EMA is advising marketing authorisation holders to submit type IA and type IAIN variations for 2023 no later than Thursday, 30 November 2023. This will enable EMA to acknowledge the validity of the submissions before the Agency’s closure between 25 December 2023 and 3 January 2024 and within the 30-day timeframe set out in Article 14 of Commission Regulation (EC) No 1234/2008.
Marketing authorisation holders are advised to submit any type IB variations or groupings of type IBs and type IAs by 30 November 2023 for a start of the procedure in 2023. For submissions received on or after 1 December 2023, the procedure may not start until January 2024…
