Required documents for applying Sample Import License
 
Required documents for applying Sample Import License for Borderline Products National Medicines Regulatory Authority

1. Preliminary evaluation report (Classification report) issued by NMRA with the approved formulation.
2. Application for a License to import a limited Quantity of any Borderline Product(s) for Testing, Examination, Distribution, Sample Analysis or Clinical Trial
3. Copy of Business Registration Certificate.
4. Copy of Letter of Authorization from the manufacturer which addressed to Director General, NMRA (If more than one local agent present, the list of local agents provided by the manufacturer).
5. Catalogue (If a device)
6. Copy of Free Sale Certificate /Copy of COPP
7. Specimen colored label and packaging materials.

1. Business registration certificate.
2. Preliminary GMP report or GMP certificate/ISO certificate.
3. Preliminary Evaluation report.
4. If New-formulation approval letter.
5. If Re Registration-Previous Registration certificate.
6. Letter of Authorization from the manufacturer which addressed to DG/NMRA (If applicable)
7. Wholesale License (If available).
8. Registration certificates of other countries
9. Manufacturing formula with batch size and master formula with function of each ingredient
10. Manufacturing process with process flow diagram clearly.
11. Manufacturing process validation report for three consecutive commercial batches (If applicable).
12. Certificate of analysis for finished Product/Finish product test-report with specifications.
13. Finish product test specifications (If applicable)
14. Analytical validation report (if applicable).
15. Stability data for 3 commercial batches (If applicable).
16. Published Clinical trial data for finish product (If applicable).
17. Catalogue (If applicable).
18. Approved Product Information Leaflet (If applicable).
19. Patient Information Leaflet (If applicable).
20. Promotional Material (If applicable).
21. Packaging materials- Specimen colored label & six side displayed secondary package (If applicable).
22. Specifications & Certificates of Analysis of Packaging materials.
23. API certificates (If applicable).
24. API GMP compliance certificates (If applicable).
25. Certificates of excipients (If applicable).
26. Two samples (If applicable).
27. Post marketing data (If applicable).

1. Business registration certificate.
2. Free Sale certificate or COPP.
3. GMP certificate/ISO certificate.
4. Manufacturing site approval letter (If applicable).
5. Preliminary Evaluation Report (Classification Report).
6. If New- Sample Import License.
7. If Re Registration -Previous Registration certificate.
8. Letter of Authorization from the manufacturer which addressed to DG/NMRA (If more than one local agent present, the list of local agents provided by the manufacturer).
9.  One local agent present for the same manufacturer, the list of local agents to be included to the letter).
10. Registration certificate of other countries.
11. Wholesale License (If applicable).
12. Manufacturing formula with batch size and master formula with function of each ingredient.
13. Manufacturing process with process flow diagram clearly.
14. Manufacturing process validation report for three consecutive commercial batches (If applicable).
15. Certificate of analysis for finished product/Finish product test-report with specifications.
16. Finish product test specifications (If applicable)
17. Analytical validation report (if applicable).
18. Stability data for 3 commercial batches (if applicable).
19. Published Clinical trial data for finish product (If applicable).
20. Catalogue (If applicable).
21. Approved Product Information Leaflet (PIL) by the NMRA
22. Patient Information Leaflet (If applicable).
23. Promotional Material (If applicable).
24. Packaging materials- Specimen colored label & six side displayed secondary package (If applicable).
25. Specifications & Certificate of Analysis of Packaging materials.
26. API certificates (If applicable).
27. API GMP compliance certificates (If applicable).
28. Certificates of excipients (If applicable).
29. Two samples (If applicable).
30. Post marketing data (If applicable).
31. Post marketing data-In SL (If applicable only).

Required documents for “Preliminary evaluation (Product Classification)” under Borderline Category National Medicines Regulatory Authority

1. Covering letter including contact details of the local agent (e-mail address, phone numbers, address)
2. Copy of Letter of Authorization from the manufacturer which addressed to Director General, NMRA
3. Formulation (for a device-not applicable)
4. Copy of Free Sale Certificate /COPP/ or a certificate to prove the registration status in country of origin (Not applicable for local manufacturer)
5. Copy of Certificate of Analysis for Finish Product
6. Specimen colored label, Packaging materials (art work acceptable)
7. Clinical evidences for claims
8. Legible product information leafletPatient information leaflet, Promotional materials (If applicable)

All applicants who submit applications under Borderline products should submit the composition of unit dose along with the batch manufacturing formula. Amount of all active ingredients per unit dose should be given in the form of vitamin or mineral and units according to the "Guideline on Product categorization Reference details Vitamins & Elements"

Examples:

1. Minerals in elemental level (Na but not as Sodium chloride)
2. Vitamins (Vitamin A but not as retinol, beta-carotene, etc)
3. Units (Vitamin D in μg/day, Zn in mg/day)

All noncompliant applications with above will be rejected with effect from 13th of July 2020.

Validity period of Preliminary Evaluation Report (Classification report) is one year and product registration dossiers should be submitted within the validity period of the Classification report.