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 2026
03 April 2026
UPDATE - Position paper common grounds seen…
modified 04/04/2026
Summary of CMDh activities 2025
modified 04/04/2026
CMDh Multi-annual Workplan to 2028 (March 2026)
modified 04/04/2026
CMDh position paper on the use of Mobile scanning and other technologies to be…
modified 04/04/2026
Instructions for RMS when preparing the PAR based on the FAR (March 2026)PAR…
modified 03/04/2026
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
Best Practice Guides (BPGs) for the Submission and Processing of Variations in…
modified 03/04/2026
Templates Variation Assessment Report
modified 03/04/2026
