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 July 2026
03 July
NEW - Summary ARs for doxazosin…
modified 03/07/2026
Doxazosin mesilate, finasteride (MIP Pharma) / Doxazosin mesilate, finasteride…
added 03/07/2026
Instructions for RMS when preparing the PAR based on the FAR (June 2026) [Track…
modified 03/07/2026
Templates - DCP (AR/Comments) · D70 Preliminary AR and D120 Draft AR
modified 03/07/2026
Post-Brexit (June 2026) [Track version]
modified 03/07/2026
QP declaration (June 2026) [Track version]
modified 03/07/2026
Best Practice Guides (BPGs) for the Submission and Processing of Variations in…
modified 03/07/2026
Variations [Track version]
modified 03/07/2026
Cover letter for Variation Applications in the Mutual Recognition Procedure
modified 03/07/2026
CMDh Best Practice Guide on the use of eCTD in the MRP/DCP
modified 03/07/2026
