Regulations Governing the Management of the Review, Registration and Issuance of Permit Documents for Food and Related Products Article 17
Applications for transference of the permit document for infant formula and follow- up infant formula, the transferee is required to submit an application form, along with the following documents or information, to the central competent authority for review, and pay the review and certificate processing fees, while the provisions in Article 7 do not apply:1.Transferor’s certificate or document of consent to transfer of permit document ownership in original copy.2.In cases of authorized sales, the original certificate of authorization issued by the original manufacturer or distributor is required.3.In cases of entrusted manufacturing, the original certificate of entrusted manufacturing issued by the entrusted manufacturer is required.4.Original permit document.5.Two copies each of the physical or color drafts of the Chinese labels, container or outer packaging, and user instruction 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 specifications, forms, and materials may be submitted.6.Where the product will be re-packed in new containers for sale, the applicant shall submit the documents set forth in Article 13 Paragraph 1 Subparagraph 12 Items 1-4 of the Regulations.7.Photocopy of the table of product ingredient content.8.Photocopy of the applicant’s company registration or business registration certificate.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.
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17條
申請嬰兒與較大嬰兒配方食品查驗登記許可文件持有人移轉者,受讓人應填具申請書,檢附下列文件、資料,並繳納審查費及證書費,向中央主管機關提出,不適用第七條規定:
一、讓與人同意讓與之證明文件正本。
二、獲授權販售者,其原製造廠或經銷商出具之授權證明正本。
三、委託製造者,其受託製造廠出具之受託製造證明正本。
四、原許可文件。
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、產品須再分裝者,檢附第十三條第一項第十二款第一目至第四目之文件。
七、產品成分含量表影本。
八、申請廠商公司登記或商業登記證明文件影本。
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。
一、讓與人同意讓與之證明文件正本。
二、獲授權販售者,其原製造廠或經銷商出具之授權證明正本。
三、委託製造者,其受託製造廠出具之受託製造證明正本。
四、原許可文件。
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、產品須再分裝者,檢附第十三條第一項第十二款第一目至第四目之文件。
七、產品成分含量表影本。
八、申請廠商公司登記或商業登記證明文件影本。
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。