Food and Drug Regulations
Version of section C.01.017 from 2011-02-10 to 2024-11-26:
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.
- SOR/95-521, s. 2
- SOR/2011-31, s. 1
- Date modified: