How do you check if a product is TGA approved?

September 7, 2023 · News

Every consumer wants to know that the products they purchase are safe and effective to use and that they live up to any claims the seller makes about that product. This becomes all the more important when that product is considered to be a therapeutic good.

That’s where the Therapeutic Goods Administration (TGA) plays a crucially important role. The TGA is the governing body responsible for regulating the sale of therapeutic products in Australia. If you want to sell a therapeutic product in Australia, it needs to be approved by the TGA—but how can you check if the TGA has approved a product for sale in Australia?

This quick guide will fill you in on what you need to know to verify if a product is TGA approved.

What products require TGA approval?

The TGA forms part of the Australian Government Department of Health and is responsible for regulating products including:

prescription medications
vaccines
sunscreens
vitamins and minerals
medical devices
blood and blood products.

Any of these products or products that make claims about providing a therapeutic benefit must be approved by the TGA before it can be supplied in Australia.

How to check if a product is TGA approved

The TGA maintains a database called the Australian Register of Therapeutic Goods (ARTG), which is a register of therapeutic goods that can be legally supplied in Australia.

When the TGA approves a product, the product name, formulation, sponsor and manufacturer details are entered into the ARTG, along with an AUST R or AUST L number. The relevant AUST number must always appear on product packaging.

The ARTG database is publically accessible from the TGA website and anyone can check if a product is approved for supply in Australia by searching for the relevant AUST number. If the AUST number isn’t listed on the ARTG database, it has not been TGA-approved.

How to seek TGA approval for your products

If you want to sell a therapeutic product in Australia, it will require approval from the TGA. To do this, the TGA advises you will first need to:

find out what type of therapeutic good the product is and review the relevant regulatory guidelines
understand the legal requirements for your product to be approved, including manufacturing requirements and product and labelling standards, and
understand the legal responsibilities of being a sponsor for that product.

Your manufacturer will be able to guide you through the registration process. More information is available by visiting the TGA website.

Need help manufacturing a therapeutic good?

If you want to produce a therapeutic good for sale in Australia, you’ll need to partner with a TGA-approved manufacturer like Wild Child Laboratories.

With extensive experience in the formulation, development and manufacturing of skin care and over-the-counter TGA-registered pharmaceuticals for the global marketplace, Wild Child Laboratories have become the preferred supplier for a range of pharmaceutical and healthcare providers in both the hospital consumables and retail pharmacy arena.

Find out more about manufacturing with Wild Child or contact us to get started.

Frequently Asked Questions

Yes, our minimum order quantities (MOQs) are a function of the calibrated weights of our mixing vessel and the capacity of our filling lines. Depending on the unit size of the final product the MOQ will typically be around 10,000 units.

We do not have a product catalogue. Products will be suggested by our Product Development team based on the information you provide through the new product enquiry form.

Yes, with a better understanding of your product requirements we will develop a lab sample(s) for your review and ultimate approval. Depending on level of customisation or development required, this service may incur a fee.

Typically, 12 – 14 weeks from the placement of purchase order and payment of the deposit. Please note, the manufacturing lead time is dependent on the availability of the raw materials and packaging components, which can be confirmed prior to the placement of your order.

No, all our pricing is EX WORKS. Whilst we do not provide freight and distribution services, we can assist with the freight quotation and booking from our Facility.

Upon placement of purchase order, a 50% deposit is required, and balance is due prior to the release of the finished goods.

Yes, we can provide packaging options based on formulation compatibility and compliance standards. Alternatively, clients can provide their own packaging with the understanding that it must be compatible with our equipment and meet compliance standards.