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New EU rules on falsified medicines

The European Union has published a new directive to prevent falsified or counterfeit medicines entering the legal supply chain

The European Union has published a new Directive (pdf) to prevent falsified or counterfeit medicines entering the legal supply chain.

Published in the Official Journal of the European Union, the directive outlines regulation to increase safety and strengthen control measures across the continent.

Methods include obligatory features on the outer packaging of medicines to demonstrate authenticity; strengthened requirements for the inspection of the manufacturers of pharmaceutical ingredients; and enforcing an obligation for manufacturers and distributors to report any suspicion of falsified medicines.

A logo that must also be placed on the websites of legally operating online pharmacies, with a link to official national registers.

The European Medicines Agency (EMA) said it welcomed the rules, and that the agency would be working closely with the European Commission over the next 18 months to implement the legislation.

The Directive is scheduled to come into force on July 21, 2011, with the application of its measures necessary from all Member States by January, 2013.

5th July 2011

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