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Pharmaceuticals: New symbol to identify medicines undergoing additional
An inverted triangle will shortly appear on the inside leaflet of
certain medicinal products on the EU market, following a legal act adopted by
the European Commission today.
The symbol will allow patients and health care professionals to easily
identify medicinal products that are undergoing additional monitoring, and its
accompanying text will encourage them to report unexpected adverse reactions
through national reporting systems.
Tonio Borg, European Commissioner for Health and Consumer Policy said:
"The symbol is easy to recognise for patients and healthcare
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."
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.
Once a medicinal product has been authorised in the Union and placed on
the market, its safety is monitored throughout its entire lifespan to ensure
that, in case of adverse reactions that present an unacceptable level of risk
under normal conditions of use, it is rapidly withdrawn from the market.
This is done through the EU system of pharmacovigilance.
The EU pharmacovigilance system is one of the most advanced and
comprehensive systems in the world ensuring a high level of public health
protection throughout the Union.
EU pharmacovigilance legislation underwent a major review that lead to
the adoption of new legislation in 2010 to strengthen and rationalise the system
for monitoring the safety of medicines on the European market and improves
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