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Agenda – 102nd meeting of the Pharmaceutical Committee (1 April 2025)

The agenda of the 102nd meeting of the Pharmaceutical Committee (1 April 2025) is the following:

1. Adoption of the draft agenda
2. Adoption of Rules of Procedure
3. Electronic product information for medicines
4. Presentation of a proposal for a Regulation laying down a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and the accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795 (‘Critical Medicines Act’)
5. Pharmaceuticals in the Environment: Presentation of the final report of the ad-hoc Working Group and discussion on possible future needs
6. Presentation of Regulation (EU) 2024/1938 on standards of quality and safety for substances of human origin intended for human application (the new ‘SOHO Regulation’)
7. Regulation (EU) 2024/568 on fees and charges payable to the European Medicines Agency (‘new fee Regulation’) discussion on inflation rate, following the annual monitoring
8. Draft Guidelines on the details of the various categories of variations, on the operation of the procedures laid down in Chapters II, IIa, III and IV of 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 and on the documentation to be submitted pursuant to those procedures
9. A.O.B.

Read the news announcement published by Directorate-General for Health and Food Safety on 14 March 2025.


OpenEdition vous propose de citer ce billet de la manière suivante :
lsgilbert (23 avril 2025). Agenda – 102nd meeting of the Pharmaceutical Committee (1 April 2025). ELSIBI. Consulté le 18 janvier 2026 à l’adresse https://doi.org/10.58079/13sky


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