Sections 6.1 and 6.2 letter B have been updated by the addition of references to annual reports from the EU signal management process. These annual reports referred to in Art. 60 para. 1bis TPO cannot be submitted as a substitute for a PSUR because they do not satisfy the minimum content requirements for a periodic safety update report as described in section 6.2 letter A (requirements in accordance with Guideline VICH GL 29).
However, Swissmedic can accept different formats provided their content meets the requirements of Guideline VICH GL 29.
The revised guidance document PSUR Signal Management TAM is valid with effect from 1 November 2025.