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Pharmaceutical Manufacturing and Packing Sourcer

Improving the Chain’s Efficiency

Falsified medicinal products represent one of the most significant challenges for patient safety and remains a key issue of public health. The Falsified Medicines Directive (FMD) 2011/62/EU will come into force on 9 February 2019. This new legislation aims to prevent counterfeit or unauthorised prescription medicine from entering the legal supply chain. Counterfeit medication costs the pharmaceutical industry billions of pounds every year, and, more importantly, it puts patients at risk. As such, serialisation is the key to ensuring that businesses become, and remain, compliant, keeping patient safety at the fore.

The Requirements

Firstly, knowing and understanding what the requirements of the Directive are is important. When looking at FMD in a broader sense, the requirements fall into five separate categories:

• An obligatory feature on the outer packaging of prescription medicines that demonstrates identification and enables product verification
• An obligatory feature on the outer packaging of prescription medicines to demonstrate that they have not been tampered with (an anti-tamper device)
• Strengthened requirements for the inspection of the manufacturers of APIs
• The obligation for manufacturers to report any suspicions of falsified medicines
• An obligatory logo to be applied to websites of legally operating online pharmacies, with a link to official national registers

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Christian Taylor is a GS1-accredited Business Consultant, specialising in serialisation and the FMD and unique device identifier legislation. With over 10 years’ experience delivering infrastructure and software solutions within industries including pharma, military, and government, Christian is one of the leading authorities in the ZetesAtlas solution in the UK and Europe.
Christian Taylor
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