Maximum Retail Prices of Medicines
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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 MoreNational Medicines Regulatory Authority,
State Engineering Corporation Building (2nd Floor),
No. 130,
W.A.D Ramanayaka Mawatha,
Colombo 02,
Sri Lanka
Notice to All Marketing Authorization Holders (MAHs)
Please be informed that the Public Day scheduled for Monday, 27 July 2026, at the Pricing Regulatory Division has been rescheduled to Tuesday, 28 July 2026, due to unavoidable circumstances.
We regret any inconvenience caused and appreciate your cooperation.
Thank You.
CEO, NMRA
Applicants who have obtained a Sample Import License (SIL) from the Licensing Division are requested to submit a copy of the issued SIL to the Medical Devices Regulatory Division (MDRD) for further processing of the relevant dossier.
CEO, NMRA
The National Medicines Regulatory Authority (NMRA) wishes to inform all applicants and stakeholders that the Cosmetic Processing Sheet has been revised with effect from 13 July 2026.
Click Here : Processing Sheet for cosmetic applications
The Medicines Regulatory Division (MRD) of the National Medicines Regulatory Authority (NMRA) has revised the "Document Submission Form to Get Initial Decision for New Molecular Entity from Medicines Evaluation Committee (MEC)". The revised document is available under the "Application Forms" section of the Medicines Regulatory Division on the NMRA website.
Accordingly, with effect from 09 July 2026, all applicants and Market Authorization Holders seeking an initial decision from the Medicines Evaluation Committee (MEC) for New Chemical Entity (NCE) applications are required to use the revised Document Submission Form to Get Initial Decision for New Molecular Entity from Medicines Evaluation Committee (MEC).
Applications shall be submitted together with a Letter of Authorization, a copy of the manufacturer's company profile, or a valid Good Manufacturing Practice (GMP) Certificate or GMP Inspection Report, as applicable, in accordance with the amended document.
Click Here : Revised Document Submission Form for New Molecular Entity (NME) Applications
Chief Executive Officer
National Medicines Regulatory Authority
The National Medicines Regulatory Authority (NMRA) wishes to inform all applicants and stakeholders that Monday and Wednesday have been designated as the Public Days of the Pharmacy Regulatory Division,effective immediately.
The public are kindly requested to visit the Pharmacy Regulatory Division only on Mondays and Wednesdays for the following services:
The public are kindly requested to refrain from visiting the Division on other working days unless specifically requested by an NMRA officer or in exceptional circumstances.
This arrangement has been introduced to improve the efficiency of service delivery, reduce waiting times, and facilitate the timely processing of applications.
The National Medicines Regulatory Authority appreciates your understanding and cooperation.
Effective Date: 08.07.2026
Pharmacy Regulatory Division
NMRA,
