Health-EU Newsletter - Pharmacovigilance – Monitoring the safety of medicines

Issue 98, 18 October 2012

In this edition


Pharmacovigilance – Monitoring the safety of medicines

By Patricia Brunko, Head of Unit, Medicinal Products – Authorisations and the European Medicines Agency, European Commission, Directorate-General for Health and Consumers

This year has been important in the area of pharmacovigilance in the European Union. It has seen the application of new rules that were agreed in 2010. This month there will be a further amendment of the legislation which is expected to fully apply by the end of 2013.


All medicinal products in the EU are subject to strict testing and assessment of their quality, safety and efficacy before being authorised for marketing. Once a medicinal product has been authorised, its safety continues to be monitored to ensure that action is taken to ensure public health when there are adverse reactions that present an unacceptable level of risk. This monitoring is called pharmacovigilance.


The EU pharmacovigilance system is one of the most advanced and comprehensive systems in the world. It represents a robust and transparent system to ensure a high level of public health protection throughout the EU.


Now patients across the EU can report directly online or by post to their national authority adverse reactions they have experienced. Next year, they will see the inclusion of a ‘black symbol’ in the information about medicines that are under additional monitoring, for example those containing a new pharmaceutical ingredient. Patients, doctors, nurses and other health practitioners will be particularly encouraged to report any adverse reactions to these medicines.


The legislation on pharmacovigilance is a part of the EU regulation on medicines that assures the safety of medicines across the EU.

News from the EU

Commission adopts communication on nanomaterials

The Second Regulatory Review describes the European Commission’s plans to improve EU law and its application to ensure safe use of nanomaterials.

One step further in cross-border organ traceability

The Commission has adopted a new piece of legislation to facilitate EU cross-border exchange of information about organs and their donors.

Workshop on organ donation for journalists

The European Commission organised on 9 October a workshop for journalists on organ donation and transplantation.

Focus on education and physical activity promotion

The plenary meeting of the European Platform for Action on Diet, Physical Activity and Health, held in Brussels on 20 September 2012, was centred on commitments in the areas of education and physical activity.

Campaign aims at educating public on food allergy

The European Academy of Allergy and Clinical Immunology (EAACI) is running a campaign to raise awareness of the sharp increase of anaphylaxis in children, an allergic reaction that is severe and potentially life-threatening.

Reporting from across Europe

Czech Republic

Czech National Plan for Rare Diseases for 2012-2014 adopted

This document delineates actions identified in the 2010-2020 Czech National Strategy, including actions on improving information, education, prevention and improving screening and diagnosis, among others.


New public health policy is centred on people

New proposal from the Swedish Government on national public health policy is based on people taking responsibility for their own health.

EU Press Releases

Nanomaterials: Case by case safety approach for breakthrough technology

The European Commission has adopted a Communication on the Second Regulatory Review on Nanomaterials.

Forthcoming Events

Conference on the European Quality Framework for Long Term Care (Brussels, 14 November 2012)

The AGE Platform Europe will host this conference at the European Parliament in Brussels to present the framework for improving the well-being and dignity of older people in need of care and assistance.

New Publications

Epidemiological situation of tick-borne encephalitis in the European Union and European Free Trade Association countries

Report published by the European Centre for Disease Prevention and Control (ECDC).

Fatal injury surveillance in mortuaries and hospitals: a manual for practitioners

Issued by the World Health Organization (WHO), it is primarily intended for professionals working in institutions responsible for the collection, compilation and use of mortality data for public health action.

What's New on Health-EU

Adoption of revised pharmacovigilance legislation

The update on legislation will provide EU citizens with greater safety.

AVERROES project – Equal access to healthcare

A project to raise awareness of migrants’ and asylum seekers’ rights to access healthcare without discrimination.


Pharmacovigilance – Monitoring the safety of medicines

Activities at EU level

Health-EU – Medicines and Treatment

European Commission – DG Health and Consumers

Public Health – The EU pharmacovigilance system

European Commission – DG Health and Consumers


EMA - European Medicines Agency

Video explaining pharmacovigilance legislation

EMA - European Medicines Agency



Questions and answers on the update of the EU legislation on pharmacovigilance.

EU Health Prize for journalists – Articles

National winners 2012 announced

In each EU Member State, independent juries evaluated the articles and chose one national nominee.

Buying medicines online – a game of Russian roulette. By Yiannis Devetzoglou, National nominee for Greece

This article alerts the readers to the very real dangers of buying medicines online, from drugs for erectile dysfunction to Tamiflu during the influenza pandemic.

Health Programme Projects

PHIS – Pharmaceutical Health Information System

This project aims to increase the level of knowledge and exchange of information on pharmaceutical policies in the European Union.

Other interesting links

The Heads of Medicines Agency

EDQM – European Directorate for Quality of Medicines and HealthCare

WHO – Medicines – Safety, efficacy and utilization

WHO – Medicines: safety of medicines – adverse drug reactions

Health-EU. The Public Health Portal of the European Union
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