National Medicines Regulatory Authority

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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To obtain list of Stop clock expired (2 months) applications, but sill not submitted requested additional documents and Still not received awaiting evaluation, from all MAH.

Click Here : Web Notice

Regarding the product categories need to be considered under Aesthetic- related purpose

Click Here : for more information.

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