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
CMDh position paper on the use of Mobile scanning and other technologies to be…
modified 07/04/2026
Instructions for RMS when preparing the PAR based on the FAR (March 2026) [Track…
modified 07/04/2026
Position paper on common grounds seen for invalidation/delaying day 0 for…
modified 07/04/2026
Added in April 2026
07 April
NEW - Ramipril/indapamide PSUR WS SmAR
03…
modified 07/04/2026
Ramipril/indapamideDate of publication: 07/04/2026
added 07/04/2026
Summary of CMDh activities 2025
modified 04/04/2026
CMDh Multi-annual Workplan to 2028 (March 2026)
modified 04/04/2026
Templates - DCP (AR/Comments) · D70 Preliminary AR and D120 Draft AR
modified 03/04/2026
Paediatric Regulation: Article 45 and Article 46
Best Practice Guide for…
modified 03/04/2026
Questions and Answers on Paediatric Regulation
modified 03/04/2026
