72. If the authorization to sell or import a natural health product for the purposes of the clinical trial is amended in accordance with subsection 71(5), the sponsor shall
(a) before commencing to sell or import the natural health product in accordance with the amended authorization
(i) cease to sell or import the natural health product in accordance with the existing authorization, and
(ii) maintain records concerning the information referred to in subparagraph 66(c)(ix), if any of that information has changed since it was submitted, and the information referred to in paragraph 66(f); and
(b) conduct the clinical trial in accordance with the amended authorization.
Additional Information and Samples
73. If the information and documents submitted in respect of an application under section 66 or an application for amendment under subsection 71(3) are insufficient to enable the Minister to determine whether the sale or importation of the natural health product should be authorized or whether the authorization should be amended, as the case may be, the Minister may request that the sponsor provide the Minister with samples of the natural health product or additional information relevant to the natural health product or the clinical trial that are necessary to make the determination.
Good Clinical Practices
74. Every sponsor shall ensure that a clinical trial is conducted in accordance with good clinical practices and, without limiting the generality of the foregoing, shall ensure that
(a) the clinical trial is scientifically sound and clearly described in a protocol;
(b) the clinical trial is conducted, and the natural health product is used, in accordance with the protocol and this Part;
(c) systems and procedures that assure the quality of every aspect of the clinical trial are implemented;
(d) for each clinical trial site, the approval of a research ethics board is obtained before the clinical trial begins at the site;
(e) at each clinical trial site, there is no more than one qualified investigator;
(f) at each clinical trial site, medical care and medical decisions, in respect of the clinical trial, are under the supervision of the qualified investigator;
(g) each individual involved in the conduct of the clinical trial is qualified by education, training and experience to perform his or her respective tasks;
(h) written informed consent, given in accordance with the applicable laws governing consent, is obtained from every person before that person participates in the clinical trial but only after that person has been informed of
(i) the risks and anticipated benefits to his or her health arising from participation in the clinical trial, and
(ii) all other aspects of the clinical trial that are necessary for that person to make the decision to participate in the clinical trial;
(i) the requirements respecting information and records set out in section 76 are met; and
(j) the natural health product is manufactured and stored in accordance with the requirements set out in Part 3 except for section 61.
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