Articles

We have issued 2 infringement notices totalling $7,716 to a Queensland-based individual for the alleged unlawful importation of counterfeit botulinum toxin type A and the unlawful advertising of cosmetic injectables.

We have issued 5 infringement notices, totalling $19,800, to a NSW-based individual, for the alleged unlawful importation of unapproved prescription-only medicines in contravention of the Therapeutic Goods Act 1989.

We will implement process enhancements to the Prescription Medicines Minor Variation (PMMV) form by 31 January 2026.

We have issued an infringement notice, to the value of $19,800, to PERDAY'S HEALTH FUNCTIONAL FOOD (AU) PTY LTD (Perdays Australia) for the alleged unlawful advertising of a listed medicine.

The TGA has updated its Advertising therapeutic goods on social media guidance to help advertisers to understand their responsibilities when promoting therapeutic goods via these platforms.

We have issued 5 infringement notices, totalling $99,000, to ACPharm Queensland Pty Ltd (ACPharm Queensland) for the alleged unlawful advertising of therapeutic goods.

The delegate believes, on reasonable grounds, that it is in the interests of public health or safety to give Hwangbo SS Pty Ltd and [REDACTED] directions under section 42YT of the Therapeutic Goods Act 1989.

We have issued a warning to online delivery service providers not to breach Australian laws regarding the supply and advertising of vaping goods.

A coordinated crackdown on illegal vapes in southeast Queensland has led to a seizure of illegal vaping and tobacco products with a street value exceeding $8.8 million.

This Legislation Amendment makes changes to the way testing of goods is conducted under the Therapeutic Goods Regulations 1990.

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.

We have accepted a court-enforceable undertaking from Midnight Health Pty Ltd in relation to the alleged unlawful advertising of prescription-only weight-loss medicines.

There has been an increase in Australians purchasing melatonin products from online stores, particularly for use in children. These products are often sold as gummies but are also available as tablets or capsules marketed as dietary supplements.

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.

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.

We have published a list of medical devices in the ARTG that incorporate artificial intelligence (AI) or machine learning (ML) technologies.

Know how we manage compliance of AI and software products that meet the definition of a medical device.

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.

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.

We have published information to clarify when digital scribes - also referred to as AI scribes or ambient scribes - are regulated as medical devices in Australia.

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.

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.