1 March 2025
Swissmedic: Changes to guidance documents “authorisation of herbal medicinal products” and “information on PSUR PBRER submission HMP”
Swissmedic has published updated guidance documents on the authorization of herbal medicinal products and information on PSUR PBRER submission HMP. The first includes editorial revisions and content-related clarifications, additions and restructurings while the second is an editorial revision. The Periodic Safety Update Report (PSUR, also referred to as the Periodic Benefit-Risk Evaluation Report (PBRER)) for a medicinal product is a pharmacovigilance document that contains a comprehensive and critical evaluation of the risk-benefit profile of the medicinal product at certain time-points after it has been authorized.