European Commission to adopt new pharma labelling regulation

10 March 2013 (Last Updated March 10th, 2013 18:30)

The European Commission (EC) is set to adopt a new regulation that will see the appearance of a black inverted triangle '▼' on the packaging leaflets of medical products in the European Union (EU) market.

Tonio Borg

The European Commission (EC) is set to adopt a new regulation that will see the appearance of a black inverted triangle '?' on the packaging leaflets of medical products in the European Union (EU) market.

The symbol will be used on products that are undergoing additional safety monitoring despite having received approval.

According to the commission, the symbol will flag to patients and health care professionals that a medicinal product is subject to additional monitoring, and the text accompanying it will encourage them to report any unforeseen adverse reaction through national reporting systems.

European Commissioner for Health and Consumer Policy Tonio Borg said the symbol, which is easy to distinguish, will help patients and healthcare professionals to obtain better information from them on possible side effects of a medicine.

"Stronger involvement of patients in the reporting on side effects is an integral part of Europe's pharmacovigilance system and, once in place, the new symbol will contribute to strengthen what is already one of the most advanced systems in the world," Borg said.

From September 2013, the black symbol will be used to identify the pharmaceutical products in question.

The products include all medicinal products that contain a new active substance, and 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, will also have the symbol.

The black inverted triangle has been selected by the commission as the symbol to appear in product information, based on the recommendation of the European Medicines Agency's Pharmacovigilance Risk Assessment Committee.


Image: European Commissioner for Health and Consumer Policy Tonio Borg; Photo: Courtesy of Herzi Pinki.