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South Korea Compliance

South Korea’s Pharmaceutical Affairs Act, Article 45, mandates that serialization be required for all pharmaceuticals at a unit level, except medical gases and clinical trials. The Act requires reporting on serialized products in each shipment. It also requires monthly reporting of non-serialized product shipments, as well as returns and destruction of product.

TraceLink’s South Korea Compliance application monitors TraceLink’s Serialized Operations Manager (SOM) application for reportable events. For example, if a delivery is created in SOM, South Korea Compliance generates a report and sends it to the South Korea Pharmaceutical Information Service (KPIS).

South Korea Compliance reports on these events:

  • Sales shipments
  • Return receipts
  • Serial number decommissioning and destruction events
  • Cancelled shipments
  • Corrected shipments
  • Error responses
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