Articles

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.

Our Good Manufacturing Practice (GMP) Clearance information resources have been updated with new information for Sponsors

A simple post from a respected person can influence the purchasing decisions of many people. If your post meets this definition of advertising, make sure you are complying with the law. Here are some of the important rules to keep in mind when creating content.

In many cases, pharmacists and prescribers are able to provide or prescribe another approved medicine that is on the Australian Register of Therapeutic Goods (ARTG) or they can give a different strength or dosage of the same medicine.

While we encourage health practitioners to prescribe approved therapeutic goods where possible, unapproved therapeutic goods can be accessed in limited circumstances.
In making these joint decisions to use an unapproved therapeutic good, your doctor is required to inform you of the potential benefits and risks.

We have issued 4 infringement notices totalling $75,120 to Queensland based pharmacy Summit Pharmacy Pty Ltd, for the alleged unlawful manufacturing of medicinal cannabis products.

We will be initiating targeted compliance reviews of selected listed medicines that are required to display a warning statement

We have accepted a court-enforceable undertaking from Your Solution Compounding Pharmacy Pty Ltd, regarding advertising of prescription-only compounded medicines for weight-loss.

We have accepted a court-enforceable undertaking from Your Solution Compounding Pharmacy Pty Ltd, regarding advertising of prescription-only compounded medicines for weight-loss.

This consent is given under sections 14 and 14A of the Therapeutic Goods Act 1989.

The defendant faces a maximum penalty of 12 months’ imprisonment and/or a fine of up to $222,000 for each charge.

Recall reforms program update and preview of the PRAC Version 1.0.

We have issued infringement notices totalling $37,560 for the alleged unlawful possession of a commercial quantity of vaping goods.

The TGA and cooperating agencies have seized a large volume of alleged illicit vapes, tobacco and other substances in coordinated operations across Australia.

The TGA has settled judicial review proceedings brought by InstantScripts in respect of infringement notices issued to it by the TGA.

In a significant move against the illicit vaping market, the TGA has played a vital role in joint enforcement activity with Victoria Police, resulting in the seizure of 200,000 vapes, worth more than $8 million

TGA has taken further action to combat the unlawful sale of vapes in Queensland, issuing an infringement notice to a retailer for the unlawful possession of a commercial quantity of vaping goods

The TGA worked alongside Victoria Police officers as part of an ongoing investigation targeting a significant crime syndicate involved in the illicit tobacco market.

The Federal Court of Australia has ordered Medtronic Australasia Pty Ltd (Medtronic) to pay $22 million in penalties for unlawfully supplying 16,267 units of the Infuse Bone Graft Kit between 1 September 2015 and 31 January 2020.

The TGA reminds businesses and media outlets that it is unlawful to publicly advertise prescription-only medicines, including prescription-only weight loss medicines.