EMA is advising marketing authorisation holders to submit individual type IA and type IA_IN 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…