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

Notice to all retail and wholesale pharmacy owners

November 7, 2025
Regulatory Updates

Notice to all retail and wholesale pharmacy owners

November 7, 2025
Regulatory Updates

Rejected Borderline Product Classification Applications as at 03/11/2025

November 4, 2025
Regulatory Updates

Average US Dollar Rate November - 2025 for Price Approvals of MRP's by NMRA

October 31, 2025
Regulatory Updates

Reliance Pathway for Registration of New Medical Device Applications

October 29, 2025
View All Announcements
Regulatory Updates

Notice to all retail and wholesale pharmacy owners

November 7, 2025

The National Medicines Regulatory Authority (NMRA) has granted a grace period until December 31, 2025, for all licensed retail pharmacies to renew their expired licenses.

This concession is crucial because, effective January 1, 2026, the NMRA will strictly enforce Clause 101 (2) of its regulations. This clause stipulates that a license will be

automatically cancelled if the renewal application is not submitted within three months of the current license's expiry date. Pharmacy owners are therefore advised to submit

renewals promptly to avoid cancellation.

Click Here for more : Notice to all retail and wholesale pharmacy owners

Regulatory Updates

Notice to all retail and wholesale pharmacy owners

November 7, 2025

The National Medicines Regulatory Authority (NMRA) announces that the temporary suspension of accepting new retail pharmacy applications, which was in effect from 01 April 2025 to 01 October 2025, has been extended from 01 October 2025 until further notice.

Click Here : Notice

Regulatory Updates

Rejected Borderline Product Classification Applications as at 03/11/2025

November 4, 2025

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 83rd (27/10/2025) and 84th (31/10/2025) Subcommittees of BPEC.]

Click Here : Rejected Borderline Product Classification Applications

Regulatory Updates

Average US Dollar Rate November - 2025 for Price Approvals of MRP's by NMRA

October 31, 2025

Notice to All Authorized Local Agents,

This is to kindly inform all authorized local agents that the USD rate considered for the month of November 2025 for processing price details of medicines / medical devices is 306.11.
Please ensure that all price submission for MRP approvals are prepared accordingly.

Regulatory Updates

Reliance Pathway for Registration of New Medical Device Applications

October 29, 2025
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.