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
Added in June 2025
30 June
UPDATE: Guidance on the application of the revised…
modified 30/06/2025
Variation Procedure
modified 30/06/2025
IMPLEMENTATION OF THE VARIATIONS FRAMEWORK
Marketing authorisation holders…
modified 30/06/2025
VARIATIONS FRAMEWORK
Variations Regulation
The revised Variations Regulation…
modified 30/06/2025
LEGAL FRAMEWORK
Regulation (EU) 2024/1701 of 11 March 2024 amending Regulation…
modified 30/06/2025
Following the revision of the Variation Regulation applicable since 1 January…
modified 30/06/2025
CMDH PRESS RELEASES 2025
modified 25/06/2025
Meeting 17-19 June 2025: AgendaMeeting 20-21 May 2025: Agenda - MinutesMeeting…
modified 20/06/2025
Questions and answers
A question-and-answer document is available for marketing…
modified 28/05/2025
Information on nitrosamines for marketing authorisation holders
modified 28/05/2025