Europe
An update to Delegated Regulation (EU) 2024/1701, which amends Regulation (EC) No 1234/2008, has been published and will come into effect on 1 January 2025. This regulation addresses the examination of variations to the terms of marketing authorisations for medicinal products for human use (referred to as the Variations Regulation).
The revision aims to enhance the efficiency of lifecycle management for medicines.
A guidance is available, providing instructions for the implementation of the amended Variations Regulation 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 (different MAHs) use of the work sharing procedure, on variations to human vaccines for public health emergencies and to the Annexes.
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