REGULATIONS FOR APPLICATION OF HEALTH FOOD PERMIT｜第 28 條｜Food and Drug Administration｜Regulation｜In Force
衛生福利部｜v1.0
Last Amended: 2024-05-17
Applications for amendment of the permit for health food by applicants pursuant to Paragraph 3 of Article 7 of the Act shall submit an application form along with the original permit to the central competent authority and pay the related fees. In addition to the foregoing requirements, the following documents and information shall be additionally submitted according to the application of amendment: 1. Product name change in Chinese or English for imported products: The certificate documents of consent to change of the product names issued by the original product manufacturer. 2. Change of name, address or responsible person of applicants holding the permit: (1) The documents and information set forth in Subparagraph 13 of Paragraph 1 of Article 2. (2) A complete list of health food products with the numbers and expiry dates of permit and product name. 3. Addition or change of product manufacturer: The documents and information set forth in Subparagraph 1, 4 to 12 and 14 of Paragraph 1 of Article 2. 4. Relocation of the product manufacturer: The documents and information set forth in Subparagraph 4, 9 and 14 of Paragraph 1 of Article 2. 5. Change of the original product manufacturer’s name: (1) The documents and information set forth in Subparagraph 14 of Paragraph 1 of Article 2. (2) A complete list of health food products with the numbers and expiry dates of permit and product name from the original product manufacturer. 6. Building number adjustment of the original product manufacturer’s address: (1) In cases of domestic manufacturers: The documents issued by a competent government agency certifying the address building number adjustment. (2) In case of foreign manufacturers: The original certificate issued by a competent government agency of the country of origin with its full title certifying the building number adjustment, whereas photocopies of the certificate shall be notarized as a true copy of the original by a notary public in the country of origin. (3) A complete list of health food products with the numbers and expiry dates of permit and product name from the original product manufacturer. 7. Change of ingredients and content of pigments, flavors or sweeteners but not of other ingredients and the no affection of product safety: The documents and information set forth in Subparagraph 1, 5, and 7 of Paragraph 1 of Article 2. 8. Amendment to the inner or outer packaging specification, form, material and trademark: (1) The documents and information set forth in Subparagraph 12 of Paragraph 1 of Article 2. (2) In cases of the change to the inner packaging: The documents and information set forth in Subparagraph 4 of Paragraph 1 of Article 2. (3) In cases of the imported products: The certificate documents of consent to the changes issued by the original product manufacturer. (4) In cases of the change to the packaging materials: The documents and information in compliance with the Sanitation Standard for Food Utensils, Containers and Packages. 9. Change of Chinese labels, outer packaging, and user instructions: (1) The documents and information set forth in Subparagraph 12 of Paragraph 1 of Article 2. (2) In cases of the imported products: The certificate documents of consent to change of Chinese labels, outer packaging, and user instructions issued by the original product manufacturer. (3) In cases of the changes of the nutrition facts labeling but not of product ingredients and content: A. The documents and information set forth in Subparagraph 1 and 5 of Paragraph 1 of Article 2. B. The evaluation report on the rationale of amendment issued by the product original manufacturer within the past one year. 10. Change of expiration date, storage methods and conditions of the product: The documents and information set forth in Subparagraph 4 of Paragraph 1 of Article 2.