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

Change of Public Day

September 28, 2026
Regulatory Updates

Publishing the list of approved MRP Revisions due to currency depreciation_List 2

September 22, 2026
Regulatory Updates

Publishing the list of approved MRP Revisions due to currency depreciation.

September 17, 2026
Regulatory Updates

Stakeholder Consultation Meeting on Dental Medical Devices

September 4, 2026
Regulatory Updates

Medical Device Application Acceptance

September 4, 2026
View All Announcements
Regulatory Updates

Change of Public Day

September 28, 2026

Notice to All Marketing Authorization Holders (MAHs)

Please be informed that the public day schedule for Monday, 28 September 2026 at the Pricing Regulatory Division has been rescheduled to Wednesday, 30 September 2026, due to unavoidable circumstances.

We regret any inconvenience caused and appreciate your cooperation.

Thank you,

CEO, NMRA

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Regulatory Updates

Publishing the list of approved MRP Revisions due to currency depreciation_List 2

September 22, 2026

Notice to all Authorized Local Agents,

Subject: Publishing the list of approved MRP Revisions due to currency depreciation_List 2

NOTICE TO ALL AUTHORIZED LOCAL AGENTS

This is to notify all Authorized Local Agents that the following is the second list (List 02) of approved MRP revisions due to currency depreciation. This list includes MRP revision applications reviewed and approved by the Pricing Division/NMRA up to 21 September 2026.

Please note that, hereinafter, individual emails will not be sent to Local Agents to notify pricing approvals for MRP revisions due to currency depreciation, as the updated list will be published on the NMRA website.

Accordingly, all relevant Authorized Local Agents are hereby requested to check the published lists and submit the relevant valid Import Licenses to the NMRA Licensing Unit without delay. Your prompt attention and cooperation in this regard are highly appreciated to avoid any further delays in processing the respective applications.

Click Here : The list of approved MRP Revisions due to currency depreciation_List 2

Regulatory Updates

Publishing the list of approved MRP Revisions due to currency depreciation.

September 17, 2026

NOTICE TO ALL AUTHORIZED LOCAL AGENTS.

Subject : Publishing the list of  approved MRP Revisions due to currency depreciation.

This is to notify all Authorized Local Agents that the following is the finalized list of approved MRP revisions due to currency depreciation.  Revision application forms reviewed up to 16-09-2026by the NMRA Pricing Division have been processed and the relevant applications have been forwarded to the NMRA Licensing Unit for further action. Please find the list below.

Accordingly, all concerned Authorized Local Agents are hereby requested to submit the relevant valid Import License(s) to the NMRA Licensing Unit without delay. Your prompt attention and cooperation in this regard are strongly requested to avoid any further delay in processing the applications.

Click Here : List of approved MRP Revisions due to currency depreciation.

Regulatory Updates

Stakeholder Consultation Meeting on Dental Medical Devices

September 4, 2026

The National Medicines Regulatory Authority (NMRA) invites dental medical device manufacturers, importers, distributors, and other relevant stakeholders to participate in
a Stakeholder Consultation Meeting to discuss current regulatory matters and challenges relating to dental medical devices.

Date: 09 September 2026

Time: 10:00 a.m.

Venue: NMRA Auditorium, 3rd Floor, No. 130, W. A. D. Ramanayake Mawatha,
Colombo 02.

Stakeholders are invited to participate and share their views and suggestions to support effective regulatory decision-making.

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Click Here : Notice

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Regulatory Updates

Medical Device Application Acceptance

September 4, 2026

Dear All,

Medical Device applications will be accepted every Tuesday from 8:30 a.m. to 3:00p.m., commencing 25.08.2026.

Applicants are kindly requested to submit their applications only during the above-mentioned time period.

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Medical Device Regulatory Division

NMRA- Sri Lanka

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Reporting falsified / Counterfeit Products
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