What to report
It is mandatory for companies to report all serious adverse events. This allows us to continuously monitor the incidence of the adverse events (AEs) locally and assess if there is a safety concern. Additionally, products in the same therapeutic class can be compared to assess their relative safety.
Note: Serious adverse events caused by accidental or deliberate overdoses and medication errors need not be reported.
The minimum information required for the submission of your initial report is:
- An identifiable reporter or healthcare professional.
- An identifiable patient.
- An adverse effect.
- A suspected product.
Refer to our guides if you are reporting an adverse event:
How to report
To report adverse events, companies must complete the Council for International Organisations of Medical Sciences (CIOMS) I form and send it to us via one of the following methods:
When to report
You should report the AEs as soon as you are made aware of it and adhere to the reporting timelines below. The initial report of an adverse event should contain as much detail as available, but should not be delayed for the sake of gathering more information.
The clock for reporting starts as soon as any personnel in your company, including sales representatives, are made aware of the serious AE. If there is uncertainty about whether the serious adverse event is reportable, you should still submit a report within the time frame stated.
| Adverse events reports
|| Report as soon as possible and no later than
| Initial reports of serious adverse events.
||15 calendar days
| Follow-up reports when additional medically relevant information is received for a previously reported case.
Note: Indicate that it is a follow-up report and link it to the original report.
| 15 calendar days
Specific adverse events reporting