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New Pharmaceutical Labelling and Serialization Rules in Sri Lanka: What MAHs and Importers Must Know | Sri Lanka Pharmaceutical Serialization
As global health authorities intensify efforts to combat counterfeit drugs, Sri Lanka’s National Medicines Regulatory Authority (NMRA) is steadily introducing new labelling and serialization mandates to enhance drug traceability and patient safety. This regulatory shift is a key milestone in the broader adoption of Sri Lanka pharmaceutical serialization practices aimed at safeguarding public health.
2024: Initial Mandates on Labels and Product Information
In July and August 2024, the NMRA outlined that every pharmaceutical pack must feature a QR code or barcode encoding essential data:
- Product and generic name
- Strength
- Batch number
- Manufacturing and expiry dates
- Price
- Manufacturer details
Stickers with “NMRA approved” and the retail price became mandatory by October 2024, with QR code implementation to follow by December 2024. These changes reflect an early phase of Sri Lanka pharmaceutical serialization requirements focused on label integrity and transparency.
2025: Serialization and 2D DataMatrix for Imported Products
In February 2025, a pivotal update allowed QR or 2D DataMatrix codes on imported pharmaceutical packs. Implementation was postponed to May 31, 2025, and these codes must include:
- Product code
- Lot number
- Manufacturing date
- Expiry date
- Serial number
The June 2025 update extended the serialization deadline to December 31, 2025, and reinforced the acceptance of 2D DataMatrix symbols for compliance. This phase strengthens Sri Lanka pharmaceutical serialization across international supply chains, emphasizing product-level security.
New MRP & MAH Requirements
Additionally, from December 2025, all imported pharmaceuticals must carry a label displaying:
- Maximum Retail Price (MRP)
- Name and address of the local MAH or importer
The label must be securely affixed or printed on the primary or secondary packaging. Compliance with Sri Lanka pharmaceutical serialization protocols ensures that pricing and responsible entity data are traceable and visible at the point of sale.
Compliance Challenges and Strategic Solutions
These updates add a compliance layer for companies exporting to Sri Lanka. Failure to meet these requirements may lead to:
- Delays during customs clearance
- Rejection of shipments
- Regulatory penalties
- Market access loss
For successful market entry, organizations must proactively align with Sri Lanka pharmaceutical serialization timelines, while adopting traceability technologies and documentation strategies.
VISIOTT | TPS: Serialization and Labelling Partner for Sri Lanka
VISIOTT | TPS offers end-to-end, GS1-compliant serialization and aggregation technologies to help you comply with NMRA regulations.
Below are two of our key solutions to ensure serialization and labelling compliance aligned with Sri Lanka pharmaceutical serialization regulations:
ISS-100
Ideal for serialization and printing requirements, ISS-100 supports high-speed applications with modular hardware and software integration options that comply with Sri Lanka pharmaceutical serialization norms.
SACP-100
SACP-100 combines serialization and checkweighing functions in one unit, offering rapid deployment and compliance with global and Sri Lanka pharmaceutical serialization standards.
Conclusion: From Labelling to Digital Traceability
Sri Lanka’s new pharmaceutical regulations represent a critical move toward securing the medicine supply chain. Serialization is no longer optional—it is a necessity in fighting counterfeit drugs and improving visibility from manufacturer to patient. With VISIOTT | TPS, you can lead this transformation with confidence by adhering to Sri Lanka pharmaceutical serialization protocols.
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