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 day for local agents - Pricing Unit

April 25, 2025
Regulatory Updates

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

April 25, 2025
Regulatory Updates

Final date for accepting classification applications

April 24, 2025
Regulatory Updates

Warning Letter

April 21, 2025
NMRA Updates

Temporary Suspension of File Submission Services

April 11, 2025
View All Announcements
Regulatory Updates

Public day for local agents - Pricing Unit

April 25, 2025

For the information of all marketing authorization holders,

The Pricing Division will hold a public day for local agents to discuss matters related to pending applications on Tuesday, 29th April 2025, at 10.00 AM. To participate, please schedule an appointment by entering your details in the book available with the security officer on the 2nd floor.

Regulatory Updates

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

April 25, 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 May 2025 for processing price details of medicines / medical devices is 300.77

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

Regulatory Updates

Final date for accepting classification applications

April 24, 2025

The final date of accepting Borderline Product Classification applications will be on 29th April 2025 as per the web notice published on NMRA website dated on 5th March 2025

Regulatory Updates

Warning Letter

April 21, 2025

Warning letter issued to local pharmaceutical manufacturer, Newgen Lanka Healthcare (Pvt) Ltd. due to repeated deviations from GMP practices.

NMRA Updates

Temporary Suspension of File Submission Services

April 11, 2025

Please be informed that file submission services for the Device Regulatory Division, Cosmetic Regulatory Division, Borderline Products Regulatory Division, Manufacturing Regulatory Division and Pharmacy Regulatory Division will be temporarily unavailable on April 15th, 16th, and 17th due to the upcoming festival celebrations.

We apologize for any inconvenience this may cause and appreciate your understanding.

Chief Executive Officer

National Medicines Regulatory Authority

Complaints QR Code
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Reporting falsified / Counterfeit Products
Scan the QR code below to report falsified or counterfeit products.