Europe
The European Commission has published draft guidelines detailing the revised framework for variations to marketing authorisations of human medicines. These guidelines follow the updated Variation Regulation (EU) 2024/1701, which became applicable on 1 January 2025, and are expected to take full effect from 15 January 2026.
The new draft guidance outlines how various types of variations – including Type IA, IB, and II – will be processed under the revised framework, aiming to streamline and future-proof the lifecycle management of authorised medicines in the EU.
Key points include:
- Type-IB and II variations submitted before 15 January 2026 will continue under the current guidelines; those submitted from 15 January 2026 onward must follow the new guidelines and use the updated electronic application form (eAF).
- Type-IA variations are handled based on the date of implementation of the change, not the submission date.
- Any submissions before 15 January 2026 must still follow current classification categories and use the current eAF; otherwise, they will not be validated.
Marketing authorisation holders (MAHs) are urged to begin preparing their systems and documentation in anticipation of the upcoming changes and monitor updates from the EMA and HMA.
Finalised guidelines will be published in the Official Journal of the European Union. Until then, the current guidelines remain in force.