WIREDGOV

Simpler way to access outcomes for nationally authorised medicines

The European Medicines Agency (EMA) has published a new search page on its website, helping users to find the outcomes of PSUSA procedures for active substances or combinations of active substances contained in nationally authorised medicines. 

Users can browse alphabetically by active substance(s) concerned, search by active substance or procedure number, and filter by regulatory outcome. 

PSUSAs are single assessments of related periodic safety update reports (PSURs) foractive substances contained in medicines authorised in the European Union (EU). A PSUR is a pharmacovigilance report submitted regularly by a marketing-authorisation holder at defined time points following a medicine's authorisation. 

When a single assessment procedure leads to a variation of marketing authorisations, marketing-authorisation holders for nationally authorised products containing the active substance(s) concerned should submit a variation to align their marketing authorisationwith the single assessment outcome. This applies even if their product was not in the direct scope of the procedure, such as a generic medicine or a medicine authorised on the basis of well-established use.

Related content

• Outcomes of periodic safety update report single assessments
• Periodic safety update reports: questions and answers