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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

For the United Kingdom, as of 1 January 2021, European Union law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland / NI.

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