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

Rejected Borderline Product Classification Applications as at 29/12/2025

December 30, 2025
Regulatory Updates

Data Collection of Currently Functioning Foreign Manufacturers

December 30, 2025
Regulatory Updates

Notice Regarding Acceptance of New Pharmacy Applications from Private Hospitals and Channelling Centres

December 29, 2025
Regulatory Updates

Notice Regarding Renewal of Expired Retail Pharmacy Licences

December 29, 2025
Regulatory Updates

Renewal of Foreign Manufacturing Site Approval

December 24, 2025
View All Announcements
Regulatory Updates

Rejected Borderline Product Classification Applications as at 29/12/2025

December 30, 2025

Description: 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 89th (29/12/2025) Subcommittee of BPEC]

Click Here: Rejected Borderline Product Classification Applications as at 29/12/2025

Regulatory Updates

Data Collection of Currently Functioning Foreign Manufacturers

December 30, 2025

All importers are requested to fill in the following Google Form and submit the required details of their currently functioning manufacturers.
Data Collection Period:19/12/2025 to 05/01/2026

Timely submission of accurate information is requested.

https://forms.gle/FioW5ZpwtQgZi7r3A

CEO/NMRA

Regulatory Updates

Notice Regarding Acceptance of New Pharmacy Applications from Private Hospitals and Channelling Centres

December 29, 2025

It is hereby notified that new applications for pharmacies established within Private Hospitals and Channelling Centres will be accepted from all districts, provided that the
respective Private Hospital or Channelling Centre is duly registered with the Private Health Services Regulatory Council (PHSRC).

Click Here : Notice Regarding Acceptance of New Pharmacy Applications from Private Hospitals and Channelling Centres

Regulatory Updates

Notice Regarding Renewal of Expired Retail Pharmacy Licences

December 29, 2025

The National Medicines Regulatory Authority (NMRA) hereby informs all licensed retail pharmacy owners that, considering the prevailing situation in the country and other acceptable reasons, the renewal of expired retail pharmacy licences will be accepted up to 28 February 2026.

Click Here : Notice Regarding Renewal of Expired Retail Pharmacy Licences

Regulatory Updates

Renewal of Foreign Manufacturing Site Approval

December 24, 2025

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 between the period of 2000 and 2010 will be required to submit applications for renewal. NMRA may 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:

  • The local agent would require submitting an application for renewal of the foreign manufacturing premises, with the required documents.
  • A six-months grace period with effect from 1st of January 2026 will be given for the submission of renewal applications.
  • The format of the application and the list of required documents is attached with this notice.
  • A renewal application fee as prescribed in the fees regulations will be charged.
  • A fee for GMP inspection - Foreign, as prescribed in the fees regulations will be charged, if decided to carry out an onsite inspection.
  • Manufacturing sites for which renewal applications are not submitted within the announced deadline will be discontinued.
  • The renewed approvals will be valid for a period of five years.

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 r enewed and new product applications (Sample import license and product registration) will not be accepted.


CEO/NMRA

Click Here : Application for Renewal of an Overseas Manufacturer of Medicines

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.