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 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
Regulatory Updates

Closure of the National Medicines Regulatory Authority (NMRA) on 15th April 2026

April 10, 2026
Regulatory Updates

Engagement of Legal Consultant (Temporary Basis)

April 8, 2026
View All Announcements
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

Regulatory Updates

Closure of the National Medicines Regulatory Authority (NMRA) on 15th April 2026

April 10, 2026

PUBLIC NOTICE

Closure of the National Medicines Regulatory Authority (NMRA) on 15th April 2026

The general public is hereby informed that the National Medicines Regulatory Authority (NMRA) will be closed on 15th April 2026 in observance of the Sinhala and Hindu New Year.

Accordingly, all operations of the Authority will be suspended on this day.

The public is kindly requested to make necessary arrangements in advance to avoid any inconvenience.

We kindly seek your understanding and cooperation in this matter.

Chief Executive Officer

National Medicines Regulatory Authority

Regulatory Updates

Engagement of Legal Consultant (Temporary Basis)

April 8, 2026

The National Medicines Regulatory Authority (NMRA) invites Expressions of Interest (EOI) from qualified legal professionals to provide Legal Consultation Services for a period of three (03) months, commencing from 01st May 2026.

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.