New EU Safety Symbol Identifies Pharmaceuticals Subject To Additional Monitoring
The European Commission has confirmed that the labels of medicinal products which are undergoing extra monitoring will be required to carry a new symbol to identify them.
This decision to make the new symbol, an inverted black triangle, a legal requirement was part of an act adopted by the European Commission late last week. The purpose of the inverted black triangle is to ensure that health professionals and patients are able to easily recognize pharmaceuticals that are still being monitored. Its intention is that people will be encouraged to report any unexpected adverse reactions to certain drugs through the national reporting processes.
The European Commissioner for Health and Consumer Policy Tonio Borg believes that the symbol is easy to recognize and so will ensure that better information about potential side effects will be gathered to support improved decision-making. “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".
The new symbol will be required to be part of pharmaceutical product labels from September 2013. There will also be accompanying text that is required to be included in the labeling system. The medicines that are a part of this requirement are:
- All medicinal products authorized after 1 January 2011 that contain a new active substance.
- Biological medicinal products, such as vaccines or plasma derived products, authorized after 1 January 2011.
- Products for which certain additional information is required post-authorization, or for which authorization is subject to conditions or restrictions on their safe and effective use.
The EU pharmacovigilance legislation went through a significant review in 2010 to strengthen and rationalize the monitoring system for pharmaceutical product safety, which identified that there was a need for improved processes for identify any increased risks with medicines. This new regulation follows a decision back in October 2012 by the Pharmacovigilance Risk Assessment Committee to include a label on products undergoing additional monitoring to highlight the process they are a part of.
The European Medicines Agency, who is responsible for maintaining the list of medicines submitted to further monitoring, outlined that stocks of human medicinal products that were produced, packaged and labeled before 1 January 2014 that do not have the inverted black triangle on their packaging can continue to be sold until stocks run out.