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

Average US Dollar Rate November-2026 for Price Approvals of MRP’s by NMRA

November 2, 2026
Regulatory Updates

Invitation for Bids - Procurement of an IT Solution for Dossier Evaluation, Retail Pharmacy Regulation, and Auxiliary Regulatory Functions, Including Capacity Building for National Medicines Regulatory Authority (NMRA)

November 2, 2026
Regulatory Updates

Submission of variation requiring notification (MIV1.N) related to medicines‍

October 20, 2026
Regulatory Updates

Data Collection - Sample Import Licence applications for New Chemical Entities (NCEs) and Innovator Products.

October 19, 2026
Regulatory Updates

Publishing the list of approved MRP Revisions due to currency depreciation List_ 4

October 13, 2026
View All Announcements
Regulatory Updates

Average US Dollar Rate November-2026 for Price Approvals of MRP’s by NMRA

November 2, 2026

Notice to all Authorized Local Agents,

This is to kindly inform all authorized local agents that the USD rate considered for the month of November-2026  for processing price details of medicines/ medical devices is 334.99
Please ensure that all price submissions for MRP approvals are prepared accordingly.

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Regulatory Updates

Invitation for Bids - Procurement of an IT Solution for Dossier Evaluation, Retail Pharmacy Regulation, and Auxiliary Regulatory Functions, Including Capacity Building for National Medicines Regulatory Authority (NMRA)

November 2, 2026

The Ministry of Health & Mass Media (the Purchaser) invites sealed bids from eligible bidders for the procurement of the following IT products. A brief description of the types of IT products is below :

Procurement of an IT Solution for Dossier Evaluation, Retail Pharmacy Regulation, and Auxiliary Regulatory Functions, Including Capacity Building for National Medicines Regulatory Authority (NMRA) of Sri Lanka.
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Click Here : Adverticement

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Regulatory Updates

Submission of variation requiring notification (MIV1.N) related to medicines‍

October 20, 2026

Minor variation requiring notification (MIV1.N) related to medicines should only be submitted to the Medicines Accepting Counter with the relevant documents, in accordance with the published NMRA variation guideline.

Notifications (MIV1.N) submitted in any other formats (eg: letters) are not accepted for consideration.

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Regulatory Updates

Data Collection - Sample Import Licence applications for New Chemical Entities (NCEs) and Innovator Products.

October 19, 2026
To All Sample Import Licence Applicants,

All applicants who have submitted Sample Import Licence applications for New Chemical Entities (NCEs) and Innovator Products during 2026 are requested to provide the required information using the relevant Google Forms linked below.
This requirement also applies to all future applicants. Accordingly, applicants who submit Sample Import Licence applications and subsequently receive an acknowledgement of
submission are required to provide the relevant information using the designated forms.
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Please use the appropriate form for your application category:

  1. New Chemical Entities (NCEs): Please complete the Google form titled “Sample Import Licence Applications for New Chemical Entities (NCEs) – Data Collection”.
  2. Innovator Products: Please complete the Google form titled “Sample Import Licence Applications for Innovator Products”.

All applicants are kindly requested to ensure that the required information is accurate and submitted in accordance with the instructions provided in the respective forms.

Thank you.

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Regulatory Updates

Publishing the list of approved MRP Revisions due to currency depreciation List_ 4

October 13, 2026

NOTICETO ALL AUTHORIZED LOCAL AGENTS

This is to notify all Authorized Local Agents that the following is the fourth list(List 04) of approved MRP revisions due to currency depreciation. This list includes MRP revision applications reviewed and approved by the Pricing Division/NMRA up to 12th October 2026.

Please note that individual emails will not be sent to Local Agents regarding MRP approvals due to currency depreciation. The updated list will be published on the NMRA website.

Accordingly,all relevant Authorized Local Agents are hereby requested to check the published lists and submit the relevant valid Import Licenses to the NMRA Licensing Unit without delay. Your prompt attention and cooperation in this regard are highly appreciated to avoid any further delays in processing the respective applications.

Click Here : list of approved MRP Revisions due to currency depreciation

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.