All sponsors of products regulated as biologicals under the biologicals framework are required to:
- Report serious threats to public health and serious and near serious adverse events related to the biological within the regulatory timeframes (see Reporting requirements)
- retain records pertaining to the reporting requirements and safety of the biological (see Record-keeping requirements)
- ensure that any request from the TGA for the provision of additional information related to the biological is answered fully and within the specified timeframe
In order to achieve this, sponsors should have a robust biovigilance system in place.
| Adverse event | Method of reporting | Reporting timeframe[*] |
|---|---|---|
|
Serious threat to public health An event or occurrence that represents a serious threat to public health |
In writing to: |
≤ 48 hours |
|
Serious adverse event An event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the biological or another person |
A number of forms and methods are available: electronic structured data preferred | ≤ 10 calendar days |
|
Near serious adverse event An event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the biological or another person |
A number of forms and methods are available: electronic structured data preferred | ≤ 30 calendar days |
| Recalls, quality defects and contaminated or counterfeit biologicals |
Human blood & tissues recall report form or email: |
with the least possible delay |
*Timeframes are in relation to when the sponsor becomes aware that there is an issue for which there is a reasonable possibility of causal relationship.