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

Submission of details of variation applications submitted along with new, renewal and re-registration applications

March 6, 2026
Regulatory Updates

Notice on Labelling Requirement‍

March 5, 2026
Regulatory Updates

General instructions for submission of applications for orthopaedic implants and instrument set

March 4, 2026
Regulatory Updates

Informed to the all marketing authorization holders of Medical devices, collecting data relating to pending files Submitted up to 31st December 2024

March 3, 2026
Regulatory Updates

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

February 27, 2026
View All Announcements
Regulatory Updates

Submission of details of variation applications submitted along with new, renewal and re-registration applications

March 6, 2026

All Marketing Authorization Holders of Medicines are kindly requested to submit following details of variation in separate Excel sheets as follows.

Excel Sheet 01 –Already Evaluated Variation Applications with renewal and re-registration applications

Please provide the application numbers and relevant details of variation applications submitted and that have already been evaluated and finalized,together with any renewal or re-registration applications.

Kindly send us an Excel sheet with the subject “Already evaluated variations with renewal and re-registration applications” including following details.

Include the following details:

1.     Application Number

2.     Submitted Date

3.     Product Name

4.     Manufacturer

5.     Local Agent

6.     Type of Variation (Major / Minor / Notification)

7.     Small Description of Variation

8.     Evaluated date

9.     Decision of the variation

Excel Sheet 02 –Pending Variation Applications with New, Renewal or Re-Registration Applications

Please provide details of variation applications where both the variation and new, renewal, or re-registration applications have been submitted but are still awaiting evaluation.

Kindly email Excel sheets with the subject of “Pending Variations Applications with New, Renewal or Re-Registration Applications”

Include the following details:

1.     Application Number

2.     Submitted Date

3.     Manufacturer

4.     Local Agent

5.     Type of Variation (Major / Minor / Notification)

6.     Small Description of Variation

Please ensure that the completed Excel Sheets (01 and 02, as applicable) are submitted on or before 8th March 2026 to aa19@nmra.gov.lk copying to pa8@nmra.gov.lk.Send your email with the heading of “Details of Variation Applications

Your cooperation and timely response are greatly appreciated.

Regulatory Updates

Notice on Labelling Requirement‍

March 5, 2026

To inform all marketing authorization holders of medicines to print or place a non-peelable Sticker on each commercial pack indicating the wording "NMRA approved product" and MRP as per discussion on MRM held on 7/1/2026


Click Here : Notice on Labelling Requirement

Regulatory Updates

General instructions for submission of applications for orthopaedic implants and instrument set

March 4, 2026
Regulatory Updates

Informed to the all marketing authorization holders of Medical devices, collecting data relating to pending files Submitted up to 31st December 2024

March 3, 2026

All Marketing Authorization Holders of Medical Devices

All Medical Device Marketing Authorization Holders (MAHs)are hereby informed that the National Medicines Regulatory Authority (NMRA) has decided to collect data relating to pending files of the following applications submitted up to 31st December 2024.

  • New Applications
  • Renewal Applications
  • Re-registration Applications
  • Variation Applications
  • FMSA Applications

 All relevant MAHs are kindly requested to review your records and provide the required details for all pending applications submitted within the above-mentioned period.

Please ensure that the requested information is submitted on or before 31st March 2026.

The details must be entered through the Google form using the link provided below

Click Here: Collecting Data relating to pending files Google form

Regulatory Updates

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

February 27, 2026

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

Notice to all Authorized Local Agents, This is to kindly inform all authorized local agents that the USD rate considered for the month of March -2026  for processing price details of medicines/ medical devices is 312.95.

Please ensure that all price submissions for MRP approvals are prepared accordingly.

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.