Sri Lanka Extends Barcode/QR Code Implementation Deadline for Pharmaceutical Labeling

Colombo, Sri Lanka - The National Medicines Regulatory Authority (NMRA) of Sri Lanka has announced an extension to the implementation deadline for barcode or QR code requirements on pharmaceutical product labeling. Originally set for October 1, 2024, the new deadline is now May 31, 2025. This extension aims to provide pharmaceutical manufacturers and distributors with additional time to ensure full compliance with the updated labeling regulations designed to enhance protection against falsified medicines.
The initial requirement for affixing stickers on pharmaceutical product packaging remains effective from October 1, 2024. However, the NMRA recognizes the complexities associated with implementing barcode and QR code systems, particularly concerning the necessary infrastructure and data integration. The extended deadline allows stakeholders to thoroughly prepare and implement robust solutions that meet the regulatory standards.
The NMRA's regulations mandate that the barcode or QR code on secondary packaging (cartons) must contain critical product information, including the product name, generic name and strength, batch number, manufacturing and expiry dates, price, and manufacturer's name and address. This initiative is part of a broader effort to strengthen the pharmaceutical supply chain and safeguard public health by improving product traceability and authentication.
Pharmaceutical companies are advised to utilize the extended period to:
1. Upgrade their labeling and packaging systems.
2. Ensure accurate data encoding in QR codes, adhering to the specified data contents.
3. Establish data exchange protocols, if necessary, to comply with potential future reporting requirements.
4. Prepare for the mandatory registration of export shipments in the NMRA's data repository.
The NMRA will continue to provide guidance and support to stakeholders throughout the implementation process to ensure a smooth transition and maintain the integrity of the pharmaceutical market in Sri Lanka.

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This release was published on openPR.