Checklist for Company Registration in Nepal under Department of Drug Administration

The Department of Drug Administration (DDA) in Nepal is responsible for regulating the import, manufacture, and sale of pharmaceutical products. Companies wishing to operate in this sector must complete a registration process with the DDA. To facilitate this process, the following checklist outlines the necessary steps and documentation required for company registration in Nepal.

1. Application by the importer for Company registration: The importer should submit an application for company registration to the DDA. The application should include details about the company's name, location, and contact information.
2. Application by the Company on its letterhead: The company should submit an application on its letterhead. The application should include details about the company's structure, ownership, and management.
3. Letter of Authority to the importer (ANNEX 2): The company should provide a letter of authority to the importer, allowing them to act on the company's behalf in matters related to product registration.
4. Site Master File (as per PICS guidelines/WHO Guidelines): The company should prepare a site master file that provides details about the manufacturing facility, quality control procedures, and personnel qualifications.
5. Notarized Copy of Up to date manufacturing license: The company should provide a notarized copy of their manufacturing license, demonstrating their ability to produce pharmaceutical products.
6. List of Products Intended to be registered in Nepal: The company should provide a list of the products they intend to register in Nepal, along with their generic names, dosage forms, strengths, and indications.
7. Letter of Warranty (Annex 3): The company should provide a letter of warranty, promising that their products meet the required quality standards and comply with all applicable laws and regulations.
8. Latest GMP internal audit report: The company should provide the latest Good Manufacturing Practice (GMP) internal audit report, demonstrating their compliance with international quality standards.
9. Photocopy of updated Wholesale registration: The company should provide a photocopy of their updated wholesale registration, demonstrating their ability to distribute pharmaceutical products in Nepal.
10. Complete Dossier of one product intended to register: The company should provide a complete dossier for one product they intend to register in Nepal, including information about the product's formulation, manufacturing process, quality control, and clinical studies.
11. WHO GMP certificate from concern regulatory authority: The company should provide a World Health Organization (WHO) GMP certificate from the relevant regulatory authority in their country of origin.
12. Product registration and market authorization in SRA countries: The company should provide evidence of product registration and market authorization in other countries that are members of the South Asian Regulatory Association (SRA).
13. REMS (Risk Evaluation and Mitigation Strategy) including PV(Pharmacovigilance) and post Marketing Surveillance: The company should provide a risk evaluation and mitigation strategy (REMS) that outlines their plan for pharmacovigilance and post-marketing surveillance.
14. Approval letter from DDA on WHO GMP compliance (applicable for Non SRA, Non UN prequalified products and company): If the company's products are not registered in SRA countries or prequalified by the United Nations, they must provide an approval letter from the DDA demonstrating their compliance with WHO GMP standards.