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Recall notifications to the TGA or to GS1 Australia's Recall Health platform

Processing recall actions for therapeutic goods

8 April 2020

This interim statement relates to the use of the Recall Health platform provided by GS1 Australia (hereafter referred to as 'the platform') and sponsor responsibilities for therapeutic goods recalls undertaken in Australia.

In line with advice first issued in December 2013, the TGA wishes to again clarify that it is NOT a Commonwealth requirement for sponsors of therapeutic goods in Australia to sign up to use the platform in order to undertake recall actions. Should sponsors opt not to utilise the platform, they are to continue to notify recalls directly to the TGA's Recalls Section and communicate with their customers in the most effective manner.

Since the platform first went live in 2014, there has been periodic but continuing confusion in some industry stakeholder groups about its use (including whether it must be used) and concerns raised about duplication of effort between this platform and sponsor obligations to notify the TGA of recall and non-recall actions.

These issues have been further discussed at recent stakeholder meetings hosted by the TGA and attended by representatives from GS1 Australia and various peak industry associations. Prior to publication of a detailed Statement of Clarification, it was agreed that the issues of concern require further consideration and this would be best accomplished in a workshop setting with all key stakeholders in attendance.

Due to current public safety requirements and travel restrictions related to the COVID-19 Pandemic, it is not possible to convene the workshop at this time and accordingly, provide a further clarifying statement. This will be done at the earliest opportunity.