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Adoption of revised pharmacovigilance legislation

Pharmacovigilance is the process and science of monitoring the safety of medicines and taking action to reduce the risks. It is essential for protection of public health. Now, new amendments to the EU legislation on pharmacovigilance aim to make the use of medicines in the EU even safer.

Why was a revision of current legislation needed?

All medicinal products in the EU are subject to strict testing and assessment before being authorised. Once on the market they are continuously monitored. On 15 December 2010, the European Parliament and the Council adopted a new regulatory framework on pharmacovigilance, which came into force in July 2012.

In 2011, some events revealed potential weaknesses in pharmacovigilance. The European Commission therefore promptly carried out a ‘stress test’ to check whether the pharmacovigilance rules adopted in 2010 needed to be further strengthened. This review identified certain gaps so the Commission proposed to amend the legislation to address them.

Based on the Commission proposals, the European Parliament and the Council are adopting amendments to the existing pharmacovigilance legislation.

New action from the EU: changes and amendments

• Introduce an automatic urgent procedure for review at EU level if there are serious safety concerns with respect to a medicinal product that is authorised in more than one Member State.

• Increase transparency by companies regarding the reasons for the withdrawal of a medicinal product from the market, so that withdrawal for safety reasons can be easily identified.

• Ensure that medicinal products, for which post-authorisation safety studies are required as a condition of the marketing authorisation will be included on the list of medicines under increased monitoring. This means that patients and healthcare professionals will  be specifically informed and asked to notify adverse reactions to the medicine.

Two new legislative texts: a directive and a regulation

This revised legislation will be formally adopted by the European Parliament and the Council before the end of 2012 and will apply by the end of 2013, at the latest. Once implemented, it will improve the detection of potentially unsafe medicinal products and remedial action.

More information:

Health-EU Portal – Medicines and Treatment

European Commission – Pharmacovigilance

European Medicines Agency