加拿大保健食品登記法規問題集

加拿大主要城市公司設立登記,商標登記，進出口證，特許行業申請等。公司設立後雲端系統支援的會計薪資服務。 加拿大多倫多與臺灣同事攜手協同爲您服務。為地球暖化盡一份心力，減少空中旅行。
Email：yto4ww@evershinecpa.com
或
加拿大永輝BPO有限公司
Canada time zone:
Manager Ian Lin 說中文和英文
或
China Time Zone:
聯絡人: 陳中成 總經理 in 台+中+英;專利師;企管碩士+企管博士
Mobile: +886-933920199 in Taiwan; Mobile: +86-139-1048-6278 in China
TEL: +886-2-27170515 E100 ;
Wechat id:evershiinecpa;
Line Id: evershinecpa
Skype: daleccchen ;
linkedin address:Dale Chen Linkedin

時間：2022/07/28 drafted by Yvonne Chen

各國健康食品登記法規問題集

HLF-TW-10
請問加拿大對於保健食品的歸類方式為何？它的正式名稱為何？不同歸類管理強度有何差異?它的政府管轄機構為何？網頁？

What are the categories of health food in Canada? What is its official name? What is the intensity of management of different categories? What is the governmental authority of health food? Website?
Evershine RD：
在加拿大，保健食品稱為天然保健品（NHP），由加拿大衛生部監管，需要處方的產品按藥品規範監管。

天然保健品是用於恢復或維持健康的天然物質。它們通常由植物製成，但也可以由動物、微生物和海洋來源製成。它們有多種形式，如片劑、膠囊、酊劑、溶液、乳膏、軟膏和滴劑。

1.天然保健品通常被稱為補充或替代藥物，包括：
．維生素和礦物質
．草藥療法
．順勢療法藥物
．傳統藥物，如中藥和阿育吠陀（東印度）藥物
．益生菌
．其他產品，如氨基酸和必需脂肪酸
．許多日常消費品，如某些牙膏、止汗劑、洗髮水、面部產品和漱口水，在加拿大也被歸類為天然保健品。
2.NHP 的使用和銷售有多種健康原因，例如預防或治療疾病或病症、降低健康風險或維持良好健康。它們必須安全才能作為非處方產品使用。需要處方的產品按照藥品進行監管。

In Canada, health foods are called natural health products (NHP), which are regulated by Health Canada, and products that require prescriptions are regulated by pharmaceutical regulations.

Natural health products are natural substances used to restore or maintain health. They are usually made from plants, but can also be made from animal, microbial and marine sources. They come in various forms such as tablets, capsules, tinctures, solutions, creams, ointments, and drops.

1. Natural health products, often referred to as complementary or alternative medicine, include:
   ．Vitamins and minerals
   ．Herbal therapy
   ．Homeopathic medicines
   ．Traditional medicines such as Chinese and Ayurvedic (East Indian) medicines
   ．Probiotics
   ．Other products such as amino acids and essential fatty acids
   ．Many everyday consumer products, such as certain toothpastes, antiperspirants, shampoos, facial products and mouthwashes, are also classified as natural health products in Canada.
2. NHPs are used and marketed for a variety of health reasons, such as preventing or treating a disease or condition, reducing health risks, or maintaining good health. They must be safe to be available as an over-the-counter product. Products that require a prescription are regulated as pharmaceuticals.

【參考連結】
https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/regulation/about-products.html#a1

HLF-TW-20
外國公司要到加拿大銷售保健食品，無論設100%子公司或分公司，需要在公司登記時取得營業特許證？假如要，其必要條件是什麼？所需文件及申請程序為何？網頁？

If a foreign company wants to sell health food in Canada, no matter if it sets up a 100% subsidiary or branch, does it need to obtain an approval from local health bureau before the company’s registration? If so, what are the requests? What are the required documents and application procedures? Website?
Evershine RD：
需要，在加拿大銷售天然保健品需要取得場地許可證(站點許可證)，外國製造的商品申請的為外國地點參考號(FSRN)，除了取得FSRN之外，要與加拿大公司建立合作夥伴關係才得以進口。

外國地點參考號(FSRN)：
1.申請網頁：
https://nnhpd-site-licence-dexploitation-dpsnso.hc-sc.gc.ca/websla/en/application#sect19
2.具備資料：
．公司名稱、公司代碼、街道、城市和國家/地區、省/州和郵政編碼。
．品質保證人的姓名、完整郵寄地址、電話號碼、傳真號碼（如果有）和電子郵件地址。如果品質保證人與本申請的聯繫人位於同一地址，則不需要完整的郵寄地址
．品質保證人資格證明
．存儲/倉庫
．活動類型：製造、包裝、標籤、進口
．產品類別：非無菌、無菌、順勢療法
．GMP 證據：質量保證報告(QAR)、淨變化摘要 (SNC)、藥品生產許可證（DEL）、合格機構頒發的 GMP 證書、NSF 標準 173 第 8 節證書、UL 報告、美國FDA機構檢驗報告（FDA EIR）
．供應鏈
．儲存條件
．鑑證

Yes, the sale of natural health products in Canada requires a site license. Foreign-made products apply for a foreign site reference number (FSRN). In addition to obtaining the FSRN, they must establish a partnership with a Canadian company before they can be imported.

Foreign Site Reference Number (FSRN):

1. Application webpage:
   https://nnhpd-site-licence-dexploitation-dpsnso.hc-sc.gc.ca/websla/en/application#sect19
2. Have information:
   ．Company name, company code, street, city and country, province/state and zip code.
   ．The quality assurance person’s name, full mailing address, telephone number, fax number (if available), and email address. The full mailing address is not required if the QA is at the same address as the contact person for this application
   ．Quality Assurer Qualification Certificate
   ．Storage/warehouse
   ．Type of activity: Manufacturing, packaging, labelling, importing
   ．Product categories: non-sterile, sterile, homeopathic
   ．GMP Evidence: Quality Assurance Report (QAR), Summary Net Change (SNC), Drug Manufacturing License (DEL), GMP Certificate issued by Qualified Institution, NSF Standard 173 Section 8 Certificate, UL Report, US FDA Agency Inspection Report (FDA EIR)
   ．Supply chain
   ．Storage conditions
   ．Authentication

【參考連結】
https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/applications-submissions/site-licensing/forms.html

HLF-TW-25

HLF-TW-30
外國公司要到加拿大銷售保健食品，可以指派加拿大公司擔任營業代理人銷售嗎? 擔任營業代理人，其必要條件是什麼？所需文件及申請程序為何？外國公司與營業代理人的產品責任為何?網頁？

If a foreign company wants to sell health food in Canada, can it assign a Canada company to act as a business agent? What are the requests for acting as a business agent? What are the required documents and application procedures? What is the product liability of foreign companies and the business agents? Website?
Evershine RD：
可以。
在加拿大銷售天然保健品需要取得場地許可證(站點許可證)。
1.申請網頁：
https://nnhpd-site-licence-dexploitation-dpsnso.hc-sc.gc.ca/websla/en/application#sect19

2. 具備資料：
   ．公司名稱、公司代碼、街道、城市和國家/地區、省/州和郵政編碼。
   ．品質保證人的姓名、完整郵寄地址、電話號碼、傳真號碼（如果有）和電子郵件地址。如果品質保證人與本申請的聯繫人位於同一地址，則不需要完整的郵寄地址
   ．品質保證人資格證明
   ．存儲/倉庫
   ．活動類型：製造、包裝、標籤、進口
   ．產品類別：非無菌、無菌、順勢療法
   ．GMP 證據：質量保證報告(QAR)、淨變化摘要 (SNC)、藥品生產許可證（DEL）、合格機構頒發的 GMP 證書、NSF 標準 173 第 8 節證書、UL 報告、美國FDA機構檢驗報告（FDA EIR）
   ．供應鏈
   ．儲存條件
   ．鑑證

產品責任
1.產品許可證持有人在天然保健品所致境內或境外不良反應的15 天內應向衛生部提出報告。

2. 銷售天然保健品許可人，應每年準備並維護一份總結報告，其中包含對天然保健品的簡明和批判性分析繳交衛生部。
   3.當發生召回事件，產品許可證持有人應在開始召回之日後三天內向衛生部報告。

Yes.
Selling natural health products in Canada requires a site permit (site permit).

1. Application webpage:
   https://nnhpd-site-licence-dexploitation-dpsnso.hc-sc.gc.ca/websla/en/application#sect19
2. Have information:
   ．Company name, company code, street, city and country, province/state and zip code.
   ．The quality assurance person’s name, full mailing address, telephone number, fax number (if available), and email address. The full mailing address is not required if the QA is at the same address as the contact person for this application
   ．Quality Assurer Qualification Certificate
   ．Storage/warehouse
   ．Type of activity: Manufacturing, packaging, labelling, importing
   ．Product categories: non-sterile, sterile, homeopathic
   ．GMP Evidence: Quality Assurance Report (QAR), Summary Net Change (SNC), Drug Manufacturing License (DEL), GMP Certificate issued by Qualified Institution, NSF Standard 173 Section 8 Certificate, UL Report, US FDA Agency Inspection Report (FDA EIR)
   ．Supply chain
   ．Storage conditions
   ．Authentication

Product responsibility
1.The product license holder shall submit a report to the Ministry of Health within 15 days of any domestic or overseas adverse reactions caused by natural health products.
2.Licensors selling natural health products shall prepare and maintain a summary report containing a concise and critical analysis of natural health products annually to the Ministry of Health.
3.In the event of a recall, the product licensee shall report to the Ministry of Health within three days of the date of the recall.

【參考連結】
https://laws-lois.justice.gc.ca/eng/regulations/sor-2003-196/page-3.html#h-700569
https://nnhpd-site-licence-dexploitation-dpsnso.hc-sc.gc.ca/websla/en/landing

HLF-TW-35

HLF-TW-40
外國公司銷售到加拿大保健食品本身，進口前需要辦理產品許可嗎？如需要，哪個單位在管理？需要什麼文件？申請程序為何？保健食品包裝內容及各種標示，需要事先核准嗎？可允許的語文有哪些？網頁？

Do foreign companies need to apply for an approval before importing health food sold to Canada? If yes, which authority is in charge? What documents are required? What is the application process? Do health food packaging and labeling require prior approval? Which languages are allowed? Website?
Evershine RD：
需要。
產品許可證(NPN)申請應向加拿大衛生部提交，包含以下資料和文件：
1.申請人的姓名、地址和電話號碼
2.申請人的傳真號碼和電子郵件地址（如有）
3.如果申請人的地址不是加拿大，需填寫在加拿大代表的姓名、地址和電話號碼。

4. 天然保健品的每種藥用成分：
   ．專有名稱和通用名稱
   ．每劑量單位的數量
   ．功效
   ．標籤上要顯示與其功效有關的說明
   ．來源材料的描述
   ．是否為合成製造的聲明
   ．建議用於天然保健品的非藥用成分的定性清單，以及所列每種成分的說明該成分用途的聲明
   ．擬銷售天然保健品的每個品牌名稱
   ．天然保健品的推薦使用條件
   ．證明天然保健品按照推薦使用條件使用時的安全性和有效性
   ．擬與天然保健品結合使用的每個標籤的文字
   ．天然保健品應符合的規格副本
   ．以下證明之一：如果天然保健品是進口的，申請人提供證明，證明該天然保健品將按照規定要求進行製造、包裝、標籤、進口、分銷和儲存；或如果天然保健品不是進口的，申請人提供該天然保健品將按照規定的要求製造、包裝、標籤、分銷和儲存的證明。

標籤

1. 天然保健品的標籤應採用英語和法語表示，包含：
   ．使用條件的所有訊息
   ．所含的每種藥用成分和每種非藥用成分的通用名稱和專有名稱(如果藥用成分或非藥用成分的通用名或專有名稱沒有英語或法語的對應名稱，則應以任何其他語言顯示該名稱)
   ．藥物成分來源材料的描述
   ．儲存條件
2. 標籤標註的表述、訊息和聲明要清晰、顯眼，在購買和使用的習慣條件下，購買者或消費者容易辨別。
3. 只有一個標籤的，該標籤應當顯示內、外標籤中需要標註的所有說明、訊息和聲明。
4. 每個批號前面應帶有下列其中一項：批號/批次/(L)
5. 順勢療法藥物前面應標有DIN-HM。
6. 其他天然保健品前面應註明NPN。
7. 天然保健品的內標籤和外標籤應顯示以下訊息
   主要顯示面上
   ．品牌名稱
   ．產品編號
   ．劑型
   ．無菌的需註明sterile和stérile
   ．以重量、尺寸或數量表示直接容器內的淨含量
   在任何顯示面上
   ．產品許可證持有者的姓名和地址
   ．進口商的名稱和地址
   ．所含每種藥用成分的通用名稱
   ．每種藥用成分的正確名稱，但前提是該正確名稱不是化學名稱
   ．按專有名稱或通用名稱（如果專有名稱是化學名稱）列出的列表，列出每個劑量單位的每種藥物成分的數量以及該藥物成分的授權效力（如果有）
   ．推薦用途或目的
   ．推薦的給藥途徑
   ．推薦劑量
   ．建議的使用期限（如有）
   ．其風險信息，包括與其使用相關的任何警告、警告、禁忌症或已知不良反應
   ．推薦的儲存條件（如有）
   ．批號
   ．到期日
   ．所含每種藥用成分的來源材料的描述
   外標籤還應顯示
   ．天然保健品所有非藥用成分的通用名定性清單，前面加上非藥用成分字樣
   ．如果天然保健品含有汞或其任何鹽類或衍生物作為非藥用成分，則需提供一份說明天然保健品中汞含量的聲明

Yes.
Product License (NPN) applications should be submitted to Health Canada and include the following information and documents:

1. Applicant’s name, address and phone number
2. Applicant’s fax number and email address (if available)
3. If the applicant’s address is not in Canada, the name, address and phone number of the representative in Canada must be filled in.
4. Each medicinal ingredient of natural health products:
   ．Proper and Common Names
   ．Quantity per dosage unit
   ．Effect
   ．The label should display a statement about its efficacy
   ．Description of source material
   ．Statement of whether it is synthetically manufactured or not
   ．A qualitative list of non-medicinal ingredients suggested for use in natural health products, along with a statement for each listed ingredient describing the ingredient’s use
   ．Each brand name under which natural health products are proposed to be marketed
   ．Recommended Conditions of Use for Natural Health Products
   ．Prove that natural health products are safe and effective when used according to recommended conditions of use
   ．Text for each label intended for use in conjunction with natural health products
   ．Copies of specifications to which natural health products are expected to comply
   ．One of the following certifications: If the natural health product is imported, the applicant provides evidence that the natural health product will be manufactured, packaged, labeled, imported, distributed, and stored in accordance with prescribed requirements; or if the natural health product is not imported, the applicant Provide evidence that the natural health product will be manufactured, packaged, labeled, distributed, and stored in accordance with prescribed requirements.

Label

1. The label of the natural health product shall be in English and French, containing:
   ．All information on conditions of use
   ．The generic and proper names of each medicinal ingredient and each non-medicinal ingredient contained (if the generic or proprietary name of a medicinal or non-pharmaceutical ingredient has no English or French equivalent, it should be substituted by display the name in any other language)
   ．Description of source material for pharmaceutical ingredients
   ．Storage conditions
2. The expressions, messages and declarations marked on the label should be clear and conspicuous, so that buyers or consumers can easily identify them under the customary conditions of purchase and use.
3. If there is only one label, the label shall display all the instructions, messages and statements that need to be marked on the inner and outer labels.
4. Each batch number should be preceded by one of the following: batch number/batch/(L)
5. Homeopathic medicines shall be preceded by DIN-HM.
6. NPN should be indicated before other natural health products.
7. The inner and outer labels of natural health products should show the following information
   main display surface
   ．Brand name
   ．Product number
   ．Formulation
   ．Sterile should be marked with sterile and stérile
   ．Expressing the net content of the immediate container by weight, measure or count on any display
   ．Name and address of product licensee
   ．Importer’s name and address
   ．Generic name of each medicinal ingredient contained
   ．The correct name of each medicinal ingredient, provided that the correct name is not a chemical name
   ．A listing, by proprietary or generic name (if the proprietary name is a chemical name), of the quantity of each drug ingredient per dosage unit and the authorized potency of that drug ingredient, if available
   ．Recommended use or purpose
   ．Recommended route of administration
   ．Recommended dosage
   ．Recommended age of use (if any)
   ．Its risk information, including any warnings, warnings, contraindications or known adverse reactions related to its use
   ．Recommended storage conditions (if any)
   ．Batch number
   ．Expiry date
   ．A description of the source material for each contained medicinal ingredient
   The outer label should also show
   ．Qualitative list of generic names of all non-medicinal ingredients in natural health products, preceded by the words non-medicinal ingredients
   ．If the natural health product contains mercury or any of its salts or derivatives as a non-medicinal ingredient, provide a statement stating the amount of mercury in the natural health product

【參考連結】
https://laws-lois.justice.gc.ca/eng/regulations/sor-2003-196/
https://laws-lois.justice.gc.ca/eng/regulations/sor-2003-196/page-2.html#docCont

HLF-TW-45

HLF-TW-50
外國公司可以用自己名義申請辦理產品許可嗎？如需要，哪個單位在管理？需要什麼文件？申請程序為何？保健食品包裝內容及各種標示，需要事先核准嗎？可允許的語文有哪些？？網頁？

Can a foreign company apply for a product license by its own name? If yes, which authority is in charge? What documents are required? What is the application process? Do health food packaging and labeling require prior approval? Which languages are allowed?? Website?
Evershine RD：
可以，但申請的資料中，仍須提供加拿大代表的姓名、地址和電話號碼。
產品許可證(NPN)申請應向加拿大衛生部提交，包含以下資料和文件：
1.申請人的姓名、地址和電話號碼
2.申請人的傳真號碼和電子郵件地址（如有）
3.如果申請人的地址不是加拿大，需填寫在加拿大代表的姓名、地址和電話號碼。

4. 天然保健品的每種藥用成分：
   ．專有名稱和通用名稱
   ．每劑量單位的數量
   ．功效
   ．標籤上要顯示與其功效有關的說明
   ．來源材料的描述
   ．是否為合成製造的聲明
   ．建議用於天然保健品的非藥用成分的定性清單，以及所列每種成分的說明該成分用途的聲明
   ．擬銷售天然保健品的每個品牌名稱
   ．天然保健品的推薦使用條件
   ．證明天然保健品按照推薦使用條件使用時的安全性和有效性
   ．擬與天然保健品結合使用的每個標籤的文字
   ．天然保健品應符合的規格副本
   ．以下證明之一：如果天然保健品是進口的，申請人提供證明，證明該天然保健品將按照規定要求進行製造、包裝、標籤、進口、分銷和儲存；或如果天然保健品不是進口的，申請人提供該天然保健品將按照規定的要求製造、包裝、標籤、分銷和儲存的證明。

標籤

1. 天然保健品的標籤應採用英語和法語表示，包含：
   ．使用條件的所有訊息
   ．所含的每種藥用成分和每種非藥用成分的通用名稱和專有名稱(如果藥用成分或非藥用成分的通用名或專有名稱沒有英語或法語的對應名稱，則應以任何其他語言顯示該名稱)
   ．藥物成分來源材料的描述
   ．儲存條件
2. 標籤標註的表述、訊息和聲明要清晰、顯眼，在購買和使用的習慣條件下，購買者或消費者容易辨別。
3. 只有一個標籤的，該標籤應當顯示內、外標籤中需要標註的所有說明、訊息和聲明。
4. 每個批號前面應帶有下列其中一項：批號/批次/(L)
5. 順勢療法藥物前面應標有DIN-HM。
6. 其他天然保健品前面應註明NPN。
7. 天然保健品的內標籤和外標籤應顯示以下訊息
   主要顯示面上
   ．品牌名稱
   ．產品編號
   ．劑型
   ．無菌的需註明sterile和stérile
   ．以重量、尺寸或數量表示直接容器內的淨含量
   在任何顯示面上
   ．產品許可證持有者的姓名和地址
   ．進口商的名稱和地址
   ．所含每種藥用成分的通用名稱
   ．每種藥用成分的正確名稱，但前提是該正確名稱不是化學名稱
   ．按專有名稱或通用名稱（如果專有名稱是化學名稱）列出的列表，列出每個劑量單位的每種藥物成分的數量以及該藥物成分的授權效力（如果有）
   ．推薦用途或目的
   ．推薦的給藥途徑
   ．推薦劑量
   ．建議的使用期限（如有）
   ．其風險信息，包括與其使用相關的任何警告、警告、禁忌症或已知不良反應
   ．推薦的儲存條件（如有）
   ．批號
   ．到期日
   ．所含每種藥用成分的來源材料的描述
   外標籤還應顯示
   ．天然保健品所有非藥用成分的通用名定性清單，前面加上非藥用成分字樣
   ．如果天然保健品含有汞或其任何鹽類或衍生物作為非藥用成分，則需提供一份說明天然保健品中汞含量的聲明

Yes, but the name, address and telephone number of the Canadian representative must still be included in the application.

A product license (NPN) application should be submitted to Health Canada, containing the following information and documents:

1. Applicant’s name, address and phone number
2. Applicant’s fax number and email address (if available)
3. If the applicant’s address is not in Canada, fill in the name, address and telephone number of the representative in Canada.
4. Each medicinal ingredient of natural health products:
   ．Proper and Common Names
   ．Quantity per dosage unit
   ．Effect
   ．The label should show a statement about its efficacy
   ．Description of source material
   ．Statement of whether it is synthetically manufactured or not
   ．A qualitative list of non-medicinal ingredients recommended for use in natural health products, along with a statement for each ingredient listed describing the ingredient’s use
   ．Each brand name under which natural health products are proposed to be marketed
   ．Recommended Conditions of Use for Natural Health Products
   ．Demonstrate the safety and effectiveness of natural health products when used according to recommended conditions of use
   ．Text for each label intended for use in conjunction with natural health products
   ．A copy of the specifications that the natural health product should meet
   ．One of the following certifications: If the natural health product is imported, the applicant provides evidence that the natural health product will be manufactured, packaged, labeled, imported, distributed, and stored in accordance with prescribed requirements; or if the natural health product is not imported, the applicant Provide evidence that the natural health product will be manufactured, packaged, labeled, distributed, and stored in accordance with prescribed requirements.

Label

1. The label of the natural health product shall be in English and French, containing:
   ．All information on conditions of use
   ．The generic and proper names of each medicinal ingredient and each non-medicinal ingredient contained (if the generic or proprietary name of a medicinal or non-pharmaceutical ingredient has no English or French equivalent, it should be substituted by display the name in any other language)
   ．Description of source material for pharmaceutical ingredients
   ．Storage conditions
2. The expressions, messages and declarations marked on the label should be clear and conspicuous, so that buyers or consumers can easily identify them under the customary conditions of purchase and use.
3. If there is only one label, the label shall display all the instructions, messages and statements that need to be marked on the inner and outer labels.
4. Each batch number should be preceded by one of the following: batch number/batch/(L)
5. Homeopathic medicines shall be preceded by DIN-HM.
6. NPN should be indicated before other natural health products.
7. The inner and outer labels of natural health products should show the following information
   main display surface
   ．Brand name
   ．Product number
   ．Formulation
   ．Sterile should be marked with sterile and stérile
   ．Expressing the net content of the immediate container by weight, measure or count on any display
   ．Name and address of product licensee
   ．Importer’s name and address
   ．Generic name of each medicinal ingredient contained
   ．The correct name of each medicinal ingredient, provided that the correct name is not a chemical name
   ．A listing, by proprietary or generic name (if the proprietary name is a chemical name), of the quantity of each drug ingredient per dosage unit and the authorized potency of that drug ingredient, if available
   ．Recommended use or purpose
   ．Recommended route of administration
   ．Recommended dosage
   ．Recommended age of use (if any)
   ．Its risk information, including any warnings, warnings, contraindications or known adverse reactions related to its use
   ．Recommended storage conditions (if any)
   ．Batch number
   ．Expiry date
   ．A description of the source material for each contained medicinal ingredient
   The outer label should also show
   ．Qualitative list of generic names of all non-medicinal ingredients in natural health products, preceded by the words non-medicinal ingredients
   ．If the natural health product contains mercury or any of its salts or derivatives as a non-medicinal ingredient, provide a statement stating the amount of mercury in the natural health product

【參考連結】
https://nnhpd-pla-dlmm-dpsnso.hc-sc.gc.ca/pla-dlmm/
https://laws-lois.justice.gc.ca/eng/regulations/sor-2003-196/

HLF-TW-55

HLF-TW-60
經過核准登記的保健食品，進口到加拿大要檢附什麼文件？經過什麼手續？在銷售時要向各地的衛生福利部相關機構事先或事後準備嗎？網頁？

What documents are required when importing approved health food into Canada? What is the procedure? Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?
Evershine RD：
須先完成產品許可證書及進口場地許可證(站點許可證)。
天然保健品商業進口須具備以下文件
1.具備產品許可證（NPN）
2.授權或許可供應商/進口商的發票/海關文件
3.進口商必須擁有開展進口活動的場地許可證(站點許可證)。

4. 海關發票
5. 銷售確認書 (COS)：聯繫人姓名、地址、城市、州/省、郵政編碼、電話號碼、傳真號碼、電子郵件地址等。
6. 形式發票：當商業發票或加拿大海關發票不可用時，可以使用形式發票。
7. CUSMA原產地認證：僅適用於來自加拿大、美國和/或墨西哥且價值超過 3,300 加元的合格貨物，根據新的北美自由貿易協定要求進入加拿大的合格商業商品降低關稅。
8. ACI 電子艙單：保稅倉庫地點、航班資訊、成員資料、省/州/國家、交通工具車牌號、拖車車牌號碼、運輸單位數量、拖車單位號、報關行、托運人姓名和地址、收貨人姓名和地址、託運商品完整描述、數量和重量等。
9. PARS通知(加拿大境內貨件通知) ：預計抵達入境口岸的時間、物流訊息、進口商名稱、件數、包裝類型、重量、承運人名稱、調度電話、司機姓名、司機電話號碼等。

於進口時就要具備場地/站點許可證，無另行銷售通知。

Must first complete the product license certificate and import site license (site license).
The following documents are required for the commercial import of natural health products

1. Possess product license (NPN)
2. Invoices/customs documents from authorized or licensed suppliers/importers
3. The importer must have a site permit (site permit) to carry out import activities.
4. Customs invoice
5. Confirmation of Sale (COS): Contact name, address, city, state/province, zip code, phone number, fax number, email address, etc.
6. Proforma Invoice: Proforma Invoice can be used when Commercial Invoice or Canadian Customs Invoice are not available.
7. CUSMA Origin Certification: Applicable only to qualified goods from Canada, the United States and/or Mexico with a value of more than 3,300 Canadian dollars, reduced tariffs for qualified commercial goods entering Canada under the new North American Free Trade Agreement requirements.
8. ACI electronic manifest: bonded warehouse location, flight information, member information, province/state/country, vehicle license plate number, trailer license plate number, transport unit quantity, trailer unit number, customs broker, shipper’s name and address, receipt The name and address of the consignor, the complete description, quantity and weight of the consigned goods, etc.
9. PARS notification (shipment notification in Canada): estimated time of arrival at the port of entry, logistics information, importer name, number of pieces, packaging type, weight, carrier name, dispatch phone number, driver name, driver phone number, etc.

Venue/Site Permit is required at the time of import without further notice of sale.

【參考連結】
https://www.cbsa-asfc.gc.ca/import/menu-eng.html
https://buyandsell.gc.ca/policy-and-guidelines/standard-acquisition-clauses-and-conditions-manual/5/C/C2610C/1
https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/importation-exportation/commercial-use-health-products-guidance/document.html#sec63

HLF-TW-70
加拿大保健食品審核機構，需要附上的實驗室檢驗資料有哪些? 網頁？

What are the laboratory inspection materials that need to be attached for verification? Website?
Evershine RD：
實驗室檢驗資料
表徵
1.化學品(高度純化的成分，例如：分離物和合成重複品)
．加工原料
．標準化萃取物
．強化萃取物
2.鑑別試驗
．植物產品的適當標示
．特定藥用成分的適當標示
．成品測試

3. 數量
   ．測定定量(植物成分、維生素和礦物質、分離物和合成重複品、活微生物、酶、輸入量化)

純度標準
1.微生物污染物
．特定產品和給藥途徑的微生物污染要求(多組分產品、液體劑型產品、無菌產品、化學污染物)
2.元素雜質
．砷
．六價鉻
．重金屬總量

3. 其他雜質
   ．黴菌毒素
   ．藍藻毒素
   ．溶劑殘留
   ．動物材料激素檢測
   ．酶製劑
   ．附帶雜質、有關物質和工藝雜質
   ．農藥殘留
   ．海洋油中的污染物
   ．蜂產品中抗生素殘留
   ．放射性
   ．油中的氧化穩定性
   ．天然保健品中的潛在摻雜物
   ．成分來源於易患傳染性海綿狀腦病（TSE）和牛海綿狀腦病（BSE）的組織

附加測試和標準
1.一般質量指標
．異物
．酸不溶性灰分的測定
．含水量
．非藥用成分
．性能測試
．解體
．解散
．劑量單位的均勻性
．順勢療法藥物的標準
．支持標籤聲明的分析測試和要求
．減少規範中的測試計劃
．抗菌效果測試
．穩定性測試

良好生產規範（GMP）
1.如果在不良 GMP 條件下製造或包裝，則可能會受到微生物、物理和/或化學污染。遵守 GMP 是強制的，因為可以確保更高品質和對產品的信心。
2.每種天然保健產品均應在設計、建造和維護的場所中製造、包裝、貼標籤和儲存，場所的設計、建造和維護方式應允許在衛生條件下進行活動，尤其著重：
．場所保持清潔和有序
．有效清潔場所內的所有表面
．適當儲存或加工天然保健品
．防止天然保健品受到污染
．防止在天然保健品中添加外來物質。

3. 人員：每種天然保健產品均應由經過教育、培訓或具有執行各自任務資格的人員製造、包裝、貼標籤和儲存。
4. 衛生計劃：每種天然保健品均應按照規定的衛生計劃進行製造、包裝、貼標籤和儲存。
5. 運營：每種天然保健品均應按照標準操作程序進行製造、包裝、標籤和儲存，旨在確保活動按照本部分的要求進行。
6. 質量保證
   ．每個製造商、包裝商、貼標商、進口商和分銷商應有一名質量保證人員
   ．負責在銷售前確保天然保健品的質量
   ．具有與所進行的活動和本部分要求相關的培訓、經驗和技術知識和調查並記錄收到的有關天然保健品質量的每一起投訴，並在必要時採取糾正措施。
   ．每種天然保健品均應僅使用在活動中使用之前已獲得質量保證人員批准用於該用途的材料來製造、包裝和貼標籤。
   ．每種天然保健品的生產、包裝、標籤和儲存均應採用在實施前經過質量保證人員批准的方法和程序。
   ．天然保健品的每批或批次均應經質量保證人員批准後方可銷售。
   ．銷售並隨後退回其製造商、包裝商、標籤商、進口商或分銷商的每一種天然保健產品，在該天然保健產品可供進一步銷售之前，均應得到品質保證人員的批准。
7. 穩定期
   ．每個製造商和每個進口商應確定天然保健品在包裝銷售後保持其純度和物理特性及其藥用成分保持其每劑量單位數量及其效力的時間期限。
8. 記錄，銷售天然保健品的生產商應當在天然保健品的生產現場保存以下記錄：
   ．生產主文件；所有成分清單、任何測試的記錄、規格副本、要求生產的記錄、每項決定的記錄以及支持該決定的訊息、生產清單、衛生計劃的副本、建議的儲存條件

Laboratory test data
Characterize
1.Chemicals (highly purified components, e.g. isolates and synthetic replicates)
．Processing raw materials
．Standardized Extracts
．Fortified Extracts
2.Differential test
．Appropriate labeling of plant products
．Appropriate labeling of certain medicinal ingredients
．Finished product test
3.Quantity
．Assay quantification (plant components, vitamins and minerals, isolates and synthetic replicates, live microorganisms, enzymes, input quantification)

Purity standard
1.Microbial Contaminants
．Microbiological contamination requirements for specific products and routes of administration (multicomponent products, liquid dosage form products, sterile products, chemical contaminants)

2. Elemental impurities
   ．Arsenic
   ．Hexavalent chromium
   ．Total heavy metals
3. Other impurities
   ．Mycotoxins
   ．Cyanotoxins
   ．Solvent remains
   ．Hormone testing of animal materials
   ．Enzyme
   ．Incidental impurities, related substances and process impurities
   ．Pesticide residue
   ．Contaminants in Marine Oil
   ．Antibiotic Residue in Bee Products
   ．Radioactive
   ．Oxidative Stability in Oil
   ．Potential Adulterants in Natural Health Products
   ．Constituents are derived from tissues predisposed to transmissible spongiform encephalopathy (TSE) and bovine spongiform encephalopathy (BSE)

Additional tests and criteria

1. General quality indicators
   ．Foreign body
   ．Determination of acid insoluble ash
   ．Water content
   ．Non-medicinal ingredient
   ．Performance Testing
   ．Disintegration
   ．Disband
   ．Dosage Unit Uniformity
   ．Standards for Homeopathic Medicines
   ．Analytical tests and requirements supporting label claims
   ．Reduce the test plan in the specification
   ．Antibacterial effect test
   ．Stability testing

Good Manufacturing Practice (GMP)

1. May be subject to microbial, physical and/or chemical contamination if manufactured or packaged under poor GMP conditions. Adherence to GMP is mandatory, as it ensures higher quality and confidence in the product.
2. Every natural health product shall be manufactured, packaged, labeled and stored in a facility designed, constructed and maintained in such a way as to permit activities under hygienic conditions, with particular emphasis on:
   ． Premises are kept clean and orderly
   ． Effectively clean all surfaces in the premises
   ． Store or Process Natural Health Products Properly
   ． Protect Natural Health Products from Contamination
   ． Prevent the addition of foreign substances in natural health products.
3. Personnel: Each natural health product shall be manufactured, packaged, labeled and stored by persons who are educated, trained or qualified to perform their respective tasks.
4. Sanitation Program: Each natural health product shall be manufactured, packaged, labeled and stored in accordance with a prescribed sanitation program.
5. Operations: Each natural health product shall be manufactured, packaged, labeled, and stored in accordance with standard operating procedures designed to ensure that activities are conducted in accordance with the requirements of this part.
6. Quality Assurance
   ．Every manufacturer, packer, labeller, importer and distributor shall have a quality assurance person
   ．Responsible for ensuring the quality of natural health products prior to sale
   ．Has the training, experience and technical knowledge relevant to the activities performed and the requirements of this part and investigates and records every complaint received concerning the quality of natural health products and takes corrective action when necessary.
   ．Every natural health product shall be manufactured, packaged, and labeled using only materials that have been approved by quality assurance personnel for that use prior to use in an activity.
   ．Each natural health product shall be manufactured, packaged, labeled and stored using methods and procedures that are approved by the quality assurance personnel prior to implementation.
   ．Each batch or lot of a natural health product should be approved by quality assurance personnel before it can be sold.
   ．Every natural health product that is sold and subsequently returned to its manufacturer, packer, labeler, importer, or distributor shall be approved by quality assurance personnel before the natural health product is made available for further sale.
7. Stabilization period
   ．Each manufacturer and each importer shall determine the period of time for which a natural health product retains its purity and physical properties and its medicinal ingredients maintains its quantity per dosage unit and its potency after it is packaged for sale.
8. Records. Manufacturers selling natural health products shall maintain the following records at the production site of the natural health product:
   ．Production master file; list of all ingredients, records of any testing, copies of specifications, records of production requirements, records of each decision and information supporting that decision, production Checklist, copy of sanitation plan, recommended storage conditions

【參考連結】
https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/legislation-guidelines/guidance-documents/clinical-trials.html
https://laws-lois.justice.gc.ca/eng/regulations/sor-2003-196/page-4.html#h-700670
https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/legislation-guidelines/guidance-documents/quality-guide.html#a2

HLF-TW-75

HLF-TW-77

HLF-TW-80
外國子公司進口保健食品後，如果委託加拿大的經銷商銷售，經銷商需要保健食品營業許可證嗎？假如保健食品有品質瑕疵的話，外國子公司和經銷商各自的責任為何？是連帶責任嗎？還是可以規範由外國子公司負責？

After a foreign subsidiary imports health food and entrusts a distributor in Canada to sell it, does the distributor need a health food business license? What are the respective responsibilities of foreign subsidiaries and distributors if cosmetic products have quality defects? Is it joint liability? Or can the responsibility of the foreign subsidiary be regulated?
Evershine RD：
需要。
在加拿大銷售天然保健品需要取得場地許可證(站點許可證)。
1.申請網頁：
https://nnhpd-site-licence-dexploitation-dpsnso.hc-sc.gc.ca/websla/en/application#sect19

2. 具備資料：
   ．公司名稱、公司代碼、街道、城市和國家/地區、省/州和郵政編碼。
   ．品質保證人的姓名、完整郵寄地址、電話號碼、傳真號碼（如果有）和電子郵件地址。如果品質保證人與本申請的聯繫人位於同一地址，則不需要完整的郵寄地址
   ．品質保證人資格證明
   ．存儲/倉庫
   ．活動類型：製造、包裝、標籤、進口
   ．產品類別：非無菌、無菌、順勢療法
   ．GMP 證據：質量保證報告(QAR)、淨變化摘要 (SNC)、藥品生產許可證（DEL）、合格機構頒發的 GMP 證書、NSF 標準 173 第 8 節證書、UL 報告、美國FDA機構檢驗報告（FDA EIR）
   ．供應鏈
   ．儲存條件
   ．鑑證

產品責任
1.產品許可證持有人在天然保健品所致境內或境外不良反應的15 天內應向衛生部提出報告。

2. 銷售天然保健品許可人，應每年準備並維護一份總結報告，其中包含對天然保健品的簡明和批判性分析繳交衛生部。
   3.當發生召回事件，產品許可證持有人應在開始召回之日後三天內向衛生部報告。

Yes.
Selling natural health products in Canada requires a site permit (site permit).

1. Application webpage:
   https://nnhpd-site-licence-dexploitation-dpsnso.hc-sc.gc.ca/websla/en/application#sect19
2. Have information:
   ．Company name, company code, street, city and country, province/state and zip code.
   ．The quality assurance person’s name, full mailing address, telephone number, fax number (if available), and email address. The full mailing address is not required if the QA is at the same address as the contact person for this application
   ．Quality Assurer Qualification Certificate
   ．Storage/warehouse
   ．Type of activity: Manufacturing, packaging, labelling, importing
   ．Product categories: non-sterile, sterile, homeopathic
   ．GMP Evidence: Quality Assurance Report (QAR), Summary Net Change (SNC), Drug Manufacturing License (DEL), GMP Certificate issued by Qualified Institution, NSF Standard 173 Section 8 Certificate, UL Report, US FDA Agency Inspection Report (FDA EIR)
   ．Supply chain
   ．Storage conditions
   ．Authentication

Product responsibility
1.The product license holder shall submit a report to the Ministry of Health within 15 days of any domestic or overseas adverse reactions caused by natural health products.
2.Licensors selling natural health products shall prepare and maintain a summary report containing a concise and critical analysis of natural health products annually to the Ministry of Health.
3.In the event of a recall, the product licensee shall report to the Ministry of Health within three days of the date of the recall.

【參考連結】
https://laws-lois.justice.gc.ca/eng/regulations/sor-2003-196/page-3.html#h-700569
https://nnhpd-site-licence-dexploitation-dpsnso.hc-sc.gc.ca/websla/en/landing

HLF-TW-85

各國健康食品登記法規問題集

Email：yto4ww@evershinecpa.com
或
加拿大永輝BPO有限公司
接洽人:
Vincent Wang 加拿大籍来自台灣
或
聯絡人: 陳中成 總經理 in 台+中+英;專利師;企管碩士+企管博士
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(版本:2022/03)

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