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Jordan Regulatory

Regulatory For

Pharma

JORDAN DRUG BARCODING REQUIREMENTS

REGULATORY AGENCY

Jordan Food and Drug Authority

REGULATION NAME

Implementation Guideline for Barcode Labeling of Prescription Drugs

COMPLIANCE DATES

JFDA Extended deadline for Datamatrix and serialization on secondary Packaging on regulated Pharmaceutical products until 30th June 2024.

APPLIES TODomestic manufacturers of medicinal products for human use
Foreign manufacturers of medicinal products for human use

SECONDARY PACKAGING

BARCODE SYMBOLOGY

GS1 Datamatrix.
BARCODE CONTENTS
  • A GTIN
  • Unique Serial Number
  • Batch/lot number
  • The expiration date of the drug
SERIAL NUMBER RANDOMIZATION Not Specified
SERIAL NUMBER REUSE

Not Specified
HUMAN READABLE EXPIRY DATE FORMAT

YYMMDD
BARCODE DATA ENCODING

GS1 standard 2D Datamatrix
PRODUCT CODE NOTES

Not Specified
FREE SAMPLES MUST BE MARKED?

No

TERTIARY PACKAGING

(A shipper containing one or more secondary packs)

BARCODE   SYMBOLOGY GS1 Datamatrix
BARCODE CONTENTS
  • A GTIN
  • Unique Serial Number
  • Batch/lot number
  • The expiration date of the drug

LOGISTICS UNIT

LOGISTICS UNITS MUST BE SERIALIZED?
 Not Specified

DATA CAPTURE

UNIT-TO-CASE AGGREGATION CAPTURE?
 Not Specified

DATA EXCHANGE

SEND UNIT DATA TO GOVERNMENT REPOSITORY?
Not yet
SEND UNIT DATA TO THIRD-PARTY REPOSITORY?

As applicable

SEND UNIT DATA TO TRADING PARTNER?

As applicable

SEND AGGREGATION DATA TO GOVERNMENT REPOSITORY?
No
SEND AGGREGATION DATA TO THIRD-PARTY REPOSITORY?

No

SEND AGGREGATION DATA TO TRADING PARTNER?
No

AUTHENTICATION

WHO OFFERS DATA REPOSITORY FOR AUTHENTICATION?Not Definied yet
MANUFACTURERS MUST REGISTER SHIPMENTS IN REPOSITORY?

No

DOWNSTREAM TRADING PARTNERS MUST AUTHENTICATE ON RECEIPT?

No

DOWNSTREAM TRADING PARTNERS MUST AUTHENTICATE ON SHIPMENT?
No

GOVERNMENT REPORTING

MANUFACTURER ACTIVITY REPORTED? No
DOWNSTREAM TRADING PARTNER ACTIVITY REPORTED?

No
Source and Credit: 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.

DISCLAIMER

This information is being provided ‘As Is’ 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.

ABOUT KEVISION SYSTEMS

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

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