Regulations Governing the Management of the Review, Registration and Issuance of Permit Documents for Food and Related Products｜第 20 條｜Food and Drug Administration｜Regulation｜In Force
第 三 章｜衛生福利部｜v1.0
Effective Date: 2024-11-30｜Last Amended: 2023-11-30
Applications for review and registration of formula for certain disease shall submit the application form, along with the following documents and information as well as product samples, to the central competent authority, and pay the related fees, while the provisions in Article 3 do not apply: 1.Original table of ingredient content: The table shall be issued by the original manufacturer and dated within the past one year and contain the detailed name and net quantity of contents of all the raw materials and food additive. 2.Original product specification: The product specification shall be issued by the original manufacturer and dated within the past one year and contain the hygiene and nutrients specification of the product. 3.Original hygiene and nutrients analysis report: The report shall be the original issued by the original manufacturer or accreditation of food testing institution by the central competent authority and dated within the past one year. 4.Manufacturing process summary. 5.Certification document verifying that the original manufacturer is legally established or registered: (1.Domestic manufacturer: Carbon copy of the factory registration certificate. (2.Foreign manufacturer: The original official certificate issued by a competent government agency responsible for product hygiene and safety or factory licensing in the country of origin and dated within the past two years, shall be provided. The certificate shall specify the name and address of the manufacturer, its business activities, categories of products, hygienic status of the factory, and 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. 6.In cases of authorized sales, the original certificate of authorization issued by the original manufacturer or distributor is required. 7.In cases of entrusted manufacturing, the original certificate of the entrusted manufacturing issued by the entrusted manufacturer is required. 8.Two copies each of the physical or color drafts of the Chinese label, container or outer packaging, and user instructions of the product; the above items shall be attached separately for different packaging specifications, forms, and materials; if the contents of the user instruction are the same, the user instruction of any specifications, forms, and materials may be submitted. 9.The applicant shall submit a carbon copy of its company registration or business registration certificate. 10.Where the complete sample is available to the market in different packaging specifications, forms or materials, the applicant is required to submit one sample for each option. 11.Where the product is intended to be re-packed in new containers for sale in Taiwan, the applicant shall submit the documents and sample set forth in Article 13 Paragraph 1 Subparagraph 12 of the Regulations. 12.All applicants, except for nutritionally complete food with balanced formula, are required to submit the following: (1.Information on the specific nutritional requirement for intended product users that would otherwise not be met without the product due to illness or medical conditions, along with supporting documents. (2.Information on why the intended users cannot otherwise meet the specific nutritional requirement described in the preceding subparagraph from the daily diet, along with supporting documents. (3.The mechanism behind the product design. (4.Information on how the intended use and quantity of intake of the product help the users to achieve the objectives described in subparagraphs (1) and (2) of this paragraph, along with supporting documents. (5.Clinical human consumption report: In case of subsequent or concurrent applications for multiple products of different pigments, flavors or sweeteners, while keeping the other ingredients identical and maintaining the same nutritional specifications with no influence on safety, the report of one of the products will suffice for application. 13.For high-protein disease-specific formulas, the applicant is required to provide information on the Protein Efficiency Ratio (PER), Protein Digestibility Corrected Amino Acid Score (PDCAAS) or other internationally-recognized protein determination indicators. 14.Other essential documents and information specified by the central competent authority. The foregoing documents or information in languages other than English and Chinese must be accompanied with English or Chinese translations provided by a registered translation agency. The permit documents issued on the applications filed in compliance with Paragraph 1 and approved pursuant to the Act shall be valid for five years.