National Medicines Regulatory Authority

Reissuance of Sample Import License (SIL)-Medical Devices

Applications for the reissuance of a Sample Import License (SIL) will be considered under the following instances:

Applicable instances:

• Expiry of the SIL prior to the importation of samples for clinical evaluation
• Requirement of additional samples as requested by the relevant clinical evaluation panel

Applications submitted under the above circumstances must be accompanied by the following mandatory documents:

Mandatory documents:

• Duly completed Application (Schedule IV / Form C)
• A formal request letter for issuance of a new SIL
• Evidence for the request made by NMRA for samples/additional samples for clinical evaluation (e.g., copy of email)
• A letter from Sri Lanka Customs confirming whether the specified product has or has not been imported into Sri Lanka.
• A copy of the previously issued SIL

Please note that submission of all mandatory documents is required. The authority may request additional documents where necessary.

CEO, NMRA

Click Here : Web Notice

‍

The Medical Devices Regulatory Division of the NMRA has revised the Consolidated Dossier Submission Checklist for New Product Registration (F-MDR-035). The revised format can be obtained from the “Application Forms” tab under the Medical Devices Regulatory Division on the NMRA website.

Accordingly, all Market Authorization Holders are advised to submit consolidated dossiers in compliance with the revised checklist with effect from 07th July 2026.

Chief Executive Officer

National medicines Regulatory Authority

‍

Notice to all Authorized Local Agents

Subject: Average US Dollar Rate May-2026  for Price Approvals of MRP’s by NMRA

This is to kindly inform all authorized local agents that the USD rate considered for the month of May-2026 for processing price details of medicines/medical devices is 315.19

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

The Pharmacies regulatory divisions of National medicines regulatory authority has introduced an online application portal for all pharmacy licenses related applications. With effect from today (21/04/2026), all applications for retail pharmacy and wholesale establishment will be accepted only through this online portal.

The link to access the portal is available on the NMRA official website under the pharmacy regulatory division. Details instructions for application submission also are provided on the portal.

All applicants are kindly requested to submit their applications accordingly.

‍

Expiry within two years from date of application.

Renewal applications will be considered if the existing license has expired within two years from the date of submission of the application to NMRA with penalty and appropriate fee for the period.

Expiry more than two years from date of application.

Renewal applications submitted after two years from the date of expiry of the existing license will be considered as a new application. Existing rules and regulations for a new pharmacy will be applicable.

The above provisions will be applicable only up to 31 December 2026.

Click Here : Renewal of Expired Pharmacy Licenses

‍