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.