Guidance is available on the implementation of the amended Variations Regulation (EU) 2024/1701 for variation applications implemented and submitted from 1 January 2025. This guidance provides instructions on the implementation of the amended Variations Regulation applicable as of 1 January 2025 that includes amendments to the Article 5 procedure, on the annual update for minor variations of type IA, on the procedure for grouping and super-grouping of Type IA variations, on the annual update of a human influenza or human coronavirus vaccine, on the mandatory (same MAH) and voluntary (differentMAHs) use of the work sharing procedure, on variations to human vaccines for public health emergencies and to the Annexes. The European Commission is also currently reviewing the guidelines on the details of the various categories of variations and operation of the procedures (Variations guidelines: Proposed amendments to the European Commission guidelines on variations categories and procedures) and an updated version is expected during 2025. During this transition period, from 1 January 2025 and until the updated Variation Guidelines become applicable, marketing authorisation holders (MAHs) should continue to rely on the current classification part of the Variations Guidelines and on specific procedural guidance that is available here below and on the EMA website. Stakeholders are invited to monitor the CMDh and EMA websites and to take the necessary measures to prepare their systems, processes, procedures and documentation for compliance with the upcoming framework. Variation applications submitted before 1 January 2025 will still follow the current provisions as defined in Regulation (EC) No 1234/2008 as amended by Commission Delegated Regulation (EU) 2021/756 until their conclusion. In case of doubt, MAHs should contact the relevant competent authority.
