South Korea

v. 2.0 – 05/06/17

Serialization Model Track and Trace
Governing Body
  • Ministry for Health and Welfaire (MoH)
  • Ministry for Food and Drug Safety (MFDS – formerly Korean FDA)
  • Health Insurance Review and Assessment Service (HIRA)
Compliance Date
  • Serialization: 30% of sales or product must be serialized by January 1, 2015 and 100% by January 1, 2016 (July 1, 2016 enforcement date)
  • All psychotrophic and biological drugs (narcotics) must be serialized first
  • Labeling requirements in effect
  • Aggregation requirements delayed
Randomization Requirements TBD
Aggregation Requirements Likely – dependent on reporting requirements and data repositories
Reporting Requirements TBD
Data Repositories TBD
Saleable Unit Data Carrier GS1 Data Matrix encoded witih GTIN, Serial Number, Lot, and Expiry Date
Saleable Unit HRI GS1 Data Matrix or GS1-128 Linear encoded with GTIN, Serial Number, Lot, and Expiry Date
Shipping Case Data Carrier GS1 Data Matrix or GS1-128 linear encoded with GTIN, Serial Number, Lot, and Expiry Date
Shipping Case HRI GS1 Data Matrix or GS1-128 linear encoded with GTIN, Serial Number, Lot, and Expiry Date
Logistics Unit Data Carrier 18 digit Serialized Shipping Container Code (SSCC18)
Logistics Unit HRI Not specified
Additional Notes

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