Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(1) 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.
(2) If:
(a) therapeutic goods that are exempt from the operation of Part 3 - 3 of the Act cease to be exempt; and
(b) 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;
the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.