The new symbol, approved by the European Commission, will be included in the package inserts from next September. It will allow patients and healthcare professionals to easily identify additionally monitored medicines for which unexpected side effect reporting is required.
08 MAR – An inverted triangle will soon appear in the package leaflets of certain medicines sold on the EU market. In fact, with a legal act adopted yesterday, the European Commission chose the new symbol which will serve to easily identify medicines that are subject to additional monitoring, while the accompanying text will invite citizens and healthcare professionals to report unexpected side effects through national systems of report.
"The symbol is easily recognizable by both patients and healthcare professionals. It will help to provide them with more complete and more precise information on possible side effects of a medicine, which can then be examined carefully. Greater involvement of patients in reporting side effects it is an integral part of the European pharmacovigilance system. Once introduced, the new symbol will help boost a system that is already among the most advanced in the world,” said Tonio Borg, European Commissioner for Health and Consumer Policy.
The symbol will be used from September 2013 to indicate the following drugs subject to additional monitoring:
• all medicines authorized after 1 January 2011 which contain a new active substance;
• medicinal products of biological origin, such as vaccines or plasma-derived products, authorized after 1 January 2011;
• products for which certain additional information is required in the post-authorisation phase, or the authorization of which is subject to compliance with certain conditions or restrictions for safe and effective use.
