Articles

Update on the progress in reducing the backlog of GMP Clearance Compliance Verification (CV) applications.

Listed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2025, which commenced on 1 March 2025

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.

Find out how listed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 3) which commenced on 27 September 2024.

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.

We have issued an infringement notice to the New South Wales based company for the alleged supply of a complementary medicine that was missing a mandatory warning statement.

Information for manufacturers and sponsors regarding a new method for GMP inspections that will be used from 1 July 2024 and the extended validity of TGA issued GMP Certificates.

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

Find out how listed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2024, which commenced on 14 June 2024.

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.

The Assessed listed medicine evidence guidelines have been updated, based on feedback, to aid sponsors in preparing their product applications.

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.

Find out how listed medicine ingredients, and requirements for their use, have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2024.