Periodic safety update report single assessments
The European Medicines Agency (EMA) publishes the outcomes of single assessments of periodic safety update reports (PSURs) for active substances or combinations of active 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.
A single assessment of related PSURs is carried out for medicines that contain the same active substance or combination of active substances, as included in the list of EU reference dates (EURD list). EMA's scientific committees (PRAC and CHMP) and the CMDh together with the lead Member State assess the information in the related PSURs to determine whether the balance of benefits and risks has changed and whether any updates should be made to the marketing authorisation. More information is available in Periodic safety update reports: questions and answers.
The outcomes of PSUR assessments for active substances found only in centrally authorised medicinal products are published as part of each medicine's European public assessment report (EPAR). The outcome for nationally authorised medicinal products included in 'mixed' procedures where centrally authorised products were also involved can be found on the Community register maintained by the European Commission.
Active substances contained in nationally authorised medicines
For the lists of nationally authorised medicines involved in PSUR single assessments for active substances contained only in nationally authorised medicinal products, together with the outcomes of assessments that lead to a variation of marketing authorisations, see:
When a PSUR 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 authorisation with the single assessment outcome, 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). This is in line with Article 23 of Directive 2001/83/EC and Article 16 of regulation (EC) No 726/2004.
Documents presenting 'CMDh scientific conclusions and grounds for the variation, amendments to the product information and timetable for the implementation' contain all language versions within a single PDF file if they were published before 17 October 2016.