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  1. Natural Health Products Regulations - SOR/2003-196 (Section 76)
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    • (3) The sponsor shall maintain complete and accurate records in respect of the use of a natural health product in a clinical trial, including

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      • (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;

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

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      • (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).

    SOR/2021-46, s. 15(E); SOR/2022-18, s. 56; SOR/2022-146, s. 15.


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