IMPLEMENTATION OF THE VARIATIONS FRAMEWORK Marketing authorisation holders (MAHs) and national competent authorities should follow certain principles to facilitate a smooth transition to the new variations framework. Type-IB and II variations (including grouped Type-IA variations) For Type-IB and / or Type-II variations submitted before 15 January 2026:  These types of variations will follow the current Variations Guidelines until the procedure is completed (even if completed after 15 January 2026).MAHs should use the current electronic application form (eAF) version for these submissions. For Type-IB and Type-II variations submitted as of15 January 2026:  These types of variations will follow the new Variations Guidelines.MAHs should use the updated eAF version for these submissions. Type-IA variations The date of implementation of the change(s) in the quality management system of the marketing authorisation holder (MAH) should be taken as the point of reference for the application of the current/new Variations Guidelines (rather than the date of submission used for type IB/II variations). To facilitate the transition for Type IA variations and minimise the overlap of the two systems the rules stated below should apply. For all Type-IA variations implemented before 15 January 2026 should be submitted before 15 January 2026 using the current electronic application form (eAF) version. If no annual update is due before 15 January 2026, the MAH should submit said implemented variations preferably as an earlier annual update submission or otherwise as individual notifications outside the annual update.For all Type-IA variations implemented as of 15 January 2026, the first type-IA variation implemented as of 15 January 2026 will start a new cycle for the annual update, unless one of the listed annual update exemptions applies to that variation. All variations For any variations submitted before 15 January 2026: The new variation classification categories and the updated electronic application form (eAF) cannot be used in anticipation of the entry into application of the new Variations Guidelines.Any variations submitted before 15 January 2026 using the updated eAF version and / or a new variation category will not be validated and the marketing authorisation holder (MAH) will have to revise its application. For any variations submitted and implemented as of 15 January 2026:  MAHs should use the updated eAF version. The updated eAF will be published before 15 January 2026 to enable MAHs to prepare applications planned for submission after 15 January 2026. EMA and CMDh will publish more guidance regarding the implementation of the new variation categories. Stakeholders should monitor the webpages on EMA and HMA websites mentioned at the Variations framework section. They should also take the necessary measures to prepare their systems, processes, procedures and documentation for compliance with the revised variation framework. In case of doubt, MAHs should contact the relevant competent authority.