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New TraceLink Compliance Module Enables Pharma Companies to Ensure Drug Supply to South Korea Market

May 19, 2016

TraceLink Inc., the world’s largest track and trace network for connecting the Life Sciences supply chain and eliminating counterfeit prescription drugs from the global marketplace, today announced the availability of its South Korea Compliance module—providing drug manufacturers and wholesale distributors with the ability to meet South Korea compliance and data management regulations in advance of the country’s July 1, 2016 enforcement deadline. TraceLink also announced that customers who are currently shipping drug products to South Korea have already used the module to successfully upload more than 600 compliance documents to the Korean Pharmaceutical Information Service Center (KPIS) system.

“The release of our South Korea Compliance module demonstrates TraceLink’s continuous commitment to be first to market with comprehensive compliance applications that allow our customers to ensure drug supply to the markets they serve without any disruption,” said Shabbir Dahod, president and CEO of TraceLink. “South Korea is known for strict enforcement of its regulatory laws, so it was crucial that we deliver a working solution with a comprehensive feature set in advance of the July 1 deadline. Unlike other solution providers that make lots of promises about what they hope to offer sometime in the future, TraceLink continues to lead the industry with proven solutions that life sciences companies can use today, in production, to minimize business risk and ensure that medicines reach patients anywhere in the world.” 

Comprehensive Compliance for South Korea

 To help pharmaceutical manufacturers and wholesale distributors meet the complex serialization and reporting requirements that South Korea plans to enforce on July 1, 2016, TraceLink has created a purpose-built South Korea Compliance software module that leverages proven and commercially tested components of the company’s other compliance applications for master data management, serialization workflow event triggers, and government report generation and message acceptance. Using the South Korea Compliance module, TraceLink customers are able to:

  • Fully transmit and receive electronic messages—through integration with the ESB Adapter for the KPIS system;
  • Generate and submit sales shipment, return receipt and decommission reports—including full support for unique data elements such as unit price, supply class, contract type, and decommission (discard);
  • Utilize built-in file management capabilities—to ensure that master file and sub file templates are correctly managed for secure KPIS compliance report submissions;
  • Perform outbound file pre-verification against KPIS pharmaceutical file – to pre-check generated reports prior to submission;
  • Search across the full compliance reporting archive—with searches based on location, report type, product code, lot, transaction, serial number, and date range to enable extensive analysis of product, shipment and serialization activities; and,
  • Meet wholesale distribution compliance requirements—by receiving messages sent by the KPIS system for upcoming shipments, processing the serialized receipts, and receiving return receipt notices from KPIS to confirm product returns sent back to the supplier.

To learn more about South Korea Compliance or other TraceLink compliance applications for the US, the EU, China, India, Brazil, Turkey, Argentina and other countries, please visit

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