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:
[...]
(e) an investigator’s brochure that contains the following information, namely,
(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,
(3) An application by the sponsor to amend the authorization for the sale or importation of a natural health product under this Part shall be submitted to the Minister and, in addition to a reference to the application submitted under section 66, shall contain the following information and documents:
(c) if the application is in respect of an amendment referred to in paragraph (1)(e), a copy of the amended investigator’s brochure or an addendum to the investigator’s brochure that indicates the new information, including supporting toxicological studies and clinical trial safety data, if any; and
63 The following definitions apply in this Part.
clinical trial means an investigation in respect of a natural health product that involves human subjects and that is intended to discover or verify its clinical, pharmacological or pharmacodynamic effects, to identify any adverse events that are related to its use, to study its absorption, distribution, metabolism and excretion, or to ascertain its safety or efficacy. (essai clinique)
