The European Commission on Friday sent a report to the European Parliament and the Council on medicines that are subject to additional pharmacovigilance monitoring, including what has happened since monitoring obligations were expanded in 2010 and 2012, and what the future may hold.
During the 2012 revision of the legislation, the mandatory scope of the additional monitoring list was extended to certain medicines with specific post-authorization obligations, including products for which a post authorization safety study (PASS) was requested. In 2013, Europe also added an inverted black triangle in the package leaflet to more clearly indicate which medicines are subject to additional monitoring.
A survey of EU member states found, according to a European Medicines Agency (EMA) report, that some countries said the inclusion of medicines with an imposed PASS in the additional monitoring list “leads to a large number of medicines which have been on the market for many years being subject to additional monitoring. Some Member States questioned the added value in these cases and the possibility for misunderstanding the reason for inclusion of the black triangle in the product information.”..