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