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

Final date for accepting classification applications

April 24, 2025
Regulatory Updates

Warning Letter

April 21, 2025
NMRA Updates

Temporary Suspension of File Submission Services

April 11, 2025
NMRA Updates

ඇල්පිටිය මහේස්ත්රාත් අධිකරණ නඩු අංකය.41353 නියෝගය සම්බන්ධවයි

April 11, 2025
Regulatory Updates

Average Dollar Rate April-2025 for Price Approvals of MRP's by NMRA

April 1, 2025
View All Announcements
Regulatory Updates

Final date for accepting classification applications

April 24, 2025

The final date of accepting Borderline Product Classification applications will be on 29th April 2025 as per the web notice published on NMRA website dated on 5th March 2025

Regulatory Updates

Warning Letter

April 21, 2025

Warning letter issued to local pharmaceutical manufacturer, Newgen Lanka Healthcare (Pvt) Ltd. due to repeated deviations from GMP practices.

NMRA Updates

Temporary Suspension of File Submission Services

April 11, 2025

Please be informed that file submission services for the Device Regulatory Division, Cosmetic Regulatory Division, Borderline Products Regulatory Division, Manufacturing Regulatory Division and Pharmacy Regulatory Division will be temporarily unavailable on April 15th, 16th, and 17th due to the upcoming festival celebrations.

We apologize for any inconvenience this may cause and appreciate your understanding.

Chief Executive Officer

National Medicines Regulatory Authority

NMRA Updates

ඇල්පිටිය මහේස්ත්රාත් අධිකරණ නඩු අංකය.41353 නියෝගය සම්බන්ධවයි

April 11, 2025

උක්ත නඩුවට අදාළව ඉදිරිපත් කර ඇති නඩු භාණ්ඩ වන ඖෂධ ඉක්මනින් හා ස්වභාවික ලෙස නෂ්‍ය වීමට යටත්වන දේපළ හෙයින් එකී ඖෂධ විකිණීමක් හෝ වෙන්දේසි කිරීමක් සිදුකරන ලෙස ඇල්පිටිය මහේස්ත්‍රාත් විසින් කර ඇති නියෝගයට අනුව එකී ඖෂධ වෙන්දේසි කිරීම සඳහා මෙම වෙබ් දැන්වීම ප්‍රසිද්ධ කරමි.

වෙන්දේසි ස්ථානය: ගාල්ල ප්‍රාදේශීය සෞඛ්‍ය සේවා අධ්‍යක්ෂක කාර්යාලයේ ඖෂධ ගබඩා පරිශ්‍රය. 

දිනය: 2025 අප්‍රේල් මස 30 වන බදාදා.

වේලාව: උදෑසන 10.00 සිට.

  

මේ පිළිඹඳව ගාල්ල දිස්ත්‍රික්කයේ ඖෂධ තොග වෙළඳුන් සඳහා ඉදිරිපත් වීමට හැකි බව දන්වන අතර වෙන්දේසිය සඳහා ඇති ඖෂධ ලැයිස්තුව මේ සමඟ පළ කර ඇත. මේ පිළිඹඳ වැඩිදුර තොරතුරු සඳහා ගාල්ල ප්‍රාදේශීය සෞඛ්‍ය සේවා අධ්‍යක්ෂක කාර්යාලය අමතන ලෙස දන්වමි.

වැඩිදුර විමසීම්:

ගාල්ල ප්‍රාදේශීය සෞඛ්‍ය සේවා අධ්‍යක්ෂක කාර්යාලය: 091 2234078

ගාල්ල ආහාර හා ඖෂධ පරීක්ෂක, එස්.එස්.හපුආරච්චි මහතා: 071 8376392

Regulatory Updates

Average Dollar Rate April-2025 for Price Approvals of MRP's by NMRA

April 1, 2025

Notice to all Authorized Local Agents

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 April 2025, the United States Dollar (USD) rate is considered as 299.58 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 submission for MRP approvals are prepared accordingly.

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Reporting falsified / Counterfeit Products
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