Local view for "http://purl.org/linkedpolitics/eu/plenary/2012-09-11-Speech-2-378-500"

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"en.20120911.32.2-378-500"2
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"The European Union had to react to the Mediator scandal, which claimed hundreds of victims, due to a lack of effective alert and response mechanisms in the face of a harmful drug. I voted for this amendment to the European legislation on pharmacovigilance because I think it is moving in the right direction: that of transparency and control. I think that the three main measures it introduces are very important: the real reasons behind a company’s decision to withdraw a medicine in a country will be known, these medicines will be systematically subjected to an urgent assessment, which will reveal the levels of hazard, and finally, a symbol on the medicine’s packaging will inform patients and practitioners if the medicine has been subject to an additional safety study. Within the framework of the organisation of the market for medicine, in which the EU has some powers, these measures will help to ensure, at EU level, that a health crisis such as the one we saw with Mediator will never happen again."@en1

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