When you must notify the Health Canada Minister of Health of changes to the Benefit/Risk Analysis conclusion and Implementation Action Items
When to notify the Health Canada Minister of Health Video
The Health Canada Minister of Health must be notified of any changes to the Benefit/Risk Analysis with 72 HOURS! Yes, that is three days which is an extremely short time frame.
Changes to the Benefit/Risk Analysis may happen when:
1) Complaints are received and reviewed for new risk management information
- New risk may be identified
- Severity of risk may increase
- Probability of occurrence may increase
- Benefits may be diminished from initial estimation
2) Post-Market Surveillance provides new data that updates the Risk Management File
How to notify the Minister of Health
- Within an Application for License Amendment
- Within a Notification of Recall
- With the Submission of a Summary Report
Implementation Action Items
