{"id":12469,"date":"2023-04-10T11:27:45","date_gmt":"2023-04-10T11:27:45","guid":{"rendered":"https:\/\/kevision.in\/?page_id=12469"},"modified":"2026-02-18T09:29:24","modified_gmt":"2026-02-18T09:29:24","slug":"japan-regulatory","status":"publish","type":"page","link":"https:\/\/kevision.in\/es\/whitepapers\/japan-regulatory\/","title":{"rendered":"Japan Regulatory"},"content":{"rendered":"
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Japan 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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Japan <\/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>\n \n Ministry of Health, Labour and Welfare (MHLW) Pharmaceuticals and\n Medical Devices Agency (PMDA)\n <\/td>\n <\/tr>\n
Regulation Name<\/strong><\/td>\n \n Ministerial Ordinance on Securing Quality, Efficacy and Safety of\n Products Including Pharmaceuticals; MHLW Notification on Barcode\n Labelling of Prescription Drugs\n <\/td>\n <\/tr>\n
Compliance Dates<\/strong><\/td>\n \n \n \n \n \n \n \n \n
Year<\/th>\n Milestone<\/th>\n <\/tr>\n
2015<\/td>\n \n Initial barcode expansion\n <\/td>\n <\/tr>\n
2018<\/td>\n \n Serialization phased implementation\n <\/td>\n <\/tr>\n
2021<\/td>\n \n Wholesaler system readiness\n <\/td>\n <\/tr>\n
April 2023<\/td>\n \n Full legal enforcement\n <\/td>\n <\/tr>\n <\/table>\n <\/td>\n <\/tr>\n
Applies to<\/strong><\/td>\n \n All prescription pharmaceutical products (branded & generics) certain\n OTC and biologics\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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Primary 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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(Saleable Unit)\n<\/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 GS1 DataMatrix (2D) \u2014 mandatory<\/td>\n <\/tr>\n
Barcode Contents<\/strong><\/td>\n \n GTIN (01), Expiry Date (17), Lot Number (10), Serial Number (21)\n <\/td>\n <\/tr>\n <\/tbody>\n<\/table>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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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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Barcode Symbology<\/strong><\/td>\n GS1 DataMatrix (2D)<\/td>\n <\/tr>\n
Barcode Contents<\/strong><\/td>\n \n
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  • GTIN<\/li>\n
  • Expiry No.<\/li>\n
  • Lot No.<\/li>\n
  • Serial No.<\/li>\n <\/ul>\n <\/td>\n <\/tr>\n
Serial Number Randomization<\/strong><\/td>\n Randomized or non-sequential required<\/td>\n <\/tr>\n
Serial Number Reuse<\/strong><\/td>\n Not permitted<\/td>\n <\/tr>\n
Human Readable Expiry Date Format <\/strong><\/td>\n YYYYMMDD (ISO format)<\/td>\n <\/tr>\n
Barcode Data Encoding<\/strong><\/td>\n GS1 Application Identifiers<\/td>\n <\/tr>\n
Product Code Notes <\/strong><\/td>\n \n Uses GTIN, linked to Japanese YJ Code (National Drug Code equivalent)\n <\/td>\n <\/tr>\n
Free Samples must be marked?<\/strong><\/td>\n If distributed, must comply with barcode standards<\/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 GS1-128 or ITF-14; SSCC for logistics<\/td>\n <\/tr>\n
Barcode Contents<\/strong><\/td>\n \n SSCC (00), GTIN (01), lot and expiry where applicable\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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Required between unit \u2192 case \u2192 pallet<\/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 Send Unit Data to Government Repository? <\/strong>\n <\/td>\n No central government database.<\/td>\n <\/tr>\n
\n Send Unit Data to Third-Party Repository? <\/strong>\n <\/td>\n Yes (industry systems)<\/td>\n <\/tr>\n
Send Unit Data to Trading Partner? <\/strong><\/td>\n Mandatory<\/td>\n <\/tr>\n
\n Send Aggregation Data to Government Repository? <\/strong>\n <\/td>\n No<\/td>\n <\/tr>\n
\n Send Aggregation Data to Third-Party Repository? <\/strong>\n <\/td>\n Yes<\/td>\n <\/tr>\n
\n Send Aggregation Data to Trading Partner? <\/strong>\n <\/td>\n Yes<\/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 Industry-run platforms (e.g, JPMA-supported systems, wholesalers’ shared\n platforms)\n <\/td>\n <\/tr>\n
\n Manufacturers Must Register Shipments in Repository? <\/strong>\n <\/td>\n Yes<\/td>\n <\/tr>\n
\n Downstream Trading Partners Must Authenticate on Receipt?\n <\/strong>\n <\/td>\n Yes<\/td>\n <\/tr>\n
\n Downstream Trading Partners Must Authenticate on Shipment?\n <\/strong>\n <\/td>\n Yes<\/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 Yes<\/td>\n <\/tr>\n
\n Downstream Trading Partner Activity Reported? <\/strong>\n <\/td>\n Yes<\/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\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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Kevision 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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Japan Regulatory Regulatory For Japan Regulatory Agency Ministry of Health, Labour and Welfare (MHLW) Pharmaceuticals and Medical Devices Agency (PMDA) Regulation Name Ministerial Ordinance on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals; MHLW Notification on Barcode Labelling of Prescription Drugs Compliance Dates Year Milestone 2015 Initial barcode expansion 2018 Serialization phased implementation 2021 […]<\/p>","protected":false},"author":1,"featured_media":0,"parent":12422,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-12469","page","type-page","status-publish","hentry"],"rankMath":{"parentDomain":"kevision.in","noFollowDomains":[],"noFollowExcludeDomains":[],"noFollowExternalLinks":false,"featuredImageNotice":"La imagen destacada debe tener al menos 200 por 200 p\u00edxeles para que Facebook y otros sitios de redes sociales puedan 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