Natural Health Products Regulations

71 (1) Subject to subsection (2), if the sale or importation of a natural health product for the purposes of a clinical trial is authorized under this Part, the sponsor may not make any of the following amendments unless the authorization is amended accordingly:

• (a) an amendment to the protocol that affects the selection, monitoring or dismissal of a clinical trial subject;

• (b) an amendment to the protocol that affects the evaluation of the clinical efficacy of the natural health product;

• (c) an amendment to the protocol that alters the risk to the health of a clinical trial subject;

• (d) an amendment to the protocol that affects the safety evaluation of the natural health product;

• (e) an amendment to the protocol that extends the duration of the clinical trial; and

• (f) an amendment to the information referred to in subparagraph 66(e)(ii) that may affect the safety or quality of that natural health product.

(2) If the sponsor is required to immediately make one or more of the amendments referred to in subsection (1) because the clinical trial or 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, the sponsor may immediately make the amendment and shall provide the Minister with the information referred to in subsection (3) within 15 days after the day on which the amendment is made.

(3) An application by the sponsor to amend the authorization for the sale or importation of a natural health product under this Part shall be submitted to the Minister and, in addition to a reference to the application submitted under section 66, shall contain the following information and documents:

• (a) if as a result of the amendment it is necessary to amend the statement referred to in paragraph 66(b),

  • (i) a copy of the amended statement that indicates the new information, and

  • (ii) for each clinical trial site, the name, address and telephone number and, if applicable, the facsimile number and electronic mail address of the research ethics board that approved the amended statement;

• (b) if the application is in respect of an amendment referred to in any of paragraphs (1)(a) to (e),

  • (i) a copy of the amended protocol that indicates the amendment,

  • (ii) a copy of the protocol submitted under paragraph 66(a),

  • (iii) the rationale for the amendment,

  • (iv) for each clinical trial site, the name, address and telephone number and, if applicable, the facsimile number and electronic mail address of the research ethics board that approved the amended protocol, and

  • (v) the name, address and telephone number and, if applicable, the facsimile number and electronic mail address of any research ethics board that has previously refused to approve any amendment to the protocol, its reasons for doing so and the date on which the refusal was given;

• (c) if the application is in respect of an amendment referred to in paragraph (1)(e), a copy of the amended investigator’s brochure or an addendum to the investigator’s brochure that indicates the new information, including supporting toxicological studies and clinical trial safety data, if any; and

• (d) if the application is in respect of an amendment referred to in paragraph (1)(f), a copy of the amended chemistry and manufacturing information that indicates the amendment, and the rationale for that amendment.

(4) The Minister shall amend the authorization to sell or import a natural health product for the purposes of a clinical trial if

• (a) the sponsor submits an application for amendment to the Minister that is in accordance with subsection (3);

• (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 for amendment, an assessment of any samples or information submitted 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.

(5) The Minister shall amend the authorization to sell or import a natural health product for the purposes of a clinical trial by sending the sponsor a notice of the amendment.