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SRI LANKA REGULATORY GUIDELINES

REGULATORY AGENCY

 National Medicines Regulatory Authority (NMRA)

REGULATION NAME

Labeling requirements of medicine to enhance protection against falsified products.

COMPLIANCE DATES

• Affix of Stickers: applicable from the first of October 2024
• Barcode or QR Code: the deadline for the implementation is extended by 31 May 2025

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
QR Code
BARCODE CONTENTS
  • Product name
  • Generic name and strength
  • Batch number
  • Date of manufacture
  • Date of expiry
  • Price of the product
  • Name of the manufacturer and site address

 

SERIAL NUMBER RANDOMIZATIONNo
SERIAL NUMBER REUSE

Not Specified

HUMAN READABLE EXPIRY DATE FORMAT

Not Specified

BARCODE DATA ENCODING

QR Code

PRODUCT CODE NOTES

NA

FREE SAMPLES MUST BE MARKED?

Not Specified

AGGREGATION DATA CAPTURE

PARENT-CHILD MAPPING AGGREGATION CAPTURE?

Not Required

DATA EXCHANGE

SEND UNIT DATA TO GOVERNMENT REPOSITORY?
NA
SEND UNIT DATA TO THIRD-PARTY REPOSITORY?

NA

SEND UNIT DATA TO TRADING PARTNER?

NA

SEND AGGREGATION DATA TO GOVERNMENT REPOSITORY?
NA
SEND AGGREGATION DATA TO THIRD-PARTY REPOSITORY?

NA

SEND AGGREGATION DATA TO TRADING PARTNER?

NA

AUTHENTICATION

WHO OFFERS DATA REPOSITORY FOR AUTHENTICATION?

NMRA

MANUFACTURERS MUST REGISTER SHIPMENTS IN REPOSITORY?

Yes (Exports)

DOWNSTREAM TRADING PARTNERS MUST AUTHENTICATE ON RECEIPT?

Not Specified

DOWNSTREAM TRADING PARTNERS MUST AUTHENTICATE ON SHIPMENT?
No

GOVERNMENT REPORTING

MANUFACTURER ACTIVITY REPORTED?Not Specified
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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