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

Google Form - Pricing - Import Licenses expired from 1st of February, 2026

January 28, 2026
Regulatory Updates

Announcement to All Market Authorization Holders: medicines

January 26, 2026
Regulatory Updates

Rejected Borderline Product Classification Applications as at 06/01/2026

January 9, 2026
NMRA Updates

Notice on Updated Labelling Requirement Amendment 04

January 2, 2026
Regulatory Updates

Rejected Borderline Product Classification Applications as at 31/12/2025

January 2, 2026
View All Announcements
Regulatory Updates

Google Form - Pricing - Import Licenses expired from 1st of February, 2026

January 28, 2026

To all importers,

Please find the Google Form (via the link/QR code provided) for the submission of price details relevant to import license applications that expire on or after 1st of   February 2026.

Please note that applicants who have already submitted price details are also required to resubmit the information through this Google Form.

A printed copy of the completed Google Form must be submitted together with the Application for License to Import a Registered Medicine [Regulation 48(3), Schedule VIII] and the Submission of Price Details for Dossiers(New/RR/Renewal/Variation) & Import Licenses Form (F-PD-001/ Effective Date: 04.09.2025 / Version 1.0 / Revision No. 0), along with the relevant supporting documents.

https://forms.gle/n3TMMxs1j9B9QW6Z9

Thank you.

Regulatory Updates

Announcement to All Market Authorization Holders: medicines

January 26, 2026

All Market Authorization Holders of medicines are hereby informed that if any new medicine application was submitted to the NMRA on or before 30 September 2024 and the initial evaluation has not yet been received, you are kindly requested to inform the  NMRA accordingly.

Please send the required information to the following email address:
pa15@nmra.gov.lk

When submitting the information, please:

  • Use the email subject as:
    “Pending evaluations : Medicine applications submitted before 30 September 2024”
  • Provide all relevant details of the application using the attached Excel template.

Please note that the completed Excel template and related information needs to be submitted on or before 4.00 p.m. on Wednesday, 28 January 2026.

Click Here:  Excel template

Thank you.
National Medicines Regulatory Authority
Sri Lanka

Regulatory Updates

Rejected Borderline Product Classification Applications as at 06/01/2026

January 9, 2026

This web notice is published to avoid inconvenience during customs importation, in accordance with the web notice issued on 51th March 2025. Relevant classification reports will be issued as early as possible.

[This publication has been initiated from 91th (06/01/2026) Subcommittee of BPEC]

Click Here: Rejected Borderline Product Classification Applications as at 06/01/2026

NMRA Updates

Notice on Updated Labelling Requirement Amendment 04

January 2, 2026

Notice on Updated Labelling Requirement Amendment 04

Extention of the grace period for product-Specific QR Codes or barcodes on Commercial packaging.

Click Here: Notice on Updated Labelling Requirement Amendment 04

Regulatory Updates

Rejected Borderline Product Classification Applications as at 31/12/2025

January 2, 2026

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 90th (31/12/2025) Subcommittee of BPEC]

Click Here: Rejected Borderline Product Classification Applications as at 31/12/2025

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.