What to know if you’re prescribed an unapproved therapeutic good

Has your doctor prescribed you an ‘unapproved therapeutic good’?

Therapeutic goods on the Australian Register of Therapeutic Goods (ARTG ) have been evaluated for quality, safety or efficacy. Products which haven’t been evaluated or registered for supply in Australia are referred to as ‘unapproved therapeutic goods’.

This doesn’t mean the therapeutic good you’ve been prescribed is illegal, unsafe or ineffective.

While we encourage health practitioners  to prescribe approved therapeutic goods where possible, unapproved therapeutic goods can be accessed in limited circumstances.

Your doctor may determine that an unapproved therapeutic good would better suit your individual situation. This could be based on your current medical condition or because a suitable approved option wasn’t available.

In making these joint decisions to use an unapproved therapeutic good, your doctor is required to inform you of the potential benefits and risks.

It’s also important to know that unapproved goods often haven’t undergone the same rigorous process for safety, quality, and efficacy as products included on the ARTG.

Once you have a prescription, we encourage you to buy the product through an Australian pharmacy. Be careful with online stores based overseas as you may not get the right product, it could be counterfeit, contaminated, or contain undisclosed dangerous or illegal ingredients. Individuals can legally import most therapeutic goods for personal use under the Personal Importation Scheme provided certain conditions are met.

Unapproved goods are not covered by the Pharmaceutical Benefits Scheme (PBS). This means you will need to pay the full price for these goods. We have no control over the price charged for unapproved goods supplied by companies in the private market. Only products on the ARTG are eligible for PBS funding.

If you are prescribed a non-PBS medicine, ask your doctor if it is an unapproved therapeutic good.

If it is, to help you make an informed decision about your treatment options, ask your health practitioner these questions if they prescribe you an unapproved good:

• Why have you selected this treatment, and have you considered all TGA-approved options?
• What are the risks and benefits in using this product?
• How much will the product cost?
• Where can I get it / do I have to buy it online or overseas?

Also ask your doctor any other questions that will help you to understand what your options are. It’s your health and these are important decisions. Make the choice that’s right for you.

Authorised by the Australian Government, Canberra