Regulations Governing the Management of the Review, Registration and Issuance of Permit Documents for Food and Related Products Article 23
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.
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23條
申請特定疾病配方食品查驗登記事項變更，應填具申請書，檢附下列文件、資料，並繳納費用，向中央主管機關提出，不適用第六條規定：
一、原許可文件。
二、變更涉及產品中文標籤、容器或外包裝及說明書者，其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。
除前項規定外，依申請變更之項目，另應檢附下列文件、資料或樣品︰一、產品名稱變更：產品為輸入者，其原製造廠出具產品名稱變更之證明或同意文件正本。
二、許可文件持有廠商名稱、地址或負責人變更：
（一）許可文件持有廠商公司登記或商業登記證明文件影本。
（二）許可文件持有廠商之所有許可產品清冊，並載明許可字號、產品中文名稱及許可文件有效期限。
三、原製造廠名稱變更︰（一）國內製造者︰工廠登記證明文件影本。
（二）國外製造者︰出產國管理產品衛生安全或核發製造廠證照之政府機關最近二年內，以全銜出具，並載明製造廠名稱、地址、營業項目、產品種類、工廠之衛生狀況，經該政府機關或其主管官員戳記或簽章；其為影本者，經原產國公證單位簽證與正本相符。
（三）原製造廠之所有許可產品清冊，並載明許可字號、產品中文名稱及許可文件有效期限。
四、原製造廠門牌整編：
（一）國內製造者︰政府機關出具，足資證明門牌整編之文件影本。
（二）國外製造者︰出產國政府機關以全銜出具，足資證明門牌整編之文件；其為影本者，經原產國公證單位簽證與正本相符。
（三）原製造廠之所有許可產品清冊，並載明許可字號、產品中文名稱及許可文件有效期限。
五、第二十條第一項第二款之產品規格變更：
（一）原製造廠最近一年內出具之變更合理性評估報告，包括變更內容前後對照表。
（二）第二十條第一項第一款及第二款規定之文件，並依變更之規格項目，檢附同條項第三款規定之文件。
六、包裝規格、型態、材質變更：
（一）產品為輸入者，其原製造廠出具包裝變更之證明或同意文件正本。
（二）型態或材質變更者，應檢附樣品。
（三）產品為須再分裝者，檢附第十三條第一項第十二款規定之文件及樣品。
七、中文標籤、容器或外包裝及說明書變更：
（一）變更前後對照表。
（二）產品為輸入者，檢附原製造廠出具中文標籤、容器或外包裝及說明書變更之證明或同意文件正本。
（三）營養標示變更者：1.原製造廠最近一年內出具之變更合理性評估報告。
2.原製造廠或中央主管機關認證之食品檢驗機構最近一年內出具之營養成分分析表正本。
3.第二十條第一項第一款及第二款規定之文件。
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。
製造廠更換、遷移或增列者，其申請程序、文件、資料與樣品之檢附，及費用之繳納，除第二十條第一項第十二款第五目之報告免檢附外，準用第二十條申請查驗登記新案之規定辦理。
辦理第一項變更應換發新證者，並應繳納證書費。
第二項第五款產品規格變更及第七款第三目營養標示變更，以產品成分及含量均未變更者為限。
但因應本辦法修正，調整產品配方微量營養素之成分或含量者，不在此限。
一、原許可文件。
二、變更涉及產品中文標籤、容器或外包裝及說明書者，其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。
除前項規定外，依申請變更之項目，另應檢附下列文件、資料或樣品︰一、產品名稱變更：產品為輸入者，其原製造廠出具產品名稱變更之證明或同意文件正本。
二、許可文件持有廠商名稱、地址或負責人變更：
（一）許可文件持有廠商公司登記或商業登記證明文件影本。
（二）許可文件持有廠商之所有許可產品清冊，並載明許可字號、產品中文名稱及許可文件有效期限。
三、原製造廠名稱變更︰（一）國內製造者︰工廠登記證明文件影本。
（二）國外製造者︰出產國管理產品衛生安全或核發製造廠證照之政府機關最近二年內，以全銜出具，並載明製造廠名稱、地址、營業項目、產品種類、工廠之衛生狀況，經該政府機關或其主管官員戳記或簽章；其為影本者，經原產國公證單位簽證與正本相符。
（三）原製造廠之所有許可產品清冊，並載明許可字號、產品中文名稱及許可文件有效期限。
四、原製造廠門牌整編：
（一）國內製造者︰政府機關出具，足資證明門牌整編之文件影本。
（二）國外製造者︰出產國政府機關以全銜出具，足資證明門牌整編之文件；其為影本者，經原產國公證單位簽證與正本相符。
（三）原製造廠之所有許可產品清冊，並載明許可字號、產品中文名稱及許可文件有效期限。
五、第二十條第一項第二款之產品規格變更：
（一）原製造廠最近一年內出具之變更合理性評估報告，包括變更內容前後對照表。
（二）第二十條第一項第一款及第二款規定之文件，並依變更之規格項目，檢附同條項第三款規定之文件。
六、包裝規格、型態、材質變更：
（一）產品為輸入者，其原製造廠出具包裝變更之證明或同意文件正本。
（二）型態或材質變更者，應檢附樣品。
（三）產品為須再分裝者，檢附第十三條第一項第十二款規定之文件及樣品。
七、中文標籤、容器或外包裝及說明書變更：
（一）變更前後對照表。
（二）產品為輸入者，檢附原製造廠出具中文標籤、容器或外包裝及說明書變更之證明或同意文件正本。
（三）營養標示變更者：1.原製造廠最近一年內出具之變更合理性評估報告。
2.原製造廠或中央主管機關認證之食品檢驗機構最近一年內出具之營養成分分析表正本。
3.第二十條第一項第一款及第二款規定之文件。
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。
製造廠更換、遷移或增列者，其申請程序、文件、資料與樣品之檢附，及費用之繳納，除第二十條第一項第十二款第五目之報告免檢附外，準用第二十條申請查驗登記新案之規定辦理。
辦理第一項變更應換發新證者，並應繳納證書費。
第二項第五款產品規格變更及第七款第三目營養標示變更，以產品成分及含量均未變更者為限。
但因應本辦法修正，調整產品配方微量營養素之成分或含量者，不在此限。