Local view for "http://purl.org/linkedpolitics/eu/plenary/2012-09-11-Speech-2-367-562"
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"en.20120911.32.2-367-562"2
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"The Mediator health scandal will at least have served to make us aware of the overwhelming need to improve pharmacovigilance in Europe – that is, the surveillance of medicines and the prevention of the risk of undesirable effects, potential or actual, resulting from their use. In 2009, France decided to withdraw this medicine produced by the Servier laboratory, which caused the death of 500 to 2 000 people, according to estimates. Since 2003, it has been withdrawn from the market in Spain and in Italy, at the request of the laboratory. From now on, when a medicine is voluntarily withdrawn from the market in a Member State, the precautionary principle will apply, and the medicine will be temporarily or permanently withdrawn from the other European countries. Businesses will also be obliged to declare whether the voluntary withdrawal of a medicine or the non-renewal of its licence was due to safety reasons."@en1
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