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, including rare diseases and paediatric medicines legislation (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.

A call for evidence was launched by the Commission in August 2023; feedback period till 26 September 2023 (30 feedback instances received).

On 11 March 2024, the Commission adopted a delegated regulation amending Regulation (EC) No 1234/2008 as regards the examination of variations to the terms of marketing authorisations for medicinal products for human use. The legal basis of this delegated regulation is Article 23b(2a) of Directive 2001/83/EC and Article 16a(3) of Regulation (EC) No 726/2004. These empower the Commission to adopt delegated acts specifying the categories in which variations are to be classified and setting out procedures for examining applications for variations to the terms of marketing authorisations. This delegated regulation amends Commission Regulation (EC) No 1234/20083 by amending and adding provisions on the applicable procedures and categories for the variations to the terms of marketing authorisations for products for human use to make the life-cycle management of medicines more efficient. 

References:

• EP Legislative Observatory, procedure file on  Examination of variations to the terms of marketing authorisations for medicinal products for human use, 2024/2653(DEA)  
• Commission Delegated Regulation amending Regulation (EC) No 1234/2008 as regards the examination of variations to the terms of marketing authorisations for medicinal products for human use,11 March 2024,  C(2024) 1627.
• Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001).
• Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing a European Medicines Agency (OJ L 136, 30.4.2004).
• Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (OJ L 334, 12.12.2008)
• 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
• European Commission, call for evidence

Author: Laurence Amand-Eeckhout, legislative-train@europarl.europa.eu