Looking to the long-term: Serialisation regulations here to stay, Tracelink

By Dan Stanton contact

- Last updated on GMT

Image: iStock/anyaivanova
Image: iStock/anyaivanova

Related tags: Falsified medicines directive, Pharmacy, Pharmacology

Pharma and CMOs must start addressing their serialization needs ahead of 2019’s EU Falsified Medicines Directive, says Tracelink which is bringing its supply chain event NEXUS to Barcelona next month.

Pharma and CMOs must start addressing their serialization needs ahead of 2019’s EU Falsified Medicines Directive, says Tracelink which is bringing its supply chain event NEXUS to Barcelona next month.

Securing pharma’s supply chain is being addressed in the US through the Drug Supply Chain Security Act (DSCSA), which requires unique serialization numbers and bar codes for the smallest saleable unit of pharmaceutical product.

With this coming into effect this year, attention is turning to Europe where similar barcoding measures will be required from early 2019, as laid out in the EU Falsified Medicines Directive (FMD).

“We’re starting to see the focus shift from DSCSA to EU FMD,” ​Shabbir Dahod, CEO of supply chain track and trace services firm TraceLink, told in-Pharmatechnologist.

As such, NEXUS, the firm’s annual global event, will be held in Barcelona, Spain next month “to allow for focused education and thought leadership on the EU FMD and other global regulations,”​ he added.

Around half of last year’s attendees were not familiar with the technical and process requirements for European serialization compliance, he continued, saying the Barcelona event looks to emphasise the need for preparation and readiness among drugmakers.

“Thousands of manufacturing companies face long lead times to address their network, scale and compliance challenges in order to meet the EU FMD regulations by 2019, so the time to begin planning is now.”

Looking to the long-term

NEXUS looks to bring pharmaceutical companies and CMOs together with parallel importers, distributors, hospitals and pharmacies to understand the operational impact of serialization, Dahod told us.

“Serialization and track and trace regulations are here to stay, so the relationship between a solution/service provider and their pharma customers should be viewed as a long-term partnership.”

But the conference will also address standardisation in the space, which Dahod said will help foster closer collaboration across the industry.

Multi-national companies have to comply with varying global regulations, while managing the different demands made by their trade partners across the supply chain. The ability to seamlessly exchange information across a network is the easiest way to accommodate these disparate regulatory laws and partner demands.”

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