The amendments of the Variation Regulation are published in the Official Journal of the European Union

The new measures for the better lifecycle management of medicine authorisations are published in the Official Journal of the European Union on 17 June 2024:

Commission Delegated Regulation (EU) 2024/1701 of 11 March 2024 amending Regulation (EC) No 1234/2008 as regards the examination of variations to the terms of marketing authorisations for medicinal products for human use