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

Current updates in regulatory requirements of Borderline Products

December 3, 2025
Regulatory Updates

Implementation of Public Appointment System for Public Engagement

December 3, 2025
Regulatory Updates

Notice Regarding Responsible Pharmacist Resignation Form (Effective 02.12.2025)

December 2, 2025
Regulatory Updates

Average US dollar rate December 2025 for MRP calculations by NMRA.

December 2, 2025
Regulatory Updates

Rejected Borderline Product Classification Applications as at 01/12/2025

December 2, 2025
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Regulatory Updates

Current updates in regulatory requirements of Borderline Products

December 3, 2025

Current updates in regulatory requirements of Borderline Products” to be published in the NMRA website on following matters;

Click here : Current updates in regulatory requirements of Borderline Products

Regulatory Updates

Implementation of Public Appointment System for Public Engagement

December 3, 2025

The National Medicines Regulatory Authority (NMRA) is pleased to announce that the Public Appointment System will be implemented starting from 8th December, to streamline and enhance public engagement on scheduled public days.

Members of the public are required to make an appointment prior to visiting the NMRA for matters related to the relevant divisions listed in the attachment.  Furthermore, from 8th December 2025 on wards, it will not be possible to visit or meet at the NMRA for public days without a prior appointment

Click Here : For more information

Regulatory Updates

Notice Regarding Responsible Pharmacist Resignation Form (Effective 02.12.2025)

December 2, 2025

Effective December 2, 2025, all resignations from the position of Responsible Pharmacist must be submitted using the new official resignation form. Any submission using an alternative form or following a different procedure will not be considered a valid resignation.

Regulatory Updates

Average US dollar rate December 2025 for MRP calculations by NMRA.

December 2, 2025

Notice to all authorized local agents,

Average US dollar rate December 2025 for price approvals of MRPs calculations by NMRA.

This is kindly inform all authorized local agents that the USFD rate considered for the month of December 2025 for processing price details of medicines/ medical devices is 306.85 LKR.

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

Regulatory Updates

Rejected Borderline Product Classification Applications as at 01/12/2025

December 2, 2025

This web notice is published to avoid inconvenience during customs importation, in accordance with the web notice issued on 5th March 2025. Relevant classification reports will be issued as early as possible.

[This publication has been initiated from 85th (26/11/2025) Subcommittee of BPEC]

Click Here: Rejected Borderline Product Classification Applications as at 01/12/2025

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.