All Complaints received on medicines
Product Quality Complaints
Within 1 business day, or 3 calendar days (whichever is earlier) of when you read the information
Within 1 business day, or 3 calendar days (whichever is earlier) from when the information is first received
Within 48 hours of your awareness
No safety report is required because the AE is mentioned in the Product label
No, you do not need to forward a report since the Health Care Professional has written a script for the patient.
No, it is not required to forward a report as it is not part of your obligation.
Yes, Forward a product safety report of this off-label use.
No safety report is required because there were no unexpected adverse events.