EMA: List of centrally authorised products requiring a notification of a change for update of annexes
August 3, 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.
Validation checklist for initial marketing authorisation applications - biologicals other than immunologicals (applicable to submissions under Regulation (EU) 2019/6)
JUNE 2022 EMA/278419/2022-Rev.1 This validation checklist is used by the Agency to validate initial marketing authorization applications for pharmaceuticals and applicants should use it as a means to...