Articles

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

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.

Infringement notices were issued to businesses and individuals for the alleged unlawful advertising of prescription-only medicines on their websites.

We have accepted an enforceable undertaking from 2San Pty Ltd in relation to breaches of the Therapeutic Goods Act 1989. This relates to the company's unlawful import and supply of medical devices.

Find out about regulatory changes to a range of medical devices and application audit requirements.

TGA has commenced proceedings in the Federal Court of Australia against Key Promotional Products Pty Ltd, and an individual, for allegedly importing and supplying unapproved rapid antigen test kits

The director of Elite Labs Pty Ltd was sentenced to 2 years imprisonment for his role in the unlawful manufacture, supply, advertising and export of performance and image enhancing therapeutic goods.

The Dolphins National Rugby League club has worked with us, agreeing to remove Alternaleaf branding from its jerseys and on signages displayed at stadiums during its games.

Infringement notices for $82,500 have been issued to Caruso’s Natural Health Pty Ltd, for an alleged failure to hold information or evidence to support therapeutic uses in relation to medicines.

Therapeutic goods and records have been seized from a pharmacy in Melbourne. This is part of our investigation into the alleged unlawful manufacture, supply and export of therapeutic goods.

The Australian Border Force (ABF) and partners have seized more than five and a half million cigarette sticks and prevented hundreds of thousands of prohibited vapes and drug items from reaching the streets of Sydney.

The TGA with the assistance of NSW Police have seized 478 sport supplements containing potentially dangerous substances from a Sydney retail store.