Health Canada citation
C.05.014 - serious unexpected adverse drug reaction reporting
Health Canada inspection citation · Food and Drug Regulations (C.R.C., c. 870), Part C
Key facts
| Requirement | C.05.014 - serious unexpected adverse drug reaction reporting |
|---|---|
| Regulation | Food and Drug Regulations (C.R.C., c. 870), Part C |
| Example observations (excerpt) | the clinical trial was not conducted according to the protocol. the clinical trial drug was not used according to the protocol. the sponsor did not inform health canada within 15 days of becoming aware of serious unexpected adverse drug reactions in or outside canada that were not fatal or life… |
At a glance
- 1–9 Health Canada inspections citing this requirement
- No Among the 20 most-cited Health Canada requirements
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Health Canada regulation sections cited in inspections
Health Canada inspection reports cite the section of the Food and Drug Regulations, Medical Devices Regulations or Blood Regulations behind each observation. This page counts the published inspections that cite the requirement.
Source: Health Canada, Drug and Health Product Inspections; citation counts by Orca1. Contains information licensed under the Open Government Licence – Canada
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