Local view for "http://purl.org/linkedpolitics/eu/plenary/2014-04-16-Speech-3-104-231"
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"en.20140416.123.3-104-231"2
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"EU pharmacovigilance legislation for medicinal products for human use was revised in 2010, in order to strengthen and rationalise the system for safety monitoring of medicines. It entered into force in July 2012 with additional amendments to pharmacovigilance legislation subsequently introduced following the 'Mediator' case (a drug developed by French drug company Servier for treating overweight diabetics that is estimated to have killed between 500-2,000 people before finally being banned in Europe). These recent changes have led to a widened remit for the European Medicines Agency (EMA), which has acquired pharmacovigilance competences also for nationally authorised medicines, in addition to reinforced competences for centrally authorised medicines. The report is proportionate an was endorsed by Conservative colleagues in committee, I therefore voted in favour of the report."@en1
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