New EU symbol to identify medicines undergoing additional monitoring

An inverted triangle will shortly appear on the inside leaflet of certain medicinal products on the EU market. According to the European Commission, this 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.

The European Commission reported that from September 2013, an inverted triangle will be used to identify these pharmaceutical products that are subject to additional monitoring. The European Medicines Agency informed stakeholders on the introduction of new pharmacovigilance legislation in February 2012.

In particular, the new symbol will be on the leaflet of 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; and 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.

The Europe's pharmacovigilance system is, according to the European Commission, one of the most advanced and comprehensive systems in the world ensuring a high level of public health protection throughout the Union. Once a medicinal product has been authorised in the Union and placed on the market, its safety is monitored throughout its entire lifespan to ensure that, in case of adverse reactions that present an unacceptable level of risk under normal conditions of use, it is rapidly withdrawn from the market.