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FDAnews Drug Daily Bulletin
Oct. 22, 2012 | Vol. 9 No. 207
Drug Withdrawals in EU Must Be Justified Under New Pharmacovigilance Rules
Manufacturers withdrawing their drugs from any market in the EU will now have to notify competent authorities of the reason, according to amended pharmacovigilance rules adopted by the Council of the European Union Oct. 4. The amended directive and regulation aim to provide a better framework for responding to cases where a drug is pulled from one member state but kept on the market in another.
International Pharmaceutical Regulatory Monitor
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