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13 Jun

[Blog] New Pharmaceutical Labeling Rules Now in Effect in Sri Lanka: Key Details for MAHs and Importers

by Milena Atanasova
in Blog, news
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New Pharmaceutical Labelling Rules Now in Effect in Sri Lanka: Key Details for MAHs and Importers

 

Published: June 2025 | Author: SoftGroup Editorial Team

 

Sri Lanka’s National Medicines Regulatory Authority (NMRA) has introduced new labelling requirements that affect all imported pharmaceutical products entering the country. The changes are effective as of 31 December 2025 and apply to Marketing Authorization Holders (MAHs), manufacturers, and importers.

 

 

What Has Changed for the Pharmaceutical Industry in Sri Lanka?

According to the updated regulation:
  • All imported finished pharmaceutical products must carry a price-marked label before they are released to the local market.
  • The label must clearly display:
  • The Maximum Retail Price (MRP)
  • The name and address of the local MAH or importer
  • Labels must be printed or securely affixed to the primary or secondary packaging, depending on the type of product.
This requirement applies to all products arriving in the country from December 2025 onward.

 

What This Means for Pharmaceutical Companies

 

The update introduces an additional compliance layer for companies exporting medicines to Sri Lanka. It reflects growing expectations from national authorities for localized labelling that supports transparency, pricing control, and accountability in the supply chain.
Pharma companies must now ensure that labelling operations are aligned with local requirements before customs clearance.
Consequences of Non-Compliance
Failure to comply may result in:
  • Delays during import clearance
  • Rejection of shipments
  • Regulatory action from the NMRA
  • Potential loss of market access

 

How SoftGroup Helps You Stay Compliant

 

SoftGroup provides technology that supports both serialization and labelling compliance in one integrated platform. Through our SATT PLATFORM, MAHs and CMOs can:
  • Apply country-specific labelling requirements, including MRP and importer data
  • Control and audit labelling processes for different markets
  • Ensure consistent compliance across packaging lines and partners
  • Respond quickly to regulatory updates with built-in flexibility
Our solution is designed for companies operating in multiple jurisdictions, helping you manage compliance with evolving local requirements, such as those now enforced in Sri Lanka.

A Broader Shift Toward Localized Compliance

 

This update is part of a wider trend in regulated markets: authorities expect not only product traceability but also market-specific labeling transparency. Pharmaceutical companies need to be ready with systems that can adapt quickly, reduce manual effort, and ensure accuracy across all levels of compliance.
Let’s make compliance your competitive edge. Request a demo of the SATT PLATFORM