Local view for "http://purl.org/linkedpolitics/eu/plenary/2012-09-11-Speech-2-233-000"
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"en.20120911.32.2-233-000"2
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"Mr President, ladies and gentlemen, I would like to express my appreciation for the adoption of this report that, once again, draws the attention of the European Union to the protection of health and to the protection of citizens.
With this report, we have, in fact, re-addressed the issue of surveillance of medicinal products, following the adoption of Directive 2010/84/EU and Regulation (EU) No 1235/2010 amending the directives on pharmacovigilance.
Since the so-called Mediator case, indeed, there has been a need to address the shortcomings identified by the tests conducted in this regard, and to refine the existing system, especially with regard to information requirements and notification of stakeholders and to the list of medicinal products subject to strengthened pharmacovigilance.
The amendments introduced, although modest in their scope, complement and reinforce the legal framework outlined previously in favour of greater transparency and efficiency and improved product safety standards, thus benefiting the health of European citizens."@en1
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