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| 健康食品申請許可辦法 | REGULATIONS FOR APPLICATION OF HEALTH FOOD PERMIT |
| 第 1 條 | Article 1 |
| 本辦法依健康食品管理法（以下簡稱本法）第七條第五項規定訂定之。 | These Regulations are set forth pursuant to Paragraph 5 of Article 7 of the Health Food Control Act (hereinafter referred to as "the Act"). |
| 第 2 條 | Article 2 |
| 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： | 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: |
| 一、產品製造廠出具之原料成分規格含量表、供貨來源。 | 1. Specifications and quantity of ingredients along with their sources of supplies issued by the product manufacturer. |
| 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。 | 2. Safety assessment report or academic literature reports as defined in the health food safety assessment methods announced by the central competent authority. |
| 三、產品保健功效評估報告。 | 3. Health care effect assessment report. |
| 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。 | 4. Stability testing plan and results of the product and the ingredients with health care effects. |
| 五、產品營養成分分析報告。 | 5. Product nutrient analysis report. |
| 六、產品衛生檢驗報告。 | 6. Product sanitation test report. |
| 七、產品保健功效成分鑑定報告及其檢驗方法。 | 7. Identification report and the testing method of ingredients with health care effect in the product. |
| 八、產品製造廠出具之產品製程圖說。 | 8. Product manufacturing process charts issued by the product manufacturer. |
| 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。 | 9. Documentary evidence to demonstrate compliance with Standards for Good Manufacturing Practices of Health Food issued by the product manufacturer. |
| 十、委託製造者，其受託製造廠出具之受託製造證明。 | 10. In cases of entrusted manufacturing for products, the certificate of entrusted manufacturing issued by the entrusted manufacturer. |
| 十一、獲授權販售者，其授權證明。 | 11. In cases of authorized sales for products, the certificate of authorization. |
| 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。 | 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. |
| 十三、廠商之公司登記、有限合夥登記或商業登記證明文件。 | 13. Documents of company, limited partnership, or business registration of the applicants. |
| 十四、產品製造廠為依法設立或登記之官方證明文件： | 14. Official certification documents verifying that the original product manufacturer is legally established or registered: |
| （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。 | (1) In cases of domestic manufacturers: the factory registration certificate but not for the manufacturers without registration by laws. |
| （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。 | (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. |
| 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。 | 15. Other relevant research reports and literature in support of the product safety and health care effect. |
| 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。 | 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. |
| 第 3 條 | Article 3 |
| 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二款規定者，應填具申請書，並檢附產品及繳納初審費用，向中央主管機關提出；其應檢附之文件、資料，依前條規定辦理。但免附前條第一項第二款、第三款及第十五款文件、資料。 | Applicants in application for permit of health food manufactured and imported registration in Paragraph 1 of Article 7 of the Act with the products specified in Subparagraph 2 of Paragraph 1 of Article 3 of the Act shall submit an application form, with the product sample, the following documents and information, and payment of the preliminary review fees to the central competent authority; the required documents and information shall be provided according to the provisions of the preceding Article, except for those mentioned in Subparagraph 2, 3 and 15 of Paragraph 1 of the preceding Article. |
| 第 4 條 | Article 4 |
| 前二條申請，應依所申請產品之保健功效項目或規格項目，分別為之。 | Separate applications in the preceding two Articles shall be filed based on the one health care effect or specification standards of the products. |
| 第 5 條 | Article 5 |
| 中央主管機關受理第二條申請案後，應就廠商檢附之文件、資料進行初審；必要時，得至現場實地查核。 | The central competent authority, upon receiving applications in Article 2, shall conduct a preliminary review of the documents and information submitted by the applicants and may conduct on-site inspections if necessary. |
| 前項文件、資料不完備者，廠商應於收受中央主管機關通知後一個月內補正；必要時，得申請延長一個月，並以一次為限。屆期未補正者，予以駁回。 | If the documents and information in the preceding paragraph are incomplete, the applicants shall, within one month after receiving of the notice of the central competent authority, submit the supplementary documents and information, and may apply for a one-month extension if necessary. The application for extension is limited to one time only. Without submitting the supplementary documents and information within the time limit results in the rejection of the application. |
| 第一項初審經駁回，廠商不服者，得提起救濟；其救濟應依下列方式之一為之： | Applicants unwilling to accept the rejection of the preliminary review can appeal for relief in either of the following manners: |
| 一、收受初審處分通知之次日起六個月內，敘明理由，向中央主管機關提出申復。申復經駁回，廠商不服者，得依訴願法提起訴願。 | 1. Appeal to the central competent authority with reasons claimed within six months from the date following receiving of the notice of the preliminary review results. If rejected, an administrative appeal can be made pursuant to the Administrative Appeal Act. |
| 二、收受初審處分通知之次日起三十日內，逕依訴願法提起訴願。 | 2. Administrative appeal filed directly pursuant to the Administrative Appeal Act within 30 days from the date following receiving of the notice of the preliminary review results. |
| 已依前項第二款提起訴願，復依前項第一款規定提出申復，或同時申請者，其申復不予受理。 | The appeal in accordance with Subparagraph 1 shall not be accepted if an administrative appeal has been filed in Subparagraph 2 of the preceding paragraph prior to the appeal, or if both an administrative appeal and an appeal are filed. |
| 第 6 條 | Article 6 |
| 第二條申請經初審通過者，得申請複審。 | Applications filed in Article 2 and having passed the preliminary review are eligible for a secondary review. |
| 前項複審，應於收受初審通過通知之次日起十五日內，填具申請書及繳納複審費用，並依初審意見，檢送文件、資料，向中央主管機關提出。屆期未繳納複審審查費或未檢送文件、資料者，予以駁回。 | Applications for the secondary review in the preceding paragraph shall be filed, within 15 days from the day following the date of the notice of the preliminary review result, to the central competent authority with the payment of fee for the secondary review and with supplementary documents and information based on comments in the preliminary review. Failure to paying the secondary review fee or to submit supplementary documents and information, within the specified length of time, shall results in the rejection of the application. |
| 第 7 條 | Article 7 |
| 中央主管機關為審查前條複審案，得組成審議小組召開會議，就產品之安全性、保健功效、包裝、標籤及說明書，予以審查；必要時，得至現場實地查核。 | For the secondary review as stated in the preceding Article, the central competent authority may organize a review committee and call meetings to review the safety, health care effect, packaging, labeling and user instruction, and may conduct on-site inspections if necessary. |
| 第 8 條 | Article 8 |
| 中央主管機關應就前條審查結果，以書面通知廠商。 | The central competent authority shall notify the applicants in writing of the results of the secondary review in the preceding Article. |
| 第 9 條 | Article 9 |
| 中央主管機關為前條複審時，認定文件、資料不完備者，廠商應於收受中央主管機關通知後一個月內補正；必要時，得申請延長一個月，並以一次為限。屆期未補正者，予以駁回。 | If the documents and information in the secondary review are incomplete considered by the central competent authority in the preceding Article, the applicants shall, within one month after receiving the notice of the central competent authority, submit the supplementary documents and information, and may apply for a one-month extension if necessary. The application for extension is limited to one time only. Without submitting the supplementary documents and information within the time limit results in the rejection of the application. |
| 第 10 條 | Article 10 |
| 第三條申請案，中央主管機關審查程序及廠商所檢附文件、資料之補正與延長、救濟，準用第五條規定。 | The review process of the central competent authority, the documents and information provided by the applicants, and corrections, extension, as well as remedies of the applications filed in Article 3 shall apply the provisions of Article 5 mutatis mutandis. |
| 前項審查結果，經認有安全或保健功效疑慮者，中央主管機關應通知廠商申請複審；其申請程序、複審程序、實地查核及補正與延長，準用第六條第二項至前條規定。 | If the review results in the preceding paragraph are considered the concerns of safety or health efficacy, the central competent authority shall notify the applicants to apply for secondary reviews. The procedures of application and secondary reviews, on-site inspections, corrections, and extensions shall apply the provisions from Paragraph 2 of Article 6 up to the preceding Article mutatis mutandis. |
| 第 11 條 | Article 11 |
| 中央主管機關認申請案產品有送驗必要者，應通知廠商於通知送達之次日起一個月內，向中央主管機關指定之檢驗機構繳交檢驗費及足夠檢驗之原裝完整樣品檢體送驗；屆期未繳交檢驗費或未檢具檢體送驗者，予以駁回。 | If the product analysis is considered necessary, the central competent authority shall notify the applicants to pay the testing fee and provide sample product in intact packaging of sufficient amount to the inspection body designated by central competent authority for testing within one month from the date following receiving of the notification. Failure to pay the testing fee or provide the samples by the deadline shall result in the rejection of the application. |
| 第 12 條 | Article 12 |
| 廠商不服中央主管機關複審結果，得提起救濟；其救濟，準用第五條第三項及第四項規定。 | Applicants unwilling to accept the rejection of the secondary review can appeal for relief. The relief shall apply the provisions from Paragraph 3 and 4 of Article 5 mutatis mutandis. |
| 第 13 條 | Article 13 |
| 申請案經審查通過者，中央主管機關應以書面通知廠商審查結果及繳納證書費，並於廠商繳納證書費後，發給健康食品許可證。 | If applications are reviewed and approved, the central competent authority shall notify the review results to the applicants in writing and the demand of payment of the permit fee, and a health food permit shall be issued after payment of the permit fee by the applicants. |
| 前項許可證之登記內容，包括下列事項： | The registered contents of the permit in the preceding paragraph shall include the following: |
| 一、中文及英文品名。 | 1. Product name in Chinese and English. |
| 二、申請廠商名稱、地址及負責人。 | 2. Name and address of the applicants and the responsible person. |
| 三、製造廠名稱及地址。 | 3. Name and address of the product manufacturer. |
| 四、原料成分及產品外觀形態。 | 4. Ingredients and appearance of the product. |
| 五、產品保健功效或品管指標之成分、含量。 | 5. The ingredients and quantities of the health care effects or serving as the quality control indicators of the product. |
| 六、產品保健功效項目及敘述。 | 6. The item and descriptions of the health care effects. |
| 七、包裝規格及材質。 | 7. Packaging specifications and materials of the product. |
| 八、產品有效期限、保存方法及條件。 | 8. Expiration date, storage methods and conditions of the product. |
| 九、產品中文標籤、容器或包裝及說明書之刊載內容。 | 9. The contents of the Chinese label, container or outer packaging, and user instructions. |
| 十、許可證發證年月日及字號。 | 10. Date and number of the permit issuance. |
| 十一、其他經中央主管機關指定之事項。 | 11. Other registration items designated by the central competent authority. |
| 第 14 條 | Article 14 |
| 第二條第一項第一款原料成分規格含量表，應視案件性質，以廠商提供之下列文件、資料審核之： | The specifications and quantity of ingredients in Subparagraph 1 of Paragraph 1 of Article 2 shall be reviewed by case based on the following documents and information provided by the applicants: |
| 一、原料品管或衛生檢驗報告。 | 1. The reports of quality control or sanitation test for the ingredient. |
| 二、保健功效原料成分之製程及檢驗報告。 | 2. The manufacturing process and test report for the ingredients of the health care effects. |
| 三、前款以外原料成分之萃取或濃縮製程。 | 3. The manufacturing process of extraction or concentration for the ingredients not covered in the preceding subparagraph. |
| 四、可供食用中藥材原料之基原鑑定報告。 | 4. Authentication reports of medicinal plant assessment if the ingredients can be used in edible Chinese herbal medicines. |
| 五、菌株原料之來源證明及菌種鑑定報告；屬乳酸菌者，並檢附菌株鑑定報告。 | 5. The origin certification of the strains and identification reports of the species if the ingredients are microorganism; identification reports of the strains if the ingredients are lactobacillus. |
| 第 15 條 | Article 15 |
| 第二條第一項第二款至第七款之評估、試驗、分析、檢驗及鑑定報告，應就工廠產製產品為之。 | The target of reports for assessment, test, analysis and identification in Subparagraph 2 to 7 of Paragraph 1 of Article 2 shall be the products manufactured from production lines in the factory. |
| 第 16 條 | Article 16 |
| 第二條第一項第二款及第三款之產品安全評估報告及產品保健功效評估報告，應由產品所採用原料研發單位以外之第三人，分別依本法第三條第二項所定之評估法規為之。 | The safety assessment report and the health care effect assessment report in Subparagraph 2 and 3 of Paragraph 1 of Article 2, respectively, shall be taken pursuant to the assessment provisions in Paragraph 2 of Article 3 of the Act by third parties other than the researching and developing units of the ingredients in the product. |
| 第 17 條 | Article 17 |
| 第二條第一項第四款至第七款之產品安定性試驗計畫書及結果報告、產品營養成分分析報告、產品衛生檢驗報告及產品保健功效成分鑑定報告，其報告應經測試；測試之方式，應依下列規定為之： | The stability testing plan and results, product nutrient analysis report, product sanitation test report, and identification report of ingredients with health care effect in the product in Subparagraph 4 to 7 of Paragraph 1 of Article 2, respectively, should be taken by testing, and the testing shall be conducted according to the following provisions: |
| 一、測試之產品，各應至少三批取自工廠生產線所產製者。 | 1. The target of reports shall be the products at least 3 batches manufactured from production lines in the factory. |
| 二、前款三批測試，至少有二批應為最近三年內完成者。 | 2. The reports using the target of the products at least 2 batches among the 3 batches in the preceding subparagraph should have been completed within the past 3 years. |
| 三、第一款產品，應為有效日期內者。 | 3. The products in the Subparagraph 1 should be within their expiration date. |
| 第 18 條 | Article 18 |
| 第二條第一項第四款保健功效成分之安定性試驗，應以該產品具保健功效之特定成分作為試驗之標的；其保健功效成分依現有技術無法確定者，得由廠商列舉具該保健功效之原料成分作為試驗之標的。 | The test objects of the stability testing for the ingredients with health care effects in Subparagraph 4 of Paragraph 1 of Article 2 should be the specific ingredients with health care effects in the product. If the specific ingredients with health care effects cannot be determined by contemporary techniques, other one with health care effects claimed by the applicants can be used as the test objects of the stability testing. |
| 第三條健康食品，其依第二條應檢附之保健功效成分安定性試驗，依中央主管機關所定健康食品規格標準之規格成分作為試驗之標的。 | The test objects of the stability testing for the ingredients with health care effects pursuant to Article 2 for the health foods in Article 3 shall be the ingredients designated by the central competent authority in the Specification Standards for Health Foods. |
| 第 19 條 | Article 19 |
| 第二條第一項第五款產品營養成分分析報告，其分析項目，應包括包裝食品營養標示應遵行事項所定之熱量及營養素。 | The items of analysis in product nutrient analysis report in Subparagraph 5 of Paragraph 1 of Article 2 shall include the values of calories and nutrients defined by Regulations on Nutrition Labeling for Prepackaged Food Products. |
| 第 20 條 | Article 20 |
| 第二條第一項第六款產品衛生檢驗報告，其項目及內容，應足以證明產品符合健康食品衛生標準之規定；上開標準未規定者，依食品安全衛生管理法相關規定辦理。 | The items and content of product sanitation test report in Subparagraph 6 of Paragraph 1 of Article 2 shall provide sufficient evidence for the product meeting the provisions of the Sanitation Standards for Health Foods. Relevant regulations of the Act Governing Food Safety and Sanitation shall apply if those are not covered in the aforementioned Sanitation Standards. Identification report and the testing method of ingredients with health care effect in the product. |
| 第 21 條 | Article 21 |
| 第二條第一項第七款產品保健功效成分鑑定報告，其項目及內容應包括保健功效成分之定性及定量試驗結果。 | The items and content of the identification report of ingredients with health care effect in the product in Subparagraph 7 of Paragraph 1 of Article 2 shall include qualitative and quantitative results of the ingredients with health care effect in the product. |
| 第三條健康食品，其依第二條應檢附之產品保健功效成分鑑定報告，其項目及內容應符合中央主管機關所定之健康食品規格標準。 | The items and content of the identification report of ingredients with health care effect in the product pursuant to Article 2 for the health foods in Article 3 shall meet the standards designated by the central competent authority in the Specification Standards for Health Foods. |
| 前二項鑑定使用之檢驗方法，應優先使用中央主管機關公告或公開建議者；採其他方法者，應檢具無差異或優於公告或公開建議檢驗方法之科學性依據及比對說明文件或參考資料。 | The testing method for the identification of ingredients with health care effect in the product in the preceding two paragraphs shall be the announced or recommended methods by the central competent authority preferentially; otherwise, scientific evidence and comparative reports indicating non-inferiority or superiority to the announced or recommended methods shall be required for using other testing method. |
| 廠商提出第一項及第二項鑑定報告時，應一併檢具有關檢驗方法標準作業程序及其查證或確效之文件、資料。 | The documents and information of the standard operating procedures and validation for the testing methods shall also be provided with the identification report submitted by applicants pursuant to Paragraph 1 and 2. |
| 有本法第三條第一項第一款後段情形者，廠商應提出具該保健功效各項原料之鑑定報告。 | If situation in the latter part of Subparagraph 1 of Paragraph 1 of Article 3 of the Act, the identification report of each ingredient with health care effect in the product shall be issued by applicants. |
| 第 22 條 | Article 22 |
| 第二條第一項第八款產品製程圖說，應包括原料調理、加工流程及加工條件。 | The product manufacturing process charts in Subparagraph 8 of Paragraph 1 of Article 2 shall include the preparation of the raw materials, processing procedures and conditions of processing. |
| 前項加工流程包括萃取者，應載明萃取方法及使用之溶劑；包括濃縮者，應載明濃縮之倍數。 | If the processing procedures involving extraction in the preceding paragraph, the method of extraction and the solvent shall be provided; the degree of concentration shall be also indicated for concentration processes. |
| 第 23 條 | Article 23 |
| 第二條第一項第九款佐證資料，應包括製程管制文件、品質管制文件、品管工程圖及其他證明符合生產國良好作業規範規定之文件、資料。 | The documentary evidence in Subparagraph 9 of Paragraph 1 of Article 2 shall include the documents of the control for the manufacturing process and quality control, engineering diagrams of quality control and other documents and information verifying compliance with good manufacturing practices. |
| 產品為輸入者，前項文件、資料得以原產國官方出具符合該國良好作業規範之證明文件代之；為國內生產且由藥廠兼製者，應提出經中央主管機關查核符合藥物優良製造準則且於有效日期內之證明文件。 | The documents and information in the preceding paragraph may be substituted with officially certificate documents verifying compliance with the respective good manufacturing practices from the country of origin for imported products; the certificate documents within effective period to be verified compliance with the Pharmaceutical Good Manufacturing Practice Regulations by the central competent authority shall be provided for domestic products manufactured by the pharmaceutical companies. |
| 第 24 條 | Article 24 |
| 產品由不同製造廠分段製造者，前條之文件、資料，應依製造廠別，分別出具。 | The documents and information in the preceding Article shall be issued separately by the respective factories for the products manufactured in different stages from different factories. |
| 產品屬前條第二項後段由藥廠兼製且由藥廠不同廠房生產者，應另檢具各藥廠之廠區平面圖。 | The floor plan of the different factories in the pharmaceutical company shall also be required for the domestic products manufactured by the pharmaceutical companies in the latter part of Paragraph 2 of the preceding Article and manufactured by the different factories. |
| 第 25 條 | Article 25 |
| 第二條第一項第十二款實體、彩色列印圖或彩色擬稿，其內容及標示方式，應符合本法第十三條、第十四條及食品安全衛生管理法相關規定。 | The content and the labeling for the physical objects, color printouts, or color drafts in Subparagraph 12 of Paragraph 1 of Article 2 shall meet the provisions in Articles 13 and Articles 14 of the Act as well as the relevant regulation of the Act Governing Food Safety and Sanitation. |
| 前項列印圖或擬稿之尺寸，應與實體一致，其文字應清晰可辨識。 | The size of the printouts and drafts shall be the same as the physical objects, and the displayed texts in printouts and drafts shall be clear and legible. |
| 第 26 條 | Article 26 |
| 第二條第一項第十五款報告、文獻資料，應具科學可靠性及正確性。 | The relevant research reports and literature in Subparagraph 15 of Paragraph 1 of Article 2 shall be reliable and accurate scientifically. |
| 第 27 條 | Article 27 |
| 廠商依本法第八條第一項規定，申請健康食品許可證展延者，應於期滿前三個月內，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： | Applications for extension of the permit for health food by applicants pursuant to Paragraph 1 of Article 8 of the Act shall submit an application form within 3 months prior to the expiry date of permit along with the following documents and information to the central competent authority and pay the related fees: |
| 一、原許可證。 | 1. Original permit. |
| 二、最近一年內製造廠出具同意依許可內容製造之證明文件或產品原料成分含量表。但許可證持有者與製造廠相同者，免附該證明文件。 | 2. The certificate documents issued by the product manufacturer within the past one year consent to manufacture products based on the content of originally issued permit or table of ingredient content, except for the certificate documents provided by the product manufacturer same as the permit holder. |
| 三、第二條第一項第十款至第十二款之文件、資料。 | 3. The documents and information set forth in Subparagraph 10 to 12 of Paragraph 1 of Article 2. |
| 四、其他中央主管機關指定之文件、資料。 | 4. Other essential documents and information designated by the central competent authority. |
| 健康食品許可證逾有效期限後，廠商仍有製造、輸入必要者，應重新申請許可證。但於逾期後六個月內重新申請者，得免提出下列文件、資料，並免申請複審： | After expiration of the health food permit, applicants with the needs of production and import for health food shall file an application for permit renewal, but the application filed within six months by the expiration of the permit may be waived of the requirement for secondary review and exempted from submission of the following documents and information: |
| 一、依第二條規定申請者：第二條第一項第二款、第三款、第四款及第十五款之文件、資料。 | 1. For applications filed pursuant to Article 2: The documents and information set forth in Subparagraph 2, 3, 4, and 15 of Paragraph 1 of Article 2. |
| 二、依第三條規定申請者：第二條第一項第四款之文件、資料。 | 2. For applications filed pursuant to Article 3: The documents and information set forth in Subparagraph 4 of Paragraph 1 of Article 2. |
| 前項申請經許可後，中央主管機關應核發新許可證及新字號。 | After approval of the applications filed pursuant to the preceding Paragraph, the central competent authority shall issue a new permit with a new permit number. |
| 第 28 條 | Article 28 |
| 廠商依本法第七條第三項規定，申請登記事項變更者，應填具申請書，檢附原許可證並繳納費用，向中央主管機關提出。 | Applications for amendment of the permit for health food by applicants pursuant to Paragraph 3 of Article 7 of the Act shall submit an application form along with the original permit to the central competent authority and pay the related fees. |
| 前項申請變更之項目屬下列情形者，應另檢附文件、資料： | In addition to the foregoing requirements, the following documents and information shall be additionally submitted according to the application of amendment: |
| 一、中文或英文品名變更且產品為輸入者：其製造廠出具產品名稱變更之證明或同意文件。 | 1. Product name change in Chinese or English for imported products: The certificate documents of consent to change of the product names issued by the original product manufacturer. |
| 二、許可證持有廠商名稱、地址或負責人變更： | 2. Change of name, address or responsible person of applicants holding the permit: |
| （一）第二條第一項第十三款之文件、資料。 | (1) The documents and information set forth in Subparagraph 13 of Paragraph 1 of Article 2. |
| （二）具二項以上健康食品者，其產品清冊，並載明許可證字號與有效期限及產品名稱。 | (2) A complete list of health food products with the numbers and expiry dates of permit and product name. |
| 三、增列或變更製造廠：第二條第一項第一款、第四款至第十二款及第十四款之文件、資料。 | 3. Addition or change of product manufacturer: The documents and information set forth in Subparagraph 1, 4 to 12 and 14 of Paragraph 1 of Article 2. |
| 四、製造廠遷廠變更：第二條第一項第四款、第九款及第十四款之文件、資料。 | 4. Relocation of the product manufacturer: The documents and information set forth in Subparagraph 4, 9 and 14 of Paragraph 1 of Article 2. |
| 五、製造廠名稱變更： | 5. Change of the original product manufacturer’s name: |
| （一）第二條第一項第十四款之文件、資料。 | (1) The documents and information set forth in Subparagraph 14 of Paragraph 1 of Article 2. |
| （二）由該製造廠製造之健康食品產品清冊，並載明許可證字號與有效期限及產品名稱。 | (2) A complete list of health food products with the numbers and expiry dates of permit and product name from the original product manufacturer. |
| 六、製造廠門牌整編： | 6. Building number adjustment of the original product manufacturer’s address: |
| （一）國內製造者︰政府機關出具足以證明門牌整編之文件。 | (1) In cases of domestic manufacturers: The documents issued by a competent government agency certifying the address building number adjustment. |
| （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，應經原產國公證單位簽證與正本相符。 | (2) In case of foreign manufacturers: The original certificate issued by a competent government agency of the country of origin with its full title certifying the building number adjustment, whereas photocopies of the certificate shall be notarized as a true copy of the original by a notary public in the country of origin. |
| （三）由該製造廠製造之健康食品產品清冊，並載明許可證字號與有效期限及產品名稱。 | (3) A complete list of health food products with the numbers and expiry dates of permit and product name from the original product manufacturer. |
| 七、色素、香料或甜味劑之成分、含量變更，而其他成分不變，且無礙產品安全者：第二條第一項第一款、第五款及第七款之文件、資料。 | 7. Change of ingredients and content of pigments, flavors or sweeteners but not of other ingredients and the no affection of product safety: The documents and information set forth in Subparagraph 1, 5, and 7 of Paragraph 1 of Article 2. |
| 八、內外包裝之規格、型態、材質、包裝粒數或商標名變更： | 8. Amendment to the inner or outer packaging specification, form, material and trademark: |
| （一）第二條第一項第十二款之文件、資料。 | (1) The documents and information set forth in Subparagraph 12 of Paragraph 1 of Article 2. |
| （二）內包裝變更者，其第二條第一項第四款之文件、資料。 | (2) In cases of the change to the inner packaging: The documents and information set forth in Subparagraph 4 of Paragraph 1 of Article 2. |
| （三）產品為輸入者，其製造廠出具變更之證明或同意文件。 | (3) In cases of the imported products: The certificate documents of consent to the changes issued by the original product manufacturer. |
| （四）材質變更者，其符合食品器具容器包裝衛生標準之相關佐證資料。 | (4) In cases of the change to the packaging materials: The documents and information in compliance with the Sanitation Standard for Food Utensils, Containers and Packages. |
| 九、中文標籤、容器或包裝及說明書變更： | 9. Change of Chinese labels, outer packaging, and user instructions: |
| （一）第二條第一項第十二款之文件、資料。 | (1) The documents and information set forth in Subparagraph 12 of Paragraph 1 of Article 2. |
| （二）產品為輸入者，其製造廠出具中文標籤、容器或包裝及說明書變更之證明或同意文件。 | (2) In cases of the imported products: The certificate documents of consent to change of Chinese labels, outer packaging, and user instructions issued by the original product manufacturer. |
| （三）營養標示變更，而產品成分及含量均未變更者： | (3) In cases of the changes of the nutrition facts labeling but not of product ingredients and content: |
| 1.第二條第一項第一款及第五款之文件、資料。 | A. The documents and information set forth in Subparagraph 1 and 5 of Paragraph 1 of Article 2. |
| 2.製造廠最近一年內出具之變更合理性評估報告。 | B. The evaluation report on the rationale of amendment issued by the product original manufacturer within the past one year. |
| 十、產品有效期限、保存方法及條件變更：第二條第一項第四款之文件、資料。 | 10. Change of expiration date, storage methods and conditions of the product: The documents and information set forth in Subparagraph 4 of Paragraph 1 of Article 2. |
| 第 29 條 | Article 29 |
| 健康食品之中文標籤、容器或包裝及說明書之變更，有下列情形之一者，免辦理變更申請： | Applications for the amendment of Chinese label, container or outer packaging, and user instructions of the health food products are exempted in one of the following situations: |
| 一、圖樣或顏色變更。 | 1. Amendment of patterns or colors. |
| 二、原核准圖文依比例縮小或放大。 | 2. Proportionate reduction or enlargement of the approved images and texts. |
| 三、原核准圖文位置變更。 | 3. Movement of the position of the approved images and texts. |
| 四、原核准文字字體變更。 | 4. Amendment of the fonts of the approved text. |
| 前項標籤、容器或包裝及說明書，刊載本法以外其他相關機關規定之內容者，其變更應依各該法規規定辦理。 | The amendment in the preceding paragraph of the labels, container or outer packaging and user instructions which contain the content stipulated by relevant authorities other than those specified in the Act shall be subject to the provisions of respective regulations. |
| 持有健康食品許可證者，應就第一項免辦理變更之事項，作成書面紀錄，並妥善保存備查。 | For items exempted from amendment applications as set forth in the first paragraph, the permit holder shall produce a written record for retention. |
| 第 30 條 | Article 30 |
| 廠商依本法第七條第三項規定，申請許可證移轉者，受讓人應填具申請書，檢附下列文件、資料，並繳納費用，向中央主管機關提出： | Applications for transference of the permit for health food by applicants pursuant to Paragraph 3 of Article 7 of the Act shall submit an application form along with the original permit to the central competent authority and pay the related fees: |
| 一、原許可證。 | 1. Original permit. |
| 二、讓與人同意讓與之證明文件。 | 2. Transferor’s certificate document of consent to transfer of the permit holder. |
| 三、製造廠出具同意由受讓人銷售產品之證明文件。 | 3. The certificate documents of consent to the transferee selling the products issued by the original product manufacturer. |
| 四、第二條第一項第十款至第十三款之文件、資料。 | 4. The documents and information set forth in Subparagraph 10 to 13 of Paragraph 1 of Article 2 issued by the transferee. |
| 第 31 條 | Article 31 |
| 健康食品許可證污損或遺失，廠商依本法第八條第二項規定申請換發或補發者，應填具申請書，並出具原許可證作廢之切結聲明及繳納費用，向中央主管機關提出；其申請換發者，應繳還原許可證。 | Applications for reissuance or replacement of the permit for health food due to defacement or loss by applicants pursuant to Paragraph 2 of Article 8 of the Act shall submit an application form along with a statement that declares the original permit document null and void to the central competent authority and pay the related fees, while the originally issued permit should be returned for replacement application. |
| 前項換發或補發之許可證，其有效期限，同原許可證。 | The new permit issued under the replacement or reissuance application as referred in the preceding paragraph shall bear the same expiration date as the original permit. |
| 第 32 條 | Article 32 |
| 廠商依第二十七條、第二十八條、第三十條或前條規定提出之申請案，經中央主管機關認定文件、資料不完備者，廠商應於收受中央主管機關通知後一個月內補正；必要時，得申請延長一個月，並以一次為限。屆期未補正者，予以駁回。 | If the documents and information are incomplete considered by the central competent authority in the applications filed by applicants pursuant to Articles 27, 28, 30 or the preceding Article, the applicants shall, within one month after receiving of the notice of the central competent authority, submit the supplementary documents and information, and may apply for a one-month extension if necessary. The application for extension is limited to one time only. Without submitting the supplementary documents and information within the time limit results in the rejection of the application. |
| 第 33 條 | Article 33 |
| 廠商依第二十七條、第二十八條、第三十條或第三十一條規定提出之申請案，其應檢具文件、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。 | The foregoing documents and information in languages other than English and Chinese in the applications filed by applicants pursuant to Articles 27, 28, 30 or 31 must be accompanied with English or Chinese translations issued by a registered translation agency. |
| 廠商依第二十七條、第二十八條、第三十條或第三十一條規定提出之申請案，其發給或重製許可證者，並應繳納證書費。 | If it is necessary to issue or reissue a new permit in the applications filed by applicants pursuant to Articles 27, 28, 30 or 31, a certificate processing fee shall be collected. |
| 第 34 條 | Article 34 |
| 本辦法所定申請案，廠商得至衛生福利部食品藥物管理署建置之食品線上申辦平臺辦理；至線上申辦平臺辦理者，其文件、資料，應以掃描電子檔上傳。 | Applications in accordance with the provisions of the Regulations may be filed by the applicants on the web platform of Taiwan Food and Drug Administration of the Ministry of Health and Welfare, and the documents and information in the applications shall be scanned and uploaded to the web platform. |
| 健康食品許可證展延、查驗登記內容變更、移轉及換發之申請案，廠商依前項規定辦理後，應將原許可證寄送中央主管機關登載用印或繳銷。 | After completion of applications by applicants for permit extension, amendment of registration contents, document transference or document replacement pursuant to provisions in the preceding paragraph, the original permit document shall be sent to the central competent authority for registration or cancellation. |
| 第 35 條 | Article 35 |
| 本辦法自發布日施行。 | These Regulations shall come into effect on the date of promulgation. |
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