Medicines Safety in Europe

Rational Use of Medicines

The process of evaluating and improving the safety of medicines (pharmacovigilance) plays a vital role in the early detection of drug-induced harm. Every medicine is tested on a relatively small number of people before it is approved for use by the wider population, where previously undetected reactions can emerge.  Each patient is a unique medicines user with a distinctive lifestyle and circumstances. Medicines that cause serious adverse drug reactions (ADRs) need to be re-evaluated or removed from the market to protect citizens.


31 May 2011- A recently published study provides recommendations on European Medicines Agency's communication on medicines. The Agency has already begun implementing some of the findings of the study.
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Direct and spontaneous patient reporting can speed up the acquisition of knowledge about adverse effects while supporting greater patient participation in the detection and management of these health threats. For these reasons, HAI Europe and our partners advocate for direct patient reporting to be incorporated into pharmacovigilance activities.
HAI Europe's partners:


30 September 2010 - HAI Europe Statement – The monitoring of medicines safety in the Europe Union (EU) took a step forward following last week’s approval by Parliament of the amendments to EU legislation on Pharmacovigilance. Read more.

Policy Briefs & Reports

HAI Europe Briefing Paper - Direct patient reporting of adverse drug reactions:A fifteen-country survey & literature review. Read more.