Updated Sri Lanka Regulatory Guidelines 21 August 2025.

Kevision Systems, a leading provider of track and trace and vision inspection solutions for the pharmaceutical and agrochemical industries, is alerting pharmaceutical manufacturers and exporters to significant updates in Sri Lanka's regulatory guidelines for medicine labeling. The changes, issued by the National Medicines Regulatory Authority (NMRA), aim to enhance protection against falsified products and introduce new standards for secondary packaging.

Key updates include a revised compliance date of December 2025 for new sticker and 2D barcode requirements. Notably, the mandated barcode symbology for secondary packaging has shifted from a QR Code to a 2D Data Matrix Code. The information required within the barcode has also been updated to include Product code, Lot number, Manufacturing date, Expiry date, and Serial Number.
These changes mark a notable shift in Sri Lanka's approach to product identification and traceability. Unlike the previous guidelines, the updated regulations do not require the inclusion of the product name, generic name, price, or manufacturer details within the 2D barcode. Furthermore, the guidelines specify that aggregation data capture is not required, and there are currently no mandates for sending unit or aggregation data to any repository except for manufacturers registering export shipments with the NMRA for authentication purposes.

"Staying ahead of evolving regulatory landscapes is crucial for pharmaceutical companies operating globally," said Ketan Khambhatta, Managing Director of Kevision. "These updates from the NMRA in Sri Lanka represent a significant change in their traceability requirements. While the move to a 2D Data Matrix Code aligns with global best practices for efficient data capture, the reduced data elements within the code and the lack of mandatory aggregation data sharing will require manufacturers to adapt their serialization strategies for this specific market."

Kevision Systems, headquartered in Ahmedabad, Gujarat, India, offers a comprehensive suite of track and trace solutions, including robust L3 and L4 software, high-speed printing and inspection systems like the Smart Flash 360, and aggregation solutions such as the Stellar Aggregation system. Our flexible and adaptable solutions are designed to help pharmaceutical manufacturers seamlessly comply with diverse and evolving global regulatory requirements, including the latest updates in Sri Lanka.
"Our expertise lies in providing tailored solutions that not only meet current regulatory demands but also offer scalability and future-proofing capabilities," Ketan added. "We are ready to assist pharmaceutical companies in understanding and implementing these new Sri Lankan guidelines, ensuring a smooth transition and continued access to this important market."

Kevision encourages pharmaceutical manufacturers exporting to Sri Lanka to carefully review the updated NMRA guidelines and assess their current serialization and labeling processes to ensure timely compliance by the December 2025 deadline.

Kevision Systems ST-101, One42, Ashok Vatika, Near Jayantilal Park BRTS, Bopal Rd, Ambli, Ahmedabad, Gujarat 380058

Kevision Systems, based in Ahmedabad, Gujarat, India, is a leading provider of innovative and reliable track and trace, and vision inspection solutions for the pharmaceutical and agrochemical industries. Our comprehensive product portfolio empowers manufacturers to enhance product safety, combat counterfeiting, ensure regulatory compliance, and optimize supply chain visibility.

This release was published on openPR.