The National Medicines Regulatory Authority (NMRA) of Sri Lanka has issued a key update for Marketing Authorization Holders (MAHs) regarding the use of barcodes on pharmaceutical products. In a move to support smoother implementation, the NMRA has officially extended the grace period for product-specific barcode compliance until the end of 2025.
Here’s what you need to know—and how to stay compliant.
Grace Period Extension: Key Dates
The extended grace period for barcode implementation now runs from: May 31, 2025 till December 31, 2025
This means MAHs have an additional seven months to ensure their pharmaceutical packaging complies with NMRA barcode requirements.
Accepted Barcode Format: 2D Data Matrix
During this grace period, the NMRA will accept a 2D Data Matrix barcode that includes the following mandatory information:
- Product Code
- Lot (Batch) Number
- Manufacturing Date
- Expiry Date
- Serial Number
Other relevant data elements as needed
This format aligns with global serialization standards and supports enhanced traceability and patient safety.
Sticker Requirements Still Apply
It’s important to note that the existing requirement to display a non-removable printed sticker remains in full effect. All medicine packages must still carry a sticker that includes:
- “NMRA Approved” label
- Marketing Authorization Holder (MAH) details
- Retail price
The barcode does not replace the sticker; both must be present on each retail pack.
Compliance Checklist for MAHs
Here’s what pharmaceutical companies and MAHs should focus on between now and December 31, 2025:
- Update Packaging Systems
Ensure your packaging lines are equipped to print or affix 2D Data Matrix barcodes with all required data fields.
- Continue Sticker Application
Do not discontinue or alter the NMRA-approved retail price sticker, this remains a legal requirement.
- Train Teams & Partners
Inform internal QA teams, packaging personnel, and third-party manufacturers or distributors about the dual requirement (barcode + sticker).
- Prepare for Full Compliance
This grace period is temporary. Use the time to transition your systems toward long-term serialization and traceability compliance.
What This Means for the Industry
This extension provides MAHs with much-needed flexibility, particularly for companies upgrading their packaging and serialization infrastructure. However, the NMRA has made it clear that compliance will be strictly enforced after December 2025.
With global regulatory bodies increasingly mandating traceability, Sri Lanka’s NMRA is aligning local standards with international best practices paving the way for a safer, more transparent pharmaceutical supply chain.
Final Thoughts
MAHs should view this as an opportunity, not a delay. While the extended grace period offers short-term relief, the long-term direction is clear: serialization, traceability, and regulatory alignment.
By acting now, companies can avoid last-minute compliance hurdles and position themselves for future market readiness.
Need help auditing your packaging lines, creating a compliance roadmap, or drafting a supplier notification? Feel free to reach out we’re here to support your global traceability efforts.