Food and Drug Regulations

C.04.421 (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.