Updated Guidelines on the Variations Regulation - but not until January 2026

‍Following adoption of Regulation (EC) No 1234/2008 (the Variations Regulation), which applied from January 2010, the European Commission published related Guidelines in 2013. The Guidelines have not subsequently been updated. As a result, the revisions to the Variations Regulation that occurred in 2021 and 2024 are not reflected in the existing version of the Guidelines.

‍ The new Variation Guidelines that were recently published reflect the 2024 amendment of the Variations Regulation (Commission Delegated Regulation (EU) 2024/1701 of 11 March 2024). This amendment introduced, among other things, procedures according to which marketing authorisation holders may submit “super groups” of the same Type IA variations related to different medicinal products. The 2024 Regulation also extended existing work sharing procedures, with all Type IB and II variations related to different medicinal products belonging to the same marketing authorisation holder required to be submitted with a single application. The Regulation entered into application in January 2025.

‍The new Guidelines will enter into application on 15 January 2026. Any variations submitted prior to that date, including those based on the 2024 amendment to the Variations Regulation, should, however, follow the 2013 guidelines. This approach is confirmed in related comments on the EMA website which underline that 15 January 2026 represents a single cut-off date for the entry into application of the new Guidelines.

While, in light of the recent entry into application of the 2024 amendment to the Variations Regulation, it is tempting to seek inspiration from the new related Guidelines prior to submission of a variation the EMA position is clear. It requires that “Until 15 January 2026, marketing authorisation holders should continue to rely on the current Variations Guidelines and on the specific procedural guidance”. Seeking to rely on the new Guidelines before that date, however practical this may appear, may result in a refusal by the EMA to validate related submissions.

It is anticipated that, to assist marketing authorisation holders with the implementation of the new Guidelines, EMA will publish updated and new procedural guidance by the end of December 2025