EMA 发布 2026 年末 type I 变更的提交日期建议

Marketing authorisation holders wishing to receive an outcome in 2026 should submit type IA annual updates, individual type IA and type IA_IN 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. 

The Agency is expecting a high number of type IA annual updates in the last quarter of 2026. This may impact our usual timelines for validation and responses to queries for all type I variations (IA and IB). Applicants are advised to submit any type IB procedure as far in advance as possible to ensure the start of the procedure in 2026. The dates given above are tentative and will depend on the number and complexity of the submissions received.

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” and category “Human Regulatory”. The subcategory to be selected is “Post-authorisation - Human”, followed by the sub-option “Variation IA queries”, “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 guidance available below in the 'Related content' and 'Related documents' sections.