Natural Health Products Regulations

67 (1) The Minister shall authorize a sponsor to sell or import a natural health product for the purposes of a clinical trial if

• (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.