Local view for "http://purl.org/linkedpolitics/eu/plenary/2012-09-11-Speech-2-376-156"
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"en.20120911.32.2-376-156"2
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"Whilst the Mediator case has brought to light severe shortcomings in the area of the safety of medicines, 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 in order to reinforce the legal framework: to create an automatic urgent procedure, to increase transparency obligations for companies, and to provide a list of ‘black symbol’ drugs subject to additional monitoring. 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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