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 |
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| Applies to | All prescription pharmaceutical products (branded & generics) certain OTC and biologics |
(Saleable Unit)
| Barcode Symbology | GS1 DataMatrix (2D) — mandatory |
| Barcode Contents | GTIN (01), Expiry Date (17), Lot Number (10), Serial Number (21) |
(A carton containing one or more primary packs and includes a “mono carton” containing one primary pack)
| Barcode Symbology | GS1 DataMatrix (2D) |
| Barcode Contents |
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| Serial Number Randomization | Randomized or non-sequential required |
| Serial Number Reuse | Not permitted |
| Human Readable Expiry Date Format | YYYYMMDD (ISO format) |
| Barcode Data Encoding | GS1 Application Identifiers |
| Product Code Notes | Uses GTIN, linked to Japanese YJ Code (National Drug Code equivalent) |
| Free Samples must be marked? | If distributed, must comply with barcode standards |
(A shipper containing one or more secondary packs)
| Barcode Symbology | GS1-128 or ITF-14; SSCC for logistics | |
| Barcode Contents | SSCC (00), GTIN (01), lot and expiry where applicable | |
|
Parent-Child Mapping Aggregation Capture? |
Required between unit → case → pallet |
| Send Unit Data to Government Repository? | No central government database. |
| Send Unit Data to Third-Party Repository? | Yes (industry systems) |
| Send Unit Data to Trading Partner? | Mandatory |
| Send Aggregation Data to Government Repository? | No |
| Send Aggregation Data to Third-Party Repository? | Yes |
| Send Aggregation Data to Trading Partner? | Yes |
| Who Offers Data Repository for Authentication? | Industry-run platforms (e.g, JPMA-supported systems, wholesalers’ shared platforms) |
| Manufacturers Must Register Shipments in Repository? | Yes |
| Downstream Trading Partners Must Authenticate on Receipt? | Yes |
| Downstream Trading Partners Must Authenticate on Shipment? | Yes |
| Manufacturer Activity Reported? | Yes |
| Downstream Trading Partner Activity Reported? | Yes |
Kevision Systems, 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’s Track & Trace Software & related equipment provide a fully integrated solution to the traceability of pharmaceutical products & Supply Chain Integrity.
Built on the cornerstone of strong quality focus, we deliver excellent solutions with very high quality & reliability.
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.
For Further Information, please contact our Compliance Team at info@kevision.in
