National Medicines Regulatory Authority

Applicants requesting NMRA approval for the clearance of a single consignment of a registered medicine with reduced residual shelf life are required to submit the following
information and supporting documents:

1. Detailed request letter with calculated residual shelf life of the consignment.
2. Valid registration certificate and import licence (Payment slip will not be considered as evidence of a valid registration or import licence)
3. Completed commercial invoice or proforma invoice with relevant consignment details.
4. Confirmation whether the consignment is intended for the private market or for government supply. For consignments intended for government supply, relevant supporting documents such as the Purchase Order (PO) shall also be submitted.
5. If the consignment has already arrived in Sri Lanka, debit application submitted date to the Department of Import and Export and if the consignment has not yet arrived to Sri Lanka, the expected date of arrival shall be provided.
6. Justification for importing the short residual shelf-life product to Sri Lanka
7. Average monthly consumption data for the last six (06) months.
8. Proposed distribution plan for the full quantity of the consignment.
9. Commitment letter declaring that the particular lot can be distributed within the remaining shelf life.

Applicants are requested to ensure that all relevant details and supporting documents are submitted along with the request form.

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Click Here : Request Form - Single Consignment With Reduced Residual Shelf-Life

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Note: Requests with an RSL below 66.66% are applicable for consideration. Submission of the above documents does not constitute approval.

National Medicines Regulatory Authority (NMRA)
Sri Lanka

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Notice to all Authorized Local Agents,

Average US Dollar Rate October -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 October -2026 for processing price details of medicines/medical devices is 336.05.

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

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All stakeholders, including manufacturers, importers, suppliers, health care facilities, and users of medical devices, are hereby informed that the official reporting formats for adverse events related to medical devices, including in vitro diagnostics (IVDs), are now available on the “Report Adverse Events” tab under the Medical Devices Regulatory Division on the NMRA website.

The following three (03) reporting forms have been published for use by the relevant parties:

1. Adverse Event Reporting Form for Importers / Supplier
2. Adverse Event Reporting Form for Manufacturer
3. Adverse Event Reporting Form for Consumers and Healthcare Facilities

All stakeholders are advised to use the relevant prescribed form when reporting any adverse event, malfunction,deterioration in performance, or safety-related issue associated with medical devices and IVDs, in line with regulatory requirements.

Timely and accurate reporting of adverse events is essential to ensure the safety, performance, and continued monitoring of medical devices used in Sri Lanka.

For further information or clarification, stakeholders are advised to refer to the NMRA website under Regulatory → Medical Devices → Report Adverse Events.

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When the actual shipper/supplier is different from the manufacturer mentioned in the Registration Certificate, you are kindly requested to upload a copy of the Letter of Authorization issued by the manufacturer to the shipper/supplier to the STRATLINK/ASYCUDA system.

Medicines Regulatory Division,

NMRA.

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This is to notify all Authorized Local Agents that the following is the Third list (List 03) of approved MRP revisions due to currency depreciation.This list includes MRP revision applications reviewed and approved by the Pricing Division/NMRA up to 28th September 2026.

Please note that, hereinafter, individual emails will not be sent to Local Agents to notify pricing approvals for MRP revisions due to currency depreciation, as 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 : The list of approved MRP Revisions due to currency depreciation_List 3