Esindajate nimetamine

Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands

An agency of the European Union Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000

© European Medicines Agency, 2026. Reproduction is authorised provided the source is acknowledged.

HE the Ambassador Permanent Representation of Estonia Rue Guimard 11–13 B-1040 Bruxelles BELGIUM

23 March 2026 EMA/HMPC/69251/2026 Executive Director

Your Excellency,

Subject: Nomination of representatives in the Committee on Herbal Medicinal Products (HMPC) of the European Medicines Agency

In accordance with Regulation (EC) No 726/2004, members and alternates of the European Medicines Agency’s Management Board and scientific committees are nominated for a three-year mandate by EU member states and EEA-EFTA countries.

The member and alternate’s mandate for your country in the Committee is vacant since 3 August 2023. I, therefore, invite you to nominate a new representative for a new three-year mandate, and inform me of the start date of the mandate.

I would like to emphasize the importance of a timely nomination of a committee member to ensure the continuous representation of your Member State in the Committee. To avoid a vacant committee member position when an alternate position is already filled, you may consider nominating the alternate (temporarily) as member.

Please also inform me if you intend to keep the position temporarily vacant. If no nomination is received, the position will be considered temporarily vacant until a nomination is received.

In making your nominations, please note that the Agency’s Management Board has determined that members of scientific committees should meet conditions concerning their declarations of interests as described in the Policy on the handling of competing interests of scientific committees’ members and experts. This policy can be found on the EMA website.

I would like to draw your attention to the attached Annex B, which lists the recommended criteria for experience and expertise of the Committee members and alternates for consideration when nominating a new representative.

As agreed with the network of the Heads of Medicines Agencies in order to address the increasing complexity in scientific developments related to the Committee’s activities, the current expertise of the Committee and the expertise required for upcoming procedures are monitored. It would be appreciated if the following specific areas of expertise that were identified as desirable for the current and upcoming work of the Committee, could be taken into consideration when nominating a new

Page 2/2

representative, subject to the availability of such expertise to the relevant competent authority in your country:

• Paediatric psychiatry

• Paediatric cardiology

• Non-clinical development of medicinal products, including expertise in juvenile animal studies to support neonatal and paediatric studies

• Biostatistics

• Paediatric neurology

• Paediatric nephrology/urology

• Paediatric radiology/imaging

• Gene therapy

• Medical genetics

• NCA staff member or Academic

An overview of the current composition of the Committee and the expertise of its members is attached for your information.

Please address the nomination to my attention at [email protected] (with copy to [email protected]), indicating full contact details for the nominee and the start date of the mandate, together with any additional information you believe may assist this nomination. In case you already provided me with your nomination, I kindly ask you to disregard this correspondence.

Yours faithfully,

Emer Cooke Executive Director Encs: Annex B Current committee composition and expertise

30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom

An agency of the European Union

Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5520

Send a question via our website www.ema.europa.eu/contact

© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.

3 February 2016 EMA/519883/2015

Procedure Management and Committee Support

Recommendation on criteria for experience and expertise

of HMPC members and alternates

Legislation

Article 16h (2) h of Directive 2001/83/EC states that each Member State shall appoint one member

and one alternate to the Committee for Herbal Medicinal Products. Members and alternates shall be

chosen for their role and experience in the evaluation of herbal medicinal products. The HMPC may co-

opt a maximum of five additional members chosen on the basis of their specific scientific competence.

With a view to the co-opting of such members, the HMPC shall identify the specific complementary

scientific competence of the additional member(s). Co-opted members shall be chosen among experts

nominated by Member States or the Agency.

Recommendation

The following recommendation on criteria for experience and expertise is made to nominating

authorities for consideration when the Agency invites them to nominate a new HMPC member and

alternate and to HMPC members and alternates when considering the nomination of co-opted

members:

 Academic expertise in the relevant scientific area, such as:

 Internationally recognised academic qualification(s)/accreditation(s) (e.g. degrees, diplomas,

post graduate qualifications (e.g. PhD), professional affiliations etc.) in life sciences or physical

sciences (medicine, pharmacy, chemistry, biology, …)

 Delivering scientific expert views/opinions to National/European/International scientific bodies.

 Direct working experience, after obtaining the academic qualification, in the relevant scientific

area, in a national competent authority, industry and/or academia/clinical practice

(university, hospital, research facility, private practise, etc.). Relevant experience will depend on

the core activities of the Committee but could be expected to include experience in one or more of

the following areas:

 Clinical expertise in one or more therapeutic areas (either as a medical doctor or as a hospital

pharmacist)

Recommendation on criteria for experience and expertise of HMPC members and

alternates

EMA/519883/2015 Page 2/3

 Clinical co-ordinator/investigator in clinical trials

 Member of Data Safety Monitoring Board or Scientific Advisory Board and/or experience of

working in or with ethics approval committees

 Pre-clinical research and expertise (e.g. in toxicology, pharmacology, animal models)

 Clinical research (e.g. clinical trials, epidemiological studies)

 Research in the relevant “quality” areas, relating to the research and development of medicinal

products (e.g. molecular biology, gene technology)

 Formulation, manufacture and control of medicinal products

 Pharmacovigilance and risk management

 Advisory experience (leading to knowledge of regulatory requirements) in committees’/

scientific bodies’ activities. (e.g. member of Working Party or SAG, nominated by EMA or NCA

for involvement in EMA activities, experience in providing scientific advice for central and/or

national MAs, involvement in WHO, EDQM, FDA activities)

 Experience in the review of dossiers, preparation and provision of assessments reports for

central and/or national MAAs, experience in peer review of Assessment Reports/List of

Questions

 Targeted publications in recognised and peer-reviewed scientific journals and/or peer reviewing

activities for scientific journals

 Members and alternates nominated to the HMPC would be expected to have expertise in at

least one of the following areas: Quality, Non-clinical, Clinical – general, Clinical – therapeutic

areas (focus OTC), and with optional expertise in other HMPC relevant areas:

 Quality

 Analytical chemistry

 Phytochemistry

 Development pharmaceutics

 Quality control (including stability)

 Botany, taxonomy, plant physiology

 Biological assays and biochemistry (including protein purification/analysis)

 Non-clinical

 Toxicology (in vitro/in vivo)

 Pharmacology (in vitro/in vivo)

 Pharmacodynamics

 Pharmacokinetics

 Clinical – general

 Clinical pharmacology (including safety pharmacology and pharmacokinetics)

 Clinical trials methodology and statistics

Recommendation on criteria for experience and expertise of HMPC members and

alternates

EMA/519883/2015 Page 3/3

 Pharmacovigilance (including epidemiology, signal detection, risk assessment and

management)

 Paediatrics

 Geriatrics

 Medical practice (i.e. medical doctor)

 Other medical practice

 Clinical - therapeutic areas (focus OTC)

 Alimentary track and metabolism (constipation, gastrointestinal disorder, loss of appetite,

mouth and throat disorders)

 Respiratory system (cough and cold, mouth and throat disorders)

 Ophthalmology (eye discomfort)

 Nervous system (mental stress and mood disorder, fatigue and weakness, pain and

inflammation, sleep disorders and insomnia)

 Dermatology (skin disorders and minor wounds, pain and inflammation)

 Urology and gynaecology/obstetrics (urinary tract and gynaecology disorders)

 Cardiovascular diseases and circulatory disorders (venous circulatory disorders)

 Other HMPC relevant areas

 Consumer protection and public health

 European traditional phytotherapy (classic)

 Anthroposophic medicine and other specific European traditional medicines

 TCM, Ayurvedic and other Asian traditional medicines

 African traditional medicines

 American traditional medicines

 Other areas as: Inspections/GMP/GLP/GCP, GACP and plant cultivation, Microbiology, Food

safety and food legislation, Medical devices, Biologicals, biotechnology, gene therapy, cell

therapy, tissue engineering

Whilst a minimum period for such post graduate experience is not defined, please note for information,

that the length of experience of CHMP and PRAC members and alternates in June 2015 ranged from 2

to 40 years and in 2 out of 3 cases the member had a greater number of years of relevant experience

compared to the alternate.

Nominating authorities in the Member States are expected to provide HMPC members and alternates

sufficient possibilities to engage in HMPC work.

Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands

An agency of the European Union Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000

© European Medicines Agency, 2026. Reproduction is authorised provided the source is acknowledged.

HE the Ambassador Permanent Representation of Estonia Rue Guimard 11–13 B-1040 Bruxelles BELGIUM

23 March 2026 EMA/HMPC/69251/2026 Executive Director

Your Excellency,

Subject: Nomination of representatives in the Committee on Herbal Medicinal Products (HMPC) of the European Medicines Agency

In accordance with Regulation (EC) No 726/2004, members and alternates of the European Medicines Agency’s Management Board and scientific committees are nominated for a three-year mandate by EU member states and EEA-EFTA countries.

The member and alternate’s mandate for your country in the Committee is vacant since 3 August 2023. I, therefore, invite you to nominate a new representative for a new three-year mandate, and inform me of the start date of the mandate.

I would like to emphasize the importance of a timely nomination of a committee member to ensure the continuous representation of your Member State in the Committee. To avoid a vacant committee member position when an alternate position is already filled, you may consider nominating the alternate (temporarily) as member.

Please also inform me if you intend to keep the position temporarily vacant. If no nomination is received, the position will be considered temporarily vacant until a nomination is received.

In making your nominations, please note that the Agency’s Management Board has determined that members of scientific committees should meet conditions concerning their declarations of interests as described in the Policy on the handling of competing interests of scientific committees’ members and experts. This policy can be found on the EMA website.

I would like to draw your attention to the attached Annex B, which lists the recommended criteria for experience and expertise of the Committee members and alternates for consideration when nominating a new representative.

As agreed with the network of the Heads of Medicines Agencies in order to address the increasing complexity in scientific developments related to the Committee’s activities, the current expertise of the Committee and the expertise required for upcoming procedures are monitored. It would be appreciated if the following specific areas of expertise that were identified as desirable for the current and upcoming work of the Committee, could be taken into consideration when nominating a new

Page 2/2

representative, subject to the availability of such expertise to the relevant competent authority in your country:

• Paediatric psychiatry

• Paediatric cardiology

• Non-clinical development of medicinal products, including expertise in juvenile animal studies to support neonatal and paediatric studies

• Biostatistics

• Paediatric neurology

• Paediatric nephrology/urology

• Paediatric radiology/imaging

• Gene therapy

• Medical genetics

• NCA staff member or Academic

An overview of the current composition of the Committee and the expertise of its members is attached for your information.

Please address the nomination to my attention at [email protected] (with copy to [email protected]), indicating full contact details for the nominee and the start date of the mandate, together with any additional information you believe may assist this nomination. In case you already provided me with your nomination, I kindly ask you to disregard this correspondence.

Yours faithfully,

Emer Cooke Executive Director Encs: Annex B Current committee composition and expertise

30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom

An agency of the European Union

Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5520

Send a question via our website www.ema.europa.eu/contact

© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.

3 February 2016 EMA/519883/2015

Procedure Management and Committee Support

Recommendation on criteria for experience and expertise

of HMPC members and alternates

Legislation

Article 16h (2) h of Directive 2001/83/EC states that each Member State shall appoint one member

and one alternate to the Committee for Herbal Medicinal Products. Members and alternates shall be

chosen for their role and experience in the evaluation of herbal medicinal products. The HMPC may co-

opt a maximum of five additional members chosen on the basis of their specific scientific competence.

With a view to the co-opting of such members, the HMPC shall identify the specific complementary

scientific competence of the additional member(s). Co-opted members shall be chosen among experts

nominated by Member States or the Agency.

Recommendation

The following recommendation on criteria for experience and expertise is made to nominating

authorities for consideration when the Agency invites them to nominate a new HMPC member and

alternate and to HMPC members and alternates when considering the nomination of co-opted

members:

 Academic expertise in the relevant scientific area, such as:

 Internationally recognised academic qualification(s)/accreditation(s) (e.g. degrees, diplomas,

post graduate qualifications (e.g. PhD), professional affiliations etc.) in life sciences or physical

sciences (medicine, pharmacy, chemistry, biology, …)

 Delivering scientific expert views/opinions to National/European/International scientific bodies.

 Direct working experience, after obtaining the academic qualification, in the relevant scientific

area, in a national competent authority, industry and/or academia/clinical practice

(university, hospital, research facility, private practise, etc.). Relevant experience will depend on

the core activities of the Committee but could be expected to include experience in one or more of

the following areas:

 Clinical expertise in one or more therapeutic areas (either as a medical doctor or as a hospital

pharmacist)

Recommendation on criteria for experience and expertise of HMPC members and

alternates

EMA/519883/2015 Page 2/3

 Clinical co-ordinator/investigator in clinical trials

 Member of Data Safety Monitoring Board or Scientific Advisory Board and/or experience of

working in or with ethics approval committees

 Pre-clinical research and expertise (e.g. in toxicology, pharmacology, animal models)

 Clinical research (e.g. clinical trials, epidemiological studies)

 Research in the relevant “quality” areas, relating to the research and development of medicinal

products (e.g. molecular biology, gene technology)

 Formulation, manufacture and control of medicinal products

 Pharmacovigilance and risk management

 Advisory experience (leading to knowledge of regulatory requirements) in committees’/

scientific bodies’ activities. (e.g. member of Working Party or SAG, nominated by EMA or NCA

for involvement in EMA activities, experience in providing scientific advice for central and/or

national MAs, involvement in WHO, EDQM, FDA activities)

 Experience in the review of dossiers, preparation and provision of assessments reports for

central and/or national MAAs, experience in peer review of Assessment Reports/List of

Questions

 Targeted publications in recognised and peer-reviewed scientific journals and/or peer reviewing

activities for scientific journals

 Members and alternates nominated to the HMPC would be expected to have expertise in at

least one of the following areas: Quality, Non-clinical, Clinical – general, Clinical – therapeutic

areas (focus OTC), and with optional expertise in other HMPC relevant areas:

 Quality

 Analytical chemistry

 Phytochemistry

 Development pharmaceutics

 Quality control (including stability)

 Botany, taxonomy, plant physiology

 Biological assays and biochemistry (including protein purification/analysis)

 Non-clinical

 Toxicology (in vitro/in vivo)

 Pharmacology (in vitro/in vivo)

 Pharmacodynamics

 Pharmacokinetics

 Clinical – general

 Clinical pharmacology (including safety pharmacology and pharmacokinetics)

 Clinical trials methodology and statistics

Recommendation on criteria for experience and expertise of HMPC members and

alternates

EMA/519883/2015 Page 3/3

 Pharmacovigilance (including epidemiology, signal detection, risk assessment and

management)

 Paediatrics

 Geriatrics

 Medical practice (i.e. medical doctor)

 Other medical practice

 Clinical - therapeutic areas (focus OTC)

 Alimentary track and metabolism (constipation, gastrointestinal disorder, loss of appetite,

mouth and throat disorders)

 Respiratory system (cough and cold, mouth and throat disorders)

 Ophthalmology (eye discomfort)

 Nervous system (mental stress and mood disorder, fatigue and weakness, pain and

inflammation, sleep disorders and insomnia)

 Dermatology (skin disorders and minor wounds, pain and inflammation)

 Urology and gynaecology/obstetrics (urinary tract and gynaecology disorders)

 Cardiovascular diseases and circulatory disorders (venous circulatory disorders)

 Other HMPC relevant areas

 Consumer protection and public health

 European traditional phytotherapy (classic)

 Anthroposophic medicine and other specific European traditional medicines

 TCM, Ayurvedic and other Asian traditional medicines

 African traditional medicines

 American traditional medicines

 Other areas as: Inspections/GMP/GLP/GCP, GACP and plant cultivation, Microbiology, Food

safety and food legislation, Medical devices, Biologicals, biotechnology, gene therapy, cell

therapy, tissue engineering

Whilst a minimum period for such post graduate experience is not defined, please note for information,

that the length of experience of CHMP and PRAC members and alternates in June 2015 ranged from 2

to 40 years and in 2 out of 3 cases the member had a greater number of years of relevant experience

compared to the alternate.

Nominating authorities in the Member States are expected to provide HMPC members and alternates

sufficient possibilities to engage in HMPC work.