Domestic Health Food Application
1. Health Food Registration Application Form.
2. Applicant certificate of identification copy and business license copy .
3.Provide the general name of the Health Food, and searching material of not the same name with approved drug name(searching from database on .China Food and Drug Administration Web site).
4.Applicant guarantee of not infringement to other approved patent.
5.Provide trademark registration document evidence (not provide if not registrar the trademark).
6.Product design report (including design thought, function screening process, intended effect).
7.Product Formula (material and accessories) and formula basis. Source of raw material and accessories and principle of usage.
8.Functional components/symbolic components, concentration and test method.
9.Manufacturing process chart and detailed description and related study material.
10.Product quality standard and drafting description (including raw material and accessories standards).
11.Type, name, quality standards and selecting basis of packaging material directly contacted products.
12.Experiment report of testing institution, and its related materials, including:
1)Testing application form;
2)Testing acceptance receipt from testing institution;
3)Safety toxicology test report;
4)Function testing report;
5)Analeptic testing report;(only apply to registration of health food to relieve energy exhausting, reduce weight and improve growth and development);
6)Functional element testing report;
7) Stability study report;
8) Sanitation study report;
9) Other testing report (such as raw material identification report and culture toxicology testing report);
13. Sample of labeling and package insert.
14. Other documents that help product review.
15. 2 unopened minimum package samples.
