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
In view of the prevailing crisis situation in the Middle East region and with the objective of minimizing fuel consumption, the Government has declared every Wednesday as a public holiday with effect from 18.03.2026, until further notice.
Accordingly, this is to kindly inform you that every Wednesday will be treated as a holiday for the operations of the Authority until further notice.
However, the Public Day of the Pharmacies Regulatory Division scheduled for Wednesday, 18.03.2026, will be held as previously arranged. Thereafter, necessary arrangements will be made to conduct the Public Day on other weekdays, and the relevant parties will be informed in due course.
We kindly seek your understanding and cooperation in this matter.
Click Here : Public Notice
Chief Executive Officer
National Medicines Regulatory Authority
Submission of manual applications for foreign manufacturing site registrations (Previous online approvals)
Please be advised that, for all foreign manufacturing site registrations previously approved via the online system, a manual dossier should be submitted.
Following supporting document submission is mandatory with the manual dossier.
Deadline for the submission-05/09/2026
CEO/NMRA
The public is hereby informed that the Online Appointment System used to reserve dates and times for public days at the National Medicines Regulatory Authority (NMRA) will be
temporarily unavailable starting from 01 April 2026 due to essential maintenance work.
However, appointments for public days with the divisions listed below can still be reserved by completing the relevant Google Form through the link provided each respective division.
For more information, please here : Web Notice
All Marketing Authorization Holders of Medicines are kindly requested to submit following details of variation in separate Excel sheets as follows.
Please provide the application numbers and relevant details of variation applications submitted and that have already been evaluated and finalized,together with any renewal or re-registration applications.
Kindly send us an Excel sheet with the subject “Already evaluated variations with renewal and re-registration applications” including following details.
Include the following details:
1. Application Number
2. Submitted Date
3. Product Name
4. Manufacturer
5. Local Agent
6. Type of Variation (Major / Minor / Notification)
7. Small Description of Variation
8. Evaluated date
9. Decision of the variation
Click Here : Sample Excel Sheet 01
Please provide details of variation applications where both the variation and new, renewal, or re-registration applications have been submitted but are still awaiting evaluation.
Include the following details:
1. Application Number
2. Submitted Date
3. Manufacturer
4. Local Agent
5. Type of Variation (Major / Minor / Notification)
6. Small Description of Variation
Click Here : Sample Excel Sheet 02
Please ensure that the completed Excel Sheets (01 and 02, as applicable) are submitted on or before 13th March 2026 to aa19@nmra.gov.lk copying to pa8@nmra.gov.lk.Send your email with the heading of “Details of Variation Applications”
Your cooperation and timely response are greatly appreciated.
To inform all marketing authorization holders of medicines to print or place a non-peelable Sticker on each commercial pack indicating the wording "NMRA Registered Product" and MRP as per discussion on MRM held on 7/1/2026 (as amendment the previous notice published 5/3/2026)
