NAtional Medicines Regulatory Authority

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We'll be back soon. In the meantime you view can view our announcements and access important notes, links and files below.

Latest Announcements

Reliance Pathway for Registration of New Medical Device Applications

October 29, 2025

Public Day for local agents-Pricing Division

October 27, 2025

Registration and Licensing of Medicines (fees) Regulations — Gazette no. 2452/39

October 27, 2025

Additional Guideline for Active Ingredients - Borderline Products Regulatory Division

October 27, 2025

Certificate of Analysis- National Medicines Quality Assurance Laboratory

October 14, 2025

Important Links

Regulatory Updates

Certificate of Analysis- National Medicines Quality Assurance Laboratory

October 14, 2025

Certificate of Analysis - New Format Update
The previous Certificate of Quality has been replaced with a revised new report format, which includes four copies printed in four different colours.

Click Here: Certificate of Analysis - New Format

Regulatory Updates

Additional Guideline for Active Ingredients - Borderline Products Regulatory Division

October 27, 2025

Additional Guideline for Active Ingredients-Borderline Products Regulatory Division

Click Here : Guideline

Regulatory Updates

Certificate of Analysis- National Medicines Quality Assurance Laboratory

October 14, 2025

Certificate of Analysis - New Format Update
The previous Certificate of Quality has been replaced with a revised new report format, which includes four copies printed in four different colours.

Click Here: Certificate of Analysis - New Format

Regulatory Updates

Reliance Pathway for Registration of New Medical Device Applications

October 29, 2025
Regulatory Updates

Public Day for local agents-Pricing Division

October 27, 2025

For the information of all marketing authorization holders;

The Pricing Division will hold a Public Day for local agents to discuss matters related to pending applications on Thursday, 30th October 2025 at 10:00 AM. To participate, please schedule an appointment by entering your details in the book available with the Security Officer on the 2nd Floor.

Regulatory Updates

Registration and Licensing of Medicines (fees) Regulations — Gazette no. 2452/39

October 27, 2025

Registration and Licensing of Medicines (Fees) Regulations 2025 - Gazette Notification No. 2452/39 - English / Sinhala / Tamil