National Medicines Regulatory Authority

Sri Lanka

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.

Providing Quality Medicine Regulation in 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.

Functions of the NMRA

Regulatory

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.

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Laboratory

National 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.

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Pharmacovigilance

Pharmacovigilance Division is responsible for monitoring and dealing with adverse drug reaction, quality failure and counterfeit medicines.

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Enforcement

Inspectorate and Enforcement Division is responsible for inspecting and investigating issues pertaining to proper implementation of the provision of the NMRA Act.

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Latest Announcements

Regulatory Updates

Notice to all Retail pharmacy and wholesale Establishment owners

February 18, 2025
Regulatory Updates

Informed to all market authorization holders 8 importers of medical devices, exemption of registration for spare parts under the medical devices.

February 7, 2025
Procurement at NMRA

Obtaining Tax Consultation Service

February 6, 2025
Regulatory Updates

Consideration of Average Dollar Rate for Price Approvals of MRP’s by NMRA

January 31, 2025
Regulatory Updates

Policy Decision on colour code for Prednisolone Tablets 1 mg

January 30, 2025
View All Announcements
Regulatory Updates

Notice to all Retail pharmacy and wholesale Establishment owners

February 18, 2025

Please be informed that all pharmacies-related regulatory activities done by the NMRA, including applications accepting, responsible pharmacists' interviews and issuing payment vouchers will be carried out only on Mondays, Wednesdays and Fridays from 8.30 am to 2.00 pm with effect from 2025/03/01.

Regulatory Updates

Informed to all market authorization holders 8 importers of medical devices, exemption of registration for spare parts under the medical devices.

February 7, 2025
Procurement at NMRA

Obtaining Tax Consultation Service

February 6, 2025

National Medicines Regulatory Authority

State Engineering Corporation Building (2nd Floor),

No.130, W.A.D Ramanayaka Mawatha,

Colombo 02, Sri Lanka

Obtaining Tax Consultation Service

National Medicines Regulatory Authority is independent authority in the Ministry of Health established in 2015 through an Act of Parliament. The NMRA is governed by a board.

We are seeking for tax consulting firm to be engaged to cater our requirements

  1. Income Tax computation and submitting tax returns for Corporate Income Tax, VAT, SSCI, WHT etc.
  2. Researching tax laws
  3. Advice on tax planning
  4. Participating for tax matters with the Inland Revenue Department, Auditors and all other authorities related to tax matters
  5. Review the Financial Statement of 2025

Self prepared application with history and experience of the company along with staff qualifications and registration with your quotation details to above address on or before 13th February 2025

Regulatory Updates

Consideration of Average Dollar Rate for Price Approvals of MRP’s by NMRA

January 31, 2025

Notice to all Authorized Local Agents

Subject : Consideration of Average Dollar Rate for Price Approvals of MRP’s by NMRA

This is to kindly inform all authorized local agents that, as discussed with the members of the SLCPI and the Pricing Committee, the NMRA will consider the average dollar rate of the previous three months for price approvals of Maximum Retail Prices (MRPs) of medicines from January 2025 onwards.

Accordingly for the month of February 2025, the United States Dollar (USD) rate is considered as 296.74 for reviewing price details of medicines.

This decision aims to ensure fair and consistent pricing of medicines while considering the fluctuations in the exchange rate.

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

Regulatory Updates

Policy Decision on colour code for Prednisolone Tablets 1 mg

January 30, 2025

The colour code for Prednisolone Tablets 1 mg is Yellow.

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Reporting falsified / Counterfeit Products
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