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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
Effective from 1st of October 2025, all regulatory matters pertaining to pharmacies (receiving applications to start/renew/make changes to a wholesale/retail pharmacy, interviews for responsible pharmacists, etc.) will require a prior appointment to visit the Pharmacy Regulation Division on public days (Mondays, Wednesdays, and Fridays). You can now book a date and time through the link available on the official NMRA website.
This web notice is published to avoid inconvenience during customs importation, in accordance with the web notice issued on 5th March 2025. Relevant classification reports will be issued as early as possible.
(This publication has been initiated from 82th Subcommittee of BPЕС.)
New Format of Excel Sheet for Submitting Price Details
This is to kindly inform all authorized local agents that the format of the Excel sheet to be used for submitting price details of import licenses has been revised.
The updated format of the Excel sheet is published together with this notice. Please note that all other instructions pertaining to the submission process will remain unchanged.
Click here - New Format of Excel Sheet
For the information of all marketing authorization holders;
The Pricing Division will hold a Public Day for local agents to discuss matters related to pending applications on Wednesday, 24th September 2025 at 10:00 AM. To participate, please schedule an appointment by entering your details in the book available with the Security Officer on the 2nd Floor.
We wish to inform about the regulatory approach concerning the use of N-acetylcysteine (NAC) as an ingredient in borderline products.
Based on safety concerns and lack of conclusive evidence supporting the benefits of NAC, it has been determined that: N-acetylcysteine (NAC) should not be permitted for use in borderline products.
This decision reflects a precautionary approach to safeguard public health and ensure regulatory compliance.
