Regulations Governing the Management of the Review, Registration and Issuance of Permit Documents for Food and Related Products｜第 14 條｜Food and Drug Administration｜Regulation｜In Force
第 二 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 infant formula and follow-up infant formula 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 product labels in Chinese, containers or outer packaging, and user instructions; 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 instruction of any specification, form, and materials may be submitted 6.Description of product usage: The report issued or signed by the original manufacturer describing the situations of domestic and overseas consumer usage of the product in the last five years, and the content of which shall at least include the sales situations, adverse reactions reported domestically and overseas, and the latest results of inspection imposed on the original manufacturer by the competent authorities or its entrusted institution. 7.Original hygiene and nutrients specifications issued by the original manufacturer within the past one year. 8.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. 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 applications for extension 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. In case that, within one year of the amendment and implementation of these Regulations on November 30, 2023, the applicant is unable to provide a description of domestic and overseas usage in the past five years as specified in Paragraph 1 Subparagraph 6, the submission of overseas sales certificates and the product, or trial usage reports with a sample size of twenty or more subjects may be accepted as a substitute.