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 April 2025
09 April
UPDATE - Report from the meeting held on 25-26…
modified 09/04/2025
CMDH PRESS RELEASES 2025
modified 09/04/2025
Template for AR for paediatric studies submitted in accordance with Article 46…
modified 09/04/2025
Template for AR for paediatric studies submitted in accordance with Article 45…
modified 09/04/2025
Concerned Member State's Comments on Lead Member State's Preliminary assessment…
modified 09/04/2025
Best Practice Guides (BPGs) for the Submission and Processing of Variations in…
modified 02/04/2025
List of active substances for which data has been submitted in accordance with…
modified 01/04/2025
Meeting 25-26 March 2025: AgendaMeeting 25-26 February 2025: Agenda -…
modified 31/03/2025
Further guidance on eSubmissions can be found on the EMA website under…
modified 28/03/2025
QP declaration [Track version] (February 2025)
modified 21/03/2025