Commonwealth Consolidated Acts

THERAPEUTIC GOODS ACT 1989 - SECT 32BI

  (1)   A person commits an offence if:

  (a)   the person uses a biological; and

  (b)   the biological is used:

  (i)   in the treatment of another person; or

  (ii)   solely for experimental purposes in humans; and

  (c)   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   32CO(1), (1A) or (2);

  (v)   the person uses the biological in accordance with an approval under subsection   32CK(1);

  (vi)   the person uses the biological in accordance with a condition applicable under regulations made for the purposes of section   32CL;

  (vii)   the person uses the biological in accordance with an authority under subsection   32CM(1) or (7A); and

  (d)   either:

  (i)   if the person used the biological in the treatment of that other person--the use of the biological has resulted in, will result in, or is likely to result in, harm or injury to that other person; or

  (ii)   if the person used the biological solely for experimental purposes in humans--the use of the biological has resulted in, will result in, or is likely to result in, harm or injury to any of those humans.

Penalty:   Imprisonment for 5 years or 4,000 penalty units, or both.

Note:   A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection   (4) instead: see section   53A.

  (4)   A person commits an offence if:

  (a)   the person uses a biological; and

  (b)   the biological is used:

  (i)   in the treatment of another person; or

  (ii)   solely for experimental purposes in humans; and

  (c)   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   32CO(1), (1A) or (2);

  (v)   the person uses the biological in accordance with an approval under subsection   32CK(1);

  (vi)   the person uses the biological in accordance with a condition applicable under regulations made for the purposes of section   32CL;

  (vii)   the person uses the biological in accordance with an authority under subsection   32CM(1) or (7A).

Penalty:   500 penalty units.

  (5)   A person commits an offence if:

  (a)   the person uses a biological; and

  (b)   the biological is used:

  (i)   in the treatment of another person; or

  (ii)   solely for experimental purposes in humans; and

  (c)   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   32CO(1), (1A) or (2);

  (v)   the person uses the biological in accordance with an approval under subsection   32CK(1);

  (vi)   the person uses the biological in accordance with a condition applicable under regulations made for the purposes of section   32CL;

  (vii)   the person uses the biological in accordance with an authority under subsection   32CM(1) or (7A).

Penalty:   100 penalty units.

  (6)   An offence against subsection   (5) is an offence of strict liability.