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

The Therapeutic Goods Administration has released a revised edition of the Uniform Recall Procedure for Therapeutic Goods 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

TGA, 27 October 2015 ; ;