Therapeutic Goods Regulations 1990

For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.

If:

therapeutic goods that are exempt from the operation of Part 3‑3 of the Act cease to be exempt; and

before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;