European Medicines Agency welcomes new rules on falsified medicines

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European Medicines Agency welcomes new rules on falsified medicines

The European Medicines Agency has welcomed the new Directive on falsified medicines, published in the Official Journal of the European Union on Friday 1 July.

The new laws aim to prevent falsified medicines entering the legal supply chain and reaching patients. They will do this by introducing harmonised safety and strengthened control measures across Europe, including:

  • obligatory features on the outer packaging of medicines to demonstrate that they are authentic;
  • strengthened requirements for the inspection of the manufacturers of pharmaceutical ingredients;
  • the obligation for manufacturers and distributors to report any suspicion of falsified medicines;
  • an obligatory logo that must be placed on the websites of legally operating online pharmacies, with a link to official national registers.

Falsified medicines are fake medicines that pass themselves off as real, authorised medicines. They may contain ingredients of low quality or in the wrong doses, be mislabelled with respect to their identity or source or have fake packaging or the wrong ingredients.

The Agency is working closely with European Commission and its national and international partners on the implementation of this legislation over the next 18 months. The Directive is coming into force on 21 July 2011 and Member States will have to start applying its measures from January 2013.

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