Health & Consumer Voice - December - 2012 Edition
Pharmacovigilance - the science related to the detection, assessment, understanding and prevention of adverse reactions to medicines – will be stepped up in the EU following the adoption of new rules by the European Parliament and the Council on 25 October.
They will enter into force in 2013.
It follows a “stress test” run by the European Commission in 2011 that identified weaknesses in the legislation.
The new rules include: