Local view for "http://purl.org/linkedpolitics/eu/plenary/2012-09-11-Speech-2-366-500"

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"en.20120911.32.2-366-500"2
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"I voted in favour of modifying the 2010 European directive on pharmacovigilance. This revision comes in the wake of the Mediator scandal. What does Parliament want here? Specifically, we want reinforcement of the obligations that apply when a medicine is withdrawn: from now on, whenever a medicine is to be withdrawn in a Member State, all the European health authorities will have to be notified and provided with a justification for the withdrawal. If there is any suspicion of a risk to health, then, in addition to the withdrawal of the product, an assessment will be carried out to anticipate the potential consequences of the product not functioning properly. We no longer want to have to wait until there is an emergency before we resolve the problems. Finally, it will be possible to look up all medicines subject to enhanced surveillance on a publicly available list – a measure that we have already voted for in France. This duty of transparency seems to us to be essential to restore confidence between citizens, health authorities and pharmaceutical laboratories."@en1

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