REGULATIONS FOR APPLICATION OF HEALTH FOOD PERMIT｜第 2 條｜Food and Drug Administration｜Regulation｜In Force
衛生福利部｜v1.0
Last Amended: 2024-05-17
Applications for permit and registration of manufacture and import for health food specified in Subparagraph 1 of Paragraph 1 of Article 3 of the Act by the applicants of health food (hereinafter referred to as applicants) pursuant to Paragraph 1 of Article 7 of the Act shall submit the application form along with product samples, the following documents and information to the central competent authority and pay the preliminary review fees: 1. Specifications and quantity of ingredients along with their sources of supplies issued by the product manufacturer. 2. Safety assessment report or academic literature reports as defined in the health food safety assessment methods announced by the central competent authority. 3. Health care effect assessment report. 4. Stability testing plan and results of the product and the ingredients with health care effects. 5. Product nutrient analysis report. 6. Product sanitation test report. 7. Identification report and the testing method of ingredients with health care effect in the product. 8. Product manufacturing process charts issued by the product manufacturer. 9. Documentary evidence to demonstrate compliance with Standards for Good Manufacturing Practices of Health Food issued by the product manufacturer. 10. In cases of entrusted manufacturing for products, the certificate of entrusted manufacturing issued by the entrusted manufacturer. 11. In cases of authorized sales for products, the certificate of authorization. 12. The physical objects, color printouts, or color drafts of the Chinese label, container or outer packaging, and user instructions; the above items shall be attached separately for different packaging specifications, forms and materials; if the contents of user instructions are the same, any one version of one with any specifications, forms and materials may be adequate. 13. Documents of company, limited partnership, or business registration of the applicants. 14. Official certification documents verifying that the original product manufacturer is legally established or registered: (1) In cases of domestic manufacturers: the factory registration certificate but not for the manufacturers without registration by laws. (2) In case of foreign manufacturers: The original official certificate issued by a competent government agency responsible for product hygiene and safety or factory licensing in the country of origin shall be provided. The certificate shall specify full name of the government agency issuing the certificate with official stamp or authorized signature. If the certificate verifying the legitimacy of the original manufacturer is a copy of the original, the document shall be a certified true copy of the original by a notary public in the country of origin. 15. Other relevant research reports and literature in support of the product safety and health care effect. The foregoing documents or information in languages other than English and Chinese must be accompanied with English or Chinese translations issued by a registered translation agency.