National Medicines Regulatory Authority

Notice to all Authorized Local Agents,

Average US Dollar Rate September -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 September -2026 for processing price details of medicines/medical devices is 338.04.

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

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The Licensing Division hereby informs all Market Authorization Holders (MAHs) that, when submitting a request to amend a Registration Certificate and/or an Import or Manufacturing License, the following requirements apply.

1.    Minimum validity requirement

 At the time of submitting an amendment request, both the Registration Certificate and the relevant Import or Manufacturing License must have at least three (03) months of validity remaining. Amendment requests will be processed only if this requirement is met.

2.    Amendment payment deadline

The amendment payment must be completed within three (3) weeks from the date of the payment confirmation email.

3.    Licenses with less than three months remaining

If the relevant Import or Manufacturing License has less than three (03) months remaining before expiry,the requested License amendment will not be processed under the normal amendment procedure. In such cases, applicants must submit the requested amendments as part of the relevant Import or Manufacturing Licenserenewal process, together with all other updated documents and information required for renewal.

4.     Important: Check the expiry date before payment

Applicants are strongly advised to check the expiry date of the relevant Registration Certificate and License before making any amendment payment.

Please note that amendment payments will not be refunded if the amendment cannot be processed because the relevant License does not meet the minimum validity requirement.

Applicants are therefore encouraged to verify the validity of their Registration Certificate and License before submitting an amendment request or making any payment.

Please ensure that the latest copy of the relevant Import or Manufacturing License is submitted along with the application.

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PUBLIC CONSULTATION ANNOUNCEMENT

Guidelines for Registration of Importers of Medicines

The National Medicines Regulatory Authority (NMRA) hereby announces the commencement of the public consultation on the Draft Guidelines for Registration of Importers of Medicines

All relevant stakeholders, including pharmaceutical manufacturers, medicine importers, Marketing Authorization Holders (MAHs), healthcare professionals,academic experts, industry representatives, and other interested parties, are invited to review the draft guideline and submit their comments and suggestions.

Stakeholders are requested to provide clear, evidence-based and, where applicable,appropriately referenced comments to support the review and finalization of the guideline.

Submission of Comments

All comments, suggestions, and technical inputs should be submitted by email to: pa28@nmra.gov.lk

Deadline for submission of comments: 10 September 2026

Stakeholders are encouraged to clearly identify the relevant section or provision of the draft guideline to which their comments relate.

All submissions received during the consultation period will be reviewed and considered by the NMRA in finalizing the Guidelines for Registration of Importers of Medicines

The NMRA appreciates the participation and valuable contributions of all stakeholders in strengthening the regulatory framework governing the importation of medicines in Sri Lanka.

See link: Guidelines for Registration of Importers of Medicines

Notice to All Marketing Authorization Holders (MAHs)

Applications for products with Maximum Retail Prices (MRPs) approved on or before 31 May 2026 and after 1 February 2026 will be considered under this process.

MAHs seeking a revision of the Maximum Retail Price (MRP) due to a fluctuation of more than 5% in the average USD exchange rate published by the NMRA may submit their applications using the designated Google Form.

The revised MRP shall apply only to consignments imported after approval of the revised MRP.

MAHs who have already submitted applications in response to the previous notice are not required to reapply.

Thank you.

CEO NMRA

Procedure for Submission

Please follow the procedure below when submitting an application:

1. Complete the designated Google Form and obtain a printed copy of the submitted form.

2. Complete and submit Form F-PD-002- "Submission of Price Details for a Maximum Retail Price (MRP) Revision Request (Medicines Applications)" (Effective Date: 12.09.2025/V1.0/Rev. No. 0), together with all relevant supporting documents. The form must bear the original signature of the responsible person.

3. Submit copies of the following documents:

• Existing Import License; and
• Existing Registration Certificate.

4. Upon receipt of the email confirming the approved revised MRP, submit the original Import License to the Licensing Division, NMRA, within three (3) days of receipt of the email for the necessary amendments.

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Click Here :

• ‍designated Google Form
• Form F-PD-002

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Notice to all Authorized Local Agents,

Average US Dollar Rate August -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 August-2026 for processing price details of medicines/medical devices is 338.63.

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

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