Canada Post market Flashcards
1
Q
Adverse event reports involving death and serious deterioration must be reported in how many days?
A
10 days
2
Q
Adverse event reports involving potential death or serious deterioration must be reported in how many days?
A
30 days
3
Q
Reportable foreign incidents need to be reported in what time frame?
A
as soon as possible (48 hours)
4
Q
It is whose responsibility to submit primary and final reports to the authority after adverse event investigation is complete?
A
Manufacturer and importer (unless manufacturer have given authorization to the importer to report on its behalf)
5
Q
In the case of a recall, if planned corrective action meets the definition of significant change, what action needs to be taken?
A
An MDL amendment application would be required
