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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

For the United Kingdom, as of 1 January 2021, European Union law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland / NI.

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