Articles

TGA SME Assist presents "Meeting your Obligations" a free workshop aimed at beginners who are unfamiliar with therapeutic goods regulation.

TGA grants provisional determination for sabizabulin for the treatment of COVID-19

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

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

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

The TGA approved Moderna Australia’s application to transition its COVID-19 vaccine, SPIKEVAX (elasomeran), from provisional to full registration.

The TGA has issued a $2,664 infringement notice to a WA-based individual for allegedly importing liquid nicotine for use in nicotine vaping products.

Information about the TGA's safety monitoring of COVID-19 vaccines.

The Federal Court of Australia has ordered Enviro Tech Holdings Pty Ltd to pay $80,000 for unlawful importation of surgical face masks.

The TGA has issued five infringement notices totalling $66,600 to 2San Pty Ltd for allegedly failing to provide information to the TGA to demonstrate the ongoing minimum level of sensitivity of two COVID-19 rapid antigen tests (RATs).

The TGA has issued a direction notice to 13 Vape Pty Ltd and an executive officer to cease promoting the use and supply of nicotine vaping products to Australian consumers.

Listed medicine ingredients and requirements are updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2022.

TGA commences evaluation of Pfizer's COVID-19 vaccine (COMIRNATY) for children aged 6 months to less than 5 years

The TGA has issued an infringement notice to a NSW-based individual for allegedly advertising nicotine vaping products for sale via their website.

The TGA has issued a direction notice to Phenix Health Pty Ltd (Phenix) to cease promoting the use and supply of nicotine vaping products to Australian consumers.

TGA accepts Enforceable Undertaking by Strapit Medical and Sports Supplies Pty Ltd in relation to breaches of the Therapeutic Goods Act.

TGA accepts Enforceable Undertaking by Strapit Medical and Sports Supplies Pty Ltd in relation to breaches of the Therapeutic Goods Act.

Information about the TGA's safety monitoring of COVID-19 vaccines.

The TGA is aware of several incorrect recent media reports asserting that some COVID-19 rapid antigen tests have been removed from the market by the TGA for failing to detect the Omicron COVID-19 variant.

TGA has released over 95 batches of influenza vaccine, consisting of over 16.8 million doses, for supply in Australia for the 2022 influenza season.

The TGA has commenced Federal Court proceedings against Vapor Kings Pty Ltd and its sole director for alleged unlawful advertising of nicotine vaping products.

The TGA has provisionally approved the Biocelect Pty Ltd (on behalf of Novavax Inc.) COVID-19 vaccine, NUVAXOVID, for use in individuals aged 12 years and older.

The TGA has approved the removal of the geographical deferral of blood and plasma donors from the UK, which was put in place to minimise the risk of variant Creutzfeldt-Jakob disease (vCJD), commonly known as 'mad cow disease'.

The TGA has issued a direction notice to 13 Vape Pty Ltd and an executive officer to cease promoting the use and supply of nicotine vaping products to Australian consumers.

This labelling exemption is granted under section 1.1(3) of Part 2 of the current Poisons Standard.