加拿大保健食品登记法规问题集

加拿大主要城市公司设立登记,商标登记，进出口证，特许行业申请等。公司设立后云端系统支援的会计薪资服务。 加拿大多伦多与臺湾同事携手协同爲您服务。为地球暖化尽一份心力，减少空中旅行。
Email：yto4ww@evershinecpa.com
或
加拿大永辉BPO有限公司
Canada time zone:
Manager Ian Lin 说中文和英文
或
China Time Zone:
联络人：林幸穗 Anny Lin 协理
手机：+886-937-606-272
skype: annylin8008
wechat: annylin8008
电话：+886-2-2717-0515 分机:110

时间：2022/07/28 drafted by Yvonne Chen

各国健康食品登记法规问题集

HLF-TW-10
请问加拿大对于保健食品的归类方式为何？它的正式名称为何？不同归类管理强度有何差异?它的政府管辖机构为何？网页？

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，保健食品称为天然保健品（NHP），由加拿大卫生部监管，需要处方的产品按药品规范监管。

天然保健品是用于恢復或维持健康的天然物质。它们通常由植物製成，但也可以由动物、微生物和海洋来源製成。它们有多种形式，如片剂、胶囊、酊剂、溶液、乳膏、软膏和滴剂。

1.天然保健品通常被称为补充或替代药物，包括：
．维生素和矿物质
．草药疗法
．顺势疗法药物
．传统药物，如中药和阿育吠陀（东印度）药物
．益生菌
．其他产品，如氨基酸和必需脂肪酸
．许多日常消费品，如某些牙膏、止汗剂、洗发水、面部产品和漱口水，在加拿大也被归类为天然保健品。
2.NHP 的使用和销售有多种健康原因，例如预防或治疗疾病或病症、降低健康风险或维持良好健康。它们必须安全才能作为非处方产品使用。需要处方的产品按照药品进行监管。

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.

【参考连结】
https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/regulation/about-products.html#a1

HLF-TW-20
外国公司要到加拿大销售保健食品，无论设100%子公司或分公司，需要在公司登记时取得营业特许证？假如要，其必要条件是什麽？所需文件及申请程序为何？网页？

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，在加拿大销售天然保健品需要取得场地许可证(站点许可证)，外国製造的商品申请的为外国地点参考号(FSRN)，除了取得FSRN之外，要与加拿大公司建立合作伙伴关係才得以进口。

外国地点参考号(FSRN)：
1.申请网页：
https://nnhpd-site-licence-dexploitation-dpsnso.hc-sc.gc.ca/websla/en/application#sect19
2.具备资料：
．公司名称、公司代码、街道、城市和国家/地区、省/州和邮政编码。
．品质保证人的姓名、完整邮寄地址、电话号码、传真号码（如果有）和电子邮件地址。如果品质保证人与本申请的联繫人位于同一地址，则不需要完整的邮寄地址
．品质保证人资格证明
．存储/仓库
．活动类型：製造、包装、标籤、进口
．产品类别：非无菌、无菌、顺势疗法
．GMP 证据：质量保证报告(QAR)、淨变化摘要 (SNC)、药品生产许可证（DEL）、合格机构颁发的 GMP 证书、NSF 标准 173 第 8 节证书、UL 报告、美国FDA机构检验报告（FDA EIR）
．供应链
．储存条件
．鑑证

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

【参考连结】
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
外国公司要到加拿大销售保健食品，可以指派加拿大公司担任营业代理人销售吗? 担任营业代理人，其必要条件是什麽？所需文件及申请程序为何？外国公司与营业代理人的产品责任为何?网页？

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。
在加拿大销售天然保健品需要取得场地许可证(站点许可证)。
1.申请网页：
https://nnhpd-site-licence-dexploitation-dpsnso.hc-sc.gc.ca/websla/en/application#sect19

2. 具备资料：
   ．公司名称、公司代码、街道、城市和国家/地区、省/州和邮政编码。
   ．品质保证人的姓名、完整邮寄地址、电话号码、传真号码（如果有）和电子邮件地址。如果品质保证人与本申请的联繫人位于同一地址，则不需要完整的邮寄地址
   ．品质保证人资格证明
   ．存储/仓库
   ．活动类型：製造、包装、标籤、进口
   ．产品类别：非无菌、无菌、顺势疗法
   ．GMP 证据：质量保证报告(QAR)、淨变化摘要 (SNC)、药品生产许可证（DEL）、合格机构颁发的 GMP 证书、NSF 标准 173 第 8 节证书、UL 报告、美国FDA机构检验报告（FDA EIR）
   ．供应链
   ．储存条件
   ．鑑证

产品责任
1.产品许可证持有人在天然保健品所致境内或境外不良反应的15 天内应向卫生部提出报告。

2. 销售天然保健品许可人，应每年准备并维护一份总结报告，其中包含对天然保健品的简明和批判性分析缴交卫生部。
   3.当发生召回事件，产品许可证持有人应在开始召回之日后三天内向卫生部报告。

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.

【参考连结】
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
外国公司销售到加拿大保健食品本身，进口前需要办理产品许可吗？如需要，哪个单位在管理？需要什麽文件？申请程序为何？保健食品包装内容及各种标示，需要事先核准吗？可允许的语文有哪些？网页？

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。
产品许可证(NPN)申请应向加拿大卫生部提交，包含以下资料和文件：
1.申请人的姓名、地址和电话号码
2.申请人的传真号码和电子邮件地址（如有）
3.如果申请人的地址不是加拿大，需填写在加拿大代表的姓名、地址和电话号码。

4. 天然保健品的每种药用成分：
   ．专有名称和通用名称
   ．每剂量单位的数量
   ．功效
   ．标籤上要显示与其功效有关的说明
   ．来源材料的描述
   ．是否为合成製造的声明
   ．建议用于天然保健品的非药用成分的定性清单，以及所列每种成分的说明该成分用途的声明
   ．拟销售天然保健品的每个品牌名称
   ．天然保健品的推荐使用条件
   ．证明天然保健品按照推荐使用条件使用时的安全性和有效性
   ．拟与天然保健品结合使用的每个标籤的文字
   ．天然保健品应符合的规格副本
   ．以下证明之一：如果天然保健品是进口的，申请人提供证明，证明该天然保健品将按照规定要求进行製造、包装、标籤、进口、分销和储存；或如果天然保健品不是进口的，申请人提供该天然保健品将按照规定的要求製造、包装、标籤、分销和储存的证明。

标籤

1. 天然保健品的标籤应採用英语和法语表示，包含：
   ．使用条件的所有讯息
   ．所含的每种药用成分和每种非药用成分的通用名称和专有名称(如果药用成分或非药用成分的通用名或专有名称没有英语或法语的对应名称，则应以任何其他语言显示该名称)
   ．药物成分来源材料的描述
   ．储存条件
2. 标籤标註的表述、讯息和声明要清晰、显眼，在购买和使用的习惯条件下，购买者或消费者容易辨别。
3. 只有一个标籤的，该标籤应当显示内、外标籤中需要标註的所有说明、讯息和声明。
4. 每个批号前面应带有下列其中一项：批号/批次/(L)
5. 顺势疗法药物前面应标有DIN-HM。
6. 其他天然保健品前面应註明NPN。
7. 天然保健品的内标籤和外标籤应显示以下讯息
   主要显示面上
   ．品牌名称
   ．产品编号
   ．剂型
   ．无菌的需註明sterile和stérile
   ．以重量、尺寸或数量表示直接容器内的淨含量
   在任何显示面上
   ．产品许可证持有者的姓名和地址
   ．进口商的名称和地址
   ．所含每种药用成分的通用名称
   ．每种药用成分的正确名称，但前提是该正确名称不是化学名称
   ．按专有名称或通用名称（如果专有名称是化学名称）列出的列表，列出每个剂量单位的每种药物成分的数量以及该药物成分的授权效力（如果有）
   ．推荐用途或目的
   ．推荐的给药途径
   ．推荐剂量
   ．建议的使用期限（如有）
   ．其风险信息，包括与其使用相关的任何警告、警告、禁忌症或已知不良反应
   ．推荐的储存条件（如有）
   ．批号
   ．到期日
   ．所含每种药用成分的来源材料的描述
   外标籤还应显示
   ．天然保健品所有非药用成分的通用名定性清单，前面加上非药用成分字样
   ．如果天然保健品含有汞或其任何盐类或衍生物作为非药用成分，则需提供一份说明天然保健品中汞含量的声明

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

【参考连结】
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
外国公司可以用自己名义申请办理产品许可吗？如需要，哪个单位在管理？需要什麽文件？申请程序为何？保健食品包装内容及各种标示，需要事先核准吗？可允许的语文有哪些？？网页？

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，但申请的资料中，仍须提供加拿大代表的姓名、地址和电话号码。
产品许可证(NPN)申请应向加拿大卫生部提交，包含以下资料和文件：
1.申请人的姓名、地址和电话号码
2.申请人的传真号码和电子邮件地址（如有）
3.如果申请人的地址不是加拿大，需填写在加拿大代表的姓名、地址和电话号码。

4. 天然保健品的每种药用成分：
   ．专有名称和通用名称
   ．每剂量单位的数量
   ．功效
   ．标籤上要显示与其功效有关的说明
   ．来源材料的描述
   ．是否为合成製造的声明
   ．建议用于天然保健品的非药用成分的定性清单，以及所列每种成分的说明该成分用途的声明
   ．拟销售天然保健品的每个品牌名称
   ．天然保健品的推荐使用条件
   ．证明天然保健品按照推荐使用条件使用时的安全性和有效性
   ．拟与天然保健品结合使用的每个标籤的文字
   ．天然保健品应符合的规格副本
   ．以下证明之一：如果天然保健品是进口的，申请人提供证明，证明该天然保健品将按照规定要求进行製造、包装、标籤、进口、分销和储存；或如果天然保健品不是进口的，申请人提供该天然保健品将按照规定的要求製造、包装、标籤、分销和储存的证明。

标籤

1. 天然保健品的标籤应採用英语和法语表示，包含：
   ．使用条件的所有讯息
   ．所含的每种药用成分和每种非药用成分的通用名称和专有名称(如果药用成分或非药用成分的通用名或专有名称没有英语或法语的对应名称，则应以任何其他语言显示该名称)
   ．药物成分来源材料的描述
   ．储存条件
2. 标籤标註的表述、讯息和声明要清晰、显眼，在购买和使用的习惯条件下，购买者或消费者容易辨别。
3. 只有一个标籤的，该标籤应当显示内、外标籤中需要标註的所有说明、讯息和声明。
4. 每个批号前面应带有下列其中一项：批号/批次/(L)
5. 顺势疗法药物前面应标有DIN-HM。
6. 其他天然保健品前面应註明NPN。
7. 天然保健品的内标籤和外标籤应显示以下讯息
   主要显示面上
   ．品牌名称
   ．产品编号
   ．剂型
   ．无菌的需註明sterile和stérile
   ．以重量、尺寸或数量表示直接容器内的淨含量
   在任何显示面上
   ．产品许可证持有者的姓名和地址
   ．进口商的名称和地址
   ．所含每种药用成分的通用名称
   ．每种药用成分的正确名称，但前提是该正确名称不是化学名称
   ．按专有名称或通用名称（如果专有名称是化学名称）列出的列表，列出每个剂量单位的每种药物成分的数量以及该药物成分的授权效力（如果有）
   ．推荐用途或目的
   ．推荐的给药途径
   ．推荐剂量
   ．建议的使用期限（如有）
   ．其风险信息，包括与其使用相关的任何警告、警告、禁忌症或已知不良反应
   ．推荐的储存条件（如有）
   ．批号
   ．到期日
   ．所含每种药用成分的来源材料的描述
   外标籤还应显示
   ．天然保健品所有非药用成分的通用名定性清单，前面加上非药用成分字样
   ．如果天然保健品含有汞或其任何盐类或衍生物作为非药用成分，则需提供一份说明天然保健品中汞含量的声明

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

【参考连结】
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
经过核准登记的保健食品，进口到加拿大要检附什麽文件？经过什麽手续？在销售时要向各地的卫生福利部相关机构事先或事后准备吗？网页？

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：
须先完成产品许可证书及进口场地许可证(站点许可证)。
天然保健品商业进口须具备以下文件
1.具备产品许可证（NPN）
2.授权或许可供应商/进口商的发票/海关文件
3.进口商必须拥有开展进口活动的场地许可证(站点许可证)。

4. 海关发票
5. 销售确认书 (COS)：联繫人姓名、地址、城市、州/省、邮政编码、电话号码、传真号码、电子邮件地址等。
6. 形式发票：当商业发票或加拿大海关发票不可用时，可以使用形式发票。
7. CUSMA原产地认证：仅适用于来自加拿大、美国和/或墨西哥且价值超过 3,300 加元的合格货物，根据新的北美自由贸易协定要求进入加拿大的合格商业商品降低关税。
8. ACI 电子舱单：保税仓库地点、航班资讯、成员资料、省/州/国家、交通工具车牌号、拖车车牌号码、运输单位数量、拖车单位号、报关行、托运人姓名和地址、收货人姓名和地址、託运商品完整描述、数量和重量等。
9. PARS通知(加拿大境内货件通知) ：预计抵达入境口岸的时间、物流讯息、进口商名称、件数、包装类型、重量、承运人名称、调度电话、司机姓名、司机电话号码等。

于进口时就要具备场地/站点许可证，无另行销售通知。

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.

【参考连结】
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
加拿大保健食品审核机构，需要附上的实验室检验资料有哪些? 网页？

What are the laboratory inspection materials that need to be attached for verification? Website?
Evershine RD：
实验室检验资料
表徵
1.化学品(高度纯化的成分，例如：分离物和合成重複品)
．加工原料
．标准化萃取物
．强化萃取物
2.鑑别试验
．植物产品的适当标示
．特定药用成分的适当标示
．成品测试

3. 数量
   ．测定定量(植物成分、维生素和矿物质、分离物和合成重複品、活微生物、酶、输入量化)

纯度标准
1.微生物汙染物
．特定产品和给药途径的微生物汙染要求(多组分产品、液体剂型产品、无菌产品、化学汙染物)
2.元素杂质
．砷
．六价铬
．重金属总量

3. 其他杂质
   ．霉菌毒素
   ．蓝藻毒素
   ．溶剂残留
   ．动物材料激素检测
   ．酶製剂
   ．附带杂质、有关物质和工艺杂质
   ．农药残留
   ．海洋油中的汙染物
   ．蜂产品中抗生素残留
   ．放射性
   ．油中的氧化稳定性
   ．天然保健品中的潜在掺杂物
   ．成分来源于易患传染性海绵状脑病（TSE）和牛海绵状脑病（BSE）的组织

附加测试和标准
1.一般质量指标
．异物
．酸不溶性灰分的测定
．含水量
．非药用成分
．性能测试
．解体
．解散
．剂量单位的均匀性
．顺势疗法药物的标准
．支持标籤声明的分析测试和要求
．减少规范中的测试计划
．抗菌效果测试
．稳定性测试

良好生产规范（GMP）
1.如果在不良 GMP 条件下製造或包装，则可能会受到微生物、物理和/或化学汙染。遵守 GMP 是强制的，因为可以确保更高品质和对产品的信心。
2.每种天然保健产品均应在设计、建造和维护的场所中製造、包装、贴标籤和储存，场所的设计、建造和维护方式应允许在卫生条件下进行活动，尤其着重：
．场所保持清洁和有序
．有效清洁场所内的所有表面
．适当储存或加工天然保健品
．防止天然保健品受到汙染
．防止在天然保健品中添加外来物质。

3. 人员：每种天然保健产品均应由经过教育、培训或具有执行各自任务资格的人员製造、包装、贴标籤和储存。
4. 卫生计划：每种天然保健品均应按照规定的卫生计划进行製造、包装、贴标籤和储存。
5. 运营：每种天然保健品均应按照标准操作程序进行製造、包装、标籤和储存，旨在确保活动按照本部分的要求进行。
6. 质量保证
   ．每个製造商、包装商、贴标商、进口商和分销商应有一名质量保证人员
   ．负责在销售前确保天然保健品的质量
   ．具有与所进行的活动和本部分要求相关的培训、经验和技术知识和调查并记录收到的有关天然保健品质量的每一起投诉，并在必要时採取纠正措施。
   ．每种天然保健品均应仅使用在活动中使用之前已获得质量保证人员批准用于该用途的材料来製造、包装和贴标籤。
   ．每种天然保健品的生产、包装、标籤和储存均应採用在实施前经过质量保证人员批准的方法和程序。
   ．天然保健品的每批或批次均应经质量保证人员批准后方可销售。
   ．销售并随后退回其製造商、包装商、标籤商、进口商或分销商的每一种天然保健产品，在该天然保健产品可供进一步销售之前，均应得到品质保证人员的批准。
7. 稳定期
   ．每个製造商和每个进口商应确定天然保健品在包装销售后保持其纯度和物理特性及其药用成分保持其每剂量单位数量及其效力的时间期限。
8. 记录，销售天然保健品的生产商应当在天然保健品的生产现场保存以下记录：
   ．生产主文件；所有成分清单、任何测试的记录、规格副本、要求生产的记录、每项决定的记录以及支持该决定的讯息、生产清单、卫生计划的副本、建议的储存条件

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

【参考连结】
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
外国子公司进口保健食品后，如果委託加拿大的经销商销售，经销商需要保健食品营业许可证吗？假如保健食品有品质瑕疵的话，外国子公司和经销商各自的责任为何？是连带责任吗？还是可以规范由外国子公司负责？

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。
在加拿大销售天然保健品需要取得场地许可证(站点许可证)。
1.申请网页：
https://nnhpd-site-licence-dexploitation-dpsnso.hc-sc.gc.ca/websla/en/application#sect19

2. 具备资料：
   ．公司名称、公司代码、街道、城市和国家/地区、省/州和邮政编码。
   ．品质保证人的姓名、完整邮寄地址、电话号码、传真号码（如果有）和电子邮件地址。如果品质保证人与本申请的联繫人位于同一地址，则不需要完整的邮寄地址
   ．品质保证人资格证明
   ．存储/仓库
   ．活动类型：製造、包装、标籤、进口
   ．产品类别：非无菌、无菌、顺势疗法
   ．GMP 证据：质量保证报告(QAR)、淨变化摘要 (SNC)、药品生产许可证（DEL）、合格机构颁发的 GMP 证书、NSF 标准 173 第 8 节证书、UL 报告、美国FDA机构检验报告（FDA EIR）
   ．供应链
   ．储存条件
   ．鑑证

产品责任
1.产品许可证持有人在天然保健品所致境内或境外不良反应的15 天内应向卫生部提出报告。

2. 销售天然保健品许可人，应每年准备并维护一份总结报告，其中包含对天然保健品的简明和批判性分析缴交卫生部。
   3.当发生召回事件，产品许可证持有人应在开始召回之日后三天内向卫生部报告。

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.

【参考连结】
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

各国健康食品登记法规问题集

Email：yto4ww@evershinecpa.com
或
加拿大永辉BPO有限公司
接洽人:
Vincent Wang 加拿大籍来自台湾
或
联络人: 林幸穗 Anny Lin 协理
手机：+886-937-606-272
skype: annylin8008
wechat: annylin8008
电话：+886-2-2717-0515 分机:110
全球永辉服务据点参考资料:
永辉100%关係企业
永辉总部、台北永辉、厦门永辉、北京永辉、上海那灵、深圳常新、纽约永辉、加州永辉、德州永辉、凤凰城永辉、东京永辉、首尔永辉、河内永辉、越南胡志明、曼谷永辉、新加坡永辉、吉隆玻永辉、雅加达永辉、马尼拉永辉、墨尔本永辉、澳洲雪梨、孟加拉永辉、新德里永辉、印度孟买、杜拜永辉、法兰克福永辉、巴黎永辉、伦敦永辉、荷兰永辉、西班牙永辉、义大利永辉、罗马尼亚永辉、多伦多永辉、墨西哥永辉、捷克永辉。
其他已提供中文化服务城市：
迈阿密、亚特兰大、俄克拉荷马、密歇根、西雅图、特拉华；
柏林; 斯图加特;布拉格；布加勒斯特；班加罗尔；泗水；
高雄、香港、深圳、东关、广州、清远、永康、杭州、苏州、崑山、南京、重庆、许昌、青岛、天津。
永辉潜在可服务城市 (2个月筹备期)：
我们为IAPA会员所,总部在伦敦，全球300个会员所，员工约1万人。
我们为LEA会员所,总部在美国芝加哥，全球600个会员所，员工约2万8千人。
Evershine is local Partner of ADP Streamline® in Taiwan.
(版本:2022/03)

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