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
Information on nitrosamines for marketing authorisation holders
modified 09/01/2025
Meeting 10-11 December 2024: AgendaMeeting 12-14 November 2024: Agenda -…
modified 09/01/2025
Questions and answers
A question-and-answer document is available for marketing…
modified 09/01/2025
Added In January 2025
07 January
UPDATE - Information on nitrosamines for…
modified 08/01/2025
CMDH PRESS RELEASES 2024
modified 08/01/2025
Variation Procedure
modified 07/01/2025
Guidance is available on the implementation of the amended Variations…
modified 07/01/2025
European Medicines Regulatory Network approach for the implementation of…
added 07/01/2025
For additional specific information related to nationally authorised products…
added 07/01/2025
Urgent Safety Restriction Members States' Standard Operating Procedure (March…
modified 07/01/2025