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Azerbaijan Regulatory

Regulatory For

Pharma

AZERBAIJAN REGULATORY

REGULATORY AGENCY

MOH – Azerbaizan

REGULATION NAME

a decree on the “Pharmaceuticals Track and Trace System”

COMPLIANCE DATES

Serialization for the first group of products: 1 June 2024. Full implementation of Track and Trace by end of 2024.

APPLIES TO

All Pharmaceutical Products.

SECONDARY PACKAGING

(A carton containing one or more primary packs and includes a “mono carton” containing one primary pack)

BARCODE SYMBOLOGY

GS1 Datamatrix

BARCODE CONTENTS
    • GTIN
    • Expiry Date
    • Batch Number
    • Serial Number

blank

SERIAL NUMBER RANDOMIZATION No
SERIAL NUMBER REUSE

Not Specified

HUMAN READABLE EXPIRY DATE FORMAT

YYMMDD

BARCODE DATA ENCODING

GS1 Standards

PRODUCT CODE NOTES

NA

FREE SAMPLES MUST BE MARKED?

Not Specified

TERTIARY PACKAGING

(A shipper containing one or more secondary packs)

BARCODE   SYMBOLOGY GS1-128 linear blank
BARCODE CONTENTS

Product code (use of the GS1 GTIN is now optional), Lot Number, Expiration Date, GS1 SSCC (SSCC may appear in a separate barcode)

AGGREGATION DATA CAPTURE

PARENT-CHILD MAPPING AGGREGATION CAPTURE?

 
Not Required

DATA EXCHANGE

SEND UNIT DATA TO GOVERNMENT REPOSITORY?
No
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?

As applicable

SEND AGGREGATION DATA TO TRADING PARTNER?

As applicable

AUTHENTICATION

WHO OFFERS DATA REPOSITORY FOR AUTHENTICATION?

Proposed

MANUFACTURERS MUST REGISTER SHIPMENTS IN REPOSITORY?

Yes (Exports)

DOWNSTREAM TRADING PARTNERS MUST AUTHENTICATE ON RECEIPT?

No (Future)

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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