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

Renewal of pharmacy and wholesale license year 2025

Regulatory Updates

Web notice of the changes of manufacturing plant approval process from 01/01/2025

December 10, 2024
Regulatory Updates

Regarding All Skin preparations Combination of a potent Steroid and an Antifungal

December 6, 2024
Regulatory Updates

Notice on updated labelling requirement

December 5, 2024
Regulatory Updates

Changing the Accepting Date of Borderline Products

November 25, 2024
View All Announcements
Regulatory Updates

Renewal of pharmacy and wholesale license year 2025

Regulatory Updates

Web notice of the changes of manufacturing plant approval process from 01/01/2025

December 10, 2024
Web Notice of the changes of Foreign Manufacturing Plant Approval Process from 01/01/2025

Please be informed that National Medicines Regulatory Authority will accept applications for registration of foreign manufacturing sites with following GMP approvals until further notice.

  1. PIC/s Approved (Pharmaceutical Inspection Co-operation Scheme)
  2. EU GMP Approved (European Union Good Manufacturing Practices)
  3. WHO Prequalified or WHO approved. (Inspection should be done by WHO team)

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.

Regulatory Updates

Regarding All Skin preparations Combination of a potent Steroid and an Antifungal

December 6, 2024

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 .

Regulatory Updates

Notice on updated labelling requirement

December 5, 2024
Regulatory Updates

Changing the Accepting Date of Borderline Products

November 25, 2024

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.

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.