The Falsified Medicines Directive

At the end, the dispensing healthcare institution must verify and decommission that product against a national hub, known as the National Medicines Verification System (NMVS).

This leaves the middle of the supply chain, where there is also a requirement for wholesalers, distributors and logistics providers to implement a ‘risk-based’ approach to the verification and decommissioning of products passing through their operation. To be compliant, manufacturers, wholesalers and distributors alike will have to make changes to their supply chain operations.

Yet, despite the impending deadline the market doesn’t appear to be advanced enough in its response. When it comes to the practical application of FMD, there are many areas that still cause confusion. Organisations can no longer afford to let these areas act as barriers to implementing robust FMD solutions. Christian Taylor, Serialisation Business Consultant, Zetes, clears up some of the key pain points.

Automated workflow: Putting confusion aside, organisations should proactively be looking to implement solutions that create minimum disruption to current working processes, drive efficiencies and are simple to use every day. Whilst some of the details around the legislation will require further clarification, businesses need to ensure they have a robust solution in place to ensure compliance and remove any chance for human error.

From batch to unit level visibility: The important thing for organisations to consider at this time is that currently, no one is handling the data of individual products on the line. To be compliant and report to the national hubs, wholesalers, distributors and logistics partners are going to have to review current processes and ensure they can handle data for any single unit within their operations.

Visibility imperative: Behind this legislation, there are distinct efficiency and quality advantages to be found. Wholesalers, distributors and logistics partners should use this opportunity to improve capability within the warehouse and business operations.

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Building a comprehensive and agile visibility layer on existing processes and cross-functional systems. This will not only ensure compliance by 9 February 2019, but these infrastructures can be built upon further, putting organisations in a better position to react to any further regulation changes with ease.