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European Commission


Brussels, 4 October 2012


What is pharmacovigilance?

Pharmacovigilance is the science of the detection, assessment, understanding and prevention of adverse drug reactions (ADRs) and all related activities. An ADR is a response to a medicine which is harmful and unintended. The limitations of clinical trials in terms of their size, duration and controlled conditions means that some ADRs will only be detected after a medicine has been authorised and has entered the market. The aim of pharmacovigilance is to identify new information about risks associated with medicines and to prevent harm to patients.

Why did existing EU legislation need to be updated?

In 2011, incidents related to pharmacovigilance, and in particular the so-called "Mediator case", revealed some weaknesses in the EU system concerning pharmacovigilance. The Commission therefore promptly carried out a "stress-test" to check whether the pharmacovigilance rules adopted in 2010 would need to be further strengthened. This review identified the following gaps:

  • The lack of an automatic assessment of a pharmacovigilance issue at EU level in case of serious safety concerns. The procedure could only be initiated based on an appreciation of the issue by Member States.

  • Marketing authorisation holders were not required to state the reasons for withdrawal of a marketing authorisation or of a product; therefore voluntary withdrawal led to unnoticed safety issues.

  • Products subject to post-authorisation safety conditions were included in the public list of additional monitoring (following consultation with the Pharmacovigilance Risk Assessment Committee), only if the Commission or a Member State's competent authority requested it. Competent authorities were therefore left to decide on a case-by-case basis whether to announce publicly that a product was subject to strengthened monitoring.

How will the new Pharmacovigilance legislation ensure greater patient safety?

The Regulation and Directive on Pharmacovigilance, agreed today by the Council, will:

  • 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 the transparency required 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 for the marketing authorisation, will be included on the list of medicines under increased monitoring. This means that patients and healthcare professional will be specifically informed and asked to notify adverse reactions to the medicine.

When will this legislation come into effect?

There is a 12 month transposition period, which means that the legislation will become applicable in the Member States by the end of 2013, at the latest.

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