Press Release: Pharmaceuticals: New symbol to identify medicines undergoing additional monitoring

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 7 March 2013.

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.

• Primary Source

ESO: Background Information: Questions and answers on implementation of pharmacovigilance legislation http://www.europeansources.info/record/questions-and-answers-on-implementation-of-pharmacovigilance-legislation/

European Commission; DG Health and Consumers: Public health: Medicinal products for human use: Pharmacovigilance http://ec.europa.eu/health/human-use/pharmacovigilance/index_en.htm

European Commission: Rapid: MEMO/13/172: Questions and answers: New 'black symbol' for medicinal products http://europa.eu/rapid/press-release_MEMO-13-172_en.htm

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