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 August 2026
04 August
UPDATE - Guidance published by Member States on…
modified 04/08/2026
Guidance published by Member States on the implementation of the Falsified…
modified 04/08/2026
CMDh letter for MAHs for medicinal products containing active ingredients in the…
added 04/08/2026
CMDh Multi-Annual Workplan to 2020 (April 2016)
modified 03/08/2026
EMA/CMDh explanatory notes on Variation Application Form - Human medicinal…
modified 30/07/2026
Templates Variation Assessment Report
modified 30/07/2026
Best Practice Guides (BPGs) for the Submission and Processing of Variations in…
modified 30/07/2026
Template of letter of intent for the submission of a worksharing procedure (July…
modified 30/07/2026
2026 (Jan-Jun) - Statistics for New Applications (MRP/DCP), Variations,…
added 29/07/2026
CMDH PRESS RELEASES 2026
modified 29/07/2026