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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
1. The valid period of Classification Report is one year and the valid period is counted from approval date of the Classification Report ("Classified as a Borderline Product").
Only two additional data submissions are allowed for one Classification Application.
If a Classification Report is issued as a "awaiting additional data" for a new application;
2. Sample Import Licence/ Formulation Approval
Sample Import Licence/ Formulation Approval requesting application to be submitted to NMRA within one year period from the date of approval of the Classification Report classified as a Borderline Product.
The valid period of Sample Import licence/ Formulation approval application is one year
3. Registration Dossier Submission.
Registration dossier to be submitted within the valid period of the Sample Import Licence/Formulation Approval.
Notes:
If any applicant is failed to submit any of the above applications (1,2 & 3) within the valid period is subjected to reject the consignment clearance approval.
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 March 2025, the corrected United States Dollar (USD) rate considered for pricing calculation is 298.01 for reviewing price details of medicines. All the prices recommended by using prevously published exchange rate, shall be recalculated and corrected.
We are apologizing for the inconvenience occurred on this.
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.
The National Medicines Regulatory Authority hereby announces the temporary withhold of accepting new retail pharmacy applications, with effective from 1st April 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, 20th March 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.
