Japan

v. 13 – 2020/01

Market Executive Summary Roadmap – migration of product/batch coding to GS1 standard

Barcoding guideline for prescription drugs voluntary from 2015. Mandatory in 2021 (see key dates in 2) Requirements Phasing)

The new act makes barcoding compulsory on the packages of Prescription Drugs and Medical Devices for securing traceability.

Implementation of ePI (electronic Package Inserts (for Med. Devices and Prescr. Drugs) must be provided. Type of barcode on the package to use for this purpose is still open but MoH seems to prefer use of QR-code.

GS1 is requesting industry support to suggest use of DM and use of Data Link.

To do there is not reference to the use of a serial component in the label coding.

Key Dates
  • 2006: issuance of guideline
  • 2012: revision of guideline
  • 31 Aug 2016: revision of guideline
  • 31 Mar 2021: enforcement date for Revised Implementation Guideline for Bar Code Labeling of Prescription Drugs