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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 September 2025 25 September NEW - Art. 46 PAR HavrixNEW - Art. 45 PAR…
modified 25/09/2025

HavrixEnd of procedure: 30/06/2025Date of publication: 25/09/2025
modified 25/09/2025

Pheniramine maleate, naphazoline hydrochlorideEnd of procedure: 11/08/2025Date…
added 25/09/2025

Overview of timetables
modified 25/09/2025

Referral decisions and new product information changes can be found on: the…
modified 25/09/2025

RMS Validation Checklist for human medicinal products in DCP (September 2025)…
modified 25/09/2025

Request for RMS in a Decentralised Procedure, medicinal products for human use
modified 25/09/2025

Meeting 16-18 September 2025: AgendaMeeting 22-23 July 2025: Agenda -…
modified 25/09/2025

2025, Q1-Q2 - Statistics for New Applications (MRP/DCP), Variations, Referrals…
modified 25/09/2025

Templates MRP/ DCP Referral to CMDh
modified 25/09/2025

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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