Food and Drug Regulations

Version of section C.04.421 from 2006-12-14 to 2014-10-22:

  •  (1) A fabricator shall notify the Minister of any serious adverse reaction

    • (a) within 24 hours after the fabricator becomes aware of the occurrence, in the case of a fatality; and

    • (b) within 15 days after the fabricator becomes aware of the occurrence, in any other case.

  • (2) In the case of a verbal notice under subsection (1), the fabricator shall submit a written report of the serious adverse reaction to the Minister within 24 hours after submitting the notice.

  • (3) The notice, if in writing, or the written report shall include a description of the serious adverse reaction and any steps taken to address it.

  • SOR/78-545, s. 1;
  • SOR/2006-353, s. 1.
Date modified: