Local view for "http://purl.org/linkedpolitics/eu/plenary/2012-09-11-Speech-2-366-375"

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"en.20120911.32.2-366-375"2
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"Whilst the Mediator affair has revealed severe shortcomings in the area of medicine safety, I welcome the agreement that we have ratified today at first reading. This pharmacovigilance package meets an additional safety requirement. This requires an amendment to the 2001 directive to reinforce the legal framework: to create an automatic urgent procedure, to increase the transparency obligations for companies and to provide for a blacklist of medicines subject to additional surveillance. These are the new features of this reform which, we hope, will be able to make up for the shortcomings and boost the reliability of the European medicine system."@en1

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