EMA: List of centrally authorised products requiring a notification of a change for update of annexes

August 3, 2022

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August 2022

EMA Regulatory and Procedural Guideline

Parallel distributors are only required to inform the EMA of changes to the labelling or leaflet related to any update of the annexes of marketing authorisation once a year in their annual update application, except in cases related to safety or quality issues. The downloadable table lists the centrally authorised products for which the EMA requires notifications of safety update before implementation.

Download List of Products

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