Articles

The TGA has issued an infringement notice for $2,664 to an individual for an alleged breach of the Therapeutic Goods Act 1989.

Legislative instrument made under 47B Provision of information concerning medicines, biologicals and medical devices.

The TGA has provisionally approved the use of the Roche Products Pty Ltd combination therapy, casirivimab + imdevimab (RONAPREVE), for the treatment and prevention of COVID-19 in specific target populations.

The TGA has issued seven infringement notices totalling $93,240 to Australia Utopia Pty Ltd for alleged unlawful advertising of nicotine vaping products on its website.

The TGA has granted provisional determination to Grand Pacific CRO (the Australian sponsor acting on behalf of Medigen Vaccine Biologics Corp) in relation to its COVID-19 vaccine: MVC-COV1901-S-2P-Protein (MVC-COV1901 Vaccine).

The TGA has issued eight infringement notices totalling $106,560 to Mason Online Pty Ltd for alleged unlawful advertising of nicotine vaping products.

The TGA has issued an infringement notice for $2,664 to a chiropractor from New South Wales for the alleged importation of ivermectin in breach of the Therapeutic Goods Act 1989.

The TGA has issued four infringement notices, totalling $53,280, for the alleged export, supply and advertising of counterfeit erectile dysfunction (ED) medicines in breach of the Therapeutic Goods Act 1989.

The TGA has granted a provisional determination to Moderna Australia Pty Ltd in relation to its COVID-19 vaccine, SPIKEVAX.

Introduction of requirements for sponsors of sartan medicines

The TGA has identified certain therapeutic goods being inappropriately promoted for the prevention or treatment of novel coronavirus (2019-nCoV) infections in Australia

The TGA has issued three infringement notices totalling $39,960 to Sydney-based company RV Global Ecommerce Pty Ltd for alleged unlawful advertising of nicotine vaping products.

The TGA has issued three infringement notices, totalling $7,992, to a Melbourne-based individual for alleged importation breaches involving nicotine vaping products.

The TGA is warning consumers to be aware of counterfeit nicotine vaping products advertised and sold online.

The TGA determined that Covaxin (manufactured by Bharat Biotech, India) and BBIBP-CorV (manufactured by Sinopharm, China) vaccines would be 'recognised' for the purpose of establishing a traveller's vaccination status.

A new Therapeutic Goods Determination for listed medicine ingredients commenced on 25 October 2021.

The TGA has provisionally approved a booster dose of the Pfizer Australia Pty Ltd COVID-19 vaccine, COMIRNATY, for individuals 18 years and older.

The TGA has issued seven infringement notices totalling $18,648 to a Melbourne-based individual, for alleged unlawful advertising of nicotine vaping products 

The TGA has commenced proceedings in the Federal Court against Enviro Tech Holdings Pty Ltd, and its executive officers for the alleged unlawful importation of surgical face masks.

This labelling exemption is granted under section 1.5.5 of Part 2 of the current Poisons Standard.

TGA has published a Joint statement on supply allocations of intravenous tocilizumab (Actemra) during serious shortage.

On 1 October 2021, the TGA granted provisional determination to Pfizer Australia in relation to a new combination medicine containing PF-07321332 and ritonavir, for the treatment of adult patients with symptomatic, confirmed coronavirus infection.

Australian consumers now require a valid prescription from any of Australia's 100,000 medical practitioners to import nicotine vaping products, purchased from overseas websites.

HealthHub247 Pty Ltd (HealthHub247) and its Director have been convicted of the unlawful manufacture, counterfeit, advertising and supply of sports supplements that contain prohibited substances in the current Poisons Standard.

The TGA has issued seven infringement notices totalling $18,648 to the individual responsible for the Invigorate Labs website, for alleged breaches that relate to the advertising of products containing cannabidiol (CBD).