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Pharmaceutical Manufacturing and Packing Sourcer

Seamless Serialisation

The introduction of serialisation, designed to ensure the authenticity and traceability of individual medicines, promises to improve patient safety and create exciting opportunities for digital health, but there is a twist. Failure to comply with the mandated EU regulation means a company cannot legally ship their product – no barcode, no trade. That is when a serial drama turns into a tragedy, and time is running out to be ready. The Falsified Medicines Directive (FMD) imposes strict serialisation requirements on pharmaceutical manufacturers, distributors, and dispensers.

The FMD, first introduced in 2011, is now heading into its final phase. The denouement arrives on 9 February 2019 when the Directive is fully enforced and the noncompliance penalties officially come into play. The FMD aims to prevent inauthentic, substandard, or harmful medicines entering the supply chain by imposing strict serialisation, traceability, and verification requirements on pharma manufacturers and their associated wholesalers, distributors, and contract manufacturers. In particular, it requires companies to print a unique identifier on the packaging of prescription medicines. Furthermore, companies are not just responsible for the data on the packaging, they are responsible for submitting it to the central data hub that will enable pharmacists to authenticate products before dispensing them. It is a complex undertaking that could be easily underestimated, but understanding some key steps can prevent this.

The implementation of serialisation is not an overnight task. It encompasses processes that have multiple touchpoints across global organisations, partner networks, and the wider supply chain. Despite this and the enormous implications of getting it wrong, many companies are still some distance from being fit-for-purpose. Indeed, in some organisations, the Directive has not yet hit their radar – but it needs to because the clock is ticking. Nevertheless, all is not lost.

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Mark Davison is Head of EU at rfxcel. He is an expert, speaker, and writer in the pharma and product security industry. Mark is a board-level operator specialising in strategic global health and Big Data issues such as serialisation, supply chain security, patient safety, and government policy. Additionally, he has a wide experience elsewhere including due diligence and international business development. Mark also has technical expertise in anti-counterfeiting technologies and vendor selection, including authentication, serialisation, and traceability and is an expert in legislation and its impact. He is currently based in the UK, with wide experience in Europe, Africa, Asia (including Japan and China), as well as North and South America. 
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