Please be advised that the amended Variations Regulation No 1234/2008 (amended by Commission Delegated Regulation (EU) 2024/1701) enter into force on 1 January 2025.
Key changes concerning the preparation of variation applications from this date include:
- amendments on the procedure for grouping and super-grouping of Type IA variations
- amendments on the annual update for minor variations of type IA - mandatory
- amendments to the Article 5 procedure
- amendments on the annual update of a human influenza or human coronavirus vaccine
- amendments on the mandatory (same MAH) and voluntary (differentMAHs) use of the work sharing procedure
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.
The amended Variation Guidelines (2013/C 223/01) are expected during 2025. Until the updated Variation Guidelines become applicable marketing authorisation holders (MAHs) should continue to rely on the current classification part of the Variations Guidelines.
For more information, please see: https://www.hma.eu/human-medicines/cmdh/procedural-guidance/variation/amended-variation-regulation.html
