{"id":12709,"date":"2023-04-10T16:21:43","date_gmt":"2023-04-10T16:21:43","guid":{"rendered":"https:\/\/kevision.in\/?page_id=12709"},"modified":"2026-02-26T07:01:34","modified_gmt":"2026-02-26T07:01:34","slug":"south-korea-regulatory","status":"publish","type":"page","link":"https:\/\/kevision.in\/ru\/whitepapers\/south-korea-regulatory\/","title":{"rendered":"South Korea Regulatory"},"content":{"rendered":"
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South Korea Regulatory\n<\/h2>\t\t<\/div>\n\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Regulatory For<\/h5>\t\t<\/div>\n\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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South Korea<\/span><\/p>\n\t\t\t\t\n\t\t\t\t<\/div>\n\t\t\t\t\n\t\t\t<\/div>\n\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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Regulatory Agency<\/strong><\/td>Ministry of Food and Drug Safety (MFDS)<\/b> \u2014 primary government
regulator responsible for pharmaceutical products in Korea.
Serialization and transaction reporting are implemented under the
Pharmaceutical Affairs Act (Enforcement Rules)<\/b> and associated
MFDS notifications (e.g., Guideline on the Use and Management of
Barcodes and RFID Tags for Drug).<\/td><\/tr>
Regulation Name<\/strong><\/td>Korea implements a\u00a0national pharmaceutical serialization system<\/b> under MFDS via barcode & RFID regulation, controlled by Guidelines under the
Pharmaceutical Affairs Act\/Enforcement Rules.<\/td><\/tr>
Compliance Dates<\/strong><\/td>

According to the MFDS implementation roadmap documented in regulatory
guidance:<\/p>

  • 2012: <\/strong>Expiration date & lot\/batch encoded barcodes mandatory for
    specified drugs.<\/li><\/ul><\/div><\/div>
    • 2013:<\/strong> Same expanded to most prescription drugs.<\/li><\/ul><\/div><\/div>
      • 2015\u2013Jan 1, 2016:<\/strong> Serial number encoding requirement introduced
        for these drugs; transaction reporting became mandatory starting
        in 2016.<\/li><\/ul><\/div><\/div><\/td><\/tr>
Applies to<\/strong><\/td>All suppliers of finished pharmaceutical products \u2014 manufacturers,
importers, and wholesalers<\/strong> \u2014 must serialize and report according to the
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Secondary Packaging<\/h3>\t\t<\/div>\n\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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(A carton containing one or more primary packs and includes a \u201cmono carton\u201d containing one primary pack)<\/p>\t\t<\/div>\n\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\n\t\t\t\t\t\t\t\n \n \n \n \n \n \n \n \n \n
Barcode Symbology <\/strong><\/td>\n \n Global standard barcodes such as GS1-DataMatrix, GS1-128, or optionally\n RFID tags are accepted and encode KD codes\n <\/td>\n <\/tr>\n
Barcode Contents<\/strong><\/td>\n \n KD Code (based on a GS1 GTIN structure), expiration date, lot\/batch\n number, serial number.\n <\/td>\n <\/tr>\n
Serial Number Randomization<\/strong><\/td>\n No<\/td>\n <\/tr>\n
Serial Number Reuse<\/strong><\/td>\n \n Serial numbers must be unique per product\/pack; reuse is allowed only\n after expiration + grace period under internal guidelines (often >1 year\n after expiry).\n <\/td>\n <\/tr>\n
Human Readable Expiry Date Format <\/strong><\/td>\n \n Encoded using GS1 standard AIs, generally YYMMDD in GS1 barcodes.\n <\/td>\n <\/tr>\n
Barcode Data Encoding<\/strong><\/td>\n \n GS1 Application Identifiers (GTIN, expiration, lot number, serial) per\n GS1 standards.\n <\/td>\n <\/tr>\n
Product Code Notes <\/strong><\/td>\n \n KD Code uses a GTIN (often GTIN-13\/GTIN-14) format assigned via Korea\u2019s\n pharmaceutical coding system.\n <\/td>\n <\/tr>\n
Free Samples must be marked?<\/strong><\/td>\n \n Samples or donated products may be reported differently (see reporting\n formats) but do not require entirely separate serialization rules.\n <\/td>\n <\/tr>\n <\/tbody>\n<\/table>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Tertiary Packaging<\/h3>\t\t<\/div>\n\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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(A shipper containing one or more secondary packs)<\/p>\t\t<\/div>\n\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Barcode Symbology<\/strong><\/td>\n \n Same GS1 standards (DataMatrix or GS1-128) with identical data elements.\n <\/td>\n <\/tr>\n
Barcode Contents<\/strong><\/td>\n \n Linear GS1-128 for logistic units (e.g., case\/shippers) is commonly\n used; SSCC or GTIN-14 plus serial can be applied.\n <\/td>\n <\/tr>\n <\/tbody>\n<\/table>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Aggregation Data Capture<\/h3>\t\t<\/div>\n\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\n Parent-Child Mapping Aggregation Capture?<\/strong>\n <\/div>\n
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\n While not strictly mandatory in all cases, aggregation (linking unit to\n case level) is recommended and supported by GS1 standards and KPIS\n guidance. focus primarily on item-level codes.\n <\/td>\n <\/tr>\n <\/tbody>\n<\/table>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Data Exchange<\/h3>\t\t<\/div>\n\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\t\t\t\t\n \n \n \n \n \n \n \n
\n Send Unit Data to Government Repository? <\/strong>\n <\/td>\n \n Mandatory transaction reporting to KPIS at the time of shipment for\n serialized products.\n <\/td>\n <\/tr>\n
\n Send Unit Data to Third-Party Repository? <\/strong>\n <\/td>\n \n Not explicitly required by regulation; suppliers may use external\n systems at their discretion\n <\/td>\n <\/tr>\n
Send Unit Data to Trading Partner? <\/strong><\/td>\n \n Producers and wholesalers share reported data via the KPIS network.\n <\/td>\n <\/tr>\n
\n Send Aggregation Data to Government Repository? <\/strong>\n <\/td>\n \n Increasingly encouraged but specific mandates vary by sub-regulation.\n <\/td>\n <\/tr>\n
\n Send Aggregation Data to Third-Party Repository? <\/strong>\n <\/td>\n \n Aggregation data to third-party repositories: Not Specified \/ No\n regulatory mandate<\/b\n>\n in Chinese national rules\n <\/td>\n <\/tr>\n
\n Send Aggregation Data to Trading Partner? <\/strong>\n <\/td>\n \n Aggregation data exchange to trading partners: Not Specified \/ No\n regulatory mandate<\/b\n>\n in Chinese traceability compliance texts.\n <\/td>\n <\/tr>\n <\/tbody>\n<\/table>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Authentication<\/h3>\t\t<\/div>\n\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\n Who Offers Data Repository for Authentication?<\/strong>\n <\/td>\n \n KPIS (Korea Pharmaceutical Information Service) \u2014 the central national\n repository operating under the MFDS framework.\n <\/td>\n <\/tr>\n
\n Manufacturers Must Register Shipments in Repository? <\/strong>\n <\/td>\n \n Yes \u2014 transactional data including serialization details must be\n registered and reported.\n <\/td>\n <\/tr>\n
\n Downstream Trading Partners Must Authenticate on Receipt?\n <\/strong>\n <\/td>\n \n Korea\u2019s system focuses on reporting rather than mandatory scanning at\n every handoff \u2014 downstream partners report receipt and outbound\n transaction data but there\u2019s no distinct legal \u201cauthenticate on receipt\u201d\n mandate separate from reporting requirements.\n <\/td>\n <\/tr>\n
\n Downstream Trading Partners Must Authenticate on Shipment?\n <\/strong>\n <\/td>\n Yes<\/b><\/td>\n <\/tr>\n <\/tbody>\n<\/table>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Government Reporting<\/h3>\t\t<\/div>\n\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Manufacturer Activity Reported?<\/strong><\/td>\n \n Yes, coded events (production, scanning, etc.) are captured.\n <\/td>\n <\/tr>\n
\n Downstream Trading Partner Activity Reported? <\/strong>\n <\/td>\n \n Scanning events entered by hospitals\/pharmacies must upload to system.\n <\/td>\n <\/tr>\n <\/tbody>\n<\/table>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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\n\t\t\t\t\t\t\tSource and Credit<\/strong>: This information is fully or partly based on the GS1 master document (all rights reserved). As GS1 does not control the content of the information, GS1 shall not be held liable, under any circumstance, if it differs from the master document.\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t
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Disclaimer\n<\/h3>\t\t<\/div>\n\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\t\t\t\tThis information is being provided \u2018As Is\u2019 with no claims of suitability for a particular purpose. It represents just a possible interpretation of information available in the public domain and that interpretation is subject to change. This information does not constitute legal advice.\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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About Kevision Systems<\/h3>\t\t<\/div>\n\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Kevision<\/strong> Systems<\/strong>, a part of the Kevin Group, is a leading solutions provider for complete end to end inspection of products & services for the inspection of pharmaceutical products like tablets, capsules and more. In addition to the inspection systems, Kevision\u2019s Track & Trace Software & related equipment provide a fully integrated solution to the traceability of pharmaceutical products & Supply Chain Integrity.<\/p>

Built on the cornerstone of strong quality focus, we deliver excellent solutions with very high quality & reliability.<\/p>

Kevision Systems is dedicated and driven to provide the finest & the most optimum solutions for the Supply Chain Integrity as well as Optical Inspection Systems. We stand strong on the pillars of integrity, professionalism, innovation and expertise and have earned the credibility to work with any size of projects. We strive to excel in terms of quality and technology and be a preferred partner for our valued clientele.<\/p>

For Further Information, please contact our Compliance Team at\u00a0info@kevision.in<\/a><\/strong><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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South Korea Regulatory Regulatory For South Korea Regulatory Agency Ministry of Food and Drug Safety (MFDS) \u2014 primary governmentregulator responsible for pharmaceutical products in Korea.Serialization and transaction reporting are implemented under thePharmaceutical Affairs Act (Enforcement Rules) and associatedMFDS notifications (e.g., Guideline on the Use and Management ofBarcodes and RFID Tags for Drug). 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