Brussels threatens legal action over fake medicines directive failures

Published: 12-Dec-2013
Regulatory

Gives Italy, Poland, Slovenia and Finland until 20 January 2014 to comply with directive


The European Commission is threatening to take legal action against Italy, Poland, Slovenia and Finland unless they demonstrate by 20 January 2014 how they will comply with the European Union’s (EU) falsified medicines directive. They were supposed to have implemented written law (directive 2011/62/EU) into their national legislation by 2 January 2012. The directive aims to prevent counterfeit medicines from reaching patients, laying down harmonised, pan-European safety and control measures, easing the identification of fakes, tightening controls at the EU’s external borders and within the EU.

'Failure to notify adequate measures could lead to the Commission referring the cases to the [European] Court of Justice,' warned Brussels. The law was agreed in 2011.

Judges have the authority to order these member states to comply, and if they refuse, the European Commission can impose daily recurring fines of thousands of Euros, payable until the directive’s rules are put in place.

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