The European Medicines Agency (EMA) has started to publish the outcomes of single assessments of periodic safety update reports (PSURs), for active substances contained only in nationally authorised medicines as well as the lists of medicines concerned. This initiative will support the harmonised implementation of safety measures, for both Member States and pharmaceutical companies.
When a PSUR single assessment procedure leads to a variation of the marketing authorisation, a whole set of information materials is published in all official EU languages:
• The scientific conclusions.
• A timetable for implementation of the variation.
• Proposed changes to the wording of the product information where amendments to the product information are required.
Marketing-authorisation holders for products containing the active substance(s) concerned should submit a variation to the relevant national competent authority to align their marketing authorisation with the single assessment outcome (this also includes generic medicines or medicines authorised on the basis of well-established use as per Art. 23 of Directive 2001/83/EC and Art.61 of Regulation (EC) No 726/2004).