National Medicines Regulatory Authority

All Marketing Authorization Holders of medicines are hereby informed that two copies of the acknowledgement forms should be attached to all variation applications submitted.

For major (MaV) and minor (MiV1)variation applications, the acknowledgement will be completed by the receiving officer at the acceptance point after payment of the relevant fee.

For minor variations for notifications (MaV2), the reviewing assessor will complete the acknowledgement form and indicate whether the notification is accepted, not accepted, or whether additional information is required. After review, the completed acknowledgement will be forwarded to the acceptance point.

For major and minor variation applications, the decision will be communicated to the applicant through an evaluation form.

For minor variations for notification, no separate approval letter will be issued. The completed acknowledgement form, indicating acceptance/non-acceptance of the notification, will be serving as the official confirmation.

• Acknowledgement of application for variation of a medicine

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-   All Marketing Authorization Holders of medicines are hereby informed that Schedule I application form (APPLICATION FOR GRANT / RENEWAL OF ACERTIFICATE OF REGISTRATION OF A MEDICINE BY A LOCAL MANUFACTURER /ANAUTHORIZED IMPORTER) shall be submitted together with every variation application with immediate effect. Please note that applications submitted without Schedule I will not be accepted.

-  All the applications shouldbe submitted with the complete index to facilitate the evaluation process.

Notice to all importers and local manufacturers,

Medicines Required for Rare Diseases and Medicines Required in Small Quantities

The National Medicines Regulatory Authority (NMRA) hereby informs all importers and local manufacturers that, in accordance with the Extraordinary Gazette Notification No. 2452/39 dated 04 September 2025; the applicable processing fee has been waived for applications relating to medicines included in the List of Medicines Required for Rare Diseases and Medicines Required in Small Quantities.

Please note that this list may be revised, updated, expanded, or amended from time to time. The latest updated list will be published on the NMRA website under the Medicines section.

Applicants are advised to refer to the most recent version of the list available on the NMRA website when submitting applications.

Click Here: Medicines Required for Rare Diseases and Medicines Required in Small Quantities

National Medicines Regulatory Authority
Sri Lanka

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Notice to all Authorized Local Agents Subject:

Average US Dollar Rate June-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 June-2026 for processing price details of medicines/medical devices is 325.79.

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

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Policy Decisions Taken by the Medicines Evaluation Committee (109th to 113th MEC Meetings)

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