Natural Health Products Regulations

77 (1) The Minister shall require a sponsor to provide, within two days after the day on which the request is received, information concerning the natural health product or the clinical trial, or samples of the natural health product, if the Minister has reasonable grounds to believe that

• (a) the use of the natural health product for the purposes of the clinical trial endangers the health of a clinical trial subject or other person;

• (b) the clinical trial is contrary to the best interests of a clinical trial subject;

• (c) a qualified investigator is not respecting the undertaking referred to in paragraph 76(3)(f); or

• (d) information submitted or provided in respect of the natural health product or the clinical trial is false or misleading.

(2) The Minister may require the sponsor to provide, within seven days after the day on which the request is received, any information or records referred to in section 76, or samples of the natural health product, in order to assess the safety of the natural health product or the health of clinical trial subjects or other persons.