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Food and Drug Regulations

Version of section C.05.014 from 2017-02-13 to 2022-07-25:

  •  (1) During the course of a clinical trial, the sponsor shall inform the Minister of any serious unexpected adverse drug reaction in respect of the drug that has occurred inside or outside Canada as follows:

    • (a) if it is neither fatal nor life threatening, within 15 days after becoming aware of the information; and

    • (b) if it is fatal or life threatening, within seven days after becoming aware of the information.

  • (2) The sponsor shall, within eight days after having informed the Minister under paragraph (1)(b), submit to the Minister a complete report in respect of that information that includes an assessment of the importance and implication of any findings made.

  • (3) Sections C.01.016 to C.01.020 do not apply to drugs used for the purposes of a clinical trial.

  • SOR/2001-203, s. 4
  • SOR/2017-18, s. 16
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