Maximum Retail Prices of Medicines
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Welcome to the official website of the National Medicine Regulatory Authority of Sri Lanka. We are dedicated to ensuring the safety and efficacy of medicines for the people of Sri Lanka.
The National Medicine Regulatory Authority of Sri Lanka is committed to ensuring the safety, efficacy, and quality of medicines in the country. We strive to protect public health by regulating the manufacturing, importation, distribution, and sale of medicines.
NMRA regulates medicines, medical devices, borderline products imported to and manufactured in Sri Lanka. We also regulate pharmacies. Clinical trials conducted in Sri Lanka are also regulated by us.
Find Out MoreNational Medicines Quality Assuarance of the NMRA is responsible for the analyzing of the quality of any medicine, medical device or borderline product forwarded by the Authority. It functions as an additional approved analyst when the circumstance so requires.
Find Out MorePharmacovigilance Division is responsible for monitoring and dealing with adverse drug reaction, quality failure and counterfeit medicines.
Find Out MoreInspectorate and Enforcement Division is responsible for inspecting and investigating issues pertaining to proper implementation of the provision of the NMRA Act.
Find Out MoreNational Medicines Regulatory Authority,
State Engineering Corporation Building (2nd Floor),
No. 130,
W.A.D Ramanayaka Mawatha,
Colombo 02,
Sri Lanka
The National Medicines Regulatory Authority (NMRA) wishes to inform all applicants and stakeholders that Monday and Wednesday have been designated as the Public Days of the Pharmacy Regulatory Division,effective immediately.
The public are kindly requested to visit the Pharmacy Regulatory Division only on Mondays and Wednesdays for the following services:
The public are kindly requested to refrain from visiting the Division on other working days unless specifically requested by an NMRA officer or in exceptional circumstances.
This arrangement has been introduced to improve the efficiency of service delivery, reduce waiting times, and facilitate the timely processing of applications.
The National Medicines Regulatory Authority appreciates your understanding and cooperation.
Effective Date: 08.07.2026
Pharmacy Regulatory Division
NMRA,
The National Medicines Regulatory Authority (NMRA) wishes to inform all applicants that, in accordance with the decision of the NMRA Management Meeting held on 05 May 2026, the following fee policy shall apply with effect from 05 May 2026:
This decision has been made to ensure the uniform implementation of the approved fee structure and the consistent application of the provisions of the applicable Gazette.
Applicants requiring further information may contact the Pharmacy Regulatory Division through the official NMRA communication channels.
This notice is effective from 05 May 2026.
Pharmacy Regulatory Division
National Medicines Regulatory Authority (NMRA)
Date of Issue: 08.07.2026
Notice to All Marketing Authorization Holders (MAHs)
Applications for products with Maximum Retail Prices (MRPs) approved on or before 31st January 2026 will be considered under this process.
MAHs seeking a revision of the Maximum Retail Price (MRP) due to a fluctuation exceeding 5% in the average USD exchange rate published by the NMRA may submit their applications using the designated Google Form.
The revised price shall apply only to consignments imported after the approval of the new MRP.
Click Here : Designated Google Form
Thank You.
CEO, NMRA
Extension of the Submission Deadline for the Foreign Medicine Manufacturing Site Renewal Application
To All Market Authorization Holders of Medicines,
Please be informed that the implementation of the renewal process for overseas Pharmaceutical manufacturing site approvals by the National Medicines Regulatory Authority (NMRA) has been extended until1 January 2027.
Initially, Manufacturing sites approved before the year 2010 will be required to submit applications for renewal.
NMRA may conduct an onsite GMP inspection of the manufacturing site, where deemed necessary, as part of the renewal process,irrespective of whether the site has previously been inspected by NMRA or an NMRA-recognized reference regulatory authority.
Please note that from 1stJanuary 2027, if the renewal application of a foreign manufacturing site has not been submitted, the following regulatory actions will apply:
· Renewal of the registration of products manufactured at that site will not be granted.
· New product applications, including applications for Sample Import Licences and Product Registration,for products manufactured at that site will not be accepted.
This extension is granted to provide Market Authorization Holders with additional time to prepare and submit the required documentation for the renewal of foreign Pharmaceutical manufacturing site approvals.
Updated Application form and the checklist for accepting renewal dossier submission are attached herewith.
Click here :
CEO/NMRA
Notice to all Authorized Local Agents,
Average US Dollar Rate July-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 July-2026 for processing price details of medicines/medical devices is 333.12.
Please ensure that all price submissions for MRP approvals are prepared accordingly.
