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
Meeting 16-18 September 2025: AgendaMeeting 22-23 July 2025: Agenda -…
modified 29/09/2025
Havrix (hepatitis A virus strain HM175 (RIT4380), inactivated)End of procedure:…
modified 26/09/2025
Added in September 2025
25 September
NEW - Art. 46 PAR HavrixNEW - Art. 45 PAR…
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
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