Therapeutic Goods Act 1989
32BFCivil penalties for importing, exporting, manufacturing or supplying a biological
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32BF Civil penalties for importing, exporting, manufacturing or supplying a biological
Importing a biological for use in humans (1) A person contravenes this subsection if: (a) the person imports into Australia a biological for use in humans; and (b) none of the following subparagraphs applies: (i) the biological is included in the Register in relation to the person; (ii) the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2); (iii) the biological is exempt under section 32CB; (iv) the biological is the subject of an approval under subsection 32CK(1) that is held by the person, being an approval covering the importation into Australia of the biological; (v) the biological is the subject of an approval under subsection 32CO(1), (1A) or (2) that is held by the person.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
Exporting a biological for use in humans (2) A person contravenes this subsection if: (a) the person exports from Australia a biological for use in humans; and (b) none of the following subparagraphs applies: (i) the biological is included in the Register in relation to the person; (ii) the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2); (iii) the biological is exempt under section 32CB; (iv) the biological is the subject of an approval under subsection 32CK(1) that is held by the person, being an approval covering the exportation from Australia of the biological.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
Manufacturing a biological for use in humans (3) A person contravenes this subsection if: (a) the person manufactures in Australia a biological for use in humans; and (b) none of the following subparagraphs applies: (i) the biological is included in the Register in relation to the person; (ii) the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2); (iii) the biological is exempt under section 32CB.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
Supplying a biological for use in humans (4) A person contravenes this subsection if: (a) the person supplies in Australia a biological for use in humans; and (b) none of the following subparagraphs applies: (i) the biological is included in the Register in relation to the person; (ii) the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2); (iii) the biological is exempt under section 32CB; (iv) the biological is the subject of an approval under subsection 32CK(1) that is held by the person, being an approval covering the supply in Australia of the biological; (v) the biological is the subject of an authority under subsection 32CM(1) or (7A) that covers the supply of the biological by the person; (vi) the biological is the subject of an approval under subsection 32CO(1), (1A) or (2) that is held by the person, being an approval covering the supply in Australia of the biological.