EU APPROVES NEW PHARMACOVIGILANCE RULES

BY KEITH NUTHALL THE EUROPEAN Union (EU) Council of Ministers and the European Parliament have agreed reforms to EU pharmacovigilance legislation. Under the revisions, if a company decides not to renew a marketing licence over safety reasons, an emergency evaluation at the EU level would be staged. Also, when companies voluntarily withdraw a drug, they must declare if it is because of safety. And all drugs subject to post-authorisation safety studies will be labelled as such, to make patients aware. The new rules will come into force by the end of 2013. They ...


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