Human Medicines
This area of the website provides information relating to the regulation of human medicines, including access to product information, pharmacovigilance and the directory of relevant agencies.
HUMAN MEDICINES | RECENTLY PUBLISHED
Pneumovax and associated names (pneumococcal polysaccharide…
modified 13/02/2026
Added in February 2026
13 February
Update - Q&A on Generics
10 February
NEW…
modified 13/02/2026
Generics
modified 13/02/2026
Elvanse (lisdexamfetamine dimesylate)SE/W/0031/pdWS/001End of procedure:…
modified 10/02/2026
IMPLEMENTATION OF THE VARIATIONS FRAMEWORK
Marketing authorisation holders…
modified 10/02/2026
CMDH PRESS RELEASES 2026
modified 04/02/2026
RELATED DOCUMENTS
EMA has issued guidance documents aligned with the revised…
modified 03/02/2026
Meeting 9-11 December 2025: Agenda - MinutesMeeting 11-13 November 2025: Agenda…
modified 03/02/2026
LEGAL FRAMEWORK
Regulation (EU) 2024/1701 of 11 March 2024 amending Regulation…
modified 03/02/2026
Contact Points
modified 27/01/2026