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Global Compliance

South Korea

Meet the complex data management challenges for both manufactured and distributed product. Serialise all pharmaceutical drugs, produce the unique, required reporting for specialised and over-the-counter (OTC) products, and integrate with the Korean Pharmaceutical Information Service (KPIS) for reporting submissions. Leverage TraceLink’s purpose-built solution and proven track record – more than 20,000 compliance documents uploaded to KPIS for 38 million units of product – to reduce the time, cost and risk associated with achieving compliance in South Korea.


  • Serialisation. Serialise at the secondary, saleable unit-level and meet South Korea’s complex specifications, such as including the Korea drug code (KDC) rather than GTIN.

  • Reporting. Manage complex requirements, including the acquisition and management of many unique master data elements, and the generation and submission of different report types.


South Korea Compliance
South Korea Compliance allows companies to meet the country’s requirements that span a broad range of pharmaceutical products, and stipulate extensive data capture and master data management for report preparation and submissions. The TraceLink application also solves for the requirements of a separate product/shipment and serialisation data template mandate and a CSV-based data format.

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