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Pharma companies can be compliant ahead of the January 1, 2020 deadline mandated by the Russian government
August 17, 2018
By: Tim Wright
Editor-in-Chief, Contract Pharma
rfxcel, a provider of track and trace solutions, has enhanced its compliance solution for Russia and introduced additional customer implementations in the Russian marketplace. Russia compliance is now fully embedded in rfxcel’s Compliance Management (rCM) and Serialization Processing (rSP) modules. The extended Russia support builds upon rfxcel’s Traceability System (rTS). rfxcel is actively rolling out its Russia compliance solution for pharmaceutical customers to meet the serialization, aggregation, traceability, and reporting requirements for the Russian market. As one of the first compliance providers to implement for Russia, rfxcel says it is strategically positioned to help pharmaceutical companies achieve compliance well in advance of the January 1, 2020 deadline mandated by the Russian government. Russia’s Federal law 425-FZ requires medicines to be uniquely identified across packing levels with additional Russia-specific cryptography. Under Russia’s Federal law, participants must track and report products in various stages of the supply chain. This information is reported to Russia’s centralized Federal State Information System for Monitoring Drug Circulation (FSIS MDC). “We are extremely proud to work with our customers to meet Russia’s compliance regulations, arguably the most complex in the world,” said Mark Davison, senior operations director, rfxcel Europe. “Delivering a serialization, aggregation and reporting solution for compliance requires not only robust software, but also demands an experienced local and international team with the skills and flexibility to manage an end-to-end project. rfxcel offers both the solution and service to ensure success.”
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