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

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 document contains table that lists the centrally authorised products for which the EMA requires a notification of change before implementation.