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
EMA/CMDh explanatory notes on Variation Application Form - Human medicinal…
modified 30/07/2026
Added in July 2026
29 July
NEW - Report from the meeting held on 21-22 July…
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
Meeting with Interested Parties - 25 June 2026
MinutesPresentationsMfE - Impact…
modified 28/07/2026
Meeting 21-22 July 2026: AgendaMeeting 23-25 June 2026: Agenda - MinutesMeeting…
modified 28/07/2026
Contact Points
modified 23/07/2026
