Compliance with Russia's "most complex" track and trace requirements given a boost

By 2020, all medicines imported into and traded within Russia must comply with Russian Federal Law No. 425-FZ.

Under Russian Federal Law No. 425-FZ, pharmaceutical companies are required to manage serialization and traceability of medicines from manufacturer to patient, and report product and transaction events to the central government system. By 2020, all medicines imported into and traded within Russia must comply with the regulation, applying to over 370 manufacturers supplying medicines within, and into the Russian market. A recent TraceLink poll showed that 82% of respondents with Russian track and trace requirements feel that Russia’s compliance regulations are more complex than any other country.

“For pharmaceutical companies complying with the complicated Russian requirements, TraceLink not only provides them with a locally implemented, global compliance platform that orchestrates compliance-related business processes between their partners, but a solution that is also agile enough to adapt to the continuous changes and evolution of the Russian law by leveraging existing integrations done with previous markets,” said Shabbir Dahod, president and CEO, TraceLink. “Furthermore, our partnership with Excellis will allow TraceLink to service the needs of the Russian market with local subject matter expertise and resources in the native Russian language, creating the best possible experience for our customers while ensuring both global and local in-market support.”

“Our partnership with Tracelink will allow pharmaceutical companies to leverage Excellis’ industry-leading subject matter expertise and a comprehensive, yet easy to manage, global compliance solution, in order to successfully meet the Russian requirements on time,” said Karan Narang, President, International at Excellis Health Solutions, an international consulting firm focused on providing track and trace implementation services in the pharmaceutical supply chain. “Excellis is already a strategic partner with Tracelink and we look forward to increased collaboration to provide local access and support to the Russian market.”

Built on TraceLink’s existing network tenant platform and instrumented with the core serialization, master data, integration, and compliance functionalities seen in all other TraceLink compliance solutions, the Russia solution is designed to meet the complex data choreography requirements for Russia compliance, TraceLink’s pre-configurable workflows and application logic enable companies to report on serialized events, and manage import, export, receipt, transfer, and shipment processes.