THERAPEUTIC GOODS ACT 1989 - SECT 35A Civil penalties relating to manufacturing therapeutic goods
THERAPEUTIC GOODS ACT 1989 - SECT 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:
(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.