EU FMD: Harsh lessons from item-level serialisation in the USA

  • By Volker Watzke
  • April 29, 2019
  • Life Sciences
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Having moved past the EU FMD deadline, we look at what pharmaceutical manufacturers can learn from the rollout of similar legislation in the USA.

Change is coming...

The EU’s Falsified Medicines Directive was implemented on 9th February 2019. This item-level serialisation legislation represented a sea change for the entire pharmaceutical supply chain. But given the operational disruption associated with FMD compliance, is the industry even fully ready post-deadline?


Is the EU pharmaceutical industry ready for FMD?

To get an idea for the EU’s potential learning from FMD, it’s worth looking at recent study conducted in the USA. In November 2017 - six months before the USA adopted its own pharmaceutical item-level serialisation legislation - AmerisourceBergen (ABC) and McKesson Pharmaceutical (McKesson), in collaboration with GS1 Healthcare US, conducted a huge study of the market readiness for serialisation by way of auditing ‘finished’ product.

The results made for stark reading.

GS1’s study surveyed 16,618 individual pharmaceutical packages from 607 unique manufacturers. Only 6.6% of the packages were compliant with the impending serialisation legislation. (Read the report here.) Just six months before the implementation of legislation, it was an alarming snapshot of the progress the US pharmaceutical industry had made towards item-level serialisation.

The difficulties encountered in the US serve as a clear call for pharmaceutical businesses in the EU who are yet to finalise their preparations for FMD compliance: the time to act is now, in fact the time to act was yesterday.


Are your barcodes compliant?

Having the right data on the medicinal package isn’t enough. It must be machine-readable too. In their US study, ABC and McKesson noted several issues with barcode colour combinations (contrast against the substrate) and size that caused problems with scanning and data capture. While colour combinations such as black and white produced no-fault scanning, others such as orange and white were impossible to read. Other problems included smudging of the barcode, patient instructions blocking the barcode and different barcodes being placed too close together.

>> 2D data matrix best practice

These are not just trivial aesthetic issues. Machine-readable data is key to FMD compliance. With that in mind it’s sensible to test your coding operations before you’ve coded tens of thousands of units. Consider circulating your products to trading partners to make sure your barcodes are universally readable. Following GS1 coding standards is a no-brainer.


Are you ready? We can help!

In their study, ABC and McKesson mused that some manufacturers may have been tempted to put off the investment required for item-level serialisation in order to save money. Yet you cannot afford to underestimate the challenge of adapting your operations for FMD compliance.

Our short e-guide has expert guidance on how to make sure your business is fully compliant with the FMD legislation. You can download it here. Or for a free consultative health check of your production lines, ask for one of our serialisation experts to visit your facilities.

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