Canada Health Food Regulations QA

WFOE Registration, Work Permit, Special Industry Permit application according to Canada Regulations, we need to do KYC (Know your client) before engagement with your assignment.

Email: yto4ww@evershinecpa.com
Or
ES CA , One of Evershine affiliates
Manager Cindy Victoria Speaks in Bahasa, English, and Chinese.
Whats App +886-989-808-249
wechatid: victoria141193

時間：2022/07/28 drafted by Yvonne Chen

HLF-TW-10
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：

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.

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

HLF-TW-20
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：

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

【Reference Link】
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
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：

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.

【Reference Link】
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
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：

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

【Reference Link】
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
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：

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

【Reference Link】
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
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：

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.

【Reference Link】
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
What are the laboratory inspection materials that need to be attached for verification? Website?
Evershine RD：
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

【Reference Link】
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
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：

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.

【Reference Link】
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

Contact Us

Email: yto4ww@evershinecpa.com
Or
ES CA , One of Evershine affiliates
Manager Cindy Victoria Speak in Bahasa, English, and Chinese.
Whats App +886-989-808-249
wechatid: victoria141193

For investment structure relevant to multi-national tax planning and Financial & Legal Due Diligence for M&A (Merge and Acquisition), send an email to HQ4yto@evershinecpa.com
Dale Chen, Principal Partner/CPA in Taiwan+China+UK will be accountable for your case.
Linkedin address: Dale Chen

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