The Official Journal of the European Union publishes today a Communication from the European Commission (Commission) containing “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” (see, attached – the New Variations Guidelines).

The New Variations Guidelines, which define the rules for modifying and updating the marketing authorisations of medicines, replace the current guidelines on variations which date from 2013. They reflect the changes which Commission Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use has undergone over the years (most recently in 2024 – see, Van Bael & Bellis Life Sciences News and Insights of 17 June 2024).

The New Variations Guidelines will apply from 15 January 2026. Submissions for variations made before that date should follow the 2013 guidelines.

The Commission noted in a press release that “[t]he revision of the Variations Guidelines is the final step of the revision of the variation framework of medicines”.