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Image header Agence Europe
Europe Daily Bulletin No. 11066
Contents Publication in full By article 14 / 21
SECTORAL POLICIES / (ae) health

Reasoned opinion to four member states over pharmacovigilance

Brussels, 24/04/2014 (Agence Europe) - On 16 April, the European Commission sent a reasoned opinion (second stage of the infringement procedure) to Denmark, Italy, the Netherlands and Slovakia, calling on them to fully transpose the European directive on pharmacovigilance into their respective national legislation. This directive sets out requirements on controlling the safety of medicines put on the European market, as well as prevention, detection and assessment of these medicines' undesirable side effects. The aim is to make the European system function as efficiently as possible in the areas of public health protection and patient security. So far, despite the warning sent to them on 28 October 2013, these four member states have still not fully integrated this directive into their national law. If no appropriate measures are notified to the Commission over the next two months, the latter may decide to refer these countries to the European Court of Justice. (IL)

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