Local view for "http://purl.org/linkedpolitics/eu/plenary/2012-09-11-Speech-2-368-500"
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"en.20120911.32.2-368-500"2
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"This report by Linda McAvan concerns the proposal for a directive of the European Parliament and of the Council amending Directive 2001/83/EC as regards pharmacovigilance. In December 2010, Parliament and the Council agreed a revision of the rules governing pharmacovigilance at EU level by adopting Directive 2010/84/EU and Regulation (EU) No 1235/2010. The range of 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 in collecting signs and acting on them, and to increased cooperation among Member States. I think European patients should be better informed about the medicines that they ingest and the secondary effects thereof. The new legislation provides for
the creation of a European web portal and national portals on the safety of medicines and methods for patients to notify the national authorities when adverse reactions occur. In this regard, the benefits of working with 500 million people, rather than each Member State working individually, are clear."@en1
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