Regulations Governing the Management of the Review, Registration and Issuance of Permit Documents for Food and Related Products｜第 22 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 extension of the permit document for formula for certain disease shall submit an application form within three months prior to the expiry date of permit, along with the following documents, information and product sample, to the central competent authority, and pay the related fees, while the provisions in Article 5 do not apply: 1.Original permit document. 2.The original certificate or document of consent to renewal of the product manufacturing agreement, or original table of ingredient content issued by the original manufacturer based on the content of originally issued permit within the past one year. 3.In cases of authorized sales, the original certificate of authorization issued by the original manufacturer or distributor is required. 4.In cases of entrusted manufacturing, the original certificate of entrusted manufacturing issued by the entrusted manufacturer is required. 5.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 instructions are the same, the user instructions of any specification, form, and materials may be submitted. 6.Original hygiene and nutrients specifications issued by the original manufacturer within the past one year. 7.Original hygiene and nutrients analysis report of the batches of production within the past year issued by the original manufacturer or accreditation of food testing institution by the central competent authority. The original analysis report of the latest batch of production shall be provided in case there is no production within the past year. 8.Clinical study report for the product under application (applications for nutritionally complete food with balanced formula or with attached clinical study report already is exempted from the requirement). 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 document issued on the extension applications filed in compliance with Paragraph 1 and approved pursuant to the Act shall be valid for five years. If it is necessary to reissue a new permit document, a certificate processing fee shall be collected.