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Indonesia Regulatory

Regulatory For

Pharma

INDONESIA DRUG BARCODING REQUIREMENTS

REGULATORY AGENCY National Agency of Drug and Food Control (BPOM)
REGULATION NAME BPOM Regulation #33 / 2018 Implementation of 2D barcode in order to improve effectiveness of medicines and processed food supervision
COMPLIANCE DATES 2023 : All products should be marked with Identification Barcode 2025 : All products should be marked with Authentication Barcode
APPLIES TO Domestic pharmaceutical manufacturers, wholesalers and pharmacies Foreign pharmaceutical manufacturers, wholesalers and pharmacies

PHARMACEUTICAL PACKAGING

BARCODE SYMBOLOGY GS1 2D Barcode
BARCODE CONTENTS Identification Barcode OR Code
    • Marketing Authorization Number, NIE Number
Authentication Barcode
QR Code/2D Datamatrix
  • GTIN
  • Serial number
  • Batch number
  • Expiry date

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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
  • Printed on the packaging with the black ink and base is white color or other color
  • In case there are two 2D Barcode that included on the packaging of drug and food product, therefore one of the 2D Barcode must contain wording “BPOM RI”
  • 2D Barcode that printed on the packaging must be easy to be scanned and can be read by BPOM track and trace application
  • The barcode must be put proportionally on the packaging with minimum size 0,6 x 0,6 cm
FREE SAMPLES MUST BE MARKED?

Not Specified

CASE PACKAGING

BARCODE   SYMBOLOGY

GS1 2D Barcode (QR/Datamatrix)

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BARCODE CONTENTS

Same as secondary

AGGREGATION DATA CAPTURE

PARENT-CHILD MAPPING AGGREGATION CAPTURE?

 
Yes

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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