Regulations Governing the Management of the Review, Registration and Issuance of Permit Documents for Food and Related Products｜第 29 條｜Food and Drug Administration｜Regulation｜In Force
第 四 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 food additives shall submit an application form, along with the following documents and information to the competent authority, and shall pay the related fees, while the provisions in Article 6 do not apply: 1.Changes of the product name: (1.Original permit document. (2.In cases of imported products, the original document issued by the manufacturer certifying the amendment of the name of product. 2.Changes of packaging specifications, forms, and materials: (1.Original permit document. (2.The original document or consent document issued by the manufacturer certifying the amendment of packaging. 3.Change of the name, address or person in charge of the manufacturer holding the permit document: (1.Original permit document. (2.A copy of the company registration or business registration certificate of the applicant, in which the business scope, in the case of importers, shall include the import of food additives, and in case of domestic manufacturers, shall include the food additive manufacturing, processing, formulation, re- packing, etc. (3.The complete list of the licensed products of the manufacturer holding the license, specifying the license number, the Chinese name of the product and the validity period of the permit document. 4.Amendment of the name of the original manufacturer: (1.Original permit document. (2.Domestic manufacturer: A copy of the factory registration certificate. (3.Foreign manufacturer: An original document issued by the manufacturer certifying the change of its name. (4.The complete list of the licensed products of the original manufacturer, specifying the license number, the Chinese name of the product and the validity period of the permit document. 5.Building number adjustment of the original manufacturer: (1.Original permit document. (2.Domestic manufacturer: The applicant shall submit a photocopy of the official certificate issued by a competent government agency certifying the building number adjustment. (3.Foreign manufacturer: The original official certificate issued by a competent government agency in its full title certifying the 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. (4.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 products, and expiry date of the permit document. 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 and the submission of documents and information, and related fees in case of change, relocation, or expansion of the manufacturer, the provisions of Article 27 on new registration applications shall apply mutatis mutandis. If it is necessary to reissue a new permit document, a certificate processing fee shall be collected.