Therapeutic Goods Act 1989
35ACivil penalties relating to manufacturing therapeutic goods
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35A Civil penalties relating to manufacturing therapeutic goods
(1) A person contravenes this subsection if: (a) the person carries out a step in the manufacture of therapeutic goods at premises in Australia; and (b) the goods are for supply for use in humans; and (c) the goods are not exempt under section 18A or 32CB; and (d) none of the following applies: (i) the goods are exempt goods; (ii) the person is an exempt person in relation to the manufacture of the goods; (iii) the person is the holder of a licence that is in force that authorises the carrying out of that step in relation to the goods at those premises.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
(2) A person contravenes this subsection if: (a) the person carries out a step in the manufacture of therapeutic goods at premises in Australia; and (b) the goods are for supply for use in humans; and (c) the goods are exempt under section 18A or 32CB; and (d) the person is not the holder of a licence that: (i) is in force; and (ii) authorises the carrying out of that step in relation to the goods at those premises.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.