Following the adoption by the Council and the European Parliament, the new legislation on pharmacovigilance was published on 31 December 2010 in the Official Journal of the EU .
The new legislation, a Regulation and a Directive, will become applicable in July 2012.
This legislation is the outcome of the legal proposals on pharmacovigilance that the Commission put forward in December 2008. The new legislation will strengthen and rationalise the current system for monitoring the safety of medicines on the European market. The strengthened legislation on Pharmacovigilance will improve patient safety and public health through better prevention, detection and assessment of adverse reactions to medicines. It will also allow patients to report adverse drug reactions directly to the competent authorities. Additionally, reporting of adverse reactions will be broadened to cover, for example, medication errors and overdose.