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The Medical Devices Regulatory Division of the NMRA has recommenced issuing Product Clarification Letters (PCLs) effective from 31st of March 2026.

Detailed instructions and the relevant application forms will be published on the NMRA website in due course.

Stakeholders are kindly advised to refer to the NMRA website for further updates.

Click Here : Public Notice

All applicants submitting Re-Registration (RR) dossiers to the National Medicines Regulatory Authority are hereby informed that a Declaration of the Product must be submitted along with the application, with effect from 1st April 2026.

Applicants are required to confirm that:

• There are no changes to the product as per the existing registration approved by NMRA;

           or

• Where applicable, provide details of any changes made in accordance with the relevant variation guidelines.

A standard declaration format is attached to this notice. Applicants are required to duly complete and sign the declaration by the authorized signatory of the Marketing Authorization Holder (MAH) and submit it together with the RR dossier.

Click Here : standard declaration format

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The Medical Devices Regulatory Division of the NMRA has recommenced issuing Product Clarification Letters (PCLs) effective from 31st of March 2026.

Detailed instructions and the relevant application forms will be published on the NMRA website in due course.

Stakeholders are kindly advised to refer to the NMRA website for further updates.

Click Here : Public Notice

To: All Market Authorization Holders

Please be informed that the Pricing Division of the National Medicines Regulatory Authority (NMRA) will implement a revised schedule for public days related to pricing regulation matters, effective from 1st April 2026.

The designated public days will be as follows:

• Second Monday of each month (1.00 pm to 4.00 pm)
• Fourth Monday of each month (1.00 pm to 4.00 pm)

Please note that the online appointment system will no longer be in effect. All interested parties may visit on the above-mentioned days and are required to mark their presence at the registry with the security officers at NMRA.

All stakeholders are kindly requested to plan their visits accordingly.

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Chief Executive Officer

National Medicines Regulatory Authority (NMRA)

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Calling for public hearing for Medicine Regulation.

The National Medicines Regulatory Authority (NMRA) will conduct a public hearing to obtain views, comments and recommendations from stockholders and the general public regarding the proposed Medicine Regulation.This hearing aims to promote transparency, inclusiveness, and stockholder participation in the policy-making process related to the regulation, safety,quality, and accessibility of medicines in Sri Lanka.

Healthcare professionals, industry represtatives, civil society organizations, academics and members of the public are invited to share their views and suggestions to improve the proposed policy. The feedback received during this consultation will be taken into consideration in the finalization of the Regulation.

As per the request of the above parties the authority decided to extend the time period. Therefore, the final date for the submission of feedback is 2026.04.21.

Written comments or feedback should be submitted to the following email. lo@nmra.gov.lk

Registered Post: Chief Executive Officer, National Medicines Regulatory Authority, State Engineering Corporation Building (2nd Floor), No. 130,W.A.D.Ramanayaka Mawatha, Colombo 02.

All references should be clearly stated as 'Public Comments regarding Medicine Regulation' the subject or in the top left corner of the envelope.

Please contact below for further information:

Telephone: 0112698896/7  email: lo@nmra.gov.lk

Click Here : Public hearing on the proposed Medicine Regulation

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Average US Dollar Rate April-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 April -2026  for processing price details of medicines/ medical devices is 313.36.

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

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