Local view for "http://purl.org/linkedpolitics/eu/plenary/2012-09-11-Speech-2-374-750"

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"en.20120911.32.2-374-750"2
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"This proposal for a directive is a response to preventing cases like that of ‘Mediator’ in France, which jeopardised the lives of thousands and killed some 500 to 2 000 people. The amendments to the 2010 directive aim to make pharmacology legislation more effective with regard to collecting signs and acting on their detection, and to increasing cooperation between Member States. Following the ‘stress tests’ conducted by the EU, a range of measures have been presented, with a view to improving the system proposed by the 2010 directive, particularly the inclusion of an automatic urgent procedure, a new trigger for the urgent procedure, clarification of transparency obligations on companies, and a longer list of medicines subject to additional monitoring. These measures will increase the effectiveness and vigilance of the authorities competent in this regard. Simultaneously, they aim to increase cooperation between Member States."@en1

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