 2025/2455,

12.12.2025, ELI: http://data.europa.eu/eli/reg/2025/2455/oj).

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Information in the register referred to in the first paragraph shall be publicly available, unless

restrictions are necessary to protect commercially confidential information. For the purpose of

setting up that register, the Agency may request marketing authorisation holders and competent

authorities to submit results of any such study already completed for products authorised in the

Union by … [24 months from the date of application of this Regulation].

Article 108

Literature monitoring

1. The Agency shall monitor selected medical literature for reports of suspected adverse

reactions to medicinal products containing certain active substances. It shall publish the list

of active substances being monitored and the medical literature subject to this monitoring.

2. The Agency shall enter into the Eudravigilance database relevant information from the

selected medical literature.

3. The Agency shall, in consultation with the Commission, Member States and interested

parties, draw up a detailed guide regarding the monitoring of medical literature and the

entry of relevant information into the Eudravigilance database.

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Article 109

Monitoring of safety of medicinal products

1. The obligations of marketing authorisation holders and of Member States laid down in

Articles 108 and 110 of Directive (EU) 2026/…+ shall apply to the recording and reporting

of suspected adverse reactions for medicinal products for human use authorised in

accordance with this Regulation.

2. The obligations of marketing authorisation holders laid down in Article 111 of Directive

(EU) 2026/…+ and the procedures under Articles 111 and 112 of that Directive shall apply

to the submission of periodic safety update reports, the establishment of Union reference

dates and changes to the frequency of submission of periodic safety update reports for

medicinal products for human use authorised in accordance with this Regulation.

The provisions applicable to the submission of periodic safety update reports laid down in

Article 112(2), second subparagraph, of that Directive shall apply to marketing

authorisation holders of marketing authorisations which were granted before 2 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 until such time as another

frequency or other dates of submission of the reports are laid down in the marketing

authorisation or are determined in accordance with Article 112 of that Directive.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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3. The assessment of the periodic safety update reports shall be carried out by a rapporteur

appointed by the Pharmacovigilance Risk Assessment Committee. The rapporteur shall

closely collaborate with the rapporteur appointed by the Committee for Medicinal Products

for Human Use or the reference Member State for the medicinal products concerned.

Within 60 days of receipt of the periodic safety update report, the rapporteur shall prepare

an assessment report and shall send it to the Agency and to the members of the

Pharmacovigilance Risk Assessment Committee. The Agency shall send the report to the

marketing authorisation holder.

Within 30 days of receipt of the assessment report, the marketing authorisation holder and

the members of the Pharmacovigilance Risk Assessment Committee may submit

comments to the Agency and to the rapporteur. Where the report includes questions

addressed to the marketing authorisation holder, the marketing authorisation holder shall

provide answers within those 30 days.

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Within 15 days of receipt of the comments referred to in the third subparagraph of this

paragraph, the rapporteur shall update the assessment report taking into account any

comments received, 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 shall issue a recommendation. That

recommendation shall mention any divergent positions and specify the grounds on which

they are based. The Agency shall include the adopted assessment report and the

recommendation in the repository set up under Article 105, and forward both to the

marketing authorisation holder.

4. In the case of an assessment report that recommends any action concerning the marketing

authorisation, the Committee for Medicinal Products for Human Use shall, within 30 days

of receipt of the report by the Pharmacovigilance Risk Assessment Committee, consider

the report and adopt an opinion on the maintenance, variation, suspension or revocation of

the marketing authorisation concerned, including a timetable for the implementation of any

necessary regulatory action as stated in that opinion. Where this opinion of the Committee

for Medicinal Products for Human Use differs from the recommendation of the

Pharmacovigilance Risk Assessment Committee, 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.

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Where the opinion states that regulatory action concerning the marketing authorisation is

necessary, the Commission shall adopt a decision, by means of implementing acts, to vary,

suspend or revoke the marketing authorisation in accordance with Article 14. Where the

Commission adopts such a decision, it may also adopt a decision addressed to the Member

States pursuant to Article 59.

5. In the case of a single assessment of periodic safety update reports concerning more than

one marketing authorisation in accordance with Article 114(1) of Directive (EU) 2026/…+

which includes at least one marketing authorisation granted in accordance with this

Regulation, the procedure laid down in Articles 114 and 116 of that Directive shall apply.

6. The final recommendations, opinions and decisions referred to in paragraphs 3, 4 and 5 of

this Article shall be made public by means of the European medicines web-portal referred

to in Article 106.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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Article 110

Agency pharmacovigilance related activities

1. The Agency shall, in collaboration with the Member States, take the following measures in

relation to medicinal products for human use authorised in accordance with this

Regulation:

(a) monitor the outcome of risk minimisation measures contained in risk management

plans and of conditions referred to in Article 13(4), points (d) to (i), or in

Article 21(1), first subparagraph, points (a), (b) and (c), and in Article 19(1), in

Article 20, and in Article 34(2) and (3);

(b) assess updates to the risk management system;

(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.

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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 Article 98 and Articles 118 to 120 of Directive (EU) 2026/…+ or

Articles 49 and 57 of this Regulation.

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.

Article 111

Non-interventional post-authorisation safety studies

1. For non-interventional post-authorisation safety studies concerning medicinal products for

human use authorised in accordance with this Regulation which have been imposed in

accordance with Articles 14 and 21 of this Regulation, the procedure laid down in

Article 121(3) to (7), Articles 122, 123, 124 and Article 125(1) of Directive (EU) 2026/…+

shall apply.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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2. Where, in accordance with the procedure referred to in paragraph 1 of this Article, the

Pharmacovigilance Risk Assessment Committee issues recommendations for the variation,

suspension or revocation of the marketing authorisation, the Committee on Medicinal

Products for Human Use shall adopt an opinion taking into account the recommendation,

and the Commission shall adopt a decision in accordance with Article 14.

Where an opinion of the Committee for Medicinal Products for Human Use differs from

the recommendation of the Pharmacovigilance Risk Assessment Committee, 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.

Article 112

Exchange of information with other organisations

1. The Agency shall collaborate with the World Health Organization in matters of

pharmacovigilance and shall take the steps necessary to promptly submit to it appropriate

and adequate information regarding the measures taken in the Union which could have a

bearing on public health protection in third countries.

The Agency shall make promptly available all suspected adverse reaction reports occurring

in the Union to the World Health Organization.

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2. The Agency and the European Union Drugs Agency established by Regulation

(EU) 2023/1322 of the European Parliament and of the Council42 shall exchange

information that they receive on the abuse of medicinal products including information

related to illicit drugs.

Article 113

International collaboration

At the request of the Commission, the Agency shall participate in collaboration with the Member

States in international harmonisation and standardisation of technical measures in relation to

pharmacovigilance.

Article 114

Cooperation with Member States

The Agency and the Member States shall cooperate to continuously develop pharmacovigilance

systems capable of achieving high standards of public health protection for all medicinal products,

regardless of the routes of marketing authorisation, including the use of collaborative approaches, to

maximise use of resources available within the Union.

42 Regulation (EU) 2023/1322 of the European Parliament and of the Council of 27 June 2023

on the European Union Drugs Agency (EUDA) and repealing Regulation

(EC) No 1920/2006 (OJ L 166, 30.6.2023, p. 6, http://data.europa.eu/eli/reg/2023/1322/oj).

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Article 115

Reports on pharmacovigilance tasks

The Agency shall perform regular independent audits of its pharmacovigilance tasks and shall

report the results to the Management Board on a two-yearly basis. The results of those audits shall

be published by the Agency.

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Chapter IX

Regulatory sandboxes

Article 116

Regulatory sandbox

1. The Commission may establish on a case-by-case basis a regulatory sandbox in accordance

with this Chapter, where all of the following conditions are met:

(a) it is not possible to develop and authorise a medicinal product or a category of

medicinal products in full compliance with the requirements applicable to medicinal

products laid down in this Regulation and Directive (EU) 2026/…+ due to methods

related to the medicinal product or due to the scientific or technical characteristics

inherent to the medicinal product, for which certain targeted and technical

adaptations to the requirements laid down in this Regulation and Directive

(EU) 2026/…+ are considered indispensable;

(b) based on available scientific evidence, the methods or characteristics referred to in

point (a) are likely to positively and distinctively contribute to the quality, safety or

efficacy of the medicinal product or category of medicinal products as provided for

in this Regulation and Directive (EU) 2026/…+ or provide a major contribution to

patient access to prevention, diagnosis or treatment, or to patient care.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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2. A regulatory sandbox sets out a controlled regulatory framework consisting of specific

requirements and may allow certain targeted technical adaptations that are necessary

during the development, authorisation and placing on the market of a medicinal product or

category of medicinal productsreferred to in paragraph 1 of this Article under the

conditions set out in this Chapter. The regulatory sandbox may allow targeted technical

adaptations to certain requirements of this Regulation, Directive (EU) 2026/…+ or

Regulation (EC) No 1394/2007 that are necessary for the purpose of assessing whether an

authorisation can be granted for a medicinal product referred to in paragraph 1 of this

Article, and to the life cycle management of that medicinal product in accordance with

Article 117 of this Regulation, and which ensure that the principles of quality, safety and

efficacy laid down in this Regulation and Directive (EU) 2026/…+ are respected.

A regulatory sandbox shall operate under direct supervision of the competent authorities of

the Member States concerned with a view to ensuring compliance with the requirements of

this Regulation and, where relevant, of other acts of Union and national law concerned by

the regulatory sandbox in relation to activities that take place on their territory. Any non-

compliance with the detailed conditions laid down in the decision referred to in

paragraph 6 or any risks to health and to environment identified shall be notified without

delay to the Commission and to the Agency.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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3. The Agency shall monitor the field of emerging medicinal products and may request

information and data from the competent authorities of the Member States, marketing

authorisation holders, developers, independent experts and researchers, and representatives

of healthcare professionals and of patients and may engage with them in preliminary

discussions.

4. Where, based on available scientific evidence, the Agency considers it appropriate to

establish a regulatory sandbox for medicinal products which are likely to fall within the

scope of this Regulation and meet the conditions laid down in paragraph 1, it shall provide

a recommendation to the Commission, following appropriate consultations, including

consultation with the competent authorities of the Member States or, where appropriate,

other competent authorities responsible for the establishment of other relevant regulatory

frameworks. The recommendation of the Agency shall list eligible medicinal products or

category of medicinal products and include a recommended regulatory sandbox plan

referred to in paragraph 5.

The Agency shall not recommend to establish a regulatory sandbox for a medicinal product

that is already advanced in its development programme.

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5. The Agency shall develop the regulatory sandbox plan based on data submitted by

developers of eligible medicinal products. The regulatory sandbox plan shall provide a

clinical, scientific and regulatory justification for the necessity to establish a regulatory

sandbox, including the identification of the requirements of this Regulation, Directive

(EU) 2026/…+ and Regulation (EC) No 1394/2007 whose adaptations are considered

indispensable from a technical and scientific viewpoint for the development and

authorisation of such medicinal products while ensuring that the principles of quality,

safety and efficacy laid down in this Regulation and Directive (EU) 2026/…+ are

respected. The regulatory sandbox plan shall include a proposed timeline for the duration

of the regulatory sandbox. Where appropriate, the regulatory sandbox plan shall provide

recommendations for alternative or mitigation measures. Where appropriate, the Agency

shall also recommend measures in order to mitigate any possible distortion of market

conditions as a consequence of establishing a regulatory sandbox. The Agency shall levy a

fee for activities under this Article.

6. The Commission shall, by means of implementing acts, adopt a decision establishing a

regulatory sandbox for the eligible medicinal products or category of medicinal products

taking into account the recommendation of the Agency and the regulatory sandbox plan

pursuant to paragraph 4 of this Article. Those implementing acts shall be adopted in

accordance with the examination procedure referred to in Article 179(2).

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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7. A decision establishing a regulatory sandbox under paragraph 6 shall be limited in time

and shall lay down detailed conditions for its implementation. It shall include:

(a) the final regulatory sandbox plan, taking into account the recommended regulatory

sandbox plan of the Agency, specifying the specific requirements and the targeted

technical adaptations, in accordance with paragraphs 2 and 5 of this Article, to the

requirements of this Regulation and of Directive (EU) 2026/…+ and Regulation

(EC) No 1394/2007;

(b) the duration of the regulatory sandbox and its expiry taking into account the time

needed for development, and, if applicable, for obtaining a marketing authorisation

and for placing on the market the medicinal products concerned;

(c) the participants of the regulatory sandbox.

8. The Commission may, by means of implementing acts, suspend or revoke a decision

establishing a regulatory sandbox at any time in any of the following cases:

(a) the requirements and conditions laid down in paragraphs 6 and 7 are no longer met;

(b) it is appropriate to protect public health, or to avoid serious risks for the

environment.

Those implementing acts shall be adopted in accordance with the examination procedure

referred to in Article 179(2).

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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Where the Agency receives information that one of the cases referred to in the first

subparagraph may be fulfilled, it shall inform the Commission accordingly.

9. Where, after the decision to establish the regulatory sandbox in accordance with

paragraph 6 of this Article, risks to public health are identified but these risks can be fully

mitigated by laying down supplementary conditions, the Commission may, after

consultation with the Agency, amend its decision referred to in paragraph 6 of this Article

and, where applicable, revoke a suspension decision adopted under paragraph 8 of this

Article by means of implementing acts. The Commission may also prolong the duration of

a regulatory sandbox by means of implementing acts. Those implementing acts shall be

adopted in accordance with the examination procedure referred to in Article 179(2).

Article 117

Medicinal products developed under a regulatory sandbox

1. When authorising a clinical trial for a medicinal product covered by a regulatory sandbox,

Member States shall take the regulatory sandbox plan referred to in Article 116(5) into

consideration.

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2. A medicinal product developed under a regulatory sandbox shall be placed on the market

only when authorised in accordance with Article 14, 19 or 20. Such authorisation may be

granted only if the benefit-risk balance of the medicinal product is favourable. The initial

validity of such authorisation shall not exceed the duration of the regulatory sandbox as

specified in the implementing act referred to in Article 116(6) and (7). The authorisation

may be renewed at the request of the marketing authorisation holder in accordance with

Article 18. The marketing authorisation holder shall submit the renewal application to the

Agency at least nine months before the validity of the marketing authorisation expires.

3. Where necessary, the marketing authorisation adopted in accordance with Article 14, 19

or 20 of a medicinal product developed under the regulatory sandbox shall specify in its

conditions the adaptations that apply to the specific medicinal product pursuant to the

decision referred to in Article 116(7). Each adaptation specified in those conditions shall

be limited to what is apt and strictly necessary to attain the objectives pursued and duly

justified. It shall not exceed the adaptations specified in the decision referred to in

Article 116(6) and (7) establishing the regulatory sandbox concerned.

4. For medicinal products developed under a regulatory sandbox for which a marketing

authorisation has been granted in accordance with paragraph 2 and where appropriate

paragraph 3, the summary of product characteristics and the package leaflet shall indicate

that the medicinal product has been developed under a regulatory sandbox. This

requirement shall apply for the duration of the regulatory sandbox.

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5. Without prejudice to Article 198 of Directive (EU) 2026/…+, the Commission shall

suspend or revoke a marketing authorisation granted in accordance with paragraph 2 of this

Article, where the regulatory sandbox has been suspended or revoked in accordance with

Article 116(8) of this Regulation.

6. The Commission shall vary the marketing authorisation to take account of the temporary

measures taken in accordance with Article 118.

7. In addition to the situations referred to in Articles 57 and 58, where the Agency concludes

that a holder of a marketing authorisation granted under a regulatory sandbox has failed to

comply with the specific conditions laid down in the marketing authorisation in accordance

with paragraph 3 of this Article, the Agency shall inform the Commission accordingly. The

Commission shall adopt a decision to vary, suspend or revoke that marketing authorisation

in accordance with the procedure laid down in Article 14.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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Article 118

General regulatory sandbox provisions

1. The regulatory sandboxes shall not affect the supervisory and corrective powers of the

competent authorities of the Member States and the Agency. In cases where risks to public

health or safety concerns associated with the use of medicinal products developed under a

regulatory sandbox are identified, competent authorities of the Member States and the

Agency shall take immediate and adequate temporary measures in order to suspend or

restrict their use and inform the Commission and the Agency in accordance with

Article 116(2).

Where it is not possible to take such measures or where such measures prove to be

ineffective, the development and testing process shall be suspended without delay until the

risks referred to in the first subparagraph of this paragraph have been effectively mitigated.

In the absence of such effective mitigation, the Agency shall recommend to the

Commission to suspend or revoke a regulatory sandbox in accordance with Article 116(8).

If applicable, the marketing authorisation provided for in accordance with Article 117 shall

be suspended or revoked accordingly.

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2. Participants in the regulatory sandbox, including the marketing authorisation holder of the

medicinal product concerned, shall remain liable under applicable Union and national law

for any harm inflicted on third parties as a result of the development and testing taking

place under the regulatory sandbox. They shall inform the Agency without undue delay of

any information which might entail the amendment of the regulatory sandbox or of any

concerns relating to the quality, safety or efficacy of medicinal products developed under a

regulatory sandbox.

3. The detailed arrangements for, and the conditions of, the operation of the regulatory

sandboxes, including the eligibility criteria and the procedure for the application for a

regulatory sandbox, the selection of eligible medicinal products, the participation in a

regulatory sandbox and exiting from it, and the rights and obligations of the participants,

shall be provided for by means of implementing acts. Those implementing acts shall be

adopted in accordance with the examination procedure referred to in Article 179(2).

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4. The Agency shall, on the basis of input from Member States, submit annual reports to the

Commission, the European Parliament and the Council on the results of the

implementation of regulatory sandboxes, including a breakdown on the number of

regulatory sandboxes granted, trends on medicinal products eligible for a regulatory

sandbox, good practices, difficulties encountered, lessons learnt, reflections on possible

future adaptations to the regulatory framework and recommendations on their

establishment and, where relevant, on the application of this Regulation and other Union

legal acts applicable within the regulatory sandbox. Those reports as well as lay summaries

shall be made publicly available by the Commission.

5. The Commission shall review the annual reports referred to in paragraph 4 of this Article

and, where appropriate, submit legislative proposals with a view to amending the legal acts

referred to in Article 116(2) of this Regulation or adopt delegated acts in accordance with

Article 31 of Directive (EU) 2026/…+.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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Chapter X

Availability and security of supply of medicinal products

SECTION 1

MONITORING AND MANAGEMENT OF SHORTAGES AND CRITICAL SHORTAGES

Article 119

Exemptions from the application of provisions of this Chapter

1. Insofar as obligations applicable to marketing authorisation holders and other relevant

actors under Articles 120(4), 121(3), 124(3), 125(7), 133(5), 135, Article 136(2),

first subparagraph, point (c), and Article 136(4), point (c), imply a risk to national security

and defence, Member States may exempt those marketing authorisation holders and other

actors from those obligations where:

(a) the medicinal products concerned are manufactured for military and defence use

only; or

(b) the specific batches of medicinal products concerned are supplied for military and

defence purposes.

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2. Member States may exempt competent authorities within their territory from the

obligations under Articles 125 and 133 to communicate information related to the

medicinal products referred to in paragraph 1 of this Article insofar as such obligations

imply a risk to national security and defence.

3. A Member State may exempt a marketing authorisation holder in possession of a

marketing authorisation for a medicinal product authorised in that Member State in

accordance with Article 208 of Directive (EU) 2026/…+ from complying with the

obligations laid down in Articles 120, 121, 123, 130, 134 and 139 of this Regulation.

4. Member States shall notify the Commission of the use of the exemptions referred to in this

Article without undue delay.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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Article 120

Marketing authorisation holder notifications

1. Without prejudice to the provisions on notification referred to in Article 25 of this

Regulation and Article 206 of Directive (EU) 2026/…+, the holder of a national marketing

authorisation for a medicinal product and the holder of a centralised marketing

authorisation for a medicinal product (both referred to in this Chapter as ‘the marketing

authorisation holder’) shall notify the competent authority of the Member State on whose

market that medicinal product has been placed and, in addition, for a centrally authorised

medicinal product, the Agency (both referred to in this Chapter as ‘the competent authority

concerned’) of the following, and explain the reasons therefor:

(a) any decision to permanently cease the marketing of a medicinal product in that

Member State no less than 12 months before the last supply of that medicinal product

into the market of that Member State by the marketing authorisation holder;

(b) any request to withdraw the marketing authorisation for that medicinal product

authorised in that Member State no less than 12 months before the last supply of that

medicinal product into the market of that Member State by the marketing

authorisation holder;

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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(c) any decision to temporarily suspend the marketing of a medicinal product in that

Member State as soon as possible and no less than six months before the start of the

temporary suspension of supply of that medicinal product into the market of that

Member State by the marketing authorisation holder;

(d) any temporary disruption in supply of a medicinal product in that Member State of

an expected duration of more than two weeks based on the demand forecast of the

marketing authorisation holder, as soon as possible and in any event no less than

six months before the start of such temporary disruption of supply.

By way of derogation from point (d) of the first subparagraph, marketing authorisation

holders shall notify the temporary disruption in supply of a medicinal product in that

Member State as soon as they become aware of such temporary disruption where

exceptional circumstances directly related to the supply disruption, which shall be duly

identified and substantiated to the competent authority concerned, prevented the marketing

authorisation holders from complying with the deadline specified therein.

The marketing authorisation holder shall make the notification electronically and in the

formats made available by the Agency. The Agency shall consult the Member States when

drawing up the formats.

2. For the purposes of the notifications made in accordance with paragraph 1,

first subparagraph, points (a), (b) and (c), the marketing authorisation holder shall provide

the information set out in Part I of Annex IV.

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For the purposes of the notifications made in accordance with paragraph 1,

first subparagraph, point (d), the marketing authorisation holder shall provide the

information set out in Part III of Annex IV.

The marketing authorisation holder shall immediately notify the competent authority

concerned, as appropriate, of any relevant changes to the information provided in

accordance with this paragraph.

3. The Commission is empowered to adopt delegated acts in accordance with Article 181 in

order to amend Annex IV as regards the information to be provided in the event of a

temporary disruption of supply, in the event of a temporary suspension or of a permanent

cessation of the marketing of a medicinal product, or of a withdrawal of the centralised or

national marketing authorisation of a medicinal product, or the information to be provided

on the content of the shortage prevention plan referred to in Article 121.

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4. Where the marketing authorisation holder intends to withdraw the marketing authorisation

for, or permanently cease to market in one or more Member States where the marketing

authorisation is valid, a critical medicinal product identified by the competent authority of

a Member State pursuant to Article 133(1) and included on the Union long list adopted by

the Commission pursuant to paragraph 2 of that Article, an additional medicinal product

identified in accordance with Article 132(4) or a priority antimicrobial pursuant to

Article 41(3), the marketing authorisation holder shall, prior to the notification referred to

in paragraph 1, first subparagraph, point (a) or (b) of this Article, as applicable:

(a) publish a declaration of its intention to offer to transfer the marketing authorisation

or its intention to issue a letter of access as referred to in Article 15 of Directive

(EU) 2026/…+ via a dedicated webpage on its website and communicate the

electronic link to such webpage to the competent authority of the Member State and

the Agency; the Agency shall compile and publish a list of such electronic links;

(b) offer, on reasonable terms, to transfer the marketing authorisation or issue a letter of

access to a third party that has declared its intention to place on the market that

medicinal product or to allow the use of the pharmaceutical non-clinical and clinical

documents contained in the file of that medicinal product for the purpose of

submitting an application in accordance with Article 15 of Directive (EU) 2026/…+;

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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(c) inform the competent authority concerned on the outcome of the negotiations with

the third party or parties.

For the purposes of this paragraph, the marketing authorisation holder shall provide as part

of the notification referred to in paragraph 1, first subparagraph, points (a) and (b),

information proving that they have taken steps to offer to transfer the marketing

authorisation or to issue a letter of access to third parties on reasonable terms.

Article 121

The shortage prevention plan

1. The marketing authorisation holder shall establish and maintain an up-to-date shortage

prevention plan for medicinal products subject to medical prescription and for medicinal

products identified in accordance with Article 132(4). That plan shall include the

information specified in Part V of Annex IV and shall be established in accordance with

the guidance drawn up by the Agency pursuant to paragraph 2 of this Article.

2. The Agency, in collaboration with the working party referred to in Article 125(1),

point (d), shall draw up guidance for marketing authorisation holders for the shortage

prevention plan. That guidance shall, in particular, indicate the relevant type and detail of

information for the shortage prevention plan according to the different level of risk,

including descriptions of the relevant shortage management measures.

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3. Whenever a medicinal product is subject to a shortage prevention plan in accordance with

this Article, the competent authority of the Member State and the Agency at any time, or

the Commission in accordance with Article 132(3), may request the marketing

authorisation holder to submit that plan to it at any time. The marketing authorisation

holder shall submit that plan within two days of receipt of such request.

4. Where relevant, the marketing authorisation holder shall update the shortage prevention

plan to include additional information, taking into account recommendations of the –

MSSG, established by Article 3(1) of Regulation (EU) 2022/123, in accordance with

Articles 128(3) and 138(1) of this Regulation.

Article 122

Shortage monitoring by the competent authority of the Member State or the Agency

1. Based on the reports referred to in Article 124(1) and Article 125(1), point (d), information

referred to in Article 123, Article 124(3) and Article 125 and the notification made

pursuant to Article 120(1), first subparagraph, points (a) to (d), and Article 124(2), the

competent authority concerned shall continuously monitor any expected or actual shortage

of the medicinal products which are the subject of those reports. In addition, the competent

authority concerned may use information contained in the repositories referred to in

Article 70(2), second subparagraph, point (e), of Directive (EU) 2026/…+ or in a national

repository.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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The Agency shall carry out that monitoring in collaboration with the competent authority

of the Member State where those medicinal products are authorised under this Regulation

or when coordinated Union action is required.

2. For the purposes of paragraph 1 of this Article, the competent authority concerned may

request any information from the marketing authorisation holder. In particular, it may

request the marketing authorisation holder to submit a shortage mitigation plan in

accordance with Article 123(2), a risk assessment of impact of suspension, cessation or

withdrawal in accordance with Article 123(3), or the shortage prevention plan referred to

in Article 121. The competent authority concerned shall set a deadline for the submission

of the information requested.

3. For the purposes of paragraph 1 of this Article, the Agency may request additional

information from the competent authority of a Member State, through the working party

referred to in Article 125(1), point (d). The Agency may set a deadline for the submission

of the information requested.

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Article 123

Obligations on the marketing authorisation holder

1. The marketing authorisation holder shall:

(a) submit the information requested in accordance with Article 122(2), Article 129(2),

first subparagraph, point (b), or Article 121(3) to the competent authority concerned,

without undue delay, using the tools, methods of and criteria for the monitoring and

reporting established pursuant to Article 127(4), point (a), by the deadline set by that

competent authority;

(b) provide updates to the information provided in accordance with point (a), where

necessary;

(c) justify any failure to provide any of the requested information;

(d) where necessary, submit a request to the competent authority concerned for an

extension of the deadline set by that competent authority in accordance with

point (a); and

(e) indicate whether the information provided in accordance with point (a) contains any

commercially confidential information, identify the relevant parts of that information

having a commercially confidential nature and explain why that information is of

such nature.

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2. To prepare the shortage mitigation plan referred to in Article 122(2), the marketing

authorisation holder shall include the information specified in Part IV of Annex IV and

take into account the guidance drawn up by the Agency in accordance with Article 127(4),

point (b).

3. To prepare a risk assessment of the impact of suspension, cessation or withdrawal referred

to in Article 122(2), the marketing authorisation holder shall include information set out in

Part II of Annex IV and take into account the guidance drawn up by the Agency in

accordance with Article 127(4), point (b).

4. In the case of medicinal products that are not subject to the obligation of preparing a

shortage prevention plan, the marketing authorisation holder shall carry out a regular

documented risk assessment of potential supply chain risks and, where necessary, take

mitigating measures.

The competent authority of the Member State or the Agency may request the marketing

authorisation holder to submit that documented risk assessment at any time. The marketing

authorisation holder shall submit that documented risk assessment within two days of

receipt of such request.

5. The marketing authorisation holder shall be responsible for providing correct, not

misleading, and complete information as requested by the competent authority concerned.

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6. The marketing authorisation holder shall cooperate with the competent authority of the

Member State or the Agency and disclose, on its own motion, any relevant information to

that authority and update the information as soon as new information becomes available.

Article 124

Obligations on other actors

1. Wholesale distributors, and natural or legal persons that are authorised or entitled to supply

to the public medicinal products authorised to be placed on the market of a Member State

pursuant to Article 6 of Directive (EU) 2026/…+, may report a shortage of a given

medicinal product to the competent authority of the Member State concerned.

2. For centrally or nationally authorised medicinal products, Member States may require that

a wholesale distributor who is not the marketing authorisation holder and who intends to

distribute a medicinal product in another Member State provide the competent authority of

the source Member State with information about that intention. That information shall

include:

(a) the name of the medicinal product and authorisation number;

(b) active substances;

(c) pharmaceutical form;

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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(d) strength;

(e) pack size;

(f) the quantity of the medicinal product which will be obtained from the source

Member State.

Based on the information provided by the wholesale distributor and on the information

available pursuant to this Chapter, the source Member State may take measures to prevent

or to mitigate shortages in the source Member State. The source Member State shall notify

the Agency of any measures taken pursuant to in this subparagraph.

The information requirement referred to in the first subparagraph and measures referred to

in the third subparagraph shall, moreover, be justified on grounds of public health

protection and be proportionate in relation to the objective of such protection, in

compliance with the Treaties.

3. For the purposes of Article 122(1), where relevant, upon request from the competent

authority concerned, entities including other relevant marketing authorisation holders,

importers and manufacturers of medicinal products or active substances and relevant

suppliers or wholesale distributors, as well as stakeholder representative associations, or

natural or legal persons that are authorised or entitled to supply medicinal products to the

public shall provide any information requested within the time limit specified by the

competent authority concerned.

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Article 125

Role of the competent authority of the Member State

1. The competent authority of the Member State shall:

(a) collect and assess information received in accordance with Article 120(1), points (a)

to (d), and Articles 123 and 124 in order to continuously monitor any expected or

actual shortages pursuant to Article 122(1);

(b) assess the merits of each confidentiality claim made by the marketing authorisation

holder in accordance with Article 123(1), point (e), and protect information which

that competent authority considers to be commercially confidential from unjustified

disclosure;

(c) publish information on actual shortages that has been assessed by that competent

authority, and provide regular updates of that information, on a publicly available

and user-friendly website and ensure that such information, including regarding

available alternatives, has been actively communicated to representatives of

healthcare professionals and patients;

(d) report to the Agency, through the single points of contact of the working party

referred to in Article 3(6) of Regulation (EU) 2022/123, any shortage that it

identifies as a critical shortage in that Member State without undue delay;

(e) consider the use of appropriate regulatory measures to mitigate the shortage.

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2. Following the reporting referred to in paragraph 1, point (d), of this Article, and to

facilitate the monitoring referred to in Article 122(1), the competent authority of the

Member State shall, through the working party referred to in paragraph 1, point (d), of this

Article:

(a) submit to the Agency the information referred to in Article 122(3) or Article 129(2),

first subparagraph, point (a), using the tools, methods of and criteria for the

monitoring and reporting established pursuant to Article 127(4), point (a), by the

deadline set by the Agency;

(b) where necessary, provide updates to the information provided in accordance with

point (a) to the Agency;

(c) justify any failure to provide any of the information referred to in point (a) to the

Agency;

(d) where necessary, submit a request to the Agency to extend the deadline set by the

Agency referred to in point (a);

(e) indicate whether the marketing authorisation holder has indicated the existence of

any commercially confidential information and provide the marketing authorisation

holder’s explanation of why that information is of a commercially confidential

nature, in accordance with Article 123(1), point (e);

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(f) inform the Agency of any actions planned or taken by that Member State to mitigate

the shortage at national level without undue delay.

3. After the expansion of the scope referred to in Article 127(6) of the European Shortages

Monitoring Platform (ESMP) established by Regulation (EU) 2022/123, and for the

purposes of Article 122(1) and Article 125(2), point (a), competent authorities of the

Member States shall make reasonable efforts that their national IT systems are gradually

made interoperable with the ESMP and allow for the automated exchange of information

with the ESMP while avoiding duplication of reporting.

4. Where the competent authority of the Member State has any relevant information in

addition to the information to be provided pursuant to this Article, it shall immediately

provide such information to the Agency through the working party referred to in

paragraph 1, point (d).

5. Following the addition of a medicinal product on the list of critical shortages of Union

concern referred to in Article 127(1), the competent authority of the Member State shall,

through the working party referred to in paragraph 1, point (d), of this Article, provide any

information requested pursuant to Article 129(2), first subparagraph, point (a), to the

Agency.

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6. Following any MSSG recommendations provided in accordance with Article 128(3), the

competent authority of the Member State shall, through the working party referred to in

paragraph 1, point (d), of this Article:

(a) report to the Agency any information received from the marketing authorisation

holder of the medicinal product concerned or from other actors pursuant to

Article 124(2) and (3);

(b) coordinate the actions that it has taken or that it plans to take with any relevant

measures taken by the Commission;

(c) take into account any MSSG recommendations referred to in Article 128(3);

(d) inform the Agency of any actions planned or taken by that Member State in

accordance with points (b) and (c) and report on any other actions taken to mitigate

or resolve the critical shortage in the Member State, as well as the results of these

actions, without undue delay.

Where Member States take an alternative course of action at national level which is not in

line with the recommendations of the MSSG, they shall communicate the reasons for doing

so to the MSSG in a timely manner.

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7. The competent authority of the Member State may require wholesale distributors, and

natural or legal persons that are authorised or entitled to supply to the public medicinal

products authorised to be placed on the market of a Member State pursuant to Article 6 of

Directive (EU) 2026/…+, to report a shortage of a medicinal product marketed in the

Member State concerned.

8. The Member States may request that the MSSG provide further recommendations pursuant

to Article 128(3).

Article 126

National websites on medicinal product shortages

The website referred to in Article 125(1), point (c), shall include the following information:

(a) the trade name of the medicinal product and International Non-proprietary Name, for

interoperability purposes;

(b) the therapeutic indication for the medicinal product of which there is a shortage;

(c) reasons for the shortages and mitigation measures taken to address the shortages, after the

deletion of any commercially confidential information;

(d) the start and expected end dates of the shortage;

(e) where relevant, other information for healthcare professionals and patients, including

information about available alternative medicinal products.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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Article 127

Role of the Agency concerning shortages

1. On the basis of Article 122(1), the Agency, in collaboration with the working party

referred to in Article 125(1), point (d), shall establish and update a list of critical shortages

of Union concern whenever a Member State requests to do so for the medicinal products

for which a critical shortage in the Member State cannot be resolved without Union

coordination.

2. The Agency shall inform the MSSG of the critical shortages in the Member States that

have been listed as critical shortages of Union concern pursuant to paragraph 1.

3. The Agency shall establish in its web-portal referred to in Article 106 a publicly available

and user-friendly webpage that provides information on actual critical shortages of Union

concern. This webpage shall also provide references to the lists of actual shortages

published by the competent authorities of the Member States pursuant to Article 125(1),

point (c).

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4. For the purpose of fulfilling the tasks referred to in Article 122(1) and Articles 128

and 129, the Agency shall, in consultation with the working party referred to in

Article 125(1), point (d):

(a) specify the tools, including the ESMP once its scope is expanded pursuant to

paragraph 6 of this Article, the methods of and criteria for the monitoring and

reporting provided for in Articles 123(1), point (a), and 125(2), point (a);

(b) draw up guidance to allow marketing authorisation holders to put in place the risk

assessment of the impact of suspension, cessation or withdrawal and the shortage

mitigation plan as referred to in Article 122(2);

(c) specify the methods for the provision of recommendations referred to in

Article 128(3);

(d) publish information covered by points (a), (b) and (c) of this paragraph on a

dedicated webpage on its web-portal referred to in Article 106.

5. For the duration of the critical shortage of Union concern, the Agency shall regularly

report to the Commission the results of the monitoring referred to in Article 129 of this

Regulation, and in particular, it shall report any event that is likely to lead to a major event,

as defined in Article 2 of Regulation (EU) 2022/123. Where a public health emergency is

recognised in accordance with Regulation (EU) 2022/2371 or where an event is recognised

as a major event in accordance with Regulation (EU) 2022/123, Regulation (EU) 2022/123

prevails.

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6. By … [one year after the entry into force of this Regulation], the Agency shall expand the

scope of the ESMP for the purposes of implementing this Chapter, including to support the

exchange of information for the purposes of the vulnerability evaluation. The Agency shall

ensure that, where relevant, data are interoperable between the ESMP, Member States’

IT systems and other relevant IT systems and databases, while avoiding duplication

of reporting.

Article 128

Role of the MSSG

1. The MSSG, following consultation of the working party referred to in Article 125(1),

point (d), shall review the status of the critical shortage of Union concern whenever

necessary and shall recommend the Agency to update the list in accordance with

Article 127(1).

2. The MSSG shall amend its rules of procedure, and the rules of procedure of the working

party referred to in Article 125(1), point (d), in accordance with the provisions laid down

in this Regulation.

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3. The MSSG may provide recommendations on measures to resolve or to mitigate the

critical shortage of Union concern, in accordance with the methods referred to in

Article 127(4), point (c), to relevant marketing authorisation holders, the Member States,

the Commission, the Agency, the representatives of healthcare professionals or other

entities. The MSSG may recommend Member States to forecast and monitor demand for

medicinal products on the list of critical shortages of Union concern, taking into account

the demand forecast from the marketing authorisation holder.

4. The MSSG shall provide recommendations to the Commission regarding the possibility,

pursuant to Article 121(1), to require a shortage prevention plan for a medicinal product

that is not subject to medical prescription. In doing so, the MSSG shall take into account

the criteria set out in Article 132(4).

Article 129

Management of the critical shortage of Union concern

1. Following the addition of a medicinal product to the list of critical shortages of Union

concern pursuant to Article 127(1) and based on the continuous monitoring carried out in

accordance with Article 122(1), the Agency, in coordination with the competent authority

of the Member State concerned, shall continuously monitor the critical shortage of Union

concern of that medicinal product.

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2. For the purposes of paragraph 1, the Agency may, if that information is not already

available to the Agency, request relevant information on that critical shortage of Union

concern from:

(a) the competent authority of the Member State concerned through the working party

referred to in Article 125(1), point (d);

(b) the marketing authorisation holder;

(c) the other actors listed in Article 124(3).

For the purposes of this paragraph, the Agency shall set a deadline for the submission of

the information requested.

Article 130

Obligations on the marketing authorisation holder

in the case of a critical shortage of Union concern

Following the addition of a medicinal product to the list of critical shortages of Union concern in

accordance with Article 127(1), or having regard to recommendations provided in accordance with

Article 128(3), the marketing authorisation holder shall:

(a) provide any additional information that the Agency may request, including regular

information on the available stocks of the concerned medicinal product;

(b) provide additional relevant information to the Agency;

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(c) take into account the recommendations referred to in Article 128(3);

(d) take into account the actions taken by the Commission pursuant to Article 132(1);

(e) inform the Agency of any measures taken pursuant to points (c) and (d) and the report on

results of such measures;

(f) inform the Agency and the competent authority of the Member State of the end date of the

critical shortage of Union concern without undue delay.

Article 131

Voluntary solidarity mechanism for medicinal products

1. In order to mitigate critical shortages in the Member States, Member States may, on a

voluntary basis and as a last resort, request to the MSSG the activation of the voluntary

solidarity mechanism for medicinal products. The voluntary solidarity mechanism for

medicinal products shall be coordinated by the MSSG and supported by the Agency.

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2. The voluntary solidarity mechanism for medicinal products referred to in paragraph 1 may

be activated by the MSSG on behalf of a requesting Member State where the following

conditions are met:

(a) the Agency has been notified of the critical shortage in the Member State in

accordance with Article 125(1), point (d), and the shortage has been brought to the

attention of the single points of contact of the working party referred to in

Article 3(6) of Regulation (EU) 2022/123;

(b) there are no therapeutic alternatives, or there are insufficient therapeutic alternatives,

available in the Member State concerned;

(c) there are insufficient quantities of the medicinal product available in the Member

State concerned to treat critical indications;

(d) import of stocks from other Member States or third countries or other short-term

measures do not provide a solution in a timely manner or in sufficient quantities;

(e) there is a risk of stockout in the Member State concerned within one month.

3. The MSSG shall establish rules of procedure to facilitate the use of the voluntary solidarity

mechanism in accordance with this Article.

4. Where any Member State is ready to provide assistance, the Agency shall put the

requesting Member State in contact with the volunteering Member States.

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5. The Agency shall facilitate the exchange of information between Member States,

coordinate requests for support, and, where necessary, liaise with marketing authorisation

holders.

Article 132

Role of the Commission

1. The Commission shall, where it considers it appropriate and necessary:

(a) take into account the MSSG recommendations;

(b) take any actions, within the limits of the powers conferred on the Commission;

(c) inform the MSSG of the actions taken pursuant to point (b).

2. The Commission may request the MSSG to provide recommendations referred to in

Article 128(3).

3. The Commission may request the information gathered by the Agency in accordance with

Section 2 of Chapter X. Where relevant, in the context of crisis preparedness, the

Commission may request the marketing authorisation holder to submit relevant

information, including the shortage prevention plan referred to in Article 121. The

Commission shall protect any information that is commercially confidential from

unjustified disclosure.

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4. The Commission is empowered to adopt delegated acts supplementing this Regulation to

identify additional medicinal products that require a shortage prevention plan, in

accordance with the requirements set out in Article 121.

Those delegated acts shall be adopted taking due account of the likelihood of shortages,

relevance for public health and patient needs relating to such medicinal products. To that

end, the following criteria shall guide the identification of those medicinal products:

(a) the number and frequency of past critical shortages in the Member States reported to

the MSSG;

(b) the specific characteristics of the medicinal products concerned and the existence of

available alternative authorised medicinal products;

(c) the therapeutic relevance of the medicinal products concerned and the conditions

intended to be treated;

(d) potential risks to public health, including crisis preparedness.

When the Commission adopts a delegated act pursuant to this paragraph, it shall take into

account MSSG recommendations adopted in accordance with Article 128(4).

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SECTION 2

SECURITY OF SUPPLY

Article 133

Identification and management of critical medicinal products

by the competent authority of a Member State

1. The competent authority of a Member State shall consult, where relevant, with healthcare

professionals and patient organisations, and shall identify critical medicinal products in

that Member State, using the methodology set out in Article 136(1), first subparagraph,

point (a).

2. The Commission shall adopt and update, on the basis of the information received from the

Agency pursuant to paragraph 3 of this Article, a list of all critical medicinal products

identified by the competent authorities of the Member States in accordance with

paragraph 1 of this Article (Union long list) by means of implementing acts and

communicate the adoption of the list and any updates to the Agency and the MSSG. Those

implementing acts shall be adopted in accordance with the examination procedure referred

to in Article 179(2).

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3. The competent authority of a Member State, acting through the working party referred to

in Article 125(1), point (d), shall report to the Agency the critical medicinal products in

that Member State identified pursuant to paragraph 1 of this Article, and all available data

relevant for the vulnerability evaluation referred to in Article 138(2), using the

methodology pursuant to Article 136(1), first subparagraph, point (b), as well as the

information received from the marketing authorisation holder. The Agency shall inform the

Commission on the critical medicinal products identified as critical by Member States

pursuant to paragraph 1 of this Article.

4. For the purposes of the identification of critical medicinal products referred to in

paragraph 1 of this Article, using the methodology pursuant to Article 136(1),

first subparagraph, point (a), and for the purposes of the vulnerability evaluation referred to

in Article 138(2), using the methodology pursuant to Article 136(1), first subparagraph,

point (b), the competent authority of the Member State concerned may request relevant

information from the relevant marketing authorisation holder.

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5. For the purposes of the identification of critical medicinal products referred to in

paragraph 1 of this Article using the methodology pursuant to Article 136(1),

first subparagraph, point (a), and for the purposes of the vulnerability evaluation referred to

in Article 138(2) using the methodology pursuant to Article 136(1), first subparagraph,

point (b), the competent authority of the Member State concerned may request relevant

information from other entities, including other relevant marketing authorisation holders,

importers and manufacturers of medicinal products or active substances, relevant suppliers

and wholesale distributors, stakeholder representative associations, or other entities,

including natural or legal persons, that are authorised or entitled to supply medicinal

products to the public.

6. The competent authority of the Member State concerned shall assess the merits of each

confidentiality claim made by the marketing authorisation holder pursuant to

Article 134(1), point (e), and shall protect any information that is commercially

confidential from unjustified disclosure.

7. For the purposes of the adoption of the Union list of critical medicinal products pursuant to

Article 137, each Member State shall, through the competent authority of the Member

State concerned:

(a) submit to the Agency the information referred to in Article 136(2),

first subparagraph, point (a), using the tools, methods of and criteria for the

monitoring and reporting established pursuant to Article 136(1), first subparagraph,

point (d), by the deadline set by the Agency;

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(b) provide any relevant information to the Agency, including information on measures

that have been taken by the Member State to strengthen the supply of that medicinal

product;

(c) provide updates to the information provided in accordance with points (a) and (b) to

the Agency, where necessary;

(d) justify any failure to provide any of the requested information;

(e) indicate the existence of any commercially confidential information reported as such

by the marketing authorisation holder pursuant to Article 134(1), point (e), and

provide the marketing authorisation holder’s explanation of why that information is

of a commercially confidential nature.

Where necessary, the competent authority of the Member State may request an extension

to the deadline set by the Agency to comply with the request for information in accordance

with point (a) of the first subparagraph.

8. Following the addition of a medicinal product to the Union list of critical medicinal

products in accordance with Article 137 or any recommendations provided in accordance

with Article 138(1), Member States shall:

(a) provide any additional information requested by the Agency;

(b) provide additional relevant information to the Agency;

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(c) coordinate their actions with any actions taken by the Commission pursuant to

Article 140(1), point (b);

(d) take into account any MSSG recommendations referred to in Article 138(1);

(e) inform the Agency of any actions taken or planned in accordance with points (c)

and (d) by that Member State, as well as the results of those actions.

9. Member States that do not coordinate their actions as referred to in paragraph 8, point (c)

of this Article, or do not follow any MSSG recommendations referred to in Article 138(1),

shall share the reasons therefor with the Agency in a timely manner.

Article 134

Obligations of the marketing authorisation holder with regard to critical medicinal products

1. For the purposes of Article 133(1) and (4), and Article 137(1), the marketing authorisation

holder shall:

(a) submit the information requested in accordance with Article 133(4) and

Article 136(2), first subparagraph, point (b), and 136(4), point (b), to the competent

authority concerned, without undue delay, using the tools, methods and criteria for

monitoring and reporting established pursuant to Article 136(1), point (d), by the

deadline set by that competent authority concerned;

(b) provide updates to the information provided in accordance with point (a) where

necessary;

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(c) justify any failure to provide any of the requested information;

(d) where necessary, submit a request to the competent authority concerned for an

extension of the deadline set by that competent authority in accordance with

point (a); and

(e) indicate whether the information provided in accordance with point (a) contains any

commercially confidential information, identify the relevant parts of that information

having a commercially confidential nature and explain why that information is of

such nature.

2. The marketing authorisation holder shall be responsible for providing correct, not

misleading, and complete information as requested by the competent authority concerned

and shall have the duty to cooperate and to disclose on its own motion any relevant

information without undue delay to that competent authority and to update the information

as soon as that information becomes available.

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Article 135

Obligations on other actors

For the purposes of Article 133(5) and Article 136(2), first subparagraph, point (c), and 136(4),

point (c), where relevant, upon request from the competent authority concerned, entities including

other relevant marketing authorisation holders, importers and manufacturers of medicinal products

or active substances and relevant suppliers and wholesale distributors, as well as stakeholder

representative associations or other natural or legal persons that are authorised or entitled to supply

medicinal products to the public, shall provide, within the time limit specified by the competent

authority concerned, any information and provide updates thereon whenever necessary.

Article 136

Role of the Agency

1. The Agency shall, in collaboration with the MSSG and the working party referred to in

Article 125(1), point (d):

(a) develop a common methodology to identify critical medicinal products on the basis

of their therapeutic relevance, and availability of appropriate alternatives to those

medicinal products, in consultation, where appropriate, with relevant stakeholders;

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(b) develop a common methodology to evaluate the vulnerabilities with respect to the

supply chains of critical medicinal products listed on the Union list of critical

medicinal products as referred to in Article 137, including the lack of supply chain

diversification and the level of dependency on third countries with respect to those

critical medicinal products or their active substances, in consultation, where

appropriate, with relevant stakeholders;

(c) specify the procedures and criteria for establishing and reviewing the Union list of

critical medicinal products referred to in Article 137, and the procedures and criteria

for prioritising the vulnerability evaluation of such medicinal products;

(d) specify the tools, including ESMP, once its scope is expanded pursuant to

Article 127(6), methods and criteria for the monitoring and reporting provided for in

Articles 133(7), first subparagraph, point (a), and 134(1), point (a);

(e) specify the methods for the provision and review of MSSG recommendations

referred to in Article 138(1) and (4).

The Agency shall publish the information referred to in points (a) to (e) on a dedicated

webpage on its web-portal.

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2. Following the reports and information provided by the Member States and marketing

authorisation holders in accordance with Article 133(3) and (7), and Article 134(1), the

Agency, may request any relevant information from:

(a) the competent authority of the Member State concerned;

(b) the marketing authorisation holder of the medicinal product, including the shortage

prevention and the shortage mitigation plan, respectively referred to in Article 121

and Article 122(2);

(c) other entities including other relevant marketing authorisation holders, importers and

manufacturers of medicinal products or active substances, relevant suppliers and

wholesale distributors, stakeholder representative associations, or other entities,

including natural or legal persons, that are authorised or entitled to supply medicinal

products to the public.

The Agency, in consultation with the working party referred to in Article 125(1), point (d),

shall report the information referred to in Article 133(3) and (7), and Article 134(1) to

the MSSG.

3. For the purposes of Articles 133(7), point (e), and 134(1), point (e), the Agency shall

assess the merits of each confidentiality claim and protect commercially confidential

information against unjustified disclosure.

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4. Following the adoption of the Union list of critical medicinal products the Agency may

request additional information from:

(a) the competent authority of the Member State concerned;

(b) the marketing authorisation holder;

(c) other entities including other relevant marketing authorisation holders, importers and

manufacturers of medicinal products or active substances and relevant suppliers or

wholesale distributors, as well as stakeholder representative associations or other

entities, including natural or legal persons, that are authorised or entitled to supply

medicinal products to the public.

5. Following the adoption of the Union list of critical medicinal products in accordance with

Article 137, the Agency shall assess any relevant information received from the marketing

authorisation holder pursuant to Article 139 and the competent authority of the Member

State in accordance with Article 133(8) and (9) and report on that information to

the MSSG.

6. The Agency shall make publicly available via the web-portal referred to in Article 106 the

MSSG recommendations referred to in Article 138(1).

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Article 137

The Union list of critical medicinal products

1. Following the reporting referred to in Article 136(2), second subparagraph, and

Article 136(5) of this Regulation, the MSSG shall consult the working party referred to in

Article 125(1), point (d) of this Regulation. Based on that consultation, the MSSG shall

propose a Union list of critical medicinal products authorised to be placed on the market of

a Member State pursuant to Article 6 of Directive (EU) 2026/…+ and for which the

coordinated Union level action provided for in this Chapter is necessary.

2. The MSSG shall propose updates to the Union list of critical medicinal products to the

Commission, where necessary, in particular taking into account the outcome of

vulnerability evaluations referred to in Article 138(2).

The first revision of the Union list of critical medicinal products shall take place no later

than one year after the date of entry into force of this Regulation. Where the results of the

vulnerability evaluation are available in accordance with the prioritisation criteria referred

to in Article 136(1), first subparagraph, point (c), the revision shall include an update of the

list taking into account the results of that evaluation.

+ OJ: Please insert in the text the number of the Directive in document ST 7106/26

(2023/0132(COD)).

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3. The Commission, taking into account the proposal of the MSSG, shall adopt and update

the Union list of critical medicinal products by means of implementing acts and

communicate the adoption of the list and any updates to the Agency and the MSSG. On the

Union list of critical medicinal products, to the extent possible, the Commission shall

specify the critical medicinal products for which a vulnerability in the supply chains is

established, taking into account the vulnerability evaluation referred to in Article 138(2)

and prioritisation criteria referred to in Article 136(1), first subparagraph, point (c). Among

those medicinal products the Commission shall also specify those critical medicinal

products, including their active substances, which are vulnerable due to a high level of

dependency on a single or limited number of third countries. Those implementing acts

shall be adopted in accordance with the examination procedure referred to in

Article 179(2).

4. Following the adoption of the Union list of critical medicinal products and of any updates

of that list in accordance with paragraph 3 of this Article, the Agency shall without delay

publish that list and those updates on the web-portal referred to in Article 106.

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Article 138

Role of the MSSG

1. On the basis of the Union list of critical medicinal products referred to in Article 137(3), in

consultation with the Agency and the working party referred to in Article 125(1), point (d),

the MSSG may provide recommendations, in accordance with the methods referred to in

Article 136(1), first subparagraph, point (e), on appropriate security of supply measures to

marketing authorisation holders, the Member States, the Commission, the Agency or other

entities, including natural or legal persons. Such measures may include, inter alia,

recommendations on diversification of suppliers, inventory management and

regulatory flexibilities.

2. The MSSG, relying on the information referred to in Article 136(2) and on the basis of the

methodology set out in Article 136(1), first subparagraph, point (b), shall evaluate the

vulnerability with respect to the supply chains of the medicinal products listed on the

Union list of critical medicinal products and in accordance with the prioritisation criteria

referred to in Article 136(1), first subparagraph, point (c).

3. The MSSG shall amend its rules of procedure, and the rules of procedure of the working

party referred to in Article 125(1), point (d), in accordance with the tasks set out in

this section.

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4. Following the report pursuant to Article 136(5), the MSSG shall review its

recommendations in accordance with the methods referred to in Article 136(1),

first subparagraph, point (e).

5. The MSSG may request the Agency to request further information from the Member States

or marketing authorisation holder of the medicinal product included on the Union list of

critical medicinal products or from other relevant actors referred to in Article 135.

Article 139

Obligations on the marketing authorisation holder after the MSSG recommendations

Following the addition of a medicinal product to the Union list of critical medicinal products in

accordance with Article 137(3) or having regard to any recommendations provided in accordance

with Article 138(1), the marketing authorisation holder for a medicinal product on that list shall:

(a) provide any additional information that the Agency requests;

(b) provide any additional relevant information to the Agency;

(c) take into account the recommendations referred to in Article 138(1);

(d) take into account the actions taken by the Commission in accordance with Article 140(1);

(e) inform the Agency of any measures taken to improve the security of supply and the results

of such measures.

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Article 140

Role of the Commission

1. The Commission:

(a) shall take into account the MSSG recommendations;

(b) shall take, if appropriate, any necessary actions within the limits of the powers

conferred on the Commission, including the development of guidelines to improve

the security of supply;

(c) may foster coordination of Member State measures aimed to ensure security of

supply within their territories;

(d) shall inform the MSSG of actions taken by the Commission;

(e) may request the MSSG to provide information or an opinion or further

recommendations referred to in Article 138(1).

2. If necessary to ensure the smooth functioning of the internal market, the Commission may,

taking into consideration the recommendations referred to in paragraph 1, draw up

recommendations for national measures to improve security of supply of medicinal

products included in the Union list of critical medicinal products.

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3. The adoption of those recommendations shall be limited to cases where the Commission

identifies a disruption, or a highly likely disruption, of the internal market which strongly

and negatively affects, or which would strongly and negatively affect, the security of

supply of critical medicinal products. They shall take into account:

(a) the severity of the disruption of the internal market, or the risk thereof;

(b) the causes of the disruption to security of supply;

(c) the existence of other available measures under this Regulation to mitigate or resolve

the disruption, or the risk thereof;

(d) the gravity and scope of risks to public health.

The recommendations shall be based on objective, factual, measurable and substantiated

data, including from the Agency and its preparatory bodies, competent authorities of the

Member States and relevant economic operators.

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Chapter XI

European Medicines Agency

SECTION 1

TASKS OF THE AGENCY

Article 141

Establishment

This Regulation establishes the European Medicines Agency.

The Agency, previously established under Regulation (EC) No 726/2004, shall continue to function

under this Regulation.

The Agency shall be responsible for coordinating the existing scientific resources put at its disposal

by Member States for the evaluation, supervision and pharmacovigilance of medicinal products for

human use and of veterinary medicinal products.

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