Food and Drug Regulations (C.R.C., c. 870)

C.01.017 The manufacturer shall submit to the Minister a report of all information relating to the following serious adverse drug reactions within 15 days after receiving or becoming aware of the information, whichever occurs first:

• (a) any serious adverse drug reaction that has occurred in Canada with respect to the drug; and

• (b) any serious unexpected adverse drug reaction that has occurred outside Canada with respect to the drug.