Articles

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.

We are updating information for nitrosamine impurities and other nitroso-structure impurities in medicines including acceptable intakes (AI)

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

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

Following our Essential Principles presentations on 11-12 September 2024, we have collated questions asked into themes to simplify finding information of relevance to you.

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.

Two new quality standards, one for MDMA and another for psilocybine, have been published.

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

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.

The company imported medical devices not included in the Australian Register of Therapeutic Goods. They supplied these devices to a national retailer, who then sold them to the public.

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

Prescription lenses supplied only for refractive correction are now exempt from inclusion in the Australia Register of Therapeutic Goods (ARTG) prior to import, export or supply in Australia.

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

Amendments to the Therapeutic Goods Regulations 1990 (Schedule 5, item 6) have been made resulting in compounded GLP-1 RA products no longer being able to be compounded by pharmacists and supplied to patients.

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.

Some online health clinics are advertising and selling compounded medicines. However, it is important to know that compounded products are not identical to TGA approved products.

Infringement notices totalling $171,972 have been issued to Better Leaf Pty Ltd, and an individual, for the alleged unlawful advertising of medicinal cannabis on its website and social media.

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.

We have issued 2 infringement notices totalling $37,560 to Global Medical Solutions Australia Pty Limited, trading as Radpharm Scientific Pty Ltd, for allegedly breaching conditions of its manufacturing licence