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.
EMA adopts first list of critical medicines for COVID-19
News On 7 June 2022, EMA’s Medicines Shortages Steering Group (MSSG) adopted the list of critical medicines for the COVID-19 public health emergency. The medicines included in the list are authorised...