Do not delay and pay the hard way

Published: 23-Oct-2014

Former AstraZeneca serialisation expert Christoph Krähenbühl demystifies the arguments around compliance with the forthcoming Safety Features regulations in the EU Falsified Medicines Directive, and questions whether some countries are dangerously behind in their implementation strategies

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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 in the shape of a 2D DataMatrix code – different from, 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 randomised serial number.

The results of the scan will give dispensing pharmacists instantaneous feedback about the status of the product to achieve the stated aims of the European Falsified Medicines Directive (EU-FMD), 2011/62/EU ‘Safety Features’ provisions. They will be able to see whether the pack number has been dispensed before and could, therefore, be a counterfeit product; they can ensure it is still within its expiration date; and check whether there is a recall or other notice against the batch.

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