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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.

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.


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.
Find Out MoreNational 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.
Find Out MorePharmacovigilance Division is responsible for monitoring and dealing with adverse drug reaction, quality failure and counterfeit medicines.
Find Out MoreInspectorate and Enforcement Division is responsible for inspecting and investigating issues pertaining to proper implementation of the provision of the NMRA Act.
Find Out MoreAll 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
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
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.
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
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.
Deadline for the submission-05/09/2026
CEO/NMRA