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Saatja: Esindus EL juures üldaadress </O=ESTONIAN MINISTRY OF FOREIGN AFFAIRS/OU=EVM/CN=RECIPIENTS/CN=ESINDUSELJUURESYLDAADR> Saaja: Tiiu Noobel Teema: FW: Estonia - 2026-03-23 - Nomination invitation letter for HMPC member and alternate From: Barbero Martina <[email protected]> Sent: Monday, March 23, 2026 1:51 PM To: Esindus EL juures üldaadress <[email protected]> Cc: Kiisk Katrin <[email protected]>; Kompus Mairi <[email protected]>; Jenas Kärolin <[email protected]>; HMPC Secretariat <[email protected]>; Nominations <[email protected]> Subject: Estonia - 2026-03-23 - Nomination invitation letter for HMPC member and alternate Your Excellency, Please find attached a letter signed by the European Medicines Agency's Executive Director requesting the nomination of a representative to the Agency's Scientific Committees. The letter is accompanied by: • Annex B • Committee composition and expertise You are kindly invited to address nominations to the European Medicines Agency’s Executive Director at [email protected] <mailto:[email protected]> (with copy to [email protected] <mailto:[email protected]> ). Please do not hesitate to contact me should you have any questions regarding this request for nomination. For the information of the National Competent Authority in cc of this email The nominee, if not registered in Experts Management Tool, will be required to register at: https://experts.ema.europa.eu/ <https://experts.ema.europa.eu/> • Registering in the Experts Management Tool, experts will be required to provide: Contact details and areas of expertise, Declaration of Interests, Curriculum Vitae. This should be completed with as much detail as possible. • Instructions on how to register in the Experts Management Tool can be found in this user manual (link <https://experts.ema.europa.eu/csp?id=kb_article_view&sysparm_article=KB0010555> ). The EMA policy and guidance document can be found on the EMA website: • European Medicines Agency policy on the handling of competing interests of scientific committees’ members and experts (link <https://www.ema.europa.eu/documents/other/policy-44-european-medicines-agency-policy-handling-competing-interests-scientific-committees_en.pdf> ) • Procedural guidance on inclusion of declared interests in the European Medicines Agency’s declaration of interests (for scientific committees’ members and experts) (link <https://www.ema.europa.eu/documents/regulatory-procedural-guideline/procedural-guidance-inclusion-declared-interests-european-medicines-agencys-electronic-declaration_en.pdf> ) Nominees will be subject to a pre-screening of any declared competing interest in line with the Agency's policy on handling of competing interests. In case of a negative outcome, the Agency will provide feedback of this screening to the nominating authority for subsequent consideration. 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. Sincerely yours, Martina Barbero Experts and Declarations of Interests Management Meeting Secretariat Office Committees and Quality Assurance Department European Medicines Agency <https://www.ema.europa.eu/> Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands Tel. +31887816550 [email protected] <mailto:[email protected]> | www.ema.europa.eu <https://www.ema.europa.eu/en> | For directions, see How to find us <https://www.ema.europa.eu/en/about-us/contact/how-find-us> Follow us: <https://www.youtube.com/user/emainfo> <https://www.linkedin.com/company/european-medicines-agency/> <https://bsky.app/profile/ema-eu.bsky.social> <https://www.instagram.com/onehealth_eu/> This message and any attachment contain information which may be confidential or otherwise protected from disclosure. It is intended for the addressee(s) only and should not be relied upon as legal advice unless it is otherwise stated. If you are not the intended recipient(s) (or authorised by an addressee who received this message), access to this e-mail, or any disclosure or copying of its contents, or any action taken (or not taken) in reliance on it is unauthorised and may be unlawful. If you have received this e-mail in error, please inform the sender immediately. Classified as internal/staff & contractors by the European Medicines Agency Classified as confidential by the European Medicines Agency 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) 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5520 Send a question via our website www.ema.europa.eu/contact An agency of the European Union © European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.   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 2/3   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. Recommendation on criteria for experience and expertise of HMPC members and alternates EMA/519883/2015 Page 3/3 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 Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands 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 An agency of the European Union © European Medicines Agency, 2026. Reproduction is authorised provided the source is acknowledged. 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 Digitally signed by Emer Cooke Date: 2026.03.23 13:06:18 +01'00' Emer Cooke Executive Director Encs: Annex B Current committee composition and expertise Page 2/2 Saatja: "Webdesktop" <[email protected]> Saaja: [email protected], "Info - SOM" <[email protected]>, "Elen Ohov - SOM" <[email protected]>, "Tiina Rootamm - SOM" <[email protected]> Teema: [Webdesktop: Incoming document] Esindajate nimetamine Euroopa Ravimiameti taimsete ravimite komiteesse (HMPC) Kuupäev: 2026-03-24 11:50 Tere! Edastan Euroopa Ravimiameti kirja. Vastamine käib esinduse kaudu. Palun saata info esinduse e-posti aadressile [email protected], cc-sse [email protected] . EV AEEL juures reg. number: 14-4/283 Reg. kuupäev: 24.03.2026 Sisu: Esindajate nimetamine Euroopa Ravimiameti taimsete ravimite komiteesse (HMPC) / Nomination of representatives (member and alternate) in the Committee on Herbal Medicinal Products (HMPC) of the European Medicines Agency (EMA) -- Heade soovidega Tiiu Noobel sekretär, EV alaline esindus EL juures +32 2227 4337