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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