II. PRODUCT LICENCE FOR NATURAL HEALTH PRODUCTS IN CANADA
In Canada, Natural Health Products require pre-market approval from Health Canada before they can be legally sold. This requires a Site Licence and Product Licence.
Pursuant to section 5 of the Natural Health Products Regulations, an application for a product licence must contain the following elements:
(i) the name, address and telephone number, and if applicable, the facsimile number and electronic mail address of the applicant;
(ii) If the address is not a Canadian address, the same elements are required for the applicant’s representative in Canada;
(iii) for each medicinal ingredient of the natural health product:
- proper name and its common name,
- quantity per dosage unit,
- potency, (if applicable)
- description of its source material, and
- statement indicating whether it is synthetically manufactured;
(iv) a qualitative list of the non-medicinal ingredients that are proposed for the product and for each ingredient listed, a statement that indicates the purpose of the ingredient;
(v) each brand name under which the product is proposed to be sold;
(vi) the recommended conditions of use for the product;
(vii) information that demonstrates the safety and efficacy of the product when it is used in accordance with the recommended conditions of use;
(viii) the text of each label that is proposed to be used in conjunction with the product;
(ix) a copy of the specifications to which the natural health product will comply; and
(x) one of the following attestations filled in by the applicant:
- If the product is imported, an attestation that the product will be manufactured, packaged, labelled, imported, distributed and stored in accordance with the requirements of Good manufacturing Practices.
- If the product is not imported, an attestation that the product will be manufactured, packaged, labelled, distributed and stored in accordance with requirements of Good Manufacturing Practices.
- After it has been decided that the product is safe and of high quality, Health Canada issues a product licence along with an eight-digit Natural Product Number (NPN), which must appear on the label.
Registrations take between 60 and 210 calendar days, depending on how much information the authorities have about the product's benefits and risks. This means that the products with the highest level of certainty (Class I products) have the shortest review time.