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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

List of documents published on CMDh website (February 2026)(to be used to locate…
modified 19/02/2026

Chairperson:  Priscilla Schoondermark
modified 19/02/2026

Training presentations on Active Substance Master File (ASMF) work sharing…
modified 19/02/2026

Guidance on the work sharing procedure for the assessment of Active Substance…
modified 19/02/2026

An Active Substance Master File (ASMF) can be used to replace the…
modified 19/02/2026

Mandate for the Working Group on Active Substance Master File…
modified 19/02/2026

Meeting with Interested Parties - 19 November 2025 MinutesPresentationsCMDh -…
modified 16/02/2026

Pneumovax and associated names (pneumococcal polysaccharide…
modified 13/02/2026

Added in February 2026 13 February Update - Q&A on Generics 10 February NEW…
modified 13/02/2026

Generics
modified 13/02/2026

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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