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Regulamentul delegat (UE) 2024/1701 al Comisiei din 11 martie 2024 de modificare a Regulamentului (CE) nr. 1234/2008 în ceea ce privește examinarea modificării condițiilor autorizațiilor de introducere pe piață acordate pentru medicamentele de uz uman
Initiative summary:
This initiative, announced in the Pharmaceutical Strategy for Europe, aims to review the current rules setting out the procedures for post-authorisation changes to a marketing authorisation for medicines for human use. The purpose is to make the lifecycle management of medicines more efficient.