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Approval Isn’t the End All for EU Medication

(CN) - European lawmakers passed a series of laws strengthening how agencies can monitor pharmaceuticals that have already been authorized for human use.

The new rules are part of ongoing efforts to improve drug safety in the wake of a scandal involving diabetes drug benfluroex, which was marketed by French pharmaceutical company as Mediator. The drug, which was on the market for 23 years before it was pulled, is thought to have contributed to high rates of heart valve disease, contributing to the deaths of 500 to 2,000 patients in France alone.

Since then, European legislators and regulators have worked to tighten rules on the pharmaceutical industry.

The European Council says that its "pharmacovigilance" campaign aims to discover potentially dangerous drugs quickly while educating the public about adverse reactions.

Drug companies that withdraw pharmaceuticals from the market must now notify European authorities and explain the reasons for the recall, even if the withdrawal is voluntary. The rules apply to recalls outside the EU as well, lawmakers said.

The council directed the European Medicines Agency to maintain a public list of recalled drugs, as well as products subject to additional monitoring. The new laws also tighten regulations of wholesale pharmaceutical distribution outside the EU.

The European Council gave member states one year to set the new rules in motion. Regulators said full compliance is expected by the end of 2013.

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