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.

Find Out More
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.

Find Out More
Pharmacovigilance

Pharmacovigilance Division is responsible for monitoring and dealing with adverse drug reaction, quality failure and counterfeit medicines.

Find Out More
Enforcement

Inspectorate and Enforcement Division is responsible for inspecting and investigating issues pertaining to proper implementation of the provision of the NMRA Act.

Find Out More

Latest Announcements

NMRA Updates

Notice on updated labeling requirement

June 6, 2025
Regulatory Updates

Notice Regarding the Medical Device Dossier submission on 10th of June 2025

June 6, 2025
NMRA Updates

Customer Satisfaction Survey and Survey for Reliance Application

June 4, 2025
Regulatory Updates

Average Dollar Rate June - 2025 for Price Approvals of MRP's by NMRA

June 2, 2025
Public Consultation

Draft guideline for the Consolidated Dossier New Application Submission and Evaluation of General Medical Devices and IVDD

May 29, 2025
View All Announcements
NMRA Updates

Notice on updated labeling requirement

June 6, 2025

NMRA has extended the grace period for the implementation of product-specific QR codes or barcodes on all commercial packing from 31st May 2025 to 31 December 2025.

Regulatory Updates

Notice Regarding the Medical Device Dossier submission on 10th of June 2025

June 6, 2025

To All Marketing Authorization Holders of Medical Devices, are hereby informed that Medical Device Dossiers will be accepted on 11th of June 2025 instead of 10th of June 2025 due to the public holiday (Poya Day). Sorry for the inconveniences caused

NMRA Updates

Customer Satisfaction Survey and Survey for Reliance Application

June 4, 2025
Regulatory Updates

Average Dollar Rate June - 2025 for Price Approvals of MRP's by NMRA

June 2, 2025

Notice to All Authorized Local Agents

This is to kindly inform all authorized local agents that the USD rate considered for the month of June 2025 for processing price details of medicines / medical devices is 301.36

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

Public Consultation

Draft guideline for the Consolidated Dossier New Application Submission and Evaluation of General Medical Devices and IVDD

May 29, 2025

Draft guideline for the Consolidated Dossier New Application Submission and Evaluation of General Medical Devices and In Vitro Diagnostics Medical Devices

NMRA welcomes your comments & feedback on the Draft Guideline for the Consolidated Dossier New Application Submission and Evaluation of General Medical Devices and In Vitro Diagnostics Medical Devices.

This will be started from 29th of May 2025 to 08th of June 2025.

Please provide your name, the organization you represent, mailing address and contact number to follow up with you to clarify any issue if necessary. Please email your feedback to pa6@nmra.gov.lk, mdrd@nmra.gov.lk, aa16@nmra.gov.Ik & aa20@nmra.gov.lk by 08th of June 2025.

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.