A black inverted triangle '▼' will shortly appear on the package leaflet of certain medicinal products on the EU market, following an Implementing Regulation adopted by the European Commission today. This symbol will flag to patients and health care professionals that a medicinal product is subject to additional monitoring, and its accompanying text will encourage them to report any unexpected adverse reaction through national reporting systems.
From September 2013, the black symbol will be used to identify the pharmaceutical products in question. They are:
- 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
- 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.
Background
The European Commission adopted new pharmacovigilance legislation in 2010 to strengthen existing rules and improve patient safety through better prevention, detection and assessment of adverse reactions to medicines. Under the new rules, medicinal products that are subject to additional monitoring after they have been placed on the market must be identified. Based on the recommendation of the European Medicines Agency's Pharmacovigilance Risk Assessment Committee, the Commission chose a black inverted triangle as the symbol to appear in product inf! ormation, including the leaflet inside the medicine pack.
For more information on the black symbol and pharmacovigilance in the EU:http://ec.europa.eu/health/human-use/pharmacovigilance/index_en.htm
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