Marketing authorisation holders wishing to receive an outcome in 2026 should submit type IA annual updates, individual type IA and type IAIN variations, and super-groupings no later than 20 November 2026. This deadline allows EMA to acknowledge the validity of submissions within the 30-day timeframe set out in Article 14 of Commission Regulation (EC) No 1234/2008 and before the Agency closes from 22 December 2026 to 4 January 2027. Submissions received after 20 November will still be processed, but the outcome may not be issued until January 2027.
Marketing authorisation holders are advised to submit any type IB variations or groupings of type IBs and type IAs by 30 November 2026 for a start of procedure in 2026. For submissions received on or after 1 December 2026, the procedure may not start until January 2027.
https://www.ema.europa.eu/en/news/advice-end-year-submission-dates-type-i-variations-2026