Document ID: chunk:federal_register_of_legislation:C2024C00632:section:35a
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 35A
Character Range: 568871–570170

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.