What to report
It is mandatory for companies to report all serious adverse events (AEs). This includes reports where the company does not agree with the reporting healthcare professional's assessment and reports where the healthcare professional has not provided a causality assessment. Serious AEs which are not suspected of being product-related by the healthcare professional should not be reported unless the company has reasons to suspect a causal association.
Note: Serious AEs 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 AE.
- A suspected product.
Refer to our guides if you are reporting an AE:
How to report
To report serious AEs, companies are to complete the Council for International Organisations of Medical Sciences (CIOMS) I form and send it to HSA via one of the following methods:
When to report
You should report the serious AEs as soon as you are made aware of them and adhere to the reporting timelines below. The initial report of a serious AE 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 AE is reportable, you should still submit a report within the time frame stated.
|Adverse event reports
| Report as soon as possible and no later than
| Initial reports of serious AEs.
|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