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.
For example, until late 2009, Servier Laboratories’ appetite suppressant, Mediator (benfluorex) was sold in France despite being pulled from the markets of other EU member states and being linked to heart valve damage that resulted in hundreds of deaths.
The amended directive also increases oversight of wholesalers’ distribution of drugs to non-EU countries. The amended directive and regulation are related to pharmacovigilance legislation adopted in 2010.
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