I want to sell a natural health product in Canada, what do I have to do?
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.
What is the process to import a natural health product into Canada?
Can I market my product without an NPN or DIN-HM?
Do I need to provide quality testing on my products?
My application has been submitted to the NNHPD, what is the estimated time to receive an approval?
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.
Are cosmetics such as creams, shampoos, toothpastes, etc. regulated by the Natural Health Products Regulations?
What are the costs for submitting a product and/or a site license application for a natural health product?
How does the Natural Health Products Directorate define Quality Assurance Person?
How do the new regulations affect my manufacturer or supplier?
Want to know if a medicinal or non-medicinal ingredient is acceptable to Health Canada?