The EMA has released new guidelines related to the update of the amended Variations Regulation (EU) 2024/1701 , that will enter into force on the 1st of January, 2025.
Key points on the updated guidance:
- Transition Period: The European Commission is currently reviewing the guidelines on the details of the various categories of variations and operation of the procedures, with an updated version expected later in 2025. During this transition, Marketing Authorization Holders (MAHs) should continue to follow the current classification and procedural guidance.
- Next Steps: Stakeholders are encouraged to monitor the CMDh and EMA websites and take necessary steps to prepare their systems, processes, procedures, and documentation for alignment with the new framework.
At Asphalion, our experts are ready to help. Contact us to learn more about how we can assist you in being compliant with the new regulations: [email protected]
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