Mediverify Database
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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
For the information of all marketing authorization holders;
The pricing Division will hold a public Day for local agents to discuss matters tp pending Applications on Friday 17th January 2025,at 9.30 A.M. To participate, please schedule an appointment by entering your details in the available with the Security Officer on the 2nd Floor.
All marketing authorization holders of medicine are here by informed that NMRA has decided to accept sample import license applications only for the medicines which have less than 5 valid registrations until further notice.
All marketing authorization holders are required to provide a copy of the medicine database from the NMRA website as evidence for the 5 valid registrations.
Categories of Sample Import License Applications
1. Sample Import Licenses – Normal
This category applies to sample Import License applications received along with the purpose of “examination”.
2. Sample Import Licenses – Other
Applications submitted with following purposes
- Test/Analysis ( Based on medicine evaluation sheet / *Acknowledgment of medicine dossier)
- Distribution as physician samples
- Tender samples ( Requested by government institutes)
*Acknowledgment of medicine dossier submission for medicine which are mandatory to tested.(Merophenam, Thyroxine and Erythromycin)
3. Sample Import Licenses - Agency Transfer
- This category applies only to sample import license applications with an agency transfer.(Only change of the market authorization holder of Sri Lanka without changing generic name, brand name and manufacturing facility of the product)
- The product must have been registered by the previous market authorization holder, with valid registration or registration expired within the last two years from the submission date of SIL application.
Mandatory Documents:
1. Part A of Form MR001 Revision 01
2. Sample License Application Form (Form XI)
Should comply with the Regulation 59(1) of the gazette No. 2145/1 and following should be included)
∙ Actual manufacturing site address
∙ Importer with the address
∙ Correct generic name dosage from and strength
∙ Brand name (if any)
∙ Requested quantity
∙ Pack size & Pack type
(Purpose of applying SIL should be correctly selected and originally signed by the applicant.)
3. Copy of Manufacturing Site Approval Letter
4. Letter of Authorization from the Manufacturer
5. Price Details
6. Other Supporting Documents (if applicable):
*Other Regulatory Compliance Documents as applicable
