TG: TG? (2)

If you require assistance navigating the tool or understanding your outcome, you may wish to contact the TGA or consider engaging a regulatory affairs consultant.

Therapeutic goods are common in daily life. We use medicines and medical devices when we:

• apply a bandage

• relieve a headache with items from the supermarket

• take vitamin tablets

• receive an injection

• undertake a prescribed course of treatment to manage a serious illness

What defines a therapeutic good?

In relation to the work of the TGA, therapeutic goods are broadly defined as products for use in humans in connection with:

• preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury

• influencing inhibiting or modifying a physiological process

• testing the susceptibility of persons to a disease or ailment

• influencing, controlling or preventing conception

• testing for pregnancy

This includes things that are:

• used as an ingredient or component in the manufacture of therapeutic goods

• used to replace or modify parts of the anatomy

NOTE: Before continuing, you should make sure that your product is not an excluded good. You should also familiarise yourself with the Poisons Standard and make sure you understand the scheduling levels.