Articles

From 3 June 2024, we will be using a new Good Manufacturing Practice (GMP) guide for medicines, active pharmaceutical ingredients and sunscreens.

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.

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

The targeted consultation is part of a proposal to change the Therapeutic Goods Regulations 1990 to mitigate safety risks in the compounding of GLP-1 RAs.

The TGA has issued 2 infringement notices totalling $37,560 to Queensland-based company Akula Foods Pty Ltd for the alleged unlawful import of unregistered complementary medicines

The TGA has issued 4 infringement notices totalling $75,120 to Liquefy Health Pty Ltd for the alleged unlawful importation and advertising of unapproved complementary medicines.

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.

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

Medicines Safety Update - Information for health professionals

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January 2024, as part of the reforms to the regulation of vaping products, the Advertising Permission for Nicotine was repealed.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 subsection 19(7D) of the Therapeutic Goods Act 1989.

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.

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.

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