Start by confirming how your product is likely to be regulated in Australia. Depending on its ingredients, presentation, intended use and the claims you want to make, it may be regulated as a therapeutic good, food, cosmetic or another type of product.

Establishing the correct pathway early helps you make more informed decisions about your formulation, evidence, manufacturer, label and launch plan - before you invest too heavily in product development.

Ingredients used in listed medicines generally need to be included in the current TGA Permissible Ingredients Determination. However, finding an ingredient in the Determination does not automatically mean it can be used in any product.

You also need to check the correct ingredient name and form, its intended role and any conditions relating to dose, route of administration, use or mandatory label statements. These conditions can affect whether your proposed formulation is suitable.

Listed medicines generally use low-level indications selected from the TGA’s list of permitted indications. The wording needs to be appropriate for the product and consistent with the type of evidence held.

Finding a permitted indication does not, by itself, mean your product can support it. Your evidence needs to be relevant to the ingredient, form, dose, target population and proposed health benefit. Claims used on labels, websites, social media and other advertising also need to remain compliant and consistent with the product’s ARTG entry.

Not necessarily. A product that complies in another country may still need changes before it can be legally supplied in Australia.

Its classification, ingredients, claims, evidence, manufacturing arrangements, label and advertising all need to be considered against Australian requirements.

Reviewing these areas early can identify potential gaps before you commit to reformulation, packaging, manufacturing or launch activities.

Relevant manufacturing steps for listed medicines need to be covered by appropriate Good Manufacturing Practice arrangements. The requirements and process will depend on where the manufacturer is located, the activities they perform and the regulatory evidence available.

A certificate alone may not establish that every required site, dosage form or manufacturing step is covered. Checking the position early is particularly important when working with an overseas manufacturer, as additional clearance activities and time may be required.

Before submitting an application, you should have confirmed the product classification, formulation, proposed indications, supporting evidence and manufacturing arrangements. Relevant quality information should be available, and the label should be reviewed against the requirements applying to the product.

The listing application is one part of the process - not the starting point. Sponsors remain responsible for the accuracy of the ARTG entry and for the product’s ongoing compliance after listing.