The regulation sets out the procedures for updating marketing authorisations when new indications are sought, or when new data (on adverse effects, efficacy, use in children, etc.) become available (1).

In February 2024, Prescrire contributed to a consultation on the draft version of this delegated regulation (2). Prescrire's "feedback" included three requested changes to the regulation:

• Provide the possibility of extending the assessment period for major (type II) variations (new or modified indications which have a significant impact on quality, efficacy or safety) to enable robust assessment;
• Increase transparency, in particular by publishing an assessment report on each type II variation;
• Process changes to combination products (composed of a medicinal product and a medical device) or in-vitro diagnostic medical devices through the procedure for major (type II) variations.

Barely two weeks after the deadline for responses to this consultation, the European Commission published the final version of the delegated regulation… None of Prescrire's requests had been taken into account (3).

References 
1- "New data after marketing authorisation: European Commission consultation" Prescrire Int 2024; 33 (261): 194-195. 
2- "Prescrire's position paper on the proposed revision of the European Commission delegated regulation related to the examination of marketing authorisation variations" 28 February 2024: 6 pages. 
3- "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 (...)" Official Journal of the European Union, 17 June 2024.

©Prescrire 1 December 2024

Source: "New data after marketing authorisation: European Commission consultation (continued)" Prescrire Int 2024; 33 (265): 307. Free.

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