Natural Health Products Regulations (SOR/2003-196)

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.

78. (1) During the course of a clinical trial, the sponsor shall notify the Minister of any serious adverse reaction and any serious unexpected adverse reaction to the natural health product that has occurred inside Canada as follows:

• (a) if it is neither fatal nor life threatening, within 15 days after the day on which the sponsor becomes aware of the information; and

• (b) if it is fatal or life threatening, within seven days after the day on which the sponsor becomes aware of the information.

(2) The sponsor shall, within eight days after the day on which the Minister is notified under paragraph (1)(b), provide the Minister with a complete report in respect of that information that includes an assessment of the importance and implication of any findings made.

79. (1) If the sponsor discontinues a clinical trial in its entirety or at a clinical trial site, the sponsor shall

• (a) notify the Minister of the discontinuance within 15 days after the day of the discontinuance;

• (b) provide the Minister with the reason for the discontinuance and its impact on the proposed or ongoing clinical trials in respect of the natural health product conducted in Canada by the sponsor;

• (c) as soon as possible, notify all qualified investigators of the discontinuance and of the reasons for the discontinuance, and advise them in writing of any potential risks to the health of clinical trial subjects or other persons; and

• (d) in respect of each discontinued clinical trial site, stop the sale or importation of the natural health product as of the day of the discontinuance and take all reasonable measures to ensure the recovery of all unused quantities of the natural health product that have been sold.

(2) If the sponsor discontinues a clinical trial in its entirety or at a clinical trial site, the sponsor may resume selling or importing the natural health product for the purposes of the clinical trial in its entirety or at the clinical trial site if, in respect of each clinical trial site where the sale or importation is to be resumed, the sponsor submits to the Minister the information referred to in subparagraphs 66(c)(ix) to (xi) and paragraphs 66(d) and (f).