Revision of the EU variation framework for medicines (REFIT)
In “Promoting our European Way of Life”
In its pharmaceutical strategy, adopted on 25 November 2020, which is in line with Europe's Beating Cancer Plan, the European Commission announced that, over the coming years, it would launch several legislative and non-legislative actions. These would include, among others, a revision of the basic pharmaceutical legislation (Directive 2001/83/EC and Regulation (EC) No 726/2004) (see separate fiche) and also a revision of the variation framework for medicines, through changes in legislation and guidelines, to make the lifecycle management of medicines more efficient and adapted to digitalisation.
According to the Commission work programme for 2023, published on 18 October 2022, the initiative would be put forward at the end of 2023.
The revision of the variation framework for medicines, complementary to the changes made in the context of the review of the pharmaceutical legislation, could lead to the reduction of administrative burden for industry and free up resources that are currently absorbed by the large number of variations. This initiative aims to review the current rules setting out the procedures for post-authorisation changes to a marketing authorisation for medicines for human use. The purpose is to make the lifecycle management of medicines more efficient.
- European Commission, Commission work programme 2023 'A Union standing firm and united', COM(2022) 548 final
- EP Legislative Observatory, A pharmaceutical strategy for Europe, 2021/2013(INI)
- European Commission, Europe's Beating Cancer Plan: A new EU approach to prevention, treatment and care, including factsheet and Q&A memo, website
Author: Laurence Amand-Eeckhout, email@example.com