One of these — that of assigning and verifying a unique product identity at item level — is potentially the most significant technical and logistical challenge that manufacturers have faced in decades. Yet, the evidence would suggest that the majority of industry players are still not ready. Domino’s Bart Vansteenkiste provides a blueprint for those yet to complete their serialisation journey.
Adopted in 2011 (FMD 2011/62/EU) and aimed at stemming the flow of falsified medicines infiltrating the legal pharmaceutical supply chain within the European Economic area, the EU Falsified Medicines Directive (FMD 2016/161/EU), due to come into force on 9 February 2019, will completely change the landscape of the European pharmaceutical supply chain. Italy, Belgium and Greece have until 2025 as they already have a unique numbering system in place that aims to prevent falsified medicines reaching the market.
The scope of the Directive places new obligations on all branches of the industry — manufacturers, generics producers, contract packers, repackers, importers, wholesalers and distributors — and on any producer intending to supply pharmaceutical products into any of the 28 EU countries. Broadly, the requirements fall into five categories:
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