Regulations Governing the Management of the Review, Registration and Issuance of Permit Documents for Food and Related Products Article 14
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 submitted6.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.
中文原文 食品與相關產品查驗登記及許可文件管理辦法第14條
申請嬰兒與較大嬰兒配方食品查驗登記許可展延，應於期滿前三個月內，填具申請書，檢附下列文件、資料及產品，並繳納費用，向中央主管機關提出，不適用第五條規定：
一、原許可文件。
二、原製造廠最近一年內出具依原許可內容繼續製造之證明或同意文件正本，或產品成分含量表正本。
三、獲授權販售者，其原製造廠或經銷商出具之授權證明正本。
四、委託製造者，其受託製造廠出具之受託製造證明正本。
五、產品中文標籤、容器或外包裝及說明書之實體或彩色擬稿各二份；其包裝規格、型態、材質不同者，分別檢附之；說明書內容相同者，得檢送任一規格、型態、材質者之說明書。
六、原製造廠出具或簽署之產品最近五年國內、外使用情形說明；其內容至少應包括產品上市情形、國內、外不良反應通報、原製造廠最近一次經政府機關或其委託機構稽查情形。
七、原製造廠最近一年內，出具之產品衛生及營養成分規格表正本。
八、原製造廠或中央主管機關認證之食品檢驗機構，出具最近一年內生產批次之產品衛生及營養成分分析表正本；最近一年內無生產者，應出具最近生產批次之分析表正本。
前項文件、資料，以非英文之外文記載者，應檢附立案翻譯社出具之中文或英文譯本。
第一項展延申請案，經審核符合本法規定者，核發有效期間五年之許可文件；其應換發新證者，並應繳納證書費。
本辦法中華民國一百十二年十一月三十日修正發布後一年內，申請案件未能依第一項第六款提供最近五年國內、外使用情形說明者，得以國外之販售證明及產品，或有效樣本數二十人以上試用報告替代之。
一、原許可文件。
二、原製造廠最近一年內出具依原許可內容繼續製造之證明或同意文件正本，或產品成分含量表正本。
三、獲授權販售者，其原製造廠或經銷商出具之授權證明正本。
四、委託製造者，其受託製造廠出具之受託製造證明正本。
五、產品中文標籤、容器或外包裝及說明書之實體或彩色擬稿各二份；其包裝規格、型態、材質不同者，分別檢附之；說明書內容相同者，得檢送任一規格、型態、材質者之說明書。
六、原製造廠出具或簽署之產品最近五年國內、外使用情形說明；其內容至少應包括產品上市情形、國內、外不良反應通報、原製造廠最近一次經政府機關或其委託機構稽查情形。
七、原製造廠最近一年內，出具之產品衛生及營養成分規格表正本。
八、原製造廠或中央主管機關認證之食品檢驗機構，出具最近一年內生產批次之產品衛生及營養成分分析表正本；最近一年內無生產者，應出具最近生產批次之分析表正本。
前項文件、資料，以非英文之外文記載者，應檢附立案翻譯社出具之中文或英文譯本。
第一項展延申請案，經審核符合本法規定者，核發有效期間五年之許可文件；其應換發新證者，並應繳納證書費。
本辦法中華民國一百十二年十一月三十日修正發布後一年內，申請案件未能依第一項第六款提供最近五年國內、外使用情形說明者，得以國外之販售證明及產品，或有效樣本數二十人以上試用報告替代之。