EMA encourages companies to submit type I variations for 2023 in November 2023

3 November 2023

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

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 below guidance.

Related documents

European Medicines Agency practical guidance on the application form for centralised type IA and IB variations

Reference Number: EMA/233564/2014 Rev.5

Pre-notification check for type IA/IAIN variations

Reference Number: EMA/746161/2014 Rev. 1

Pre-notification check for type IB Variations

Reference Number: EMA/413829/2015