FAQs

In order to market your products in Canada, the Natural Health Products Regulations first require you to obtain the necessary product and site licenses.

Product Licensing: Before any natural health product can be sold in Canada, it must first undergo a pre-market review where it will be assessed for safety, efficacy, and quality. Evidence demonstrating this must be submitted to Health Canada by means of a product license application (one for each product). Products, which meet the required criteria, will be authorized for sale and each issued a Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM).

Site Licensing: The Natural Health Products Regulations require any Canadian site where natural health products are manufactured, imported, labelled, packaged, distributed, and/or stored to have a site license. Businesses can choose to have a single site license for all their operations (i.e. multiple sites) or an individual license for each site. Site licenses are obtained by demonstrating that the above mentioned activities are conducted in a manner that is congruent with the requirements of the Canadian Good Manufacturing Practices (GMPs) for NHPs.

How does a natural health product get approved for importing into Canada? Canadian importers must have a site license and the onus is on them to provide evidence that imported products come from sites that meet the Canadian Good Manufacturing Practices (GMPs), or equivalent standards. The Canadian importer is responsible for submitting a Quality Assurance Report for each site with their site license application. Site licenses are issued only to Canadian sites (not to foreign sites). Foreign manufacturers will be covered under the Canadian importer’s site license.

No, all products must have valid a NPN or a DIN-HM before you are allowed to sell in Canada.

Each of your products must go through quality testing for microbial and heavy metal contaminants. Pesticides testing is required only if a particular ingredient is not organic.  Testing of raw materials can be done at the raw material stage, and you can also quantify ingredients by input on the Finished Product Specification form and lab test. This testing can be done outside of Canada if your company imports products into Canada. Note that the Canadian importer will be required to do yearly purity tests on each dosage form they import.

Timeline for Health Canada to complete the Review of License Applications:

The NNHPD has developed monographs as a tool to support the safety and efficacy of many commonly used NHP ingredients. Applications containing one or more ingredient(s) supported   by NNHPD monograph(s) for safety, efficacy and/or quality are required to submit a Monograph Attestation form.

A new three-class review system has been introduced through Monograph Attestation Forms to accelerate NHP review and licensing.

Three Class Review System requests applicants classify their applications as Class I, II, or III.  Applications proceeding to class III review will be sent for full assessment after the thirty    calendar day screening period is complete.  The waiting period for this class could be 180 days.

• Class I applications that comply with all requirements will receive a Product License within 30 days after submission.
• Class II applications are general and traditional applications supported entirely by a combination of 2 or more NNHPD monographs as well as the following scenarios:
  • Applications supported entirely by an individual NNHPD monograph with a deviation to one or more monograph statements which maintains the intent of the monograph(s) statements (e.g. “statements to the effect of”);
  • Applications supported entirely by a combination of NNHPD monographs with a deviation to one or more monograph statements which maintains the intent of the monograph(s) statements (e.g. “statements to the effect of”);
  • Products supported entirely by a combination of NNHPD monographs with the addition of common fruits or vegetables listed in the Canadian Nutrient File, excluding source materials listed as “refuse”, with a daily dose of up to 10 g (of crude material or quantity crude equivalent for non-standardized extracts).

  Homeopathic applications with specific claims are not accepted in Class II.

• Class III applications are comprised of general, traditional and homeopathic applications requiring full assessment (not captured above in Class I or II) and include, but are not limited to, the following scenarios:
  • Products with a novel preparation and/or dosage delivery system presenting unique safety and/or efficacy profiles;
  • Applications referencing a Master File to support safety, efficacy and/or quality (see section 4.5 for information on Master Files, including a definition).
  • Products with ingredient combination issues (including those covered by a monograph) that may require safety assessment. These combinations include but not exclusive to the following lower certainty combinations and combination risk factors (e.g. stimulant laxatives combined with diuretics, weight management ingredients/claims in combination with diuretics, combination hormonal effect products, combination sedative ingredients). These combinations are reviewed on a case by case basis.
  • Applications partially referencing monograph information but going beyond the parameters established in the relevant monograph(s). For example, a dosage form or route of administration not indicated on the monograph(s) that requires further assessment.
  • Homeopathic applications with specific claims.

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Cosmetics are regulated as natural health products only if they meet both the function and substance components of the NHP definition. This refers to the intended use of the product, such as diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms in humans; restoring or correcting organic functions in humans; or modifying organic functions in humans, such as modifying those functions in a manner that maintains or promotes health.

Presently, there are no costs or fees associated with the submission and review of product and site license applications. However, the natural health products directorate will be initiating consultations with industry stakeholders on a proposed cost recovery framework for natural health products. As it has done in the past, the directorate will undertake a transparent and collaborative process to ensure that this framework is appropriate for the natural health products industry.

In the good manufacturing practice guidance document, the quality assurance person is defined as “the person who is responsible for assuring the quality of the natural health product before it is made available for sale. this person should be qualified by education/technical knowledge, training and experience relating to the specific activity (e.g., manufacturing, packaging, labelling and importing).

These new Health Canada regulatory requirements have a direct impact on how natural health products are manufactured, imported and distributed throughout Canada. Each organization that is involved in the overall supply of the natural products (i.e. manufactures, packagers, labelers and importers) must have valid site licenses. Also, in order for a product to be imported into Canada, the importation must be performed by a fully compliant facility that has been officially licensed by Health Canada. Failure to be compliant will result in the products not being allowed to enter the country or at least held at the border until the proper documents can be provided.

Natural Health Products Ingredients Database is a vast source of scientific terms, ingredients and monographs pre-cleared, public information approved by the NNHPD. The principal use of this database is to validate ingredients for use in natural health products. If your product uses ingredients that are not in the database they need to be added, which may take some time, and requires supporting evidence. Canadian Natural Health Product Registry can help you through this procedure.

Licensed Natural Health Products Database