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

MRP Revision Due to Currency Depreciation (February-May 2026)

August 24, 2026
Regulatory Updates

Average US Dollar Rate August-2026 for Price Approvals of MRP’s by NMRA‍

August 4, 2026
Regulatory Updates

Announcement to All Market Authorization Holders: Medicines

August 3, 2026
Regulatory Updates

To publish the web notice on "Devices for Modification of Appearance or Anatomy (Aesthetic-related purpose)‍

July 28, 2026
Regulatory Updates

Change of Public Day

July 20, 2026
View All Announcements
Regulatory Updates

MRP Revision Due to Currency Depreciation (February-May 2026)

August 24, 2026

Notice to All Marketing Authorization Holders (MAHs)

Applications for products with Maximum Retail Prices (MRPs) approved on or before 31 May 2026 and after 1 February 2026 will be considered under this process.

MAHs seeking a revision of the Maximum Retail Price (MRP) due to a fluctuation of more than 5% in the average USD exchange rate published by the NMRA may submit their applications using the designated Google Form.

The revised MRP shall apply only to consignments imported after approval of the revised MRP.

MAHs who have already submitted applications in response to the previous notice are not required to reapply.

Thank you.

CEO NMRA

Procedure for Submission

Please follow the procedure below when submitting an application:

1. Complete the designated Google Form and obtain a printed copy of the submitted form.

2. Complete and submit Form F-PD-002- "Submission of Price Details for a Maximum Retail Price (MRP) Revision Request (Medicines Applications)" (Effective Date: 12.09.2025/V1.0/Rev. No. 0), together with all relevant supporting documents. The form must bear the original signature of the responsible person.

3. Submit copies of the following documents:

  • Existing Import License; and
  • Existing Registration Certificate.

4. Upon receipt of the email confirming the approved revised MRP, submit the original Import License to the Licensing Division, NMRA, within three (3) days of receipt of the email for the necessary amendments.

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Regulatory Updates

Average US Dollar Rate August-2026 for Price Approvals of MRP’s by NMRA‍

August 4, 2026

Notice to all Authorized Local Agents,

Average US Dollar Rate August -2026  for Price Approvals of MRP’s by NMRA

This is to kindly inform all authorized local agents that the USD rate considered for the month of August-2026 for processing price details of medicines/medical devices is 338.63.

Please ensure that all price submissions for MRP approvals are prepared accordingly.

Regulatory Updates

Announcement to All Market Authorization Holders: Medicines

August 3, 2026

To obtain list of Stop clock expired (2 months) applications, but sill not submitted requested additional documents and Still not received awaiting evaluation, from all MAH.

Click Here : Web Notice

Regulatory Updates

To publish the web notice on "Devices for Modification of Appearance or Anatomy (Aesthetic-related purpose)‍

July 28, 2026

Regarding the product categories need to be considered under Aesthetic- related purpose

Click Here : for more information.

Regulatory Updates

Change of Public Day

July 20, 2026

Notice to All Marketing Authorization Holders (MAHs)

Please be informed that the Public Day scheduled for Monday, 27 July 2026, at the Pricing Regulatory Division has been rescheduled to Tuesday, 28 July 2026, due to unavoidable circumstances.

We regret any inconvenience caused and appreciate your cooperation.

Thank You.

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.