On 6 July 2015, the European Medicines Agency (“EMA”) announced that it would begin publishing the outcome of single assessments of period safety update reports (“PSURs”) for active ingredients contained in nationally authorised medicinal products.
Periodic safety update reporting is performed during certain stages of the post-authorisation phase of the medicinal product. The report provides an assessment of the benefit-risk balance of the medicinal product. Such reporting is required in accordance with Regulation (EC) No 726/2004 and Directive 2001/83/EC.
The publication of the single assessment of PSURs for active ingredients found in nationally authorised medicinal products is coordinated by the EMA. The regulatory outcome for the active substance will be published on the EMA’s website. This publication will include a list of medicinal products which contain the concerned active ingredient. In practice, the publication of this information could enable companies to better identify and potentially address the findings of the single assessment concerning active substances.
In cases where the single assessment of the active ingredient leads to the conclusion that a variation to the initial marketing authorisation is required, the EMA will subsequently publish the supporting documentation in every official language of the European Union (“EU”). This could include the following information;
- Scientific conclusions and grounds for variation to the terms of the marketing authorisations;
- Amendments to the product information of the nationally authorised medicinal product(s); and
- Timetable for implementation.
If a variation to the terms of a marketing authorisation is required the marketing authorisation holder must submit an application for a variation to the competent authority of the relevant EU Member State in accordance with Article 23 of Directive 2001/83/EC and Article 16 of Regulation (EC) No 726/2004.
The publication of the outcome of single assessments of PSURs for active ingredients contained in centrally authorised medicinal products began in July 2012. This information is published as part of the European public assessment report. For both centrally and nationally authorised medicinal products, the publication of the single assessment of PSURs for active ingredients commenced in April 2013. The outcome of the procedure is published on the Community Register of the European Commission.
Marketing authorisation holders of nationally authorised medicinal products are recommended by the EMA to regularly check for updates on outcomes concerning active substances which could potentially affect their medicinal product.