South Korea

South Korea's Track and Trace Regulations Overview

As of 2016, serialization requirements in South Korea cover 100% of pharmaceutical drug products. Compliance reporting responsibilities are coming into play, including unique reporting requirements for specialized and over-the-counter (OTC) drug products. All in all, manufacturers have a very complex data management challenge for manufactured and distributed product.

Serialization Highlights

Serialization and Aggregation: The current law, which started phasing in on January 1, 2015, now requires companies to uniquely serialize drug products following GS1 standards. Aggregation is voluntary but encouraged by regulators, and strongly requested by supply chain partners.

  • Secondary (saleable unit)-level serialization – mandatory. South Korea has some notable complexities and is known for strict enforcement of its regulatory laws. For instance, serialized product must contain the Korea drug code (KDC) rather than GTIN. Expiration date, lot number, and a 2D data matrix or linear barcode are required. An RFID tag can be used as an optional data carrier.
  • Tertiary (case)-level serialization – not required by regulation, although trade partners, internal distribution sites, and 3PL partners may desire tertiary serialization for operational efficiency reasons.

Reporting Highlights

South Korea compliance reporting goes through the Korean Pharmaceutical Information Service (KPIS). Reporting is complex and requires the acquisition and management of many unique master data elements, such as unit price, supply class, and contract type. Manufacturers and importers must generate and submit several different report types, including sales shipment, return receipt, discard/destruction shipment correction, and shipment cancellation reports.

The report contents and frequency varies depending on whether the product type is a regular pharmaceutical drug, a specialized drug product, or an OTC medicine. The required data format is CSV-based, and every shipment of serialized pharmaceutical drugs must use two matching templates: a master file template for general product and shipment information, and a sub-file template for serialization data.

Full-scale reporting requirements are phasing in between now and 2017:

  • Manufacturers/Importers: Full regulatory requirements and enforcement begins July 1, 2016, after a six-month transitional period, and requires manufacturers to report drug products to the Korean Pharmaceutical Information Service (KPIS). Per-shipment reporting is required for both fully serialized and mixed (serialized, non-serialized) shipments, while non-serialized (specialized and OTC) drug product reporting is required monthly. 

  • Wholesale distributors: Details of product shipments must be reported to KPIS. Beginning July 1, 2017, serialization reporting will be required by all wholesale distributors. 

How TraceLink Can Help

TraceLink provides a complete end-to-end South Korea compliance solution for supply chain companies to meet today's complex South Korea serialization and reporting requirements. Master data management, serialization management, serialized operations management, and compliance reporting modules are available on the cloud platform to support your business and your supply network.

Our latest integrated solution, the South Korea Compliance module, is purpose-built for comprehensive South Korea compliance reporting management. South Korea Compliance delivers full KPIS integration, and complete compliance data management supporting unique data, file, and wholesale distribution requirements to help companies reduce the time, cost, and risk associated with achieving compliance in South Korea.

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South Korea at a Glance 

Government agency KFDA 
Regulatory scope Serialization
Product scope All pharmaceutical products
Participants Manufacturers/importers, wholesale distributors
Next deadline July 1, 2017: reporting enforcement for wholesale distributors
Serial # format Manufacturer-generated GS1 standard
Reporting flow Reporting requirement for manufacturers in 2016; wholesale distributors in 2017
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