Risk mitigation measures
Marketing authorisation holders are obliged to apply for a change to the product information of a medicinal product if new findings concerning its safety come to light. Swissmedic also initiates action ex officio when it becomes aware of new risks.
Update to the guidance document “RMP ICH E2E Information for submission HMP”
Identification of officially ordered educational materials with the "Blue safety information" symbol and editorial revision
01.07.2025
The guidance document RMP ICH E2E Information for submission HMP has been thoroughly revised and supplemented.
Training materials will henceforth be referred to as educational materials. At the same time, officially ordered educational materials will be defined and described and the identification of these materials specified. With effect from 1 July 2025, educational materials that are officially ordered for the first time will have to be identified with the "Blue safety information" symbol. A transitional period applies to existing officially ordered educational materials.
With immediate effect, the latest RMP approved by the reference authority must be submitted in Module 1.8.2 for authorisations under Art. 13 TPA. If the reference authority is the FDA, an RMP should also be submitted in Swiss Module 1.8.2.
If EU RMPs are involved, standalone RMPs should always be submitted to Swissmedic only after they have been approved by the EMA.
The revised guidance document RMP ICH E2E Information for submission HMP is valid with effect from 1 July 2025.
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.
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.
