EMA encourages companies to submit type I variations for 2024 by end November 2024

15 November 2024

EMA is advising marketing authorisation holders to submit type I variations for 2024 no later than 30 November 2024.

EMA is advising marketing authorisation holders to submit type IA and type IA_INvariations for 2024 no later than 30 November 2024. This will enable EMA to acknowledge the validity of the submissions before the Agency's closure between 20 December 2024 and 5 January 2025, 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 2024 for a start of procedure in 2024. For submissions received on or after 1 December 2024, the procedure may not start until January 2025.

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”. For queries related to fees, please raise it via the dedicated mailbox: [e-mail]

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

• Variations including extensions of marketing authorisations
• Fees payable to the European Medicines Agency | European Medicines Agency (EMA)

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