We are actively involved throughout the recall process.
Once a therapeutic good is available in Australia, we continue to monitor it through therapeutic product vigilance activities.
This sometimes leads to identifying an issue that is likely to require recall. In this situation, we contact the sponsor and provide all the relevant information.
In rare cases, a TGA delegate of the Secretary will mandate the sponsor to recall a therapeutic good.
For immediate recalls, phone the Australian Recall Coordinator.
For all recalls, we send the TGA Recall Notice to all State and Territory recall coordinators.
On this page: Our role in recalls | Working with ACCC | Providing information
Our role in recalls
Our role includes:
- Independently and objectively assessing the risk posed by the affected therapeutic goods.
- this is a critical step in the recall procedure. It verifies, through independent assessment, the potential or real risks to the public and verifies the effectiveness of the proposed recall action to mitigate the potential or real risks to public health and safety.
- Agreeing to the recall and communication strategy:
- this is critical for ensuring the messages and strategy are commensurate with the risk posed by the affected goods.
- Sending the agreed letter to the sponsor.
- Notifying others:
- includes state and territory recall coordinators
- parties contacted are listed on our website.
- Reviewing the recall at the end of the process:
- sometimes this results in further investigations, such as an inspection of the manufacturer. This is critical for the effectiveness of the recall.
We maintain an up-to-date list of state and territory recall Coordinators.
We contact relevant state and territory recall coordinators at Step 8 of the recall procedure.
Working with ACCC
We liaise with the ACCC when necessary for safety-related recalls of therapeutic goods that are also consumer goods.
Providing information
We are responsible for communicating:
- the recall procedure
- details about specific recalls through the public database (SARA)
- TGA alerts for recalls such as hazard alerts, consumer level recalls and recalls that may have wider implications for public health safety. The alert is sent to appropriate organisations and professional colleges after publication
- the contact list for the state and territory Recall Coordinators
- a list of those other parties we contact as part of this procedure.