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.
Guidance and resources
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FormsForm to notify the TGA of the Exceptional Release of a non-conforming biological.