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TGA consultations which maybe of interest to ATSA members

By February 1st, 2023No Comments

Please read the following to see if they are relevant to your business and either reply directly to the TGA if you would like to make a submission or send any comments you may have to margaret.noonan@atsa.org.au by the dates indicated below.

The Therapeutic Goods Administration (TGA) has published a new discussion paper on the TGA Consultation Hub today. We are seeking your valuable feedback on improvements to the therapeutic goods recalls process as part of the new Recall Reforms Program to investigate potential improvements to our processes and updates to the Uniform Recall Procedure for Therapeutic Goods (URPTG).

Based on feedback and information from both internal and external stakeholders, we have reviewed the current recall process and identified potential improvements.

We want to know what you think about our proposed changes. We have grouped these into five themes:

  • Increasing awareness and understanding about recalls
  • Improving communication
  • Better recall descriptions
  • Improving sponsor letters and other recall documents
  • Reporting progress with a recall

We also welcome any other comments or suggestions you would like to provide on the recalls process. The consultation period will close on 13 March 2023. Please note that late submissions after this date may not be considered.

You can provide feedback by either filling in the electronic survey on the TGA Consultation Hub, or download the full Discussion Paper and upload your own response document on the final page of the TGA Consultation Hub or sending your comments to margaret.noonan@atsa.org.au by cob 6th March 2023.

The discussion questions are optional – you can skip any section, or individual questions within a section, if you do not wish to respond to some of them. Please feel free to share this email and the consultation link with others in your professional and community network/s. If you have any questions about this consultation please email us at recalls.reforms@health.gov.au