Press Release: European Medicines Agency publishes a video explaining the concept of medicines under additional monitoring

The European Medicines Agency (EMA), on 1 October 2013, published a video and a factsheet in all official EU languages, explaining the meaning of the black triangle, which is now starting to appear in the product information of certain authorised medicines in the EU. The black triangle has recently been introduced in the EU as part of the concept of medicines under additional monitoring and is an important deliverable of the new European pharmacovigilance legislation.

The purpose of the symbol is to actively encourage healthcare professionals and patients to report any suspected adverse reactions observed with the medicine, either because the medicine is new to the market or because there is a limitation to the data available on its safety.

• Primary Source

EMA: Press Release: EMA/589330/2013 (01.10.13): European Medicines Agency publishes a video explaining the concept of medicines under additional monitoring http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2013/09/WC500150694.pdf

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