Regulations Governing the Management of the Review, Registration and Issuance of Permit Documents for Food and Related Products｜第 17 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 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.