Articles

This instrument is made under section 39 of the current Poisons Standard.

This instrument is made under Schedule 5A to the Therapeutic Goods Regulations 1990 and Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002.

Listed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2025, which commenced on 19 September 2025.

The TGA has identified a discrepancy between the wording of the ‘POTAS1’ warning statement available in the Code Tables compared to the requirements for potassium chloride and glucosamine sulfate potassium chloride in the Therapeutic Goods (Permissible Ingredients) Determination (the Determination).

The TGA has issued a direction notice to Cholrem Pty Ltd and its executive officer to cease advertising a therapeutic good not entered in the Australian Register of Therapeutic Goods (ARTG). They were also directed to cease advertising such goods in a way that contravened the Therapeutic Goods Advertising Code, and for indications relating to heart disease and stroke, amongst others.

We have issued 10 infringement notices, totalling $198,000, to Midnight Health Pty Ltd (Midnight Health) for the alleged unlawful advertising of prescription-only weight-loss medicines.

A blitz undertaken on Chapel Street retailers over two days this week has resulted in seizures of illegal vaping goods with a street value of over $40,000 and more than 24,000 nicotine pouches.

We have issued 3 infringement notices totalling $11,268 to a Victorian-based individual for allegedly importing unapproved prescription-only medicines.

Robust scientific evidence shows no causal link between the use of paracetamol in pregnancy and autism or ADHD, with several large and reliable studies directly contradicting these claims.

We have issued 6 infringement notices, totalling $118,800, and a direction notice to Dispensed Pty Ltd (Dispensed) for the alleged unlawful advertising of medicinal cannabis.

Instructions for searching Australian manufacturers licensed for the manufacture of medicines, blood and biologicals.

A two-day blitz on the sale of illegal vaping goods in Hobart and surrounds has resulted in seizures across 5 retail businesses for the alleged unlawful possession of commercial quantities of vaping goods and illegal tobacco.

We have issued 3 infringement notices totalling $59,400, to Victorian-based companies for the alleged unlawful advertising of therapeutic goods, in contravention of the Therapeutic Goods Act 1989.

From 1 September 2025, the TGA will adopt an updated version of the PIC/S Guide to GMP (PE009-17), with changes focused on Annex 1 for sterile medicines, and a phased compliance approach for manufacturers.

The TGA has issued a direction notice to Dispensed Pty Ltd to cease advertising of medicinal cannabis on all websites, social media accounts or other advertising platforms.

The TGA, assisted by Victoria Police, seized illicit vapes worth approximately $40,000 from a retail outlet in a highly prominent location in Melbourne’s CBD.

The TGA has facilitated the seizure of millions of counterfeit and illegal therapeutic goods as part of a global initiative targeting illegal trade.

The TGA suggests extra safety measures for some sunscreen ingredients but advises Australians to keep using sunscreen. Public consultation will determine safe levels.

Australians who rely on medical devices will benefit from new measures introduced by the Australian Government to enhance the identification and management of device-related safety concerns.

We are aware that recent media reports have stated that the TGA estimates that more than 10 million vapes are sold nationally every month on the black market. These reports are incorrect.

The TGA has accepted a court-enforceable undertaking from The Aussie Gelatin Company Pty Ltd (Aussie Gelatin) in relation to the alleged unlawful manufacture, supply and advertising of therapeutic goods.

We have issued an infringement notice of $18,780 to Victorian-based company, Nourishmeorganics Pty Ltd, for the alleged unlawful supply of a therapeutic good not entered in the ARTG.

We have commenced proceedings in the Federal Court of Australia against Atlus and its sole director, Mamamia, News Life and Straight Up for advertising medicinal cannabis in alleged contravention of the Therapeutic Goods Act 1989.

Listed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2025, which commenced on 20 June 2025.

The Therapeutic Goods Administration has commenced proceedings in the Federal Court of Australia against Philips Electronics Australia Limited (PEAL) for the alleged unlawful supply of medical devices that did not meet Australian safety and performance requirements.