Pharmaceuticals: New symbol '▼' to identify medicines undergoing additional monitoring
The black symbol '▼' to be included in product information for certain categories of medicinal products will help patients and healthcare professionals identify medicinal products that are subject to additional monitoring after authorisation.
Tonio Borg, European Commissioner for Health and Consumer Policy said: "The symbol is easy to recognise for patients and healthcare professionals. It will help to obtain more and better information from them on possible side effects of a medicine which then can be thoroughly analysed. 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."
It has been introduced according to the EU pharmacovigilance legislation of 2010 which strengthens existing rules and improves patient safety through better prevention, detection and assessment of adverse reactions to medicines. It will be fully introduced on 1 September 2013.
From September 2013, the symbol will be used to identify these pharmaceutical products that are subject to additional monitoring:
- 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.
Although all authorised medicinal products on the EU market have been extensively tested and have already undergone rigorous tests to demonstrate their quality, safety and efficacy and to prove that their benefits outweigh their risks, it is important to continue to monitor their use once on the market, and look out for adverse reactions that are not listed in the product information.
The black symbol is intended to identify the medicines which are subject to more intensive post marketing monitoring (additional monitoring), so that new emerging information can be immediately shared with the regulatory authorities, medical communities, marketing authorisation holders and patients.
Reporting adverse reactions to medicines
Patients and healthcare professionals are encouraged to report adverse reactions (side effects) of any medicine to a doctor, pharmacist or nurse or directly through the national reporting system.
The EU pharmacovigilance system is one of the most advanced and comprehensive systems in the world.
In 2010 EU pharmacovigilance legislation underwent a major review that lead to the adoption of new legislation to strengthen and rationalise the system for monitoring the safety of medicines on the European market and improve patient safety and public health through better prevention, detection and assessment of adverse reactions to medicines. The Regulation adopted today is an Implementing Act of this legislation.