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보건식품 허가 준비서류

빠르고 확실한 허가등록을 해드립니다!

보건식품 허가 신청 준비 서류

  1. Imported health food registration application form;
  2. Copies of applicant’s ID card, business license or legally registered certificates of other institutions;
  3. Retrieval information (retrieved from CFDA government website database) proving that the generic names of the health foods being applied don’t overlap with the names of products already registered;
  4. Letter of guarantee ensuring non-infringement of patents already obtained by others nformation
  5. Provide trademark registration certificates (unregistered trademarks can do without);
  6. Product development report (including research and development ideas, feature selection process, the expected functions, etc.);
  7. Product formulation (APIs and excipients) and formula basis;
  8. Functional components/ Characteristic ingredients, contents and functional components / testing methods of characteristic ingredients;
  9. Production process diagram and detailed description, and the associated research data;
  10. Product quality standards and preparation explanations (including quality standards of APIs and excipients);
  11. Types, names, quality standards and selection basis of packaging materials in direct contact with the product;
  12. The testing report issued by the testing institutions and related information usually by Chinese institute;
  13. Samples of product labels and package inserts;
  14. Technical requirements and Confirmation form of successful upload of technical requirements;
  15. Other information that helps product review;
  16. two samples of minimum unopened sales package;
  17. If the functions are not within the scope of CFDA announced items, relevant documents shall be provided as required;
  18. Certifying documents issued by related institutions of the country or region of origin proving GMP compliance of the manufacturer
  19. For registration affairs run by overseas manufacturer’s Permanent Representative in China, a copy of the "registration certificate of overseas enterprise’s permanent Chinese representative offices" shall be provided; for registration affairs run by domestic agencies entrusted by overseas manufacturers, the applicant shall provide the original notarized certificate of entrustment and copies of business license of the agencies entrusted;
  20. Documents proving that the product has been marketed more than a year in the producing country (region), which shall be notarized by notary institutions of the producing country (region) and confirmed by the Chinese Embassy in the country;
  21. Product-associated standards issued by the product producing country (region) or international organizations;
  22. Real samples of the packaging, labels, package inserts for products marketed in the producing country (region), which shall be attached to the corresponding entries in the application form;
  23. Three consecutive batches of samples, the number of which shall triple the amount required for testing.