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Our Good Manufacturing Practice (GMP) Clearance information resources have been updated with new information for Sponsors

A simple post from a respected person can influence the purchasing decisions of many people. If your post meets this definition of advertising, make sure you are complying with the law. Here are some of the important rules to keep in mind when creating content.

In many cases, pharmacists and prescribers are able to provide or prescribe another approved medicine that is on the Australian Register of Therapeutic Goods (ARTG) or they can give a different strength or dosage of the same medicine.

Risk of Guillain-Barre syndrome added to Product Information.

Updated illustrations clarify how to use measuring syringe for oral solutions.

Like all goods available in Australia, therapeutic goods can sometimes experience problems. When this happens, we decide if a ‘market action’ is needed. A market action aims to correct the problem. There are four types of market actions you should be aware of.

Complementary medicines are therapeutic goods that are often derived from traditional medicine practices. They can usually be purchased from supermarkets, health stores and pharmacies without seeing a doctor or pharmacist.
However, just because a medicine is available without a prescription, or claims to be ‘natural’ or ‘healthy’, doesn’t mean it’s safe for you.

While we encourage health practitioners to prescribe approved therapeutic goods where possible, unapproved therapeutic goods can be accessed in limited circumstances.
In making these joint decisions to use an unapproved therapeutic good, your doctor is required to inform you of the potential benefits and risks.

Updated information for nitrosamine impurities in medicines consistent with recent EMA updated information.

Information for health professionals about medicines with safety related updates to their Product Information.

The dual labelling period for some medicine ingredients is ending on 30 April 2025.

We are seeking applications from professionals with relevant expertise in medicine and science, and consumers with relevant expertise in consumer perspectives and issues.

We have issued 4 infringement notices totalling $75,120 to Queensland based pharmacy Summit Pharmacy Pty Ltd, for the alleged unlawful manufacturing of medicinal cannabis products.

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.

Updates further highlight potential risks of mood-related changes and sexual disorders.

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.

The Prescription Medicines in Pregnancy database has now been updated to include the following new entries:

Listed medicine compliance review reports database March 2025 update

Information for health professionals about medicines with safety related updates to their Product Information.

Your participation in this online activity will help us create a more user-friendly website that works better for everyone.

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

The updated plan emphasises solidifying our collaborative processes, aligning expectations with industry, and improving our communication strategies.