The Amended Variations Regulation No 1234/2008 enter into force on 1 January 2025
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...
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