The TGA has issued seven infringement notices totalling $93,240 to Melbourne-based global biopharmaceutical company Starpharma Holdings for alleged illegal advertising of a nasal spray that is not approved for use in Australia.
Starpharma allegedly promoted, on two of the company's websites and its YouTube channel, the use and supply in Australia of a nasal spray called Viraleze that was not entered on the Australian Register of Therapeutic Goods.
The Therapeutic Goods Act 1989 prohibits advertising to the public for therapeutic goods that are not entered on the ARTG (unless a specific exemption, approval or authority applies).
The alleged advertising, on two of Starpharma's websites, included a restricted representation claiming that Viraleze is an antiviral nasal spray that stops SARS-CoV-2, the virus that causes COVID-19. Any claims or references to preventing or treating a serious form of a disease, condition, ailment or defect are restricted representations.
Under the Act, the use of restricted representations in advertisements for therapeutic goods is unlawful without the prior authorisation of the TGA. No relevant authorisation has been granted for the advertised claims in this case.