Summary
EMA advises marketing authorisation holders to submit specified Type IA variations by 20 November and Type IB filings by 30 November 2026. The dates are tentative and may shift with submission volumes and complexity.
The European Medicines Agency (EMA) has advised medicine marketing authorisation holders to submit specified Type I variation applications by late November 2026 if they want procedures to reach particular milestones before the end of the year. The agency says the dates are tentative and depend on the volume and complexity of applications it receives.
A variation is a change to the terms of an existing medicine marketing authorisation. Type IA and Type IB are different regulatory categories for handling such post-authorisation changes.
The November dates and what they cover
For holders seeking an outcome in 2026, EMA advises submitting Type IA annual updates, individual Type IA and Type IAIN variations, and super-groupings by 20 November 2026. The deadline is intended to give the agency time to acknowledge the submissions’ validity within the 30-day timeframe set out in Article 14 of Commission Regulation (EC) No 1234/2008, before EMA closes from 22 December 2026 to 4 January 2027. Submissions received after 20 November will still be processed, but their outcome may not be issued until January 2027.
For a start of procedure in 2026, EMA advises submitting Type IB variations, or groupings of Type IBs and Type IAs, by 30 November. Applications received on or after 1 December 2026 may not enter the procedure until January 2027.
Workload may affect processing
EMA expects a high number of Type IA annual updates in the last quarter of 2026. The agency says this could affect its usual validation and response-to-query timelines for all Type I variations, including IA and IB. It recommends submitting Type IB procedures as far in advance as possible when a 2026 start is sought.
The dates are planning guidance rather than fixed guarantees: EMA says they depend on the number and complexity of submissions. Marketing authorisation holders with procedural or regulatory questions about human-medicine variations can contact EMA through its Service Desk, using the “Human Regulatory” and relevant post-authorisation variation query categories.