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

Checklist for Document Accepting of Consolidated new Medical Device applications

May 20, 2026
Regulatory Updates

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

April 30, 2026
Regulatory Updates

Notice to Applicants - Retail Pharmacies and Wholesale Establishments

April 22, 2026
Regulatory Updates

Public Notice — Renewal of Expired Pharmacy Licenses

April 22, 2026
Regulatory Updates

Notice to All Local Manufacturers - Manufacturing and Distribution data (2023,2024 & 2025)

April 21, 2026
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Regulatory Updates

Checklist for Document Accepting of Consolidated new Medical Device applications

May 20, 2026

The Medical Devices Regulatory Division of the NMRA has revised the Consolidated Dossier Submission Checklist for New Product Registration (F-MDR-035). The revised format can be obtained from the “Application Forms” tab under the Medical Devices Regulatory Division on the NMRA website.

Accordingly,all Market Authorization Holders are advised to submit consolidated dossiers in compliance with the revised checklist with effect from 02nd June 2026.

Chief Executive Officer

National medicines Regulatory Authority

Regulatory Updates

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

April 30, 2026

Notice to all Authorized Local Agents

Subject: Average US Dollar Rate May-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 May-2026 for processing price details of medicines/medical devices is 315.19

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

Regulatory Updates

Notice to Applicants - Retail Pharmacies and Wholesale Establishments

April 22, 2026

The Pharmacies regulatory divisions of National medicines regulatory authority has introduced an online application portal for all pharmacy licenses related applications. With effect from today (21/04/2026), all applications for retail pharmacy and wholesale establishment will be accepted only through this online portal.

The link to access the portal is available on the NMRA official website under the pharmacy regulatory division. Details instructions for application submission also are provided on the portal.

All applicants are kindly requested to submit their applications accordingly.

Regulatory Updates

Public Notice — Renewal of Expired Pharmacy Licenses

April 22, 2026
Expiry within two years from date of application.

Renewal applications will be considered if the existing license has expired within two years from the date of submission of the application to NMRA with penalty and appropriate fee for the period.

Expiry more than two years from date of application.

Renewal applications submitted after two years from the date of expiry of the existing license will be considered as a new application. Existing rules and regulations for a new pharmacy will be applicable.

The above provisions will be applicable only up to 31 December 2026.

Click Here : Renewal of Expired Pharmacy Licenses

Regulatory Updates

Notice to All Local Manufacturers - Manufacturing and Distribution data (2023,2024 & 2025)

April 21, 2026

The National Medicines Regulatory Authority (NMRA) requires all local manufacturers to submit comprehensive production and supply chain data for the calendar years2023, 2024, and 2025.Please refer the attachment.

Submission Method: Please email your data to mc@nmra.gov.lk.

Format: Submissions must be in a digital format(Excel preferred) to ensure accuracy.

For any technical clarifications or inquiries, please contact the Market Surveillance and Control Division through mc@nmra.gov.lk

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.