Amended Variations Regulation

The European Commission has introduced Regulation (EU) 2024/1701, amending Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use. Effective from 7 July 2024, this regulation aims to streamline post-authorisation procedures, enhancing the efficiency and future-proofing of the lifecycle management of human medicines.

Guidance on implementing the amended Variations Regulation (EU) 2024/1701 is available for variation applications submitted from 1 January 2025. This guidance includes instructions on:

• Annual updates for minor variations of type IA
• Procedures for grouping and super-grouping of Type IA variations
• Mandatory (same MAH) and voluntary (different MAHs) use of the work-sharing procedure
• Variations to human vaccines for public health emergencies

The European Commission is also reviewing the guidelines detailing the various categories of variations and the operation of the procedures, with an updated version expected during 2025.

During the transition period from 1 January 2025 until the updated variation guidelines are applicable, marketing authorisation holders (MAHs) should continue to refer to the current classification in the variation guidelines and consult specific procedural guidance available on the CMDh website.

Stakeholders are advised to regularly check the EMA and CMDh websites to ensure their systems, processes, and documentation comply with the forthcoming framework.