Articles

Announcement about the launch of the pilot Single Inspection Program, a global approach to Good Manufacturing Practice inspections of third country manufacturers.

The TGA has issued 13 infringement notices totalling $42,900 to a New South Wales-based individual for the alleged unlawful advertisement and supply of erectile dysfunction medicines.

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.

This instrument is made under regulation 97 of the Therapeutic Goods Regulations 1990.

This instrument is made under Schedule 5A to the Therapeutic Goods Regulations 1990 and Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002.

Medicines Safety Update - Information for health professionals

The TGA has issued 18 infringement notices totalling $157,752 to Kilpatrick & Douglas Pty Ltd and two directors, for the alleged unlawful advertising of nicotine vapes

On 1 January 2024, as part of the reforms to the regulation of vaping products, the Advertising Permission for Nicotine was repealed.

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

We issued an infringement notice for $13,320 to the New South Wales based company Marvel Health (Australia) Pty Ltd. This was for an alleged failure to comply with a notice to provide information about a complementary (listed) medicine.

Medicines Safety Update - Information for health professionals

We executed a search warrant on a residential property in Brisbane, with assistance from Queensland authorities. This was part of an investigation into the alleged importation, manufacture, supply, and advertising of unapproved therapeutic goods.

This instrument is made under Schedule 5A of the Therapeutic Goods Regulations 1990 and Schedule 4 of the Therapeutic Goods (Medical Devices) Regulations 2022.

This instrument is made under regulation 97 of the Therapeutic Goods Regulations 1990.

This instrument is made under subsection 19(7D) of the Therapeutic Goods Act 1989.

TGA has accepted a court enforceable undertaking from Yossef Wahib, operator of the online store Aussie Mega Supplements. Mr Wahib was also issued an infringement notice for $3,756.

The TGA has accepted a court enforceable undertaking from Yossef Wahib, operator of the online store Aussie Mega Supplements, in relation to alleged illegal manufacture, supply and advertising of unregistered therapeutic goods.

If your business is involved with medicinal cannabis, read our updated guidance about advertising medicinal cannabis to consumers.

We have issued infringement notices for $13,656 to 2 registered nurses for allegedly importing unapproved cosmetic injectables and advertising prescription-only medicines.

From 1 January 2024, the importation of disposable vapes will be prohibited, subject to very limited exceptions. Read more about the first stage of Australia’s vaping reforms.

We are advising sponsors, who are intending to register new prescription medicines, of a new way to pursue work-sharing for priority applications.

We have issued a notice to Pracmed Healthcare Pty Ltd to cease advertising indications related to weight loss surgery and cognitive function.

We've created a new GMP clearance Sponsor Information Dashboard (SID) to provide industry with current information about our processing times, workload and key messages. We have also updated our GMP clearance guidance.

Find out about how GMP clearances for manufacturing sites in Bulgaria can now be assessed via the Mutual Recognition Agreement (MRA) pathway.

Information about GMP clearances issued via the MRA Pathway that expire on 31 December 2023 as well as information on the ongoing use of the GMP clearance questionnaire.