Planned maintenance may cause outages to the Department of Health and Aged Care’s network from 5:15 pm AEDT on 30 November to 10:00 pm AEDT on 1 December 2024. Access to TGA databases such as TBS Portal, ARTG and DAEN may be affected. We apologise for any inconvenience.
A revised edition of the Uniform Recall Procedure for Therapeutic Goods has been published for consultation. It includes the following changes.
The document
- has been drafted as accessible interlinking webpages with print options rather than a PDF document to enhance navigation and usability
- includes a Step-by-step guide through the recall procedure with supporting information:
- Roles in recalling therapeutic goods, which includes roles of sponsors, manufacturers, TGA, state and territory Recall Coordinators, wholesalers and distributors, health professionals and consumers
- Examples of different classes of recall actions for medicines, devices and biologicals and blood components
- Sponsor's customer letter requirements (hazard alert letters be titled as 'Implant Hazard Alerts')
- Mandatory recall actions
- includes requirements for recalling biologicals
- provides greater clarity on the requirements for medical devices (including IVDs) recall actions
- includes new/changes to recall terminologies
- Recall for Product Defect Correction (change to the terminology)
- Hazard Alert (implanted medical devices and biologicals)
- Product Defect Alert (new term)
- includes–probability aspects (previously classification only considered severity of the issues) in Classification of recalls
- clarifies the requirements of safety alerts (non-recall action)
- updates publication of safety alerts (non-recall action) in SARA (currently only recall actions are published) and publication of recall letters on a case-by-case basis in SARA
- includes the outcomes of the review of recall actions
