How do I determine whether my product is a 'therapeutic good'?

In ordinary circumstances, the main issues which the TGA considers initially are:

• What is this product/substance for? Is it for therapeutic use in humans?
• Is it in the Food Standard or has a tradition of use as a food?
• Is it exempt or excluded under the provisions of the Act?

The formal definition (from the Therapeutic Goods Act 1989) is as follows:

"therapeutic goods" means goods:

1. that are represented in any way to be, or that are, whether because of the way in which the goods are presented or for any other reason, likely to be taken to be:
   1. for therapeutic use; or
   2. for use as an ingredient or component in the manufacture of therapeutic goods; or
   3. for use as a container or part of a container for goods of the kind referred to in subparagraph (i) or (ii); or
2. included in a class of goods the sole or principal use of which is, or ordinarily is, a therapeutic use or a use of a kind referred to in subparagraph (a)(ii) or (iii);

and includes medical devices and goods declared to be therapeutic goods under an order in force under section 7, but does not include:

3. goods declared not to be therapeutic goods under an order in force under section 7; or
4. goods in respect of which such an order is in force, being an order that declares the goods not to be therapeutic goods when used, advertised, or presented for supply in the way specified in the order where the goods are used, advertised, or presented for supply in that way; or
5. goods (other than goods declared to be therapeutic goods under an order in force under section 7) for which there is a prescribed standard in the Australia New Zealand Food Standards Code as defined in subsection 3(1) of the Australia New Zealand Food Authority Act 1991; or
6. goods which, in Australia or New Zealand, have a tradition of use as foods for humans in the form in which they are presented.

The Act defines therapeutic use as follows:

"therapeutic use" means use in or in connection with:

1. preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons or animals; or
2. influencing, inhibiting or modifying a physiological process in persons or animals; or
3. testing the susceptibility of persons or animals to a disease or ailment; or
4. influencing, controlling or preventing conception in persons; or
5. testing for pregnancy in persons; or
6. the replacement or modification of parts of the anatomy in persons or animals.

Top of page