The Falsified Medicines Directive (FMD) imposes strict serialisation requirements on pharmaceutical manufacturers, distributors and dispensers. Mark Davison, Head of Operations in the EU for rfxcel, outlines everything you need to know and what you need to do for a seamless serialisation process – before regulators remove your right to trade.
Pharma manufacturers are currently the main actors in a serial drama where getting their lines right is paramount. Well, four lines of data, to be precise; in (and next to) DataMatrix barcodes applied to every pack of prescription medicines. 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’s a twist in the plot. Failure to comply with the EU regulation that mandates it means you cannot legally ship your product. No barcode, no trade. That’s when a serial drama turns into a tragedy. And time is running out to be ready.
The unfolding story of the Falsified Medicines Directive (FMD), which was first introduced in 2011, is into its final episodes. The denouement arrives on February 9, 2019, when the Directive is fully enforced and the penalties for non-compliance officially come into play. FMD is an attempt to prevent inauthentic, substandard or harmful medicines entering the supply chain. It imposes strict serialisation, traceability and verification requirements on pharmaceutical manufacturers and their associated wholesalers, distributors and contract manufacturers. In particular, it mandates companies to print a unique identifier on the packaging of prescription medicines. Furthermore, companies aren’t just responsible for the data that goes on the packaging, they’re responsible for submitting it to the central data hub that will enable pharmacists to authenticate products before they dispense them. It’s a complex undertaking that could be easily underestimated - but not if you understand some key steps.
The implementation of serialisation is not an overnight task – it encompasses processes that have multiple touch-points across global organisations, partner networks and the wider supply chain. Yet despite this – and despite 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. It needs to – because the clock is ticking. But all is not lost. Here are seven steps to successful serialisation.
1: Get executive buy-in
The significance of serialisation is often underestimated. It’s typically considered a production issue and punted to manufacturing as an operational challenge. Yet serialisation is a board level issue, with ramifications that could directly affect business performance. Indeed, it’s not a manufacturing cost – it’s a business continuity risk that touches every aspect of an organisation. So the first step towards serialisation – one that’s often overlooked – is to appoint an executive sponsor, ideally with board level oversight, to lead a holistic strategy. Implementation will naturally be delegated to project teams, but executive leadership will be crucial to making things happen quickly.
2: Assemble a multi-disciplinary team
Multi-disciplinary engagement is essential. Many organisations don’t understand all their business processes in sufficient detail to overlay serialisation. It’s therefore vital that a multi-disciplinary team (MDT) is convened at the earliest opportunity to map the process flow of the business and establish a roadmap of how serialisation can be applied across multiple organisational boundaries. An MDT should actively engage representatives from manufacturing, supply chain, IT, legal/regulatory and partner/contract management.
3: Establish long-term user requirements to ensure you’re ‘future ready’
The next step is to def...
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