South Korea Medicines Compliance

KPIS Traceability and Reporting Requirements

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Global Regulations

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Labelling

Products are required to display information in writing.

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Unit Level Traceability

Sellable units are uniquely identified enabling a more granular traceability.

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Aggregation

The packaging hierarchy of products is required to be identified and documented.

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Central repository

The traceability documentation is required to be centralized in a unique system.

Summary

South Korea enforces serialization and supply chain visibility through the Korea Pharmaceutical Information Service (KPIS) operated by the Ministry of Food and Drug Safety (MFDS). All prescription medicines and many OTC products must be serialized and reported across the supply chain.

Reporting focuses on traceability using GS1 standards, shipment-level visibility and real time updates for critical movements. Manufacturers, importers and distributors must follow strict timelines to avoid compliance penalties.

Labelling Requirements 

Each sellable unit must include a GS1 DataMatrix with:

  • GTIN
  • Serial Number
  • Batch Number
  • Expiry Date

Human readable data must match the encoded values.

Cases and pallets should include SSCC barcodes to support aggregation and shipping visibility.

Regulatory Timeline 

  • 2012 – South Korea begins phased serialization adoption.
  • 2015 – Serialization becomes mandatory for most prescription medicines.
  • 2016 – Full KPIS reporting for manufacturers and importers.
  • 2018 onward – Enforcement expands across wholesalers, hospitals and pharmacies.

Reporting Requirements 

Operation
Data to Report
When to Report
Commission
GTIN, Serial, Batch, Expiry
During packaging
Aggregation
Parent SSCC with Child Serials
When forming cases or pallets
Shipment Dispatch
Sender, Receiver, SSCC or Serial List
Before shipping out
Receiving
SSCC or Serial List
At warehouse receipt
Import Reporting
Serial list + shipment details
Before distribution in Korea
Distribution
Serialized supply event
At wholesaler to pharmacy movement
Returns
Serial and return status
When returned
Decommission
Serial and reason
When expired, destroyed or written off

Operational Timelines for Industry 

  1. Register with KPIS and configure integration credentials.
  1. Set up GTINs and serialized artwork.
  1. Print serialized labels during packaging.
  1. Build SSCC aggregations for all outbound shipments.
  1. Report serialization, aggregation and shipment events before dispatch.
  1. Complete import reporting before releasing goods to the local market.
  1. Report distribution, returns and decommission events in near real time.

Reporting Hub

  • South Korea uses the KPIS system for medicine traceability.
  • Reporting is managed under the MFDS authority.
  • Integration can be done via API or portal upload.
  • Importers must ensure pre-market reporting before products enter distribution.

Aggregation Requirements 

  • Aggregation is required for accurate shipment reporting.
  • Parent child hierarchy must be complete for all cases and pallets.
  • Incorrect or missing aggregation may cause reporting failures or distribution delays.

Common Errors to Avoid 

  • Missing SSCC aggregation for cases and pallets.
  • Serial mismatch between printed pack and reported data.
  • Incorrect sender or receiver details.
  • Reuse of SSCCs.
  • Late reporting causing distribution holds.
  • Incomplete data for returns or write off events.

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EPCIS Data Encoder,Capital Wholesale Drug
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