The Pharmacovigilance team in WHO aims to assure the safety of medicines and vaccines by ensuring reliable and timely exchange of information on safety issues, promoting pharmacovigilance activities throughout the Organization and encouraging participation in the WHO Programme for International Drug Monitoring. This text was developed in consultation with the WHO Collaborating Centre for International Drug Monitoring and the national pharmacovigilance centres participating in the WHO Programme for International Drug Monitoring.
Number of pages: 36
Publication date: October 2012
Languages: English; Russian; Spanish
ISBN: 978 92 4 150319 8
This document aims to provide practical guidelines on how to set up national systems for consumers to report adverse reactions to medicines. Throughout this document, the phrase “consumer reporting” is used to refer to reporting of adverse drug reactions (ADRs) by the general public.
The EU pharmacovigilance system is now one of the most advanced and comprehensive systems in the world and represents a robust and transparent instrument to ensure a high level of public health protection throughout the Union.
The EU pharmacovigilance legislation has been subject to a major review that led to the adoption of new legislation in 2010.
The new legislation, a Regulation, amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 (972 KB) and a Directive, amending, as regards pharmacovigilance, Directive 2001/83/EC (2 MB), became applicable in July 2012 : see Eudralex volume 1 >>>
The 2010 legislation strengthens and rationalises the system for monitoring the safety of medicines on the European market. It improves patient safety and public health through better prevention, detection and assessment of adverse reactions to medicines. It also allows patients to report adverse drug reactions directly to the competent authorities. Additionally, reporting of adverse reactions is broadened to cover, for example, medication errors and overdose.
The legal framework of pharmacovigilance for medicines marketed within the EU is provided for in Regulation (EC) No 726/2004 with respect to centrally authorised medicinal products and in Directive 2001/83/EC with respect to nationally authorised medicinal products (including those authorised through the mutual recognition and decentralised procedures).
In addition, Commission Implementing Regulation (EU) No 520/2012 on the performance of pharmacovigilance activities stipulates operational details in relation to certain aspects of pharmacovigilance to be respected by marketing authorisation holders, national competent authorities and EMA.
Finally, the EMA has released good pharmacovigilance practice guidelines (GVP) in order to facilitate the performance of pharmacovigilance activities. These GVP modules replace Volume 9A of "The rules governing medicinal products in the European Union - Pharmacovigilance".