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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 (July 2025)(to be used to locate…
modified 16/07/2025

Added in July 2025 16 July UPDATE - List of documents published on CMDh…
modified 16/07/2025

Bridging requirements for formulations in a well-establish use application
modified 16/07/2025

MRP / RUP
modified 16/07/2025

Deletion of interaction between broad spectrum antibiotics and combined oral…
modified 16/07/2025

CMDh letter for MAHs for medicinal products containing active ingredients in the…
modified 16/07/2025

Recommendations on submission dates for Applications of the Mutual Recognition…
modified 15/07/2025

Meeting with Interested Parties - 19 June 2025 AgendaPresentationsCMDh -…
modified 09/07/2025

Contact Points
modified 08/07/2025

CMDH PRESS RELEASES 2025
modified 07/07/2025

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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