Documents Required for New Drug, Industry Registration in Nepal

Documents Required for New Drug, Industry Registration in Nepal

New Drug Registration in Nepal, Pharmacy Registration, Drug Industry Registration and Product Renew is done in the Department of Drug Administration – DDA

Checklist for Company Registration

1. Application by the importer for Company registration
2. Application by the Company on its letterhead.
3. Letter of Authority to the importer (ANNEX 2)
4. Site Master File (as per PICS guidelines/WHO Guidelines)
5. Notarized Copy of Up to date manufacturing license
6. List of Products Intended to be registered in Nepal
7. Letter of Warranty (Annex 3)
8. Latest GMP internal audit report
9. Photocopy of updated Wholesale registration
10. Complete Dossier of one product intended to register
11. WHO GMP certificate from concern regulatory authority
12. Product registration and market authorization in SRA countries
13. REMS (Risk Evaluation and Mitigation Strategy) including PV(Pharmacovigilance) and post Marketing Surveillance
14. Approval letter from DDA on WHO GMP compliance (applicable for Non SRA, Non UN prequalified products and company)

Checklist for Product Registration

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

Checklist for Product Renewal

1. Application for renewal of 4 E and 7
2. Original 4 E and 6
3. Notarized COPP
4. Notarized Valid Mfg. Lic
5. Notarized Valid GMP
6. Sample
7. Annual Product Review
8. Stability information
9. Declaration on ADR
10. Price to importer, wholesaler, retailer and MRP
11. Approval of variation made under the period
12. Evidence of export to SRA in case of company registered under SRA export
13. COA ( Certificate of analysis)

Documents Required for Import of Intra Ocular Lenses (IOL)

1. Application by Importer
2. Application by Company
3. Manufacturing License
4. Site Master File (SMF)
5. ISO 9000 : 2000 Certificate
6. EC Directives 93/42/EEC Annex II- CE Certification
7. ISO 13485 : 2003 (Quality Management System of the Industry)
8. ISO 11979 : 1999 (Standard of the Product)
9. Quality Manual
10. Sources of the Materials used in the Lens
11. Authority Letter from the Manufacturer
12. Test Report of the Lens
13. Letter of Warranty
14. Unit Price

Documents Required for Import of Radioactive Substances

1. Application by Importer
2. Industry Registration Certificate
3. Company Registration Certificate
4. Approval letter from Government Agency for handling radioactive substances.
5. Material Safety Data Sheet
6. Performa Invoice
7. License from authorized Atomic Energy Regulatory Board
8. Standard Operating Procedures for Transport, Handling, Storage and Disposal.
9. Radiation Protection Manual
10. Consumption Repor

Application Demo 

Instant Hand Sanitizer (Alcohol Based) Guideline Department of Drug Administration 

National List of Essential Medicines Nepal