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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:
How will the new Pharmacovigilance legislation ensure greater patient safety?
The Regulation and Directive on Pharmacovigilance, agreed today by the Council, will:
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.