Regulations Governing the Management of the Review, Registration and Issuance of Permit Documents for Food and Related Products Article 22
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.
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22條
申請特定疾病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、原製造廠最近一年內，出具之產品衛生及營養成分規格表正本。
七、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。
八、臨床人體食用研究報告，其曾檢附或屬營養均衡完整配方者免附。
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。
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、原製造廠最近一年內，出具之產品衛生及營養成分規格表正本。
七、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。
八、臨床人體食用研究報告，其曾檢附或屬營養均衡完整配方者免附。
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。