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
IMPLEMENTATION OF THE VARIATIONS FRAMEWORK
Marketing authorisation holders…
modified 16/01/2026
CMDh Recommendation for classification of unforeseen variations according to…
modified 16/01/2026
Variations [Track version]
modified 16/01/2026
EMA/CMDh explanatory notes on Variation Application Form - Human medicinal…
modified 16/01/2026
Template for MAHs to provide their responses during type II variations or…
modified 16/01/2026
CMDh SOP on the processing of PSUR single assessment for nationally authorised…
modified 16/01/2026
Recommendation for implementation of Commission Decisions or CMDh agreements…
modified 16/01/2026
Best Practice Guides (BPGs) for the Submission and Processing of Variations in…
modified 16/01/2026
Templates
modified 16/01/2026
Member State agreement upon conditions under which the RMS can start renewal…
modified 16/01/2026