Consultation on a revised edition of the Uniform Recall Procedure for Therapeutic Goods

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