Mediverify Database
.png)
.png)
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
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 Wednesday,27th August 2025 at 10.00 A.M. To participate please schedule an appointment by entering your details in the book available with the Security Officer on the 2nd Floor. Please ignore the previous notice and sorry for any inconvenience if occurred.
This web notice is published to avoid inconvenience during customs importation, in accordance with the web notice issued on 5thMarch 2025. Relevant classification reports will be issued as early as possible.
(This publication has been initiated from 81st Subcommittee of BPEC)
Click Here: Rejected Borderline Product Classification Applications
Importing Medicines for Personal Use
If a particular medicine required by a patient is not registered or not available in Sri Lanka, NMRA allows import of such a medicine through a personal user Letter of Authorization.
The general public can apply for a personal user license by sending an email to aa19@nmra.gov.lk or by handing over the relevant documents directly to NMRA during working hours. .
The following documents are required:
A maximum of 100 doses can be imported by using the Personal User License. No fee is charged by NMRA for this purpose.
INSTRUCTION FOR TRAVELERS
A person travelling to Sri Lanka can carry medicine for his personal use, without prior approval of the NMRA under the following conditions. The quantity of any single medicine required for the duration of his stay in Sri Lanka or the quantity required up to ninety days whichever is less. Prior approval of the NMRA should be obtained for quantities exceeding 90-day requirement. The medicine administered through intramuscular or intravenous route is not permitted.
The medicine specified in Schedule III is not permitted. The medicine should be packed in the original container, if it is not in the original container, it should be appropriately labeled to identify the name and strength of the medicine with usage instructions Medical records or prescription should be produced when necessary
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 Monday, 27th August 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.
This is a reminder regarding the earlier notice issued on 5th of March 2025, concerning the labeling requirement for registered borderline products.
As stated in the earlier notice, it will be mandatory for all registered borderline products to carry a sticker or label on the commercial pack, effective from 31st of August 2025.We kindly urge all relevant stakeholders to ensure full compliance with this requirement by the stated deadline.
Model label:
