National Medicines Regulatory Authority

Sri Lanka

Welcome to the official website of the National Medicine Regulatory Authority of Sri Lanka. We are dedicated to ensuring the safety and efficacy of medicines for the people of Sri Lanka.

Providing Quality Medicine Regulation in Sri Lanka

The National Medicine Regulatory Authority of Sri Lanka is committed to ensuring the safety, efficacy, and quality of medicines in the country. We strive to protect public health by regulating the manufacturing, importation, distribution, and sale of medicines.

Functions of the NMRA

Regulatory

NMRA regulates medicines, medical devices, borderline products imported to and manufactured in Sri Lanka. We also regulate pharmacies. Clinical trials conducted in Sri Lanka are also regulated by us.

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Laboratory

National Medicines Quality Assuarance of the NMRA is responsible for the analyzing of the quality of any medicine, medical device or borderline product forwarded by the Authority. It functions as an additional approved analyst when the circumstance so requires.

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Pharmacovigilance

Pharmacovigilance Division is responsible for monitoring and dealing with adverse drug reaction, quality failure and counterfeit medicines.

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Enforcement

Inspectorate and Enforcement Division is responsible for inspecting and investigating issues pertaining to proper implementation of the provision of the NMRA Act.

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Latest Announcements

Regulatory Updates

Rejected Borderline Product Classification Applications as at 06/01/2026

January 9, 2026
NMRA Updates

Notice on Updated Labelling Requirement Amendment 04

January 2, 2026
Regulatory Updates

Rejected Borderline Product Classification Applications as at 31/12/2025

January 2, 2026
Regulatory Updates

Distance Criteria Exemption for Owner Pharmacists

January 2, 2026
Regulatory Updates

Public Notice: Reporting Sale of Medicines Above Maximum Retail Price

January 1, 2026
View All Announcements
Regulatory Updates

Rejected Borderline Product Classification Applications as at 06/01/2026

January 9, 2026

This web notice is published to avoid inconvenience during customs importation, in accordance with the web notice issued on 51th March 2025. Relevant classification reports will be issued as early as possible.

[This publication has been initiated from 91th (06/01/2026) Subcommittee of BPEC]

Click Here: Rejected Borderline Product Classification Applications as at 06/01/2026

NMRA Updates

Notice on Updated Labelling Requirement Amendment 04

January 2, 2026

Notice on Updated Labelling Requirement Amendment 04

Extention of the grace period for product-Specific QR Codes or barcodes on Commercial packaging.

Click Here: Notice on Updated Labelling Requirement Amendment 04

Regulatory Updates

Rejected Borderline Product Classification Applications as at 31/12/2025

January 2, 2026

This web notice is published to avoid inconvenience during customs importation, in accordance with the web notice issued on 5th March 2025. Relevant
classification reports will be issued as early as possible.
[This publication has been initiated from 90th (31/12/2025) Subcommittee of BPEC]

Click Here: Rejected Borderline Product Classification Applications as at 31/12/2025

Regulatory Updates

Distance Criteria Exemption for Owner Pharmacists

January 2, 2026

Notice regarding the distance criteria exemption for new pharmacies of owner pharmacists.

Click Here : Distance Criteria Exemption for Owner Pharmacists

Regulatory Updates

Public Notice: Reporting Sale of Medicines Above Maximum Retail Price

January 1, 2026

The National Medicines Regulatory Authority (NMRA) requests the support of the public to ensure that all registered medicines are sold strictly at or below the officially approved Maximum Retail Prices (MRP).

If you observe any pharmacy, private hospital, or other outlet selling medicines at prices higher than those listed in the NMRA Maximum Retail Price List, you are kindly requested to submit a complaint using the QR code provided below or by emailing the details to complaints@nmra.gov.k

When submitting a complaint, please include the following information where possible:

  • Name and address of the pharmacy/outlet
  • Date of purchase or observation
  • Name of the medicine, strength, and pack size
  • Price charged (attach a photo of the bill/receipt if available)
  • Photo of the product pack (optional)
  • Your contact details (optional, for clarification)

Your cooperation helps us safeguard patient rights and maintain fair pricing across the country.

CEO,
NMRA

Complaints QR Code
Scan the QR code below to submit your complaints.
Reporting falsified / Counterfeit Products
Scan the QR code below to report falsified or counterfeit products.