Checklist for Product Registration

When seeking product registration with the Department of Drug Administration (DDA), pharmaceutical companies in Nepal must ensure that they have provided all the necessary information and documentation. The following checklist outlines the requirements for product registration with the DDA.

1. An Application in the form of Schedule 4 ‘C’(DDA document): The company must complete an application in the form of Schedule 4 ‘C’, providing details about the product and the company.
2. An application in the form Schedule 6 (DDA document): The company must also complete an application in the form Schedule 6, providing additional details about the product, including its intended use and formulation.
3. Notarized Up-to-date manufacturing license issued: The company must provide a notarized copy of their up-to-date manufacturing license, demonstrating their ability to produce pharmaceutical products.
4. Notarized Copy of Valid COPP as recommended by WHO: The company must provide a notarized copy of their Certificate of Pharmaceutical Product (COPP), which is a document recommended by the World Health Organization (WHO) that certifies the pharmaceutical product's quality.
5. Detail formulation including excipients, colour, flavour, etc.: The company must provide a detailed formulation of the product, including information about its excipients, color, flavor, and other relevant details.
6. In case of new drug combination / new molecule (document in the format designed by the Department): If the product contains a new drug combination or new molecule, the company must provide a document in the format designed by the DDA.
7. BA/BE if non pharmacopeial and modified release: If the product is non-pharmacopeial or modified release, the company must provide a bioavailability or bioequivalence study.
8. Product Specification: The company must provide a product specification that outlines the product's physical and chemical properties.
9. Method of Analysis: The company must provide a method of analysis that details the analytical procedures used to test the product.
10. Monograph if pharmacopoeia: If the product is included in a pharmacopoeia, the company must provide a monograph.
11. Analytical Method Validation if non pharmacopoeial: If the product is non-pharmacopeial, the company must provide analytical method validation.
12. Samples of label and carton: The company must provide samples of the product's label and carton.
13. Sample of the product: The company must provide a sample of the product.
14. Analytical report from Company’s own laboratory: The company must provide an analytical report from its own laboratory that demonstrates the product's quality.
15. Analytical report from Independent laboratory (authorized): The company must provide an analytical report from an authorized independent laboratory that demonstrates the product's quality.
16. Real-time stability (Zone IVb) of two batches for claimed shelf life: The company must provide real-time stability data for two batches of the product that demonstrate its shelf life.
17. Letter of Attorney (Annex 5): The company must provide a letter of attorney, allowing the DDA to act on its behalf in matters related to product registration.
18. Price commitment for a lower price than the exporting company: The company must commit to providing a lower price for the product than the exporting company.
19. Comparative Price of at least 5 bands if available: If available, the company must provide comparative pricing data for at least five bands.
20. Company inspection report of DDA if audited: If the company has been audited by the DDA, it must provide an inspection report.