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Documents Required for New Drug, Industry Registration in Nepal

Format of Documents for Imporat New Drugs in Nepal 

Nabin Bista by Nabin Bista
January 9, 2021
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Documents Required for New Drug, Industry Registration in Nepal
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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 

 

Documents Required for New Drug, Industry Registration in Nepal

Documents Required for New Drug, Industry Registration in Nepal

Documents Required for New Drug, Industry Registration in Nepal


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

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Nabin Bista

Hello, Thank You for visiting my blog I am Nabin Bista, Dedicated and self motivated young Pharmacist from Nepal. Blogging is my passion. I am studying B Pharmacy at Institute of Medicine - IOM. If you want me to write about any posts that you found confusing/difficult, please mention in the comments below.

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