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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 May 2025 02 May  UPDATE - MRP/RUP request formNEW - Report from the…
modified 02/05/2025

MRP / RUP
modified 02/05/2025

CMDH PRESS RELEASES 2025
modified 02/05/2025

Meeting 23-24 April 2025: AgendaMeeting 25-26 March 2025: Agenda -…
modified 29/04/2025

Member: Daniela Elena Popa National Medicines Agency and Medicinal Devices of…
modified 25/04/2025

Template for AR for paediatric studies submitted in accordance with Article 46…
modified 09/04/2025

Template for AR for paediatric studies submitted in accordance with Article 45…
modified 09/04/2025

Concerned Member State's Comments on Lead Member State's Preliminary assessment…
modified 09/04/2025

Best Practice Guides (BPGs) for the Submission and Processing of Variations in…
modified 02/04/2025

List of active substances for which data has been submitted in accordance with…
modified 01/04/2025

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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