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

Public Notice

March 25, 2026
Regulatory Updates

Revision of Public Days and Appointment System - Pharmacies Regulatory Division

March 25, 2026
Regulatory Updates

Public Notice

March 24, 2026
Regulatory Updates

Public hearing on the proposed Medicine Regulation

March 23, 2026
Regulatory Updates

Notice to Local Manufacturers - Manufacturing data Submission

March 20, 2026
View All Announcements
Regulatory Updates

Public Notice

March 25, 2026

The Medical Devices Regulatory Division of the NMRA has recommenced issuing Product Clarification Letters (PCLs) effective from 31st of March 2026.

Detailed instructions and the relevant application forms will be published on the NMRA website in due course.

Stakeholders are kindly advised to refer to the NMRA website for further updates.

Click Here : Public Notice

Regulatory Updates

Revision of Public Days and Appointment System - Pharmacies Regulatory Division

March 25, 2026

To all owners of Retail and Wholesale Pharmacies and Responsible Pharmacists in Sri Lanka,

Please be informed that the Pharmacies Regulatory Division of the NMRA will implement a new schedule for public days for document submissions, effective from April 1st, 2026.

The public days are as follows.

  • Monday - License Renewals (With or without changes/amendments)
  • Friday - New Pharmacy Applications

To ensure a smooth process, please adhere to the following:

Step 1: All visitors must schedule an appointment before visiting pharmacies' regulatory division through the official NMRA portal.
Click Here : official NMRA portal link

Step2: Appointment Confirmation Email will be sent by NMRA with a specific appointment date and instructions.

Step3: You must present to NMRA with a printed or digital copy of the Appointment Confirmation Email sent by the NMRA.

Individuals without a valid appointment for the specific service day will not be accepted.

We appreciate your cooperation in helping us enhance the efficiency of our regulatory functions.

 

Chief Executive Officer

National Medicines Regulatory Authority (NMRA)


Click Here: Notice

Regulatory Updates

Public Notice

March 24, 2026

In view of the prevailing crisis situation in the Middle East region, and with the objective of minimizing fuel consumption, the Government has declared every Wednesday as a public holiday with effect from 18.03.2026.

However, the public is hereby informed that the functions of the National Medicines Regulatory Authority will continue to be carried out on Wednesdays by calling in a limited number of officers.

Accordingly, although the Government has declared Wednesdays as public holidays, the functions of the National Medicines Regulatory Authority will continue as usual without closing the office.

Click Here : Public Notice

Chief Executive Officer

National Medicines Regulatory Authority

Regulatory Updates

Public hearing on the proposed Medicine Regulation

March 23, 2026

Calling for public hearing for Medicine Regulation.

The National Medicines Regulatory Authority (NMRA) will conduct a public hearing to obtain views, comments and recommendations from stockholders and the general public regarding the proposed Medicine Regulation.This hearing aims to promote transparency, inclusiveness, and stockholder participation in the policy-making process related to the regulation, safety,quality, and accessibility of medicines in Sri Lanka.

Healthcare professionals, industry represtatives, civil society organizations, academics and members of the public are invited to share their views and suggestions to improve the proposed policy. The feedback received during this consultation will be taken into consideration in the finalization of the Regulation.

The final date for the submission of feedback and for the public hearing is 05.04.2026

Written comments or feedback should be submitted to the following email. lo@nmra.gov.lk

Registered Post: Chief Executive Officer, National Medicines Regulatory Authority, State Engineering Corporation Building (2nd Floor), No. 130,W.A.D.Ramanayaka Mawatha, Colombo 02.

All references should be clearly stated as 'Public Comments regarding Medicine Regulation' the subject or in the top left corner of the envelope.

Please contact below for further information:

Telephone: 0112698896/7  email: lo@nmra.gov.lk

Click Here : Public hearing on the proposed Medicine Regulation

Regulatory Updates

Notice to Local Manufacturers - Manufacturing data Submission

March 20, 2026

All Local Manufacturers of Medicines, Medical Devices, Cosmetics and Borderline Products are kindly requested to submit their manufacturing data using the provided Excel template, effective from 1st of April 2026

Click Here : Notice to Local Manufacturers - Manufacturing data Submission

Click Here : Excel Sheet

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.