Regulatory update – EMA encourages companies to submit type I variations for 2022 by end of November

The European Medicines Agency (EMA) is advising marketing authorisation holders to submit type IA and type IA_IN variations for 2022 no later than Wednesday, 30 November 2022. This will enable EMA to acknowledge the validity of the submissions before the Agency’s closure between 23 December 2022 and 3 January 2023 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 2 December 2022 for a start of the procedure in 2022. For submissions received on or after 5 December 2022, the procedure may not start until January 2023.

For procedural or regulatory queries related to these procedures for human medicines, marketing authorisation holders can raise a ticket via the EMA Service Desk, using the “Question” option. The Type of question to be selected is “Post-authorisation queries”, followed by sub-option “Variation IA” or “Variation IB A&B scopes” or “Variation IB C scopes”. 

In support of the preparation of the variation(s) submission, please consult the below guidance.