While the consultation is open you can make a submission at our TGA Consultation Hub. We will then review the submissions. After that, a summary of responses will be published on the same page at the TGA Consultation Hub.
About this consultation
The Therapeutic Goods Administration (TGA) is seeking feedback on improvements to the therapeutic goods recalls process.
In Australia, recalls should be done in accordance with the procedures in our guidance document - the Uniform Recall Procedure for Therapeutic Goods (URPTG). Performing recalls in accordance with standardised and agreed procedures is important to effectively respond to issues with therapeutic goods which may pose a risk to public health and safety, and efficiently communicate information in the right way.
The URPTG has been in place for many years and while it has been effective, there have been changes to our regulatory landscape over time. There are new types of products being used, increased complexity in supply chains and changes to the ways in which we communicate.
Based on feedback, we have reviewed the current recall process and identified some potential improvements. We want to know what you think about our proposed changes.
Responding to the consultation
The consultation is open from Friday, 30 January 2023 to Monday, 13 March 2023. Submissions in response to the consultation paper can be made through the link above during this time period. You can also download the discussion paper and open a new tab to access the paper while going through the online survey, or upload your own response document to the Consultation Hub.
Enquiries
Any questions relating to submissions should be emailed to recalls.reforms@health.gov.au
All recent TGA consultations can be found at the TGA consultation hub.