Natural Health Products Regulations

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 demonstrates 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.