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Bahrain Regulatory

Regulatory For

Pharma

BAHRAIN DRUG BARCODING REQUIREMENTS

REGULATORY AGENCY

National Health Regulatory Authority (NHRA)

REGULATION NAME

System for Tracking and Tracing Medicine Provision and Supply Chain inside the Kingdom of Bahrain

COMPLIANCE DATES
  • 31st December, 2019 : All the drugs must have barcode with serialization
  • May, 2022 : All the drugs must comply with aggregation requirements (Aggregation Data Capture)
APPLIES TO
  • Domestic manufacturers of pharmaceutical products
  • Importers of pharmaceutical products

PHARMACEUTICAL PACKAGING

BARCODE SYMBOLOGY

GS1 Datamatrix
BARCODE CONTENTS
  • A GTIN
  • Unique Serial number
  • Batch/lot number

  • The expiration date of the drug;
SERIAL NUMBER RANDOMIZATION No
SERIAL NUMBER REUSE

Not Specified
HUMAN READABLE EXPIRY DATE FORMAT

GS1 HRI standards
BARCODE DATA ENCODING

GS1 Standards
PRODUCT CODE NOTES

Not Specified
FREE SAMPLES MUST BE MARKED?

Not Specified

CASE PACKAGING

BARCODE   SYMBOLOGY

GS1 standard (Presumably SSCC format will be used)

 blank
BARCODE CONTENTS

Perhaps, similar to Unit-level packaging

AGGREGATION DATA CAPTURE

PARENT-CHILD MAPPING AGGREGATION CAPTURE?

 

Yes, by May 2022

DATA EXCHANGE

SEND UNIT DATA TO GOVERNMENT REPOSITORY?
Yes
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

AUTHENTICATION

WHO OFFERS DATA REPOSITORY FOR AUTHENTICATION?NHRA
MANUFACTURERS MUST REGISTER SHIPMENTS IN REPOSITORY?

Yes (Exports)

DOWNSTREAM TRADING PARTNERS MUST AUTHENTICATE ON RECEIPT?

Not Specified

DOWNSTREAM TRADING PARTNERS MUST AUTHENTICATE ON SHIPMENT?
Not Specified

GOVERNMENT REPORTING

MANUFACTURER ACTIVITY REPORTED?Yes
DOWNSTREAM TRADING PARTNER ACTIVITY REPORTED?

Not Specified

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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