1 October 2013 – The European Medicines Agency (EMA) and the European Commission have today officially launched the Black Triangle – medicinal products under additional monitoring. In April 2013 the EMA published the first list of medicines which are subject to such monitoring and, from 1 October, their package leaflets will feature the Black Triangle symbol.
The Black Triangle symbol was introduced as part of recent pharmacovigilance legislation as a way of clearly demonstrating which medicines are under additional monitoring by the EMA. From 1 October, the symbol will be published on the package leaflet of all drugs monitored in this way, a list of which is publicly available on the EMA website. The Black Triangle alerts patients and healthcare professionals to the importance of reporting side effects or adverse experiences in the use of particular medicines. Products subject to additional monitoring are not any less safe, but less information about them is generally know, for example because they are new on the market.
As the triangle enters into wide circulation, the EMA and the Commission is also moving into the second stage of its awareness campaign around use of the symbol. This campaign targets patients and healthcare professionals and has produced a number of resources and materials, also released on 1 October. These include:
The aim of the campaign is to increase awareness of the symbol and its meaning. In this second stage, it provides materials for use by health professionals and patients’ organisations, as well as national authorities, to raise such awareness and to encourage patients and healthcare professionals to report adverse effects experienced whilst using medicines that are under additional monitoring. Materials are accessible in all of the EU languages and patients and healthcare professionals are encouraged to consult the resources and disseminate them within their networks to strengthen the monitoring of higher-risk medicines.
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EPHA related articles:
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– Further information: