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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 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

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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