Departement of Drug administration ask for below listed document for any new products (Generic or ANDA) products in Nepal:
1. An Application in the form of Schedule 4 ‘C’(DDA document)
2. An application in the form Schedule 6 (DDA document)
3. Notarized Up-to-date manufacturing license issued
4. Notarized Copy of Valid COPP as recommended by WHO
5. Detail formulation including excipients, colour, flavour, etc.
6. In case of new drug combination / new molecule (document in the
format designed by the
Department).
7. BA/BE if non pharmacopeial and modified release
8. Product Specification
9. Method of Analysis
10. Monograph if pharmacopoeia
11. Analytical Method Validation if non pharmacopoeial
12. Samples of label and carton
13. Sample of the product
14. Analytical report from Company’s own laboratory.
15. Analytical report from Independent laboratory (authorized)
16. Real time stability (Zone IVb) of two batches for claimed
shelf life
17. Letter of Attorney (Annex 5)
18. Price commitment for lower price than exporting company
19. Comparative Price of at least 5 bands if available
20. Company inspection report of DDA if audited
Formate:
Reference:
https://www.dda.gov.np/content/format-of-document-for-import
Prepared by:
Phr. Namuna Adhikari