SPL first applied for “TGA marketing approval” for Viraleze in March 2022 (over 2 years ago) as medical device as determined by category adjudication on TGA error in categorising Viraleze with Astodrimer sodium as a Medicine
https://amp.smh.com.au/business/companies/australian-covid-nasal-spray-not-on-shop-shelves-amid-tga-dispute-20220303-p5a1c6.html
This was confirmed again at SPL Webinar in May 2024 In response to an email to the TGA scheduling branchThis is what TGA said in June 2024 after Astodrimer sodium as nasal spray was approved as Pharmacy Medicine applicable 1 June 2024 proving it is a TGA delays not SPL DELAYS
RE: Astodrimer sodium nasal spray re: marketing approval ARTG [SEC=OFFICIAL]
June 25 2024
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Thank you for your patience with this enquiry. I have received an update from the relevant section regarding product registration/marketing approval and have been advised that this is still under review. No timeframe has been specified.
Kind regards,
MelissaThe Chemicals and Medicines Scheduling Secretariat Team
Scheduling and Chemical Policy Section
June 16 2024
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Thank you for your email.
We are currently seeking advice from the relevant internal area in relation to your enquiry concerning product registration/marketing approval and we will endeavour to respond to your email as soon as possible.
Kind regards, Melissa
The Chemicals and Medicines Scheduling Secretariat Team
Scheduling and Chemical Policy Section
