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
Please be informed that National Medicines Regulatory Authority will accept applications for registration of foreign manufacturing sites with following GMP approvals until further notice.
This decision will be implemented with the effect from 01/01/2025
This temporary measure is implemented to maintain a high standard of quality and safety of medicines imported to Sri Lanka and to apply reliance regulatory approach recommended by WHO.
Please note that any manufacturing site with unregistered products and without above GMP approvals will be considered case by case. The requests should be submitted to CEO, NMRA in this regard. All such requests will be subjected to manufacturing peer review committee for consideration.
This decision is only applicable for medicines manufacturing sites applications.
Although all skin preparations containing a combination of a potent steroid and an antifungal are not allowed to be registered in Sri Lanka , the NMRA deiced allowing to market only the remaining stock of such products in the market . New consignments will strictly not be allowed .
Note : The potency of the steroid is considered as per the Topical corticosteroid preparation potencies classification in the BNF .
For the information of all marketing authorization holders;
Borderline files accepting date will be held on 26th November (Tuesday) 2024 due to an unavoidable reason. [Only for this week]
From December onwards borderline file accepting date will be held on Thursday as usual.
