Reporting PSUR proceedings of foreign authorities

Risk-minimizing measures ordered in the context of PSUR/PBRER/PSUSA procedures must be reported to Swissmedic within 3 months (see Guidance document Drug Safety Signals HMP, chapter 7.2.). Day 0 is defined as the day on which the marketing authorisation holder (MAH) is informed by the evaluating authority about the necessary measures. If safety-relevant results are defined by the PRAC rapporteur in a PSUR preliminary assessment report, the associated measures can be rejected by the Committee for Medicinal Products for Human Use (CHMP) with an appropriate justification or - which is usually the case - confirmed. In this case, day 0 is also the day on which the MAH becomes aware of the measures. In this case, it would be the PRAC recommendation and not the CHMP decision. As a rule, these recommendations are also confirmed by the CHMP. However, for the implementation in Switzerland, the CHMP decision is not the only decisive factor.