Regulations Governing the Management of the Review, Registration and Issuance of Permit Documents for Food and Related Products｜第 23 條｜Food and Drug Administration｜Regulation｜In Force
第 三 章｜衛生福利部｜v1.0
Effective Date: 2024-11-30｜Last Amended: 2023-11-30
Applications for amendment of the permit document for certain disease shall submit an application form, along with the following documents or information, to the central competent authority, and pay the related fees, while the provisions in Article 6 do not apply: 1.Original permit document. 2.Two copies each of the physical or color drafts of the Chinese label, container or outer packaging, and user instruction that are involved in amendment; 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. In addition to the foregoing requirements, the following documents, information or sample shall be additionally submitted according to the application of amendment: 1.Product name change: The certificate or document of consent to change of the product name issued by the original manufacturer for imported products. 2.Change of name, address or person-in-charge of the manufacturer holding the permit document: (1.Photocopy of the company registration or business registration certificate of the manufacturer holding the permit document. (2.A complete list of product items shown on the permit document held by the manufacturer. The list is required to contain the registration numbers, Chinese names of the product items, and expiry date of the permit document. 3.Change of the original manufacturer’s name: (1.Domestic manufacturer: Carbon copy of the factory registration certificate. (2.Foreign manufacturer: The original official certificate issued by a competent government agency responsible for product hygiene and safety or factory licensing in the country of origin and dated within the past two years, shall be provided. The certificate shall specify the name and address of the manufacturer, its business activities, categories of products, hygienic status of the factory, and full name of the government agency issuing the certificate with official stamp or authorized signature. If the certificate verifying the legitimacy of the original manufacturer is a copy of the original, the document shall be a certified true copy of the original by a notary public in the country of origin. (3.A complete list of product items of the original manufacturer shall be provided. The list is required to contain the registration numbers, Chinese names of the product items, and expiry date of the permit document. 4.Building number adjustment of the original manufacturer’s address: (1.In cases of domestic manufacturers: The applicant shall submit a photocopy of the official certificate issued by a competent government agency certifying the building number adjustment. (2.In cases of foreign manufacturers: The original official certificate issued by a competent government agency of the country of origin in its full title certifying the address building number adjustment, whereas the certificate submitted is a photocopy, the document shall be notarized as a true copy of the original by a notary public in the country of origin. (3.A complete list of product items of the original manufacturer shall be provided. The list is required to contain the registration numbers, Chinese names of the product items, and expiry date of the permit document. 5.Amendment of the product specifications as set forth in Article 20, Paragraph 1, Subparagraph 2: (1.The evaluation report on the rationale of amendment issued by the original manufacturer within the past one year (including a chart of comparison of the content before and after the changes). (2.The documents set forth in Article 20, Paragraph 1, Subparagraphs 1 and 2, attaching those set forth in Subparagraph 3 of the same Article and Paragraph, based on the amended items of specifications. 6.Amendment to the packaging specification, form and material: (1.For imported product items, the original manufacturer’s certificate or document of consent to the change of packaging in original copy shall be submitted. (2.Product samples are required if changes involve product forms or materials. (3.Where the product will be re-packed in new containers for sale, the applicant shall submit the documents or sample set forth in Article 13 Paragraph 1 Subparagraph 12 of the Regulations. 7.Amendment of Chinese label, container or outer packaging, and user instructions of the product: (1.A chart of comparison of the content before and after the changes. (2.For imported product items, the original manufacturer’s certificate or document of consent to the amendment of Chinese label, container or outer packaging, and user instructions in original copy shall be submitted. (3.For amendment to the nutrition facts label (with no changes of the product ingredients and content): A.The evaluation report on the rationale of amendment issued by the original manufacturer within the past one year; B.The original copy of the nutrition analysis report issued by the original manufacturer or accreditation of food testing institution by the central competent authority within the past one year. C.The documents set forth in Article 20, Paragraph 1, Subparagraphs 1 and 2. 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. For the application process, attachment of documents and information and product samples, and fee payment in cases of change, relocation or expansion of the manufacturer, except for the exemption provided for the clinical report under Article 20, Paragraph 1, Subparagraph 12, Item 5, the provisions of Article 20 on new case applications shall apply mutatis mutandis. If it is necessary to reissue a new permit document, a certificate processing fee shall be collected. For the product specifications as set forth in Subparagraph 5 of Paragraph 2 and the nutrition facts in Item 3 of Subparagraph 7, amendment shall be limited to cases where neither the product composition nor the content has been amended. This does not apply to cases where the ingredients or content of the micronutrients in the product formula are adjusted in accordance with the revisions to the regulations.