Variations to MRP/DCP marketing authorisations

The Commission Regulation (EU) No. 2024/1701 of 11th March 2024 amending Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products became effective on 1st January 2025. The consolidated version is available on EUR-Lex website.

The communication from the Commission – Guidelines on the details of the various categories of variation, on the operation of the procedures laid down in Chapters II, IIa, III and IV of Commission Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use, and on the documentation to be submitted pursuant to those procedures becomes effective on 15th January 2026. The communication is available on EUR-Lex website.