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Preparing Parallel Importers for Post EU-FMD Success

The EU Falsified Medicines Directive (EU-FMD) has been front-of-mind for pharmaceutical companies since the countdown to the legislation began in February 2016. This was when the delegated regulation that set out the details of the safety features requirements was first published. The impact of applying the safety features, particularly the serialisation of every pack, is wide-reaching and affects all parties in the pharma supply chain. One sector which has faced some unique challenges from the legislation is parallel importers (PIs).

The Challenge

Initially, it was observed that the focus of the EU-FMD activity was on manufacturers and their in-house assets. Later, focus shifted to the manufacturers’ extended supply chain participants, such as CMOs and wholesalers. More recently, attention has focussed on the manufacturers’ logistics service providers or third-party logistics.

Something of a ‘scale effect’ has occurred, with the larger manufacturers and their supply chain partners generally implementing first. However, many smaller and medium-sized companies were later to act, and now, in the final rush to compliance before 9 February 2019, many of these companies are still in the process of implementation.

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Ian Haynes is Senior Director at Excellis Europe, specialising in product security, coding, and serialisation. He has an extensive background in the pharma and fine chemical sectors, including technology road-mapping, new product design and introduction, product security coding, serialisation, and engineering projects.
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