10.02.2016 - In future, meds will come in packages sporting a unique barcode and an anti-tampering device. These measures are part of the EU’s new regulation to safeguard against falsified medicines.
The Falsified Medicines Directive was published on Tuesday in the Official Journal of the European Union, after being adopted in October last year. It introduces a new medicine verification system on the packaging of medicines for human use. “Directive 2011/62/EU introduces obligatory ‘safety features’ – a unique identifier and an anti-tampering device - to allow the verification of the authenticity of medicinal products subject to prescription and protect patients and business alike from the risks of falsified medicines”, states the European Commission. To guide drug marketers, the European Medicines Agency and the European Commission have prepared an implementation plan (PDF) for centrally authorised medicines. The marketing-authorisation holders have until February 2019 to bring the new safety features in place.
Falsified medicines pass themselves off as the real thing, while being anything but. Fake meds have been found to contain ingredients that are of bad quality or wrongly dosed. They are a “major threat to public health”, the European Commission points out. In 2011, the EU adopted a new directive on falsified medicines for human use. However, as falsifications become more sophisticated, new measures are necessary to keep phony meds off the market.
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