Pharmaceuticals: New symbol to identify medicines undergoing additional monitoring

Very soon an inverted triangle will appear on the inside leaflet of certain medicinal products on the EU market, following a legal act adopted by the European Commission. The symbol will allow patients and health care professionals to easily identify medicinal products that are undergoing additional monitoring, and its accompanying text will encourage them to report unexpected adverse reactions through national reporting systems. Tonio Borg, European Commissioner for Health and Consumer Policy said: “The symbol is easy to recognise for patients and healthcare professionals. It will help to obtain more and better information from them on possible side effects of a medicine, which then can be thoroughly analysed. Stronger involvement of patients in the reporting on side effects is an integral part of Europe’s pharmacovigilance system and – once in place – the new symbol will contribute to strengthen what is already one of the most advanced systems in the world.” From September 2013, the symbol will be used to identify these pharmaceutical products that are subject to additional monitoring: All medicinal products authorised after 1 January 2011 that contain a new active substance; Biological medicinal products, such as vaccines or plasma derived products, authorised after 1 January 2011; Products for which certain additional information is required post-authorisation, or for which authorisation is subject to conditions or restrictions on their safe and effective use.

Europa, 7 March 2013 ; ;