Risk Management (Signalmanagement, PSURs, RMPs/RMP summaries)

8 avril 2022 – The update to the guidance document “Information on PSUR [Periodic Safety Update Reports] / PBRER [Periodic Benefit-Risk Evaluation Reports]” regarding section 5.2 came into force on 1 April 2022 with a transitional period of 30 days.

For more information, see here.