Brussels, 07/03/2013 (Agence Europe) - An inverted triangle will soon feature on the package leaflet of certain drugs sold on the EU market, in line with a legal action adopted by the European Commission on 7 March. This symbol will allow patients and healthcare professionals easily to identify drugs which are the subject of additional monitoring. The text accompanying it will also encourage them to notify any undesirable and unexpected side-effects by means of national notification systems. European Commissioner for Health and Consumer Policy Tonio Borg said: “The symbol is easy for patients and healthcare professionals to recognise. It will make it possible to obtain from them additional and more specific information on any secondary effects of a drug, which can then be the subject of an in-depth analysis. Reinforcing the patients' role in the notification of side-effects is an integral part of the European pharmacovigilance system and, once it is in place, the new system will help to improve what is already one of the most advanced systems in the world”.
As of September 2013, the symbol will be used to identify pharmaceutical products which are the subject of additional monitoring, specifically: 1) all drugs authorised after 1 January 2011 and containing a new active substance; 2) biological medicinal products, such as vaccines or plasma-derived products, authorised after 1 January 2011; 3) products for which certain additional information is required post-authorisation, or for which authorisation is subject to conditions or restrictions as to their safe and effective use.
Once a drug has been authorised in the European Union and placed onto the market, the European pharmacovigilance system provides for its safety to be monitored for its entire life-cycle. This makes it possible to withdraw it from the market quickly in the event of any undesirable side-effects presenting an unacceptable level of risk under normal conditions of use and, thereby, to guarantee a high level of public health protection throughout the EU. The legislation was the subject of an in-depth review which led to the adoption, in 2010, of new provisions aiming to reinforce the safety control system for drugs and to improve patients' security, by means of new methods for the prevention, identification and assessment of side-effects. The regulation adopted today is an executing act of this legislation. (IL/transl.fl)