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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
Please be informed that the checklist for submitting documents for new cosmetic registration applications has been revised. Please refer to Annexure 01 for the updated version. The updated checklist will be effective from 01 June 2025.
The forms related to Borderline Products Regulatory Division have been updated and you are requested to use the revised and new formats where necessary for application submission.
To all Local Medical Device Manufacturers
Notice Regarding GMP Inspection Waiver for Listed and Class 1 Medical Device Manufacturing Sites
The National Medicines Regulatory Authority (NMRA) has decided to waive the GMP inspection requirement for manufacturing sites involved in the production of Listed and Class 1 medical devices (refer to the attached list & Annexed 1).
Manufacturers may now apply for product registration without prior GMP approval, provided the following criteria are met:
Manufacturers must submit the following documents to the Manufacturing Regulatory Division (MFRD) on Thursday:
Site Master File with,
Upon review of the submitted documents, the MFRD will issue a GMP Waiver Document. This document must then be submitted along with the product registration application in place of GMP approval.
NMRA has granted two years blanket GMP approval to allow the relevant manufacturers to obtain ISO 9001 for the above category of products with effect from 10/05/2025 to 09/05/2027
After 09/05/2027 NMRA will only accept ISO 9001 in lieu of GMP inspection for the above categories.
For any inquiries, please contact the Manufacturing Regulatory Division
CEO/NMRA
To all Market Authorization Holders of Medicines,
You are hereby informed that NMRA will initiate a renewal process for overseas manufacturing sites with effect from 1st August 2025. Initially, manufacturing sites approved on or before 31st December 2005 will be required to submit applications for renewal. NMRA will carry out an onsite GMP inspection if the site has not been inspected by NMRA reference authority.
The following conditions will be applied for the renewal process:
You may contact Manufacturing Regulatory Division, NMRA for further clarifications.
Note that, If the renewal of manufacturing site is not completed, the product registration will not be renewed and new product applications (Sample import license and product registration) will not be accepted.
CEO/NMRA
Request for quotation, Testing of the load capacity of the standby generator National Medicines Quality Assurance Laboratory (NMQAL)
