National Medicines Regulatory Authority

Sri Lanka

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.

Providing Quality Medicine Regulation in 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.

Functions of the NMRA

Regulatory

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.

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Laboratory

National 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.

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Pharmacovigilance

Pharmacovigilance Division is responsible for monitoring and dealing with adverse drug reaction, quality failure and counterfeit medicines.

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Enforcement

Inspectorate and Enforcement Division is responsible for inspecting and investigating issues pertaining to proper implementation of the provision of the NMRA Act.

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Latest Announcements

Regulatory Updates

Email Address to access the Google sheet on NMRA website

November 6, 2024
Regulatory Updates

Registration of Cefuroxime injection 1000 mg

November 4, 2024
Regulatory Updates

Regarding All Skin Preparations Containing a Combination of a potent Steroid and an Antifungal

October 29, 2024
Regulatory Updates

Registration of Multivitamin & Multimineral

October 29, 2024
Regulatory Updates

Regulatory Strengthening of Controls on Falsified Products-Borderline Product Category

October 22, 2024
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Regulatory Updates

Email Address to access the Google sheet on NMRA website

November 6, 2024

To all MAH of Medicines,

In our ongoing efforts to ensure transparency within the National Medicines Regulatory Authority (NMRA), we are implementing a new procedure for accessing the Google sheet titled "Reviewing Status of New Medicinal Products" available on the NMRA website.

To facilitate this, we kindly request each company to provide one email address that will be used to access the aforementioned Google sheet by scanning and filling the below QR code on or before 20th of November 2024. This step is crucial for maintaining a streamlined and secure review process.

Your cooperation in this matter is highly appreciated.

https://docs.google.com/forms/d/e/1FAIpQLSdJfGjk9NJ-qkW-OD-lXgh1KwHoqVXpTJp-TWj1oGM1jbV9gQ/viewform?usp=sf_link

CEO 
NMRA

Regulatory Updates

Registration of Cefuroxime injection 1000 mg

November 4, 2024

Cefuroxime injection 1000 mg is not accepted for registration under "Need" clause.

Regulatory Updates

Regarding All Skin Preparations Containing a Combination of a potent Steroid and an Antifungal

October 29, 2024

All skin preparations containing a combination of a potent steroid and an antifungal are not allowed to be registered in Sri Lanka. All the certificates of such combinations should be returned to the NMRA before 04th of November 2024 and all available products in the market should be recalled by the relevant marketing authorization holders within 30 days from 28th October 2024.

Regulatory Updates

Registration of Multivitamin & Multimineral

October 29, 2024

Multivitamin & Multimineral products having amount more then or equal to therapeutic level as per the BNF for at least one are considered for registration under Medicines.

Regulatory Updates

Regulatory Strengthening of Controls on Falsified Products-Borderline Product Category

October 22, 2024

Apply wording "NMRA approved" for registered borderline products

To inform all marketing authorization holders of bordering products to print or place a non-peelable sticker on each commercial pack indicating the wording ' NMRA approved' and the details of market authorization holder with effect from 1st November 2024.

(Date: if applicable)

Complaints QR Code
Scan the QR code below to submit your complaints.
Reporting falsified / Counterfeit Products
Scan the QR code below to report falsified or counterfeit products.