Japan – Enacted

v. 1.0 – 11/03/17

Serialization Model TBD
Governing Body Ministry for Health, Labour and Welfare (MHLW) – Japan
Compliance Date April 2021
Randomization Requirements TBD
Aggregation Requirements TBD
Reporting Requirements TBD
UoU Data Carrier GS1 DataBar Recommended encoded with GTIN, Expiry, and Lot (or SN)
UoU HRI Not Specified
Saleable Unit Data Carrier GS1 DataBar

  • Biologics: GTIN, Expiry, Lot (or SN)
  • All other Rx: GTIN
Saleable Unit HRI Not Specified
Intermediate Package Data Carrier GS1-128

  • GTIN, Expiry, Lot, Qty
  • HRI – Not Specified
Additional Notes
  • MHLW revised the guideline on August 31,
    2016
  • Not mandatory until March 2021; however,
    in the interest of public health and safety, the industry is expected to follow guidance

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