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New Symbol for Monitoring Medicines in Europe 

The European Commission says that an inverted triangle will shortly appear on the inside leaflet of certain drugs “to easily identify medicinal products that are undergoing additional monitoring”.  

EMA states that Patients and healthcare professionals should be able to easily identify medicinal products that are subject to additional monitoring in order to allow them to share with the competent authorities and the marketing auth­orisation holder any information they have from the use of the medicinal product and in particular to report suspected adverse reactions. To ensure transparency, all medicinal products that are subject to additional monitoring are included in a list that is set up and maintained by the European Medicines Agency.. Additionally, they are labelled with a black symbol. On 3 October 2012 the Pharmacovigilance Risk Assessment Committee adopted a recommendation stating that the black symbol should be an inverted equi­lateral black triangle. The recommendation took into account the views of patients and healthcare professionals as expressed by the Patients’ and Consumers’ Working Party and the Healthcare Professionals’ Working Group established by the European Medicines Agency. 

The black upside-down triangle and accompanying text will encourage patients and doctors to report unexpected adverse reactions through national reporting systems. From September 2013, the symbol will be applied to all drugs authorised after January 1, 2011 that contain a new active substance, plus biological medicines, such as vaccines or plasma-derived products. The new symbol will also be used on products “for which certain additional information is required post-authorisation”, or for which approval is subject to “conditions or restrictions on their safe and effective use”. Following input from different stakeholders, the European Medicines Agency identified two main options for the symbol – an inverted black triangle and a magnifying glass. The agency opted for the former after taking into account the views of patients and healthcare professionals. 

The agency also clarified that Stocks of human medicinal products produced, packaged and labelled before 1 January 2014, which do not include the black symbol in the package leaflet may continue to be placed on the market, distributed, dispensed, sold and used until stocks are exhausted.