South Korea
| Regulatory Agency | Ministry of Food and Drug Safety (MFDS) — primary government regulator responsible for pharmaceutical products in Korea. Serialization and transaction reporting are implemented under the Pharmaceutical Affairs Act (Enforcement Rules) and associated MFDS notifications (e.g., Guideline on the Use and Management of Barcodes and RFID Tags for Drug). |
| Regulation Name | Korea implements a national pharmaceutical serialization system under MFDS via barcode & RFID regulation, controlled by Guidelines under the Pharmaceutical Affairs Act/Enforcement Rules. |
| Compliance Dates | According to the MFDS implementation roadmap documented in regulatory |
| Applies to | All suppliers of finished pharmaceutical products — manufacturers, importers, and wholesalers — must serialize and report according to the system |
(A carton containing one or more primary packs and includes a “mono carton” containing one primary pack)
| Barcode Symbology | Global standard barcodes such as GS1-DataMatrix, GS1-128, or optionally RFID tags are accepted and encode KD codes |
| Barcode Contents | KD Code (based on a GS1 GTIN structure), expiration date, lot/batch number, serial number. |
| Serial Number Randomization | No |
| Serial Number Reuse | Serial numbers must be unique per product/pack; reuse is allowed only after expiration + grace period under internal guidelines (often >1 year after expiry). |
| Human Readable Expiry Date Format | Encoded using GS1 standard AIs, generally YYMMDD in GS1 barcodes. |
| Barcode Data Encoding | GS1 Application Identifiers (GTIN, expiration, lot number, serial) per GS1 standards. |
| Product Code Notes | KD Code uses a GTIN (often GTIN-13/GTIN-14) format assigned via Korea’s pharmaceutical coding system. |
| Free Samples must be marked? | Samples or donated products may be reported differently (see reporting formats) but do not require entirely separate serialization rules. |
(A shipper containing one or more secondary packs)
| Barcode Symbology | Same GS1 standards (DataMatrix or GS1-128) with identical data elements. | |
| Barcode Contents | Linear GS1-128 for logistic units (e.g., case/shippers) is commonly used; SSCC or GTIN-14 plus serial can be applied. | |
|
Parent-Child Mapping Aggregation Capture? |
While not strictly mandatory in all cases, aggregation (linking unit to case level) is recommended and supported by GS1 standards and KPIS guidance. focus primarily on item-level codes. |
| Send Unit Data to Government Repository? | Mandatory transaction reporting to KPIS at the time of shipment for serialized products. |
| Send Unit Data to Third-Party Repository? | Not explicitly required by regulation; suppliers may use external systems at their discretion |
| Send Unit Data to Trading Partner? | Producers and wholesalers share reported data via the KPIS network. |
| Send Aggregation Data to Government Repository? | Increasingly encouraged but specific mandates vary by sub-regulation. |
| Send Aggregation Data to Third-Party Repository? | Aggregation data to third-party repositories: Not Specified / No regulatory mandate in Chinese national rules |
| Send Aggregation Data to Trading Partner? | Aggregation data exchange to trading partners: Not Specified / No regulatory mandate in Chinese traceability compliance texts. |
| Who Offers Data Repository for Authentication? | KPIS (Korea Pharmaceutical Information Service) — the central national repository operating under the MFDS framework. |
| Manufacturers Must Register Shipments in Repository? | Yes — transactional data including serialization details must be registered and reported. |
| Downstream Trading Partners Must Authenticate on Receipt? | Korea’s system focuses on reporting rather than mandatory scanning at every handoff — downstream partners report receipt and outbound transaction data but there’s no distinct legal “authenticate on receipt” mandate separate from reporting requirements. |
| Downstream Trading Partners Must Authenticate on Shipment? | Yes |
| Manufacturer Activity Reported? | Yes, coded events (production, scanning, etc.) are captured. |
| Downstream Trading Partner Activity Reported? | Scanning events entered by hospitals/pharmacies must upload to system. |
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