Applying Sample Import License of Medicines 

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”. 

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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)  

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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.

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Sample Import License Application Requirements: 

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): 

• Previous Registration Certificate (Mandatory for SIL Agency Transfer and existing product). 
• Agency Transfer (Mandatory for SIL Agency Transfer). 
• MEC Approval Letter for New Molecular Entities. 
• Declaration Letter for import samples from other category (Mandatory for SIL - Other). 

*Other Regulatory Compliance Documents as applicable

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