EMA is advising marketing authorisation holders to submit individual type IA and type IAIN variations and super-groupings for 2025 no later than 21 November 2025. This will enable EMA to acknowledge the validity of the submissions before the Agency’s closure between 23 December 2025 and 5 January 2026, within the 30-day timeframe set out in Article 14 of Commission Regulation (EC) No 1234/2008. Annual updates should be submitted according to the timelines stated in the revised Variation Regulation and published guidance on application of revised variations.
Marketing authorisation holders are advised to submit any type IB variations or groupings of type IBs and type IAs by 30 November 2025 for a start of procedure in 2025. For submissions received on or after 1 December 2025, the procedure may not start until January 2026.
The Agency is expecting a high number of annual updates and type IA submissions in the last quarter of 2025 ahead of the implementation of the new Variations Guidelines that come into force on 15 January 2026. This may impact our usual timelines for validation and responses to queries for all type I variations (IA and IB). Applicants are advised to submit any type IB procedure as far in advance as possible to ensure the start of the procedure in 2025. The dates given above are tentative and will depend on the number and complexity of the submissions received.
For procedural or regulatory queries related to these procedures for human medicines, marketing authorisation holders can raise a ticket via the EMA Service Desk, selecting the tab “Business Services”, category “Human Regulatory”. The subcategory to be selected is “Post-authorisation – Human”, followed by the sub-option “Variation IA queries” or “Variation IB A&B scopes queries” or “Variation IB C scopes queries”.
In support of the preparation of the variation(s) submission, please consult the guidance available below in the ‘Related content’ and ‘Related documents’ sections.