Mediverify Database
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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 Authorized Local Agents
This is to kindly inform all authorized local agents that the USD rate considered for the month of June 2025 for processing price details of medicines / medical devices is 301.36
Please ensure that all price submission for MRP approvals are prepared accordingly.
Draft guideline for the Consolidated Dossier New Application Submission and Evaluation of General Medical Devices and In Vitro Diagnostics Medical Devices
NMRA welcomes your comments & feedback on the Draft Guideline for the Consolidated Dossier New Application Submission and Evaluation of General Medical Devices and In Vitro Diagnostics Medical Devices.
This will be started from 29th of May 2025 to 08th of June 2025.
Please provide your name, the organization you represent, mailing address and contact number to follow up with you to clarify any issue if necessary. Please email your feedback to pa6@nmra.gov.lk, mdrd@nmra.gov.lk, aa16@nmra.gov.Ik & aa20@nmra.gov.lk by 08th of June 2025.
Please be informed that board approval has been granted to implement a Single File Submission with up to ten colour variants with in the same cosmetic product series, for new and re-registration application. The charge for one file will be the charge of ten different files.
Notice to All Clinical Trial Document Submission Personnel
The National Medicines Regulatory Authority (NMRA) wishes to inform to allrelevant personnel regarding the following submission requirements for clinicaltrial applications:
Timely submission is essential to ensure that applications are reviewedwithout delay.
Submissions received after the deadline will be considered for inclusion inthe following month's CTEC meeting agenda.
Thank you for your cooperation.
CEO/NMRA
