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THERAPEUTIC GOODS ACT 1989 - SECT 32BH

Criminal offence relating to wholesale supply

                   A person commits an offence if:

                     (a)  the person supplies a biological in Australia for use in humans; and

                     (b)  none of the following subparagraphs applies:

                              (i)  the biological is included in the Register;

                             (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) that is held 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; and

                     (c)  the person to whom the biological is supplied is not the ultimate consumer of the biological.

Penalty:  120 penalty units.



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