Pharma
| REGULATORY AGENCY | CRPT-Center for Research in Perspective Technologies under the Russian Ministry of Health defines and regulates medicinal track and trace system for medicinal product |
| REGULATION NAME | Implementation Guideline for Barcode Labeling of Prescription Drugs |
| COMPLIANCE DATES | Deadline of electronic leaflet: 1st August 2021 Deadline barcoding for drugs and medical devices: 1st December 2022. |
| APPLIES TO | Drug manufacturers who have manufacturing and/or packaging facilities within Japan, and who export drugs to any other countries. |
| BARCODE SYMBOLOGY | GS1 Datamatrix. |
| BARCODE CONTENTS |
(that must be obtained from a government subcontractor’s cloud-based service, or, for local manufacturers, from a government supplied piece of hardware and which shall be carried in AI(91) and AI(92). |
| SERIAL NUMBER RANDOMIZATION | No |
| SERIAL NUMBER REUSE | Not Specified |
| HUMAN READABLE EXPIRY DATE FORMAT | YYMMDD |
| BARCODE DATA ENCODING | GS1 Standards |
| PRODUCT CODE NOTES | In the case of “mono cartons”, a manufacturer or exporter shall affix the bar code on mono cartons containing one primary pack on an optional basis until further notice |
| FREE SAMPLES MUST BE MARKED? | Not Specified |
(A shipper containing one or more secondary packs)
| BARCODE SYMBOLOGY | GS1 128 with SSCC or sGTIN / Aggregation required | | |
| BARCODE CONTENTS | GS1-128 (SSCC) | ||
|
PARENT-CHILD MAPPING AGGREGATION CAPTURE? |
Yes |
| SEND UNIT DATA TO GOVERNMENT REPOSITORY? | Yes (Chestny Znak) |
| SEND UNIT DATA TO THIRD-PARTY REPOSITORY? |
As applicable |
| SEND UNIT DATA TO TRADING PARTNER? |
As applicable |
| SEND AGGREGATION DATA TO GOVERNMENT REPOSITORY? | Yes |
| SEND AGGREGATION DATA TO THIRD-PARTY REPOSITORY? |
As applicable |
| SEND AGGREGATION DATA TO TRADING PARTNER? |
As applicable |
| WHO OFFERS DATA REPOSITORY FOR AUTHENTICATION? | CRPT |
| MANUFACTURERS MUST REGISTER SHIPMENTS IN REPOSITORY? |
Yes (Import & Exports) |
| 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