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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.

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

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

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.

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.

The Assessed listed medicine evidence guidelines have been updated, based on feedback, to aid sponsors in preparing their product applications.

Listed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2023.

The TGA is aware of several scams targeting consumers seeking semaglutide (Ozempic). Consumers are strongly advised not to use products unless they have come from a trusted source.

Supplies of Ozempic (semaglutide) have begun distribution in Australia but will remain quite limited for some time.

New guidelines and mandatory requirements for listed medicines ingredients have come into effect on 1 February 2023.

Before you take a weight loss supplement or medicine, there are things to consider.

Listed medicine ingredients and requirements are updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 5) 2022.

The Pharmacovigilance Inspection Program (PVIP) Risk Assessment Survey is now open until 18 December 2022 for medicine sponsors to complete.

Listed medicine ingredients and requirements are updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2022.

Listed medicine ingredients and requirements are updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2022.

A new Therapeutic Goods Determination for listed medicine ingredients commences on 1 March 2022.

A new Therapeutic Goods Determination for listed medicine ingredients commenced on 18 January 2022.

A new Therapeutic Goods Determination for listed medicine ingredients commenced on 25 October 2021.

The Therapeutic Goods (Permissible Ingredients) Determination has been updated.

The Therapeutic Goods (Permissible Ingredients) Determination has been updated.

The Therapeutic Goods (Permissible Indications) Determination has been updated

The Therapeutic Goods (Permissible Ingredients) Determination has been updated.

Today the TGA announced a final decision to down-schedule certain low dose cannabidiol (CBD) preparations