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Health & Consumer Voice - December - 2012 Edition

Better monitoring of medicines from 2013

Pharmacovigilance - the science related to the detection, assessment, understanding and prevention of adverse reactions to medicines – will be stepped up in the EU following the adoption of new rules by the European Parliament and the Council on 25 October.

They will enter into force in 2013.

It follows a “stress test” run by the European Commission in 2011 that identified weaknesses in the legislation.

The new rules include:

  • An automatic urgent review procedure, at EU level, if serious safety concerns present in a product authorised in more than one EU country;
  • Clear labelling of products for which post-authorisation safety studies are required, explaining the product’s characteristics and asking users to report adverse reactions;
  • More transparency, when medicinal products are withdrawn from the market for safety reasons.

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