From 20 October 2023, EMA is publishing RMPs (main body and annexes 4 and 6) for all centrally authorised products:
initial evaluations;
RMP updates.
EMA no longer publishes RMP summaries from the same date.
The aim is to increase transparency of the safety review process for all centrally authorised products.
The RMP or RMP summary is available on each medicine page. Alternatively, a historical list of all RMP summaries is available.
For further information on RMPs and on the anonymisation of personal data (PD) and assessment of commercially confidential information (CCI) during the preparation of RMPs, please refer below link
EMA RMP https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/pharmacovigilance/risk-management/risk-management-plans#:~:text=Publication%20of%20RMPs%20and%20their%20summaries%20(updated),-Update%3A%20From%2020&text=EMA%20no%20longer%20publishes%20RMP,available%20on%20each%20medicine%20page.
https://www.ema.europa.eu/en/search/search/type/ema_document/ema_editorial_content/ema_document/field_ema_doc_type%253Aname_field/EPAR%20-%20Risk-management-plan%20summary
Leave a Reply