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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 shall not make any of the following amendments unless the authorization is amended accordingly:
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(c) an amendment to the protocol that alters the risk to the health of a clinical trial subject;
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(e) an amendment to the protocol that extends the duration of the clinical trial; and
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(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.
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(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:
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(b) if the application is in respect of an amendment referred to in any of paragraphs (1)(a) to (e),
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(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
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(4) The Minister shall amend the authorization to sell or import a natural health product for the purposes of a clinical trial if
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(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
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SOR/2018-69, s. 58; SOR/2022-146, s. 13(E).
