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Natural Health Products Regulations (SOR/2003-196)

Regulations are current to 2019-11-19 and last amended on 2018-10-17. Previous Versions

PART 4Clinical Trials Involving Human Subjects (continued)

Sponsor’s Obligations (continued)

Records

  •  (1) The sponsor shall record, handle and store all information in respect of a clinical trial in a way that allows its complete and accurate reporting as well as its interpretation and verification.

  • (2) The sponsor shall maintain complete and accurate records to establish that the clinical trial is conducted in accordance with good clinical practices and these Regulations.

  • (3) The sponsor shall maintain complete and accurate records in respect of the use of a natural health product in a clinical trial, including

    • (a) a copy of all versions of the investigator’s brochure for the natural health product;

    • (b) records respecting each change made to the investigator’s brochure, including the rationale for each change and documentation that supports each change;

    • (c) records respecting all adverse events in respect of the natural health product that have occurred inside or outside Canada, including information that specifies the dosage form and the use and purpose of the natural health product at the time of the adverse event;

    • (d) records respecting the enrolment of clinical trial subjects, including information sufficient to enable all clinical trial subjects to be identified and contacted in the event that the sale of the natural health product may endanger the health of the clinical trial subjects or other persons;

    • (e) records respecting the shipment, receipt, disposition, return and destruction of the natural health product;

    • (f) for each clinical trial site, an undertaking from the qualified investigator that is signed and dated by the qualified investigator prior to the commencement of his or her responsibilities in respect of the clinical trial, that states that

      • (i) the qualified investigator will conduct the clinical trial in accordance with good clinical practices, and

      • (ii) the qualified investigator will immediately, on discontinuance of the clinical trial by the sponsor, in its entirety or at a clinical trial site, notify both the clinical trial subjects and the research ethics board of the discontinuance, provide them with the reasons for the discontinuance and advise them in writing of any potential risks to the health of clinical trial subjects or other persons;

    • (g) for each clinical trial site, a copy of the protocol, informed consent form and any amendment to the protocol or informed consent form that have been approved by the research ethics board for that clinical trial site; and

    • (h) for each clinical trial site, an attestation, signed and dated by the research ethics board for that clinical trial site, stating that it has reviewed and approved the protocol and informed consent form and that the board carries out its functions in a manner consistent with good clinical practices.

  • (4) The sponsor shall maintain all records referred to in this Part for a period of 25 years.

Submission of Information and Samples

  •  (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.

  • SOR/2018-69, s. 60(F)

Reaction Reporting

  •  (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.

Discontinuance of a Clinical Trial

  •  (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).

Suspension and Cancellation

  •  (1) Subject to subsection (2), the Minister may suspend the authorization to sell or import a natural health product for the purposes of a clinical trial, in its entirety or at a clinical trial site, if the Minister has reasonable grounds to believe that

    • (a) the sponsor has contravened these Regulations or any provisions of the Act relating to the natural health product;

    • (b) any information submitted or provided in respect of the natural health product or clinical trial is false or misleading;

    • (c) the sponsor has failed to comply with good clinical practices; or

    • (d) the sponsor has failed to

      • (i) provide information or samples of the natural health product as required under section 73 or 77, or

      • (ii) notify the Minister or provide a report under section 78.

  • (2) Subject to section 81, the Minister shall not suspend the authorization unless

    • (a) the Minister has sent the sponsor a notice that indicates whether the authorization is intended to be suspended in its entirety or at a clinical trial site and the reason for the intended suspension; and

    • (b) the sponsor has not, within 30 days after the day on which the notice referred to in paragraph (a) is received, provided the Minister with information or documents demonstrating that the authorization should not be suspended on the grounds that

      • (i) the situation giving rise to the intended suspension did not exist, or

      • (ii) the situation giving rise to the intended suspension has been corrected.

 The Minister shall suspend the authorization to sell or import a natural health product for the purposes of a clinical trial, in its entirety or at a clinical trial site, before giving the sponsor an opportunity to be heard if, as a result of any circumstance, the Minister has reasonable grounds to believe that it is necessary to do so to prevent injury to the health of a clinical trial subject or other person.

  • SOR/2018-69, s. 61(F)

 If the Minister suspends the authorization under section 80 or 81, the Minister shall send the sponsor a notice that sets out the reason for the suspension, the day on which the suspension is effective and indicating whether the authorization is suspended in its entirety or at a clinical trial site, and the Minister shall

  • (a) reinstate the authorization in its entirety or at a clinical trial site, as the case may be, if within 30 days after the day on which the suspension is effective the sponsor provides the Minister with information or documents demonstrating that the situation giving rise to the suspension did not exist or that it has been corrected; or

  • (b) cancel the authorization in its entirety or at a clinical trial site, as the case may be, if within 30 days after the day on which the suspension is effective the sponsor has not provided the Minister with the information or documents referred to in paragraph (a).

 
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