Articles

Six monthly report – supply of unapproved therapeutic goods by a sponsor.

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.

The Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 will take effect on 1 July 2024, following passage through the Australian Parliament.

TGA has issued 35 infringement notices totalling $627,252 to 6 businesses and 2 individuals for the alleged unlawful advertising of medicinal cannabis on their websites and social media platforms.

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

Medicines Safety Update - Information for health professionals

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 Bill is part of reforms to prevent and reduce the use of vapes in Australia, unless clinically appropriate for stopping smoking or the management of nicotine dependence.  

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.

Annex 16 will apply to therapeutic goods manufactured from 3 September 2024. Find out about the transition period.

This instrument is the Therapeutic Goods (Poisons Standard) (Benzylpenicillin—Seqirus) Approval 2024.

We are reviewing the safety information supporting notifications of the highest-risk medical devices used in first-in-human clinical trials. Find out how the changes we have implemented impact you as a sponsor. 

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.

One of the key functions of the Therapeutic Goods Administration (TGA) is to closely monitor the safety of therapeutic goods. But to properly monitor safety, we need everyone to report any side effects and problems they have.

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.

An infringement notice of $18,780 has been issued to Myers Pharmacy Pty Ltd for the alleged unlawful advertising of Ozempic, a prescription-only medicine.

The Product Information (PI) documents for antidepressants have been updated with warnings about sexual dysfunction continuing in some patients, after they stop using the medicines.

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.

Medicines Safety Update - Information for health professionals

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

Victoria-based nurse has been issued 2 infringement notices totalling $7,512 for allegedly importing unapproved prescription-only and cosmetic injectable products.