Risk Management (Signalmanagement, PSURs, RMPs/RMP summaries)
01.06.2025 – Changes to the form PSUR/PBRER for human medicines
Changes to the form PSUR/PBRER for human medicines
Information on the RMP update
01.06.2025
The form PSUR / PBRER for human medicines has been modified. Aspects relating to safety concerns, additional pharmacovigilance activities and/or additional risk-minimising measures affected by the RMP update must now be specified. The RMP summary no longer need be submitted simultaneously. In this connection, please also note the guidance document RMP ICH E2E Information for submission HMP.
The revised form PSUR/PBRER for human medicines comes into force on 1 June 2025.
01.03.2025 – Changes to the Guidance document “Information on PSUR PBRER submission HMP”
Changes to the Guidance document “Information on PSUR PBRER submission HMP”
Editorial revision
01.03.2025
The Guidance document Information on PSUR PBRER submission HMP has undergone a thorough editorial revision with the aim of explaining the applicable formal and regulatory aspects more clearly for marketing authorisation holders, and thus helping them to submit documents correctly. Some sections have been added or refined for a better understanding.
The revised Guidance document Information on PSUR PBRER submission HMP comes into force on 1 March 2025.
