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South Korea Prescription Drug Tracking


The recent focus has been on regulations relating to the South Korean the Ministry of Health and Welfare notification 2011- 58 amending "Controlling and indicating barcodes of pharmaceutical products" sets the law relating to drug traceability."

Under the law, pharmaceutical barcode or RFID tag must be adhered to primary, secondary and external containers as well as packaging materials, per items, and per packaging units. Likewise, expiration date and lot number information is mandated in bar codes for traceability of specified drugs from 2012 and prescription drugs from 2013, respectively.

Manufacturer must adhere or indicate barcode or RFID tag to distributed pharmaceuticals that are domestically manufactured or imported (excluding high pressure gas for medical use, drug substances manufactured just for other manufacturing process, herbal medicines, product for clinical trials). However, pharmaceutical barcode or RFID tag can be omitted for empty capsules.

Pharmaceutical barcode or RFID tag must be adhered to primary, secondary and external containers as well as packaging materials, per items, and per packaging units.

There are several very specific requirements for manufacturers and wholesalers that will be defined based on your company procedures and business systems.

Projects have delivered (1) strategy, (2) project roadmap and plans, (3) User Requirement Specification (URS) for (a) enterprise serialization, (b) packaging systems, (c) warehouse/shipping (referred to as EDGE), and (d) regulatory reporting such as e-pedigree, (4) contract manufacturer and logistics provider requirements and governance, (5) compliance with global regulatory requirements, (6) functional and design specifications, (8) business system and packaging designs and architectures, (9) pilot planning and scenarios, (10) GAMP based validation, and (11) vendor selection.

Projects have included solutions involving serialization, track and trace, electronic pedigree (e-Pedigree), country traceability reporting (i.e., Turkish Ministry of Health, China, etc.), radio frequency identification (RFID), barcoding and scanning, GS1 electronic product code information services (EPCIS), supply chain, warehousing and Electronic Data Interchange (EDI). Pharma Logic Solutions is a longstanding Solution Provider for GS1 US Healthcare.

Strategy, business and user requirements, designs and implementations have included solutions from SAP (ECC, SCM, Aii, OER, Aie), JD Edwards, Oracle (OPSM, OPM), Manhattan Associates, MAPICS, Acsis (ProducTrak), Axway, rfXcel, Frequentz, Systech, Optel Vision (TrackSafe, Line Master, PharmaProof), Cognex, Mettler Toledo, Seidenader (Körber Medipak), Antares Vision (Xyntek), Laetus, ROC-IT Solutions, TAKE Solutions, Uhlmann, Nosco, Werum PAS-X, Tracelink, Videojet and others.

Contact us to discuss your needs and contrast the Pharma Logic Solutions solutions against previous providers to see why our approach is the ideal solution. 


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Updated: Sunday June 23, 2024.