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South Africa Regulatory

Regulatory For

Pharma

SOUTH AFRICA DRUG BARCODING REQUIREMENTS

REGULATORY AGENCY National Department of Health (NDoH)
REGULATION NAME National Department of Health; Phased Implementation of GTIN-14 Datamatrix Barcodes
COMPLIANCE DATES 30th June, 2022 : Complete Pharmaceutical product serialization on secondary and tertiary level packaging along with other standard GS1 elements Note : The data has not been updated by South African Government since 2018
APPLIES TO
  • Domestic manufacturers of pharmaceutical products
  • Importers of pharmaceutical products

SALEABLE UNIT PACKAGING

BARCODE SYMBOLOGY

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

Not Specified
HUMAN READABLE EXPIRY DATE FORMAT

Not Specified
BARCODE DATA ENCODING

GS1 Standards
FREE SAMPLES MUST BE MARKED?

Not Specified

TERTIARY PACKAGING

(A shipper containing one or more secondary packs)

BARCODE   SYMBOLOGY GS1 2D Datamatrix or GS1 1D-128 blank blank
BARCODE CONTENTS Same as secondary

AGGREGATION DATA CAPTURE

PARENT-CHILD MAPPING AGGREGATION CAPTURE?
 Not Specified

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?Not Specified
MANUFACTURERS MUST REGISTER SHIPMENTS IN REPOSITORY?

Not Specified

DOWNSTREAM TRADING PARTNERS MUST AUTHENTICATE ON RECEIPT?

Not Specified

DOWNSTREAM TRADING PARTNERS MUST AUTHENTICATE ON SHIPMENT?
Not Specified

GOVERNMENT REPORTING

MASTER DATA UPLOAD? Not Specified
MANUFACTURER ACTIVITY REPORTED? Not Specified
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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