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
CMDh SOP on the processing of PSUR single assessment for nationally authorised…
modified 11/02/2025
Member: vacantAlternate: Elisa SulleiroAgencia Española del Medicamento y…
modified 11/02/2025
2021 - Statistics for New Applications (MRP/DCP), Variations, Referrals and…
modified 10/02/2025
2020 - Statistics for New Applications (MRP/DCP), Variations, Referrals and…
modified 10/02/2025
Added In February 2025
06 February
UPDATE - Template for Request for RMS in…
modified 06/02/2025
Best Practice Guide on (1) Introduction of substances/combinations onto the EURD…
modified 06/02/2025
Best Practice Guides (BPGs) for the Submission and Processing of Variations in…
modified 06/02/2025
Pamorelin LA 22.5 mg (triptorelin pamoate)End of procedure: 04/12/2024Date of…
modified 06/02/2025
CMDh SOP on decision-making process for new active substance status or extension…
modified 06/02/2025
Procedural Advice on Repeat Use
modified 06/02/2025