Articles

Updated to include new section on Reprocessing of PPE by Healthcare facilities

The TGA has issued eight infringement notices to Sydney-based company for allegedly failing to provide information and face mask samples to the TGA when required to do so, and for providing false and misleading information.

Healthcare professionals and public health authorities will have a central role in discussing vaccination against COVID-19 with their patients.

The Therapeutic Goods (Permissible Indications) Determination has been updated

The TGA has granted a provisional determination to Biocelect Pty Ltd (on behalf of Novavax Inc.) in relation to the COVID-19 Vaccine, NVX-CoV2373.

In recent days the TGA has received reports of about 30 deaths in over 40,000 elderly individuals in Norway vaccinated with the Pfizer BioNTech vaccine

The TGA has issued an infringement notice to Melbourne-based company Enviro Tech Holdings Pty Ltd for the alleged unlawful importation of surgical face masks in relation to COVID-19.

The TGA has issued an infringement notice to Brisbane-based company PPE Direct Pty Ltd, trading as Infinity Biotech for the alleged unlawful advertising of a COVID-19 Rapid Test kit under the Therapeutic Goods Act 1989.

The TGA is warning consumers that off-label use of so-called smart drugs, such as Modafinil, is not a wise choice.

From 1 October 2021, the law for consumers to import nicotine e-cigarettes and liquid nicotine will align with the law for them to buy such products domestically

The Regulation Impact Statement (RIS) and the regulatory burden costing have been published alongside the delegate's final decision on the scheduling of nicotine.

The TGA has issued three infringement notices to a Sydney man for the alleged unlawful advertising of a disinfectant and a hand sanitiser in relation to COVID-19

The TGA has issued four infringement notices totalling $10,656 to a West Australian man, for alleged unlawful advertising of cannabidiol (CBD)

The Therapeutic Goods (Permissible Ingredients) Determination has been updated.

Today the TGA announced a final decision to down-schedule certain low dose cannabidiol (CBD) preparations

A woman from Melbourne has been convicted on three charges of unlawful importation of therapeutic goods

The Access Consortium regulatory authorities have pledged their collective support in countering the COVID-19 global pandemic

The TGA notes the emergency use authorisation related to the COVID-19 vaccine BNT162b2 supplied by Pfizer and BioNTech.

The system is an Australian first and will allow tracking and tracing of medical devices that have been implanted in patients.

The electronic application form for a Conformity Assessment Certificate has been updated

The TGA has issued an infringement notice for $13,320 to Sydney-based company Nafara Australia Pty Ltd (Nafara Australia) for the alleged unlawful importation of medical face masks in relation to COVID-19.

The TGA has issued an infringement notice for $2,664 to a man from Sydney for the alleged unlawful importation of medical face masks in relation to COVID-19.

ANPROS Pty Ltd fined $39,960 for alleged unlawful advertising of hydrogen peroxide.

The TGA has  has issued four infringement notices totalling $10,656 to a man from Sydney for the alleged unlawful advertising of hydrogen peroxide and Condy's crystals (potassium permanganate)