• 2. (1) These Regulations apply to

  • (a) the sale of natural health products;

  • (b) the manufacture, packaging, labelling and importation for sale of natural health products;

  • (c) the distribution of natural health products; and

  • (d) the storage of natural health products for the purposes of any of the activities referred to in paragraphs (b) and (c).

• (2) For the purposes of these Regulations, a substance or combination of substances or a traditional medicine is not considered to be a natural health product if its sale, under the Food and Drug Regulations, is required to be pursuant to a prescription when it is sold other than in accordance with section C.01.043 of those Regulations.

3. Except where otherwise indicated in these Regulations, the provisions of the Food and Drug Regulations do not apply to natural health products.

• 4. (1) Subject to subsections (2) and (3), no person shall sell a natural health product unless a product licence is issued in respect of the natural health product.

• (2) No product licence holder, manufacturer, importer or distributor of a natural health product for which a product licence is issued shall sell the natural health product during any period that the sale of that natural health product is directed to be stopped under section 17.

• (3) No person shall sell a natural health product for which a product licence is issued

  • (a) during the period of any suspension of the licence under section 18 or 19; or

  • (b) after cancellation of the licence under paragraph 20(b).

5. An application for a product licence shall be submitted to the Minister and shall contain the following information and documents:

• (a) the name, address and telephone number, and if applicable, the facsimile number and electronic mail address of the applicant;

• (b) if the address submitted under paragraph (a) is not a Canadian address, the name, address and telephone number, and if applicable, the facsimile number and electronic mail address of the applicant’s representative in Canada to whom notices may be sent;

• (c) for each medicinal ingredient of the natural health product,

  • (i) its proper name and its common name,

  • (ii) its quantity per dosage unit,

  • (iii) its potency, if a representation relating to its potency is to be shown on any label of the natural health product,

  • (iv) a description of its source material, and

  • (v) a statement indicating whether it is synthetically manufactured;

• (d) a qualitative list of the non-medicinal ingredients that are proposed for the natural health product and for each ingredient listed, a statement that indicates the purpose of the ingredient;

• (e) each brand name under which the natural health product is proposed to be sold;

• (f) the recommended conditions of use for the natural health product;

• (g) information that supports the safety and efficacy of the natural health product when it is used in accordance with the recommended conditions of use;

• (h) the text of each label that is proposed to be used in conjunction with the natural health product;

• (i) a copy of the specifications to which the natural health product will comply; and

• (j) one of the following attestations, namely,

  • (i) if the natural health product is imported, an attestation by the applicant that the natural health product will be manufactured, packaged, labelled, imported, distributed and stored in accordance with the requirements set out in Part 3 or in accordance with requirements that are equivalent to those set out in Part 3, or

  • (ii) if the natural health product is not imported, an attestation by the applicant that the natural health product will be manufactured, packaged, labelled, distributed and stored in accordance with requirements set out in Part 3.