Europe
Following the revision of the Variation Regulation effective as of 1 January 2025, the European Commission (EC) has adopted and published the final version of the guidelines concerning the classification of variations and the operation of the relevant procedures: Guideline.
The final document establishes a single cut-off date for its entry into application, namely 15 January 2026.
Until that date, marketing authorisation holders are expected to continue to follow the currently applicable Variations Guidelines together with the existing procedural guidance.
Source: Guidance on the application of the revised variations framework | European Medicines Agency (EMA)