Local view for "http://purl.org/linkedpolitics/eu/plenary/2012-09-11-Speech-2-372-375"

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"en.20120911.32.2-372-375"2
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"Taking into account the fact that, in December 2010, Parliament and the Council agreed on a revision of the rules governing pharmacovigilance at EU level by adopting Directive 2010/84/EU and Regulation (EU) No 1235/2010, the measures adopted in this new legislation will lead to improved safety of medicines at EU level by strengthening the role of the European Medicines Agency (EMA). However, the emergence of a major medicine safety enquiry in France, the ‘Mediator’ case, in 2011, made an urgent review of EU pharmacovigilance systems necessary. While the new legislation did strengthen pharmacovigilance at EU level, there are some potential weaknesses in the EU system that need to be addressed. I voted in favour of the proposal."@en1

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