Natural Health Products Regulations

66 An application by a sponsor for authorization to sell or import a natural health product for the purposes of a clinical trial shall be submitted to the Minister and shall contain the following information and documents:

• (a) a copy of the protocol for the clinical trial;

• (b) a copy of the statement, as it will be set out in each informed consent form, that states the risks and anticipated benefits arising to the health of clinical trial subjects as a result of their participation in the clinical trial;

• (c) a clinical trial attestation, signed and dated by the sponsor, containing

  • (i) the title of the protocol and the clinical trial number,

  • (ii) the brand name or the code for the natural health product,

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

    • (A) the proper name and common name of the ingredient, and

    • (B) the quantity of the ingredient per dosage unit of the natural health product,

  • (iv) a qualitative list of the non-medicinal ingredients of the natural health product,

  • (v) the dosage form of the natural health product,

  • (vi) the name, address and telephone number and, if applicable, the facsimile number and electronic mail address of the sponsor,

  • (vii) if the natural health product is to be imported, the name, address and telephone number and, if applicable, the facsimile number and electronic mail address of the sponsor’s representative in Canada who is responsible for the sale of the natural health product,

  • (viii) the address of each clinical trial site,

  • (ix) for each clinical trial site, the name, address and telephone number and, if applicable, the facsimile number and electronic mail address of the qualified investigator,

  • (x) for each clinical trial site, the name, address and telephone number and, if applicable, the facsimile number and electronic mail address of the research ethics board that approved the protocol referred to in paragraph (a) and approved an informed consent form containing the statement referred to in paragraph (b),

  • (xi) for each clinical trial site, the name, address and telephone number and, if applicable, the facsimile number and electronic mail address of any research ethics board that has previously refused to approve the protocol referred to in paragraph (a), its reasons for doing so and the date on which the refusal was given, and

  • (xii) a statement

    • (A) that the clinical trial will be conducted in accordance with good clinical practices and these Regulations, and

    • (B) that all information contained in, or referenced by, the application is complete and accurate and is not false or misleading;

• (d) an attestation, signed and dated by the research ethics board for each clinical trial site, that it has reviewed and approved the protocol referred to in paragraph (a) and an informed consent form containing the statement referred to in paragraph (b) and that the board carries out its functions in a manner consistent with good clinical practices;

• (e) an investigator’s brochure that contains the following information, namely,

  • (i) the physical, chemical and, if any, the pharmaceutical properties of the natural health product,

  • (ii) the chemistry and manufacturing information of each synthetically manufactured medicinal ingredient of the natural health product,

  • (iii) the pharmacological properties of the natural health product, if any, including its metabolites in all animal species tested,

  • (iv) the pharmacokinetics of the natural health product and the natural health product metabolism, if any, including the biological transformation of the natural health product in all animal species tested,

  • (v) the toxicological effects, if any, in any animal species tested under a single dose study, a repeated dose study or a special study in respect of the natural health product,

  • (vi) the results of carcinogenicity studies in any animal species tested in respect of the natural health product, if any,

  • (vii) the results of clinical pharmacokinetic studies of the natural health product, if any,

  • (viii) the information regarding natural health product safety, pharmacodynamics, efficacy and dose responses of the natural health product that were obtained from previous clinical trials in humans, if any,

  • (ix) the known contra-indications for and the precautions to be taken in respect of the natural health product, and

  • (x) the recommended treatment in the event of an overdose of the natural health product, if any; and

• (f) the proposed date for the commencement of the clinical trial at each clinical trial site.