VARIATIONS FRAMEWORK Variations Regulation The revised Variations Regulation applies since 1 January 2025 for variation applications implemented and submitted from 1 January 2025. Variations Guidelines A single cut-off date for the entry into application (i.e., 15 January 2026) is set out in the final version of the Variations Guidelines. Until 15 January 2026, marketing authorisation holders should continue to rely on the current Variations Guidelines and on the specific procedural guidance. To find procedural guidance on both the Variations Regulation and current Variations Guidelines, see the EMA and CMDh websites: Variations including extensions of marketing authorisationsCMDh: Variation procedure
