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 March 2025
13 March
UPDATE - Q&A on QP declaration
11 March
UPDATE…
modified 13/03/2025
QP declaration [Track version] (February 2025)
modified 13/03/2025
Templates for ASMF Procedures
modified 11/03/2025
Member: María Teresa Sanz PortilloAlternate: Elisa SulleiroAgencia Española del…
modified 10/03/2025
Contact Points
modified 10/03/2025
Lead Member State PSUR Follow-Up assessment report (February 2025) [Track…
modified 07/03/2025
Template - PSUR Assessment Report (February 2025) [Track version]
modified 07/03/2025
List of active substances and agreed SmPC wordings - EU work sharing procedure…
modified 07/03/2025
List of active substances for which data has been submitted in accordance with…
modified 07/03/2025
Templates Variation Assessment Report
modified 07/03/2025