What products need TGA approval?

WHY HEALTH CLAIMS TRIGGER REGULATION – AND HOW TO AVOID COSTLY MISSTEPS

In Australia, any product making a health claim must be approved by the TGA before import or sale—even items like sunblock, vitamins, and some cosmetics.

While it may not be obvious your product falls under TGA regulation, overlooking this can lead to seized shipments and fines, making it essential to assess your claims before market entry.

VIDEO SCRIPT

I wanted to talk today about something you might not be aware of if you want to import a product that makes health claims into Australia.

If your product makes a health claim, it must be approved by Australia’s Therapeutic Goods Administration (TGA) and entered on the Australian Therapeutic Goods Register before it can be imported into and sold in Australia.

It’s obvious, that ‘making health claims’ would cover medicines and medical equipment. However, exporters to Australia are often surprised how much further the TGA’s scope extends.

In addition to medicines and medical devices, the TGA must approve many types of products.  These include (but are certainly not limited to):

• Complementary medicines
• Vitamins
• Sunblocks
• Rehabilitation aids
• Adhesive bandages
• Some types of cosmetics and some types of disinfectants

One of the reasons why Australia doesn’t have the same range of cosmetics as some European countries or those that you find in Asia is precisely because those cosmetics contain sunscreens and that can put them in the category of requiring TGA approval before they can be imported into Australia.

Whether your product needs TGA approval depends on what claims you make about the benefits of your product.  It’s critical, therefore, that you know whether your claims bring your product within the TGA’s scope.  You don’t want to have your product in front of Australian customer only to have it seized and/or be fined by the TGA because it isn’t approved.

At Argyll Law we have over 30 years’ experience in helping companies outside Australia set up their businesses on the firmest footing.  If you need TGA sponsorship, we know how to set up your sponsorship in the way that gives you autonomy and protection.  That relationship continues with us providing ongoing advice and support on the ground in Australia.