Articles

Listed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2025, which commenced on 10 December 2025.

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

The delegate believes, on reasonable grounds, that it is in the interests of public health or safety to give Hwangbo SS Pty Ltd and [REDACTED] directions under section 42YT of the Therapeutic Goods Act 1989.

The TGA has issued a direction notice to Hwangbo SS Pty Ltd and its executive officer in relation to vaping products under section 42DZK of the Therapeutic Goods Act 1989.

The TGA has issued a direction notice to Iquality Group Pty Ltd and its executive officer in relation to the advertising of vaping goods under section 42DZK of the Therapeutic Goods Act 1989.

The TGA has issued a direction notice to Iget Brands Pty Ltd and its executive officer in relation to the advertising of vaping goods under section 42DZK of the Therapeutic Goods Act 1989.

This instrument is made under section 39 of the current Poisons Standard.

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

Listed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2025, which commenced on 19 September 2025.

The TGA has identified a discrepancy between the wording of the ‘POTAS1’ warning statement available in the Code Tables compared to the requirements for potassium chloride and glucosamine sulfate potassium chloride in the Therapeutic Goods (Permissible Ingredients) Determination (the Determination).

The TGA has issued a direction notice to Cholrem Pty Ltd and its executive officer to cease advertising a therapeutic good not entered in the Australian Register of Therapeutic Goods (ARTG). They were also directed to cease advertising such goods in a way that contravened the Therapeutic Goods Advertising Code, and for indications relating to heart disease and stroke, amongst others.

Instructions for searching Australian manufacturers licensed for the manufacture of medicines, blood and biologicals.

From 1 September 2025, the TGA will adopt an updated version of the PIC/S Guide to GMP (PE009-17), with changes focused on Annex 1 for sterile medicines, and a phased compliance approach for manufacturers.

The TGA has issued a direction notice to Dispensed Pty Ltd to cease advertising of medicinal cannabis on all websites, social media accounts or other advertising platforms.

Listed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2025, which commenced on 20 June 2025.

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

Listed medicines indications and requirements for their use have been updated in the Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025.

This instrument is made under subsection 7C(1) of the Therapeutic Goods Act 1989.

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

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

This instrument is made under subsections 19(5AA), 32CM(1A) and 41HC(1A) of the Therapeutic Goods Act 1989.

This instrument is made under the Therapeutic Goods Regulations 1990, the Therapeutic Goods (Medical Devices) Regulations 2002 and the Therapeutic Goods Act 1989.

MRA GMP clearances that are expiring on 31 December 2024 will be automatically extended.

This instrument is made under section 39 of the current Poisons Standard.