SAFETY MONITORING of MEDICINAL PRODUCTS

Overview

A handbook for consumer reporting of ADRs was discussed and requested at the thirty-first meeting of the National Pharmacovigilance Centres held in Uppsala, Sweden from 20–23 October 2008, and the development of this publication has been incorporated into the aims of the Seventh Framework Programme of the Research Directorate of the European Commission and its project Monitoring Medicines (http://www.monitoringmedicines.org/). 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.