Local view for "http://purl.org/linkedpolitics/eu/plenary/2010-09-22-Speech-3-207"

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"en.20100922.20.3-207"2
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"Pharmacovigilance is the system used to monitor the safety of medicines after they have been authorised for public use. Under current EU legislation, medicines can be authorised in two ways: a) through a central procedure where an application is made by a pharmaceutical company to the EMEA (European Medicines Agency), or b) through a system of mutual recognition where one country leads on the assessment of the new drug and coordinates with other Member States through mutual recognition. Rules governing the procedure for the decentralised system are set out in Directive 2001/83/EC. I voted for this report as European patients will be better protected and informed about the use of medicines and their adverse effects. The new regulations provide for the creation of national and European websites, specifically for medicines, which can offer patients more information. The latter will have the opportunity to inform the national authorities about the drugs’ adverse effects."@en1

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