GS1 The Data Debate - EU Falsified Medicines Directive

Thoughts must now turn to how the framework within which the data generated will be managed, the role of those bodies supervising the generation of data and those responsible for its management - and how manufacturers can prepare the ground for positive data management.

In the third of a series of features designed to help pharmaceutical manufacturers prepare for the impending implementation of the EU Falsified Medicines Directive (FMD), Craig Stobie, head - global Life Sciences team at Domino Printing Sciences, examines the thinking behind how the vast amounts of data acquired under the auspices of the FMD will be collected, stored and interrogated – and why.

In previous features relating to the Falsified Medicines Directive and how it affects pharmaceutical manufacturing and packing, we looked firstly at the Hidden Challenges of Serialisation from a hardware and Overall Equipment Effectiveness (OEE) perspective and subsequently Beyond Serialisation at the potential benefits of data aggregation – creating hierarchical relationships at each stage of the packaging process – to the supply chain. Effectively we have considered how best to achieve item-level serialisation and how going ‘beyond the brief’ [aggregation is not a specified requirement of the FMD] to create linkages between bundles, cartons, cases and pallets can offer significant return on investment.

While for most producers the past couple of years will rightly have been about building the correct hardware eco-system and setting the correct operating landscape to achieve a consistently high standard of robust marking, thoughts must now turn to the framework within which the data generated will be managed.