The unfolding story of the Falsified Medicines Directive (FMD): SME doesn’t equal Simple -

The unfolding story of the Falsified Medicines Directive (FMD): SME doesn’t equal Simple

Published by PharmaVOICE

Pharma manufacturers, regardless of the size of the company, 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 code, 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. And as with all good plots, it requires all actors to play their part – large or small – for a successful denouement. In the case of FMD, this 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. Arguably more so for SMEs, who face the same degree of logistical challenge than their larger counterparts, with less resource to focus on and get to grips with the nuances and extent of the regulation. Moreover, with a high level of outsourced production, SMEs play a key role in the global pharmaceutical supply chain.

The bad news for those yet to take action is that the implementation of serialisation is not a quick, overnight task. It encompasses processes that have multiple touch-points across the organisation, partner networks and the wider supply chain. The good news is that all is not lost. By taking the following seven steps, successful serialisation is still readily achievable.

1: Get executive buy-in

Serialisation is significant. It is a board level issue, with ramifications that could directly affect business performance. The first step is to recognise that this is not a production issue to be passed down to manufacturing as an operational challenge; 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 is 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 outsourcing/partner/contract management.

3: Establish long-term user requirements to ensure you’re ‘future ready’

The next step is to define your user requirements and establish a template for the solution that will help ensure you’re compliant. In particular, SMEs must consider immediate and long-term factors to ensure ROI from their investment and a future-proof solution. For example, which markets do you currently ship product to and which do you plan to target in the future? Which products in both your portfolio and your pipeline will need to be coded? Is there a potential future requirement to be able to track and trace products as they journey through the supply chain? Regulations – from FMD to the US Drug Supply Chain Security Act (DSCSA), and those in China, India, Russia and elsewhere – differ from country to country and are constantly evolving. Take the opportunity to become ‘future ready’ by creating a design template that doesn’t just focus on FMD but is flexible enough to be interoperable and implementable between national systems and provides the flexibility to adapt to change as it happens.

4: Understand the data implications of FMD

The barcodes required for FMD must include 4 lines of data; Global Trade Item Number (GTIN), serial number, batch number and expiry date. Some countries require a fifth element, usually for national reimbursement purposes. These datasets often live in disparate systems within organisations. The master data – including GTINs – is fixed information that’s commonly stored in an enterprise resource planning (ERP) system. Although that data doesn’t change, it still requires attention to ensure it’s clean and accurate when uploaded to the repositories. In terms of variable data, the processes required to generate serial numbers, transfer them to production and ensure they’re used appropriately are complex. Managing these numbers throughout the supply chain lifecycle is hugely important; mistakes can lead to expensive delays, medicines shortages and loss of revenue – all of which any organisation, especially SMEs, can ill afford. Serialisation software is therefore an essential requirement to help you maintain control of all aspects of fixed and variable data.

5: Choose the right software

There are numerous factors to consider when selecting software:


Serialisation should not be divorced from the founding principle of Good Manufacturing Practice (GMP) – quality. GMP guidelines, as well as data integrity advice from regulators such as the UK MHRA, state that users of computer systems must always be in control. However, multi-tenant serialisation solutions (where multiple independent entities share the same instance of a software solution) can sometimes impose software updates without prior dialogue, leaving users out of control. The potential impact on quality is significant. Passive acceptance of change is not an option. Multi-tenant solutions require license-holding companies to ensure that risk assessment processes are in place to monitor and adapt to change. By contrast, the most effective solutions allow users to maintain control of their specific software instance and to dictate the timing, relevance and nature of upgrades.

Data Validation

An effective solution will focus on both connectivity and data integrity. Some systems concentrate on enabling a connection and flow of data across and between organisations but are blind to data quality. Companies should never assume that the data entering, or generated within, their systems is clean, tidy and accurate. Internal data checks are essential. The best solutions routinely monitor data to detect human error, inaccuracy and duplication. Smart solution providers validate data flowing through a system – in some cases up to 70 data validation checks on incoming records to ensure its integrity – essentially preventing bad data entering the EU hub.

Network connectivity

It’s not enough to ensure your own business is ready: your partners must be ready too. With outsourcing now common across the industry, it’s important that the software you use connects all parties to a single version of the truth. For SMEs this is a particularly significant consideration. The most effective solution providers connect your entire partner network as standard. This means more than just having a potential connection – it means working with you and your partners to make sure that data really flows.

6: Choose the right partner

This is arguably the most important step for SMEs in their road to successful serialisation. It’s important to find a vendor that can partner with you to guide you through the end-to-end process – from designing responsive solutions that go beyond technology to guaranteeing data integrity and connectivity, and of course ensuring compliance by being a European Medicines Verification Organisation (EMVO) certified ‘Gateway Provider’. Your partner of choice should be a recognised provider with experience, credibility and evidence that shows it can implement effectively within tight timeframes. Finally, a good partner will be committed to your success, keeping you abreast of fluctuating global regulations, and collaborating with you to customise solutions that adapt to changes in your business and the wider marketplace.

7: Act now

The complexities of serialisation mean that a failure to act now could make it extremely difficult to complete implementation in time for the FMD deadline. The internal costs of your project will inevitably rise if you wait. However, the biggest price of non-compliance will be your inability to ship product. So why risk it?

Act now and you can prevent your serial drama becoming a reality.

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