Former AstraZeneca serialisation expert, Christoph Krähenbühl, demystifies the arguments around compliance with the forthcoming EU Safety Features regulations in the EU’s Falsified Medicines Directive (EU-FMD), and asks whether UK pharma companies are ahead of the curve or dangerously behind in their implementation strategies.
In 2018, patients will see a fundamental change to the European Healthcare supply chain: every time a pack of medicines is dispensed, the bar code this pack will carry will be scanned in the pharmacy and a series of automatic checks will be carried out - all within a fraction of a second - against a Europe-wide medicines verification infrastructure of systems.
This unique pack identification code in the shape of a 2D DataMatrix code - different to, but not unlike, the familiar QR codes – will be globally unique. It will contain the product code (and possibly national healthcare reimbursement number), the batch/lot number, the expiry date and a highly randomized serial number.
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