Finding a TGA Sponsor for your products in Australia

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 want to talk about sponsorship requirements for the Therapeutic Goods Association today.  If your product is one of the many that requires TGA approval, you’ll need an Australian sponsor to apply for the approval.  The TGA requires products to have an Australian sponsor so there is someone in Australia for the TGA to work with and who can be held responsible for the product.

Your Australian sponsor can be;

• your distributor
• an Australian company owned 100% by you; or
• another Australian person or company.

The requirement for a sponsor is not intended to make it hard to do business in Australia, so sponsorship isn’t difficult to arrange.

Although it’s not difficult to arrange sponsorship, you should consider carefully how you set up the arrangement with the sponsor.  Primarily, because the TGA will deal only with your sponsor.  That means:

1. during the approvals process, the TGA will accept information only through your sponsor.
2. your sponsor must hold information like – your product’s ingredients, your manufacturing processes, highly sensitive intellectual property.
3. your sponsor must be able to supply that information to the TGA on request
4. your sponsor holds the key to your product’s registration, without which your product can’t be sold in Australia.

The TGA will continue to deal only with your sponsor if:

• there are complaints about your product;
• someone suffers an adverse reaction to your product and/or
• your product needs to be recalled.

These considerations mean that your sponsor has significant responsibility not just to the TGA but also to you because your sponsor holds your intellectual property, such as your product formulas and manufacturing processes;

How your sponsor works with the TGA could impact whether your product gets (and keeps) approval

Your sponsor holds the registrations which permit your products to be sold in Australia, not you.

Clearly, you have significant interests that need to be protected when establishing sponsorship. Establishing sponsorship in a way that protects you means considering what will happen if:

1. you disagree with your distributor;
2. you want to trade in Australia without a distributor, now or in the future; or
3. your product is the subject of a complaint, recall or litigation.

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.