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Falsified Medicines (Definition-any medicinal product with false…
Falsified Medicines
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Directive 2011/62/EU
increase security by: control of supply chain,safety features,internet sale and active substance
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Counterfeit,does not comply with intellectual property or infringes on patent and trademark rights
Falsified Medicines Directive-2011/62/EU,looking at measures of increasing security of supply chain in EU
Commission Delegated Regulation (EU)2016/161-enacting new safety features,coming on 9th Feb 2019
Commission Implementing Regulation (EU)699/2014-design for common logo for internet pharmacies,technical requirements for ensuring authenticity
Unique Identifier-secondary packs,product code < 50 characters,ISO coding agency
Provisions of the directive-serialisation and anti-tampering,API and active substances,wholesalers and pharmacy internet logo in EU
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10% of worlds medicines counterfeit,50% of medicines purchased over the internet counterfeit,30% of medicines in developing counteries counterfeit.
Targets API and excipient manufacturers,finished produst manufacturers,repackagers,overlabellers,wholesalers,brokers and internet pharmacies
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remember-API and excipients,safety feature,serialisation and wholesaler distribution