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Natural Health Products Regulations (SOR/2003-196)

Regulations are current to 2022-11-16 and last amended on 2022-06-21. Previous Versions

PART 4Clinical Trials Involving Human Subjects (continued)

Amendment (continued)

 If an authorization to sell or import a natural health product for the purposes of a clinical trial is amended in accordance with subsection 71(5), the sponsor shall sell or import the natural health product and conduct the clinical trial in accordance with the amended authorization.

Additional Information and Samples

 If the information and documents submitted in respect of an application under section 66 or an application for amendment under subsection 71(3) are insufficient to enable the Minister to determine whether the sale or importation of the natural health product should be authorized or whether the authorization should be amended, as the case may be, the Minister may request that the sponsor provide the Minister with samples of the natural health product or additional information relevant to the natural health product or the clinical trial that are necessary to make the determination.

Sponsor’s Obligations

Good Clinical Practices

 Every sponsor shall ensure that a clinical trial is conducted in accordance with good clinical practices and, without limiting the generality of the foregoing, shall ensure that

  • (a) the clinical trial is scientifically sound and clearly described in a protocol;

  • (b) the clinical trial is conducted, and the natural health product is used, in accordance with the protocol and this Part;

  • (c) systems and procedures that assure the quality of every aspect of the clinical trial are implemented;

  • (d) for each clinical trial site, the approval of a research ethics board is obtained before the clinical trial begins at the site;

  • (e) at each clinical trial site, there is no more than one qualified investigator;

  • (f) at each clinical trial site, medical care and medical decisions, in respect of the clinical trial, are under the supervision of the qualified investigator;

  • (g) each individual involved in the conduct of the clinical trial is qualified by education, training and experience to perform his or her respective tasks;

  • (h) written informed consent, given in accordance with the applicable laws governing consent, is obtained from every person before that person participates in the clinical trial but only after that person has been informed of

    • (i) the risks and anticipated benefits to his or her health arising from participation in the clinical trial, and

    • (ii) all other aspects of the clinical trial that are necessary for that person to make the decision to participate in the clinical trial;

  • (i) the requirements respecting information and records set out in section 76 are met; and

  • (j) the natural health product is manufactured and stored in accordance with the requirements set out in Part 3 except for section 61.

Labelling

  •  (1) The sponsor shall ensure that the natural health product bears a label that sets out the following information in both official languages:

    • (a) a statement indicating that the natural health product is an investigational natural health product to be used only by a qualified investigator;

    • (b) the brand name or code of the natural health product;

    • (c) the expiry date of the natural health product;

    • (d) the recommended storage conditions for the natural health product, if any;

    • (e) the lot number of the natural health product;

    • (f) the name and address of the manufacturer;

    • (g) the name and address of the sponsor; and

    • (h) the protocol code or identification.

  • (2) Sections 86 to 94 do not apply to a natural health product used for the purposes of a clinical trial.

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 demonstrate 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;

    • (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; and

    • (i) for each clinical trial referred to in an application submitted under section 66 or subsection 71(3), the information referred to in subparagraph 66(c)(ix) and paragraph 66(f).

  • (4) The sponsor shall maintain all records referred to in this Part for a period of 15 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 date of the notice referred to in paragraph (a), 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).

 If the Minister cancels the authorization under paragraph 82(b), the Minister shall send the sponsor a notice that sets out the reason for the cancellation, the day on which the cancellation is effective and indicating whether the authorization is cancelled in its entirety or at a clinical trial site.

PART 5General

Electronic Signatures

 Any signature that is required by these Regulations to be shown on a record or document may be an electronic reproduction of the required signature.

Electronic Records

 Any record that is required to be maintained by these Regulations may be maintained in any electronic format from which a printed copy of the record can be produced.

Labelling and Packaging

General

  •  (1) No person shall sell a natural health product unless it is labelled and packaged in accordance with these Regulations.

  • (2) Despite subsection (1), a person may sell a natural health product that is not labelled and packaged in accordance with these Regulations if the sale is to a manufacturer or distributor.

  •  (1) Subject to subsection (2), when required by these Regulations to be shown on a label, the following information respecting a natural health product shall be in both English and French:

    • (a) any of the information referred to in paragraphs (a) to (f) of the definition recommended conditions of use in subsection 1(1);

    • (b) the common name and proper name of each medicinal ingredient and each non-medicinal ingredient that it contains;

    • (c) a description of the source material of a medicinal ingredient; and

    • (d) its storage conditions.

  • (2) The common name or proper name of a medicinal ingredient or non-medicinal ingredient shall be shown in any other language if the name does not have an English or French equivalent.

 The statements, information and declarations required by these Regulations to be shown on a label of a natural health product shall be

  • (a) clearly and prominently displayed; and

  • (b) readily discernible to the purchaser or consumer of the natural health product under the customary conditions of purchase and use.

 
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