Are you ready for EU FMD? Urgency, consistency and planning are key
Vikash Pushpraj, Senior Vice President, rfxcel
With the deadline looming for enactment of EU FMD and US DSCSA, Vikash Pushpraj, SVP, rfxcel, explains how achieving compliance is about much more than technology. Companies not yet set up for serialisation will need to adopt best practices and leverage the know-how of implementation experts in their methodology to go-live on time.
Despite the proximity of the regulatory deadlines, a surprising number of companies have not yet established the infrastructure and processes required for serialisation. While it’s not unusual for organisations to wait as late as possible before adapting operations to meet compliance obligations, it’s easy to underestimate the complexity of adding serialisation capabilities to operations.
In February 2019, the delegated regulation to the Falsified Medicines Directive (FMD) comes legally into force in Europe, mandating Marketing Authorisation Holders (MAHs) to serialise individual medicine packs for authentication at the point of dispensation. With just months to go, it’s a tight deadline to meet. But an even tighter deadline is just around the corner.In November 2018, DSCSA requirements for package-level serialisation finally come into play, midway through a 10-year roadmap for end-to-end traceability across the US supply chain.
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