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Connecting the Disconnected

The US Drug Supply Chain Security Act and the EU Falsified Medicines Directive, introduced late 2018 and early 2019 respectively, require that all pharmaceutical products must be traceable across the entire supply chain. Serialisation or ‘track and trace’ are terms commonly used to describe these requirements, and this is an initiative that’s gathering pace globally in the war against counterfeit medicines.

Likewise, the medical device industry has been responding to new regulations that increase levels of patient safety. The FDA’s Unique Device Identification (UDI) System and the EU’s medical device regulations/ in vitro diagnostic regulations compel device manufacturers to allocate and submit a UDI for every device sold. With serialisation, UDI is a global initiative with Brazil, China, India, and South Korea, among others.

While differing in their detail, aspects of traceability are common to both. With increasing convergence of pharma and medical device companies, perhaps it is time to look for solutions that go beyond today’s regulatory requirements to bring organisation-wide transparency and traceability to product and package labelling.

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Kallik is a leading provider of integrated, cloud-based labelling and artwork management solutions for highly regulated global industries. Their solutions help the industry accelerate time to market, reduce the risk of noncompliance, and eliminate costly product recalls caused by labelling inaccuracies. They also help organisations overcome process bottlenecks and achieve a faster return on investment through increased transparency and greater levels of collaboration.
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Graham Francis
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