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Malaysia Regulatory

Regulatory For

Pharma

MALAYSIA DRUG BARCODING REQUIREMENTS

REGULATORY AGENCY

National Pharmaceutical Regulatory Agency (NPRA)

REGULATION NAME

National Pharmaceutical Track & Trace System

COMPLIANCE DATES

January, 2023 : Complete national track and trace system to be functional

APPLIES TODomestic manufacturers of all registered pharmaceutical products
Foreign manufacturers of all registered pharmaceutical products

SALEABLE UNIT 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

Not Specified

BARCODE DATA ENCODING

GS1 Standards

PRODUCT CODE NOTES

Not Specified

FREE SAMPLES MUST BE MARKED?

Not Specified

TERTIARY PACKAGING

BARCODE   SYMBOLOGY

GS1 1D-128

blank
BARCODE CONTENTS

Same as secondary

AGGREGATION DATA CAPTURE

PARENT-CHILD MAPPING AGGREGATION CAPTURE?
Not Specified

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?

Government (MoH)

MANUFACTURERS MUST REGISTER SHIPMENTS IN REPOSITORY?

Yes

DOWNSTREAM TRADING PARTNERS MUST AUTHENTICATE ON RECEIPT?

Dispenser authentication at the time of dispense

DOWNSTREAM TRADING PARTNERS MUST AUTHENTICATE ON SHIPMENT?

Not Specified

GOVERNMENT REPORTING

MASTER DATA UPLOAD?Yes
MANUFACTURER ACTIVITY REPORTED?Yes
DOWNSTREAM TRADING PARTNER ACTIVITY REPORTED?

Yes

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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