In 2021 public consultations were called by TGA to change Schedule 3 Poison Appendix F (use description) and Appendix H (representation advertising) and in March 2022 the delegate made an Interim decision that Appendix F would be altered but Appendix H with its prohibition on advertising remained unchanged
https://www.tga.gov.au/sites/default/files/notice-interim-decisions-proposed-amendments-poisons-standard-acms-accs-joint-acms-accs-meetings-november-2021.pdfHowever in April 2022 a second round of consultation was established and written submissions made by the Pharmacy Guild and Starpharma are published on this website.
https://consultations.tga.gov.au/tga/november_2021_interim/consultation/published_select_respondentStarpharma only partially approved the published interim decision and sought changes to Appendix F and more significantly Appendix H should allow representations. Reading the FINAL decision which was difficult to find as some TGA headers have not been updated
https://www.tga.gov.au/sites/default/files/notice-final-decisions-amend-or-not-amend-current-poisons-standard-acms-36-joint-acms-accs-29-accs-32.pdf (dated 23 May 2023) it appears that Appendix H can now include
"ASTODRIMER SODIUM for the treatment and relief of bacterial vaginosis and for the prevention of recurrent bacterial vaginosis."
Although there is no mention of Viraleze™ as another product currently approved and sold in 30+ countries and using ingredient astodrimer sodium - it seems that this significantly challenges the REASON for the $93K fine.
So it would seem that when and if TGA finally approved Viraleze although a variation in Astodrimer's Appendix H inclusions will not be constrained anymore by no representations.
Maybe I have read this wrongly but I hope I have understood the complex interim and final decisions
I still find it strange that the Jane Halton report to the Minister on the current and future state of vaccines and treatments makes NO MENTION of Viraleze even though reference is made to international monoclonal antibody and antiviral treatments - with a large number of redactions not only in the vaccines sections but also in antivirals maybe Viraleze is behind the BLACK.
