Page last updated at 20:54 GMT, Monday, 10 September 2012 21:54 UK

MEPs back medicine monitoring laws

Tougher laws to increase the monitoring of medicines have been welcomed by MEPs.

On 10 September 2012, MEPs debated revisions to the so-called pharmacovigilance package, which is designed to increase communication between EU member states over concerns about medicines.

Under the proposed changes, there would be an automatic emergency procedure, allowing for an EU-wide withdrawal of a drug if one member state decided to withdraw it from the market for safety reasons.

The pharmacovigilance package was initially implemented in 2010, but a number of "stress tests" carried out by the Commission showed up a number of loopholes.

The parliament's lead negotiator on the package, British Labour MEP Linda McAvan, said the new changes would "strengthen the hand of regulators".

She added that pharmaceutical companies would now be under more scrutiny when they withdrew a product anywhere in the world, with automatic notification to the European Medicines Agency.

Any concerns about medicine safety will now lead to an investigation at EU level.

Health Commissioner John Dalli welcomed the support of MEPs, saying it would lead to greater transparency as to the reasons why a particular drug is withdrawn from the market.

The new rules were approved during the daily voting session on 11 September 2012.

Useful links:

Democracy Live's guide to how the plenary sessions work.

A disclaimer on the use of simultaneous interpretations, on the European Parliament's website.

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