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

Notice to Local Manufacturers - Manufacturing data Submission

March 20, 2026
Regulatory Updates

Import Consigment Data Submission - Amendment 1

March 20, 2026
Regulatory Updates

Notice to all retail pharmacy owners and responsible pharmacists.

March 18, 2026
Regulatory Updates

Public Notice

March 17, 2026
Regulatory Updates

Submission of manual applications for foreign manufacturing site registrations (Previous online approvals)

March 17, 2026
View All Announcements
Regulatory Updates

Notice to Local Manufacturers - Manufacturing data Submission

March 20, 2026

All Local Manufacturers of Medicines, Medical Devices, Cosmetics and Borderline Products are kindly requested to submit their manufacturing data using the provided Excel template, effective from 1st of April 2026

Regulatory Updates

Import Consigment Data Submission - Amendment 1

March 20, 2026

All market authorization holders for imported Medicines, Medical Devices, Cosmetics and Borderline Products are kindly requested to submit their import/consignment data using the provided Excel template, effective from 1st of April 2026

Regulatory Updates

Notice to all retail pharmacy owners and responsible pharmacists.

March 18, 2026

The grace period for renewal of expired retail pharmacy licenses was over the 28th of February, 2026. The attached notice is applied to all applications that are submitted after the 1st of March, 2026.

Click Here : Notice to all retail pharmacy owners and responsible pharmacists.

Regulatory Updates

Public Notice

March 17, 2026

In view of the prevailing crisis situation in the Middle East region and with the objective of minimizing fuel consumption, the Government has declared every Wednesday as a public holiday with effect from 18.03.2026, until further notice.

Accordingly, this is to kindly inform you that every Wednesday will be treated as a holiday for the operations of the Authority until further notice.

However, the Public Day of the Pharmacies Regulatory Division scheduled for Wednesday, 18.03.2026, will be held as previously arranged. Thereafter, necessary arrangements will be made to conduct the Public Day on other weekdays, and the relevant parties will be informed in due course.

We kindly seek your understanding and cooperation in this matter.

Click Here : Public Notice

Chief Executive Officer

National Medicines Regulatory Authority

Regulatory Updates

Submission of manual applications for foreign manufacturing site registrations (Previous online approvals)

March 17, 2026

Submission of manual applications for foreign manufacturing site registrations (Previous online approvals)

Please be advised that, for all foreign manufacturing site registrations previously approved via the online system, a manual dossier should be submitted.

Following supporting document submission is mandatory with the manual dossier.

  • Copy of the e-NMRA manufacturing site approval certificate issued by the National Medicines Regulatory Authority
  • Previous payment receipt
  • Copy of the previously issued approval letter for the manufacturing site (if available)

Deadline for the submission-05/09/2026

CEO/NMRA

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.