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

Medicines Recall and Revocation Database - Updated

November 14, 2025
Regulatory Updates

Prioritization Request Form – Medicine Application and sample import license

November 12, 2025
Regulatory Updates

Evaluated Dossiers without payments by Importers and Local Manufacturers (Medicines/Device/Cosmetics)

November 10, 2025
Regulatory Updates

Notice to all retail and wholesale pharmacy owners

November 7, 2025
Regulatory Updates

Notice to all retail and wholesale pharmacy owners

November 7, 2025
View All Announcements
Regulatory Updates

Medicines Recall and Revocation Database - Updated

November 14, 2025

This publicly accessible database provides official information on medicines recall and revocation notifications that are taken to remove unsafe / ineffective/ substandard medicines from the market. This database is continuously updated and please find the current updated version of the database as of 2025.11.14

Click Here : Medicines Recall and Revocation Database - Upto 14.11.2025‍

Regulatory Updates

Prioritization Request Form – Medicine Application and sample import license

November 12, 2025

All Market Authorization Holders (MAH) are here by informed that the Prioritization Request Form (Form No: F-MR-030) shall be used for requesting prioritization of new medicine applications and sample import license.

Effective 15 November 2025, a hard copy of the completed form must be submitted by the respective local agents together with all relevant supporting documents.

In addition to the hard copy submission, the corresponding Google Form must also be duly completed and submitted.

Your cooperation in ensuring compliance with this updated submission procedure is highly appreciated.

Link to Form: Prioritization Request Form [F-MR-030]
Link to Google Form: Prioritization Request Form

Regulatory Updates

Evaluated Dossiers without payments by Importers and Local Manufacturers (Medicines/Device/Cosmetics)

November 10, 2025

The following dossiers are currently laid down in the Licensing Division without payments by the local agents and local manufacturers. Therefore, it is required to make the necessary payments for the registration certificates and licenses.

Make the relevant payment within two (02) weeks,

or

 If you plan, not to proceed with registration further,inform NMRA by email within two (02) weeks email address: ma9@nmra.gov.lk

If NMRA do not receive any response within two (02) weeks, your dossier will be considered as inactive and will be moved to the store.

Click Here : Payment Pending Evaluation Lists

Regulatory Updates

Notice to all retail and wholesale pharmacy owners

November 7, 2025

The National Medicines Regulatory Authority (NMRA) has granted a grace period until December 31, 2025, for all licensed retail pharmacies to renew their expired licenses.

This concession is crucial because, effective January 1, 2026, the NMRA will strictly enforce Clause 101 (2) of its regulations. This clause stipulates that a license will be

automatically cancelled if the renewal application is not submitted within three months of the current license's expiry date. Pharmacy owners are therefore advised to submit

renewals promptly to avoid cancellation.

Click Here for more : Notice to all retail and wholesale pharmacy owners

Regulatory Updates

Notice to all retail and wholesale pharmacy owners

November 7, 2025

The National Medicines Regulatory Authority (NMRA) announces that the temporary suspension of accepting new retail pharmacy applications, which was in effect from 01 April 2025 to 01 October 2025, has been extended from 01 October 2025 until further notice.

Click Here : Notice

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.