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
To all Marketing Authorization Holders,
This is to inform you that the Sub MEC decisions and the list of rejected medicine applications will be published on the NMRA website with effect from May 2026
Please refer to the attached lists. Updated lists will be uploaded under the "Medicines Evaluation Subcommittee Decisions" and "List of Rejected Medicine Applications" tabs on the NMRA website.
CEO,
NMRA
All Marketing Authorizing Holders (MAHs) of medicines are hereby informed that the following New/RR/Renewal application (lists are attached), which remain pending at the pricing division due to non-response to price request details within three months from the initial communication from the NMRA, will be considered for rejection from both the pricing review process and the registration process at the NMRA.
Allow 2 weeks grace period from the date of this notice and if no response is received a notification letter will be issued to inform the withdrawal and closure of these applications and applicants can submit any concerns or clarification regarding this decision within one month of this letter. Failure to respond within this period will result in the permanent rejection of your application by the NMRA.
Please note that after rejection, if the applicants wish to proceed further, these product registration applications must be resubmitted as a new application to the NMRA
Reissuance of Sample Import License (SIL)-Medical Devices
Applications for the reissuance of a Sample Import License (SIL) will be considered under the following instances:
Applicable instances:
Applications submitted under the above circumstances must be accompanied by the following mandatory documents:
Mandatory documents:
Please note that submission of all mandatory documents is required. The authority may request additional documents where necessary.
CEO, NMRA
Click Here : Web Notice
The Medical Devices Regulatory Division of the NMRA has revised the Consolidated Dossier Submission Checklist for New Product Registration (F-MDR-035). The revised format can be obtained from the “Application Forms” tab under the Medical Devices Regulatory Division on the NMRA website.
Accordingly, all Market Authorization Holders are advised to submit consolidated dossiers in compliance with the revised checklist with effect from 07th July 2026.
Chief Executive Officer
National medicines Regulatory Authority
