All natural health products must have a product licence before they can be sold in Canada. To get a licence, applicants must give detailed information about the product to Health Canada, to support the safety, efficacy and quality of the products. 

Once Health Canada has assessed a product and decided it is safe, effective and of high quality, it issues a product licence along with an eight-digit Natural Product Number (NPN), which must appear on the label. This number lets you know that the product has been reviewed and approved by Health Canada.

Classes of Applications

There are three classes of applications, which are differentiated by their use of NNHPD monographs.

1. Class I: Class I applications are those that must comply with all of the parameters of one individual NNHPD monograph (exactly as worded in the monograph). The processing time is about 3~4 months.
2. Class II: Class II applications are general and traditional applications supported entirely by a combination of 2 or more NNHPD monographs. Usually, it takes about 4~6 months to get the product licence.
3. Class III: 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.

·        Products with ingredient combination issues that may require safety assessment.

·        Applications partially referencing monograph information but going beyond the parameters established in the relevant monograph(s). Homeopathic applications with specific claims.

The processing time for class 3 applications varies from 7 months to 12 months. 

Click here to get a free assessment and quotation of NPN application