Natural Health Products Regulations
(a) the sponsor submits an application to the Minister that is in accordance with section 66;
(b) the sponsor provides the Minister with all additional information or samples requested under section 73; and
(c) the Minister has reasonable grounds to believe, based on an assessment of the application, an assessment of any samples or information provided under section 73 or a review of any other information that
(i) the use of the natural health product for the purposes of the clinical trial will not endanger the health of a clinical trial subject or other person,
(ii) the clinical trial is not contrary to the best interests of the clinical trial subjects, and
(iii) the objectives of the clinical trial will be achieved.
(2) The Minister shall authorize the sponsor to sell or import a natural health product for the purposes of a clinical trial by sending the sponsor a notice of the authorization.
- SOR/2018-69, s. 56(F)
- Date modified: