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 December 2025
8 December
NEW - 9-11 December CMDh agenda
Added in…
modified 08/12/2025
Meeting 9-11 December 2025: AgendaMeeting 11-13 November 2025: AgendaMeeting…
modified 08/12/2025
CMDh Best Practice Guide on the compilation of the dossier for New Applications…
modified 27/11/2025
Templates - DCP (AR/Comments) · D70 Preliminary AR and D120 Draft AR
modified 27/11/2025
Instructions for RMS when preparing the PAR based on the FAR (November 2025)PAR…
modified 27/11/2025
Botox (botulinum toxin type A)End of procedure: 04/11/2023Date of publication:…
modified 27/11/2025
Cleviprex (clevidipine)End of procedure: 30/07/2025Date of publication:…
modified 27/11/2025
Pentavac/Pentaxim (diphtheria, tetanus, pertussis (acellular, component),…
modified 27/11/2025
Recommendations on contacts with Representative Organisations (Last update:…
modified 27/11/2025
Meeting with Interested Parties - 19 November 2025
PresentationsCMDh - CTS…
modified 27/11/2025