REGULATIONS FOR APPLICATION OF HEALTH FOOD PERMIT Article 2
Applications for permit and registration of manufacture and import for health food specified in Subparagraph 1 of Paragraph 1 of Article 3 of the Act by the applicants of health food (hereinafter referred to as applicants) pursuant to Paragraph 1 of Article 7 of the Act shall submit the application form along with product samples, the following documents and information to the central competent authority and pay the preliminary review fees:1. Specifications and quantity of ingredients along with their sources of supplies issued by the product manufacturer.2. Safety assessment report or academic literature reports as defined in the health food safety assessment methods announced by the central competent authority.3. Health care effect assessment report.4. Stability testing plan and results of the product and the ingredients with health care effects.5. Product nutrient analysis report.6. Product sanitation test report.7. Identification report and the testing method of ingredients with health care effect in the product.8. Product manufacturing process charts issued by the product manufacturer.9. Documentary evidence to demonstrate compliance with Standards for Good Manufacturing Practices of Health Food issued by the product manufacturer.10. In cases of entrusted manufacturing for products, the certificate of entrusted manufacturing issued by the entrusted manufacturer.11. In cases of authorized sales for products, the certificate of authorization.12. The physical objects, color printouts, or color drafts of the Chinese label, container or outer packaging, and user instructions; the above items shall be attached separately for different packaging specifications, forms and materials; if the contents of user instructions are the same, any one version of one with any specifications, forms and materials may be adequate.13. Documents of company, limited partnership, or business registration of the applicants.14. Official certification documents verifying that the original product manufacturer is legally established or registered:(1) In cases of domestic manufacturers: the factory registration certificate but not for the manufacturers without registration by laws.(2) In case of foreign manufacturers: The original official certificate issued by a competent government agency responsible for product hygiene and safety or factory licensing in the country of origin shall be provided. The certificate shall specify 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.15. Other relevant research reports and literature in support of the product safety and health care effect.The foregoing documents or information in languages other than English and Chinese must be accompanied with English or Chinese translations issued by a registered translation agency.
中文原文 健康食品申請許可辦法第2條
健康食品業者（以下簡稱廠商）依本法第七條第一項規定，申請健康食品製造、輸入查驗登記，發給許可證，其產品屬本法第三條第一項第一款規定者，應填具申請書，並檢附產品及下列文件、資料，繳納初審費用，向中央主管機關提出：
一、產品製造廠出具之原料成分規格含量表、供貨來源。
二、產品安全評估報告，或依中央主管機關公告之健康食品安全評估方法所定學術文獻報告。
三、產品保健功效評估報告。
四、產品及其保健功效成分之安定性試驗計畫書及結果報告。
五、產品營養成分分析報告。
六、產品衛生檢驗報告。
七、產品保健功效成分鑑定報告及其檢驗方法。
八、產品製造廠出具之產品製程圖說。
九、產品製造廠出具落實健康食品良好作業規範標準之佐證資料。
十、委託製造者，其受託製造廠出具之受託製造證明。
十一、獲授權販售者，其授權證明。
十二、產品中文標籤、容器或包裝及說明書之實體、彩色列印圖或彩色擬稿；其包裝規格、型態或材質不同者，應分別檢附之；說明書內容相同者，得檢送任一規格、型態、材質者之說明書。
十三、廠商之公司登記、有限合夥登記或商業登記證明文件。
十四、產品製造廠為依法設立或登記之官方證明文件：
（一）國內製造者：工廠登記證明文件。
但屬依法免辦工廠登記者，免附。
（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，以全銜出具，經該政府機關或其主管官員戳記或簽章之證明文件；其為影本者，經原產國公證單位簽證與正本相符。
十五、其他佐證產品安全、保健功效之相關研究報告、文獻資料。
前項文件、資料，以英文以外之外文記載者，應檢附立案翻譯社出具之中文或英文譯本。
一、產品製造廠出具之原料成分規格含量表、供貨來源。
二、產品安全評估報告，或依中央主管機關公告之健康食品安全評估方法所定學術文獻報告。
三、產品保健功效評估報告。
四、產品及其保健功效成分之安定性試驗計畫書及結果報告。
五、產品營養成分分析報告。
六、產品衛生檢驗報告。
七、產品保健功效成分鑑定報告及其檢驗方法。
八、產品製造廠出具之產品製程圖說。
九、產品製造廠出具落實健康食品良好作業規範標準之佐證資料。
十、委託製造者，其受託製造廠出具之受託製造證明。
十一、獲授權販售者，其授權證明。
十二、產品中文標籤、容器或包裝及說明書之實體、彩色列印圖或彩色擬稿；其包裝規格、型態或材質不同者，應分別檢附之；說明書內容相同者，得檢送任一規格、型態、材質者之說明書。
十三、廠商之公司登記、有限合夥登記或商業登記證明文件。
十四、產品製造廠為依法設立或登記之官方證明文件：
（一）國內製造者：工廠登記證明文件。
但屬依法免辦工廠登記者，免附。
（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，以全銜出具，經該政府機關或其主管官員戳記或簽章之證明文件；其為影本者，經原產國公證單位簽證與正本相符。
十五、其他佐證產品安全、保健功效之相關研究報告、文獻資料。
前項文件、資料，以英文以外之外文記載者，應檢附立案翻譯社出具之中文或英文譯本。