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
Templates for ASMF Procedures
modified 11/03/2025
Added in March 2025
11 March
UPDATE - AR template Active Substance Master File…
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
Templates - DCP (AR/Comments) · D70 Preliminary AR and D120 Draft AR
modified 06/03/2025