THERAPEUTIC GOODS ACT 1989 - SECT 32BD Criminal offences for supplying a biological

THERAPEUTIC GOODS ACT 1989 - SECT 32BD

  (1)   A person commits an offence 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; and

  (c)   either:

  (i)   the use of the biological has resulted in, will result in, or is likely to result in, harm or injury to any person; or

  (ii)   the use of the biological, if the biological were used, would result in, or would be likely to result in, harm or injury to any person.

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

Note 1:   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.

Note 2:   For the liability of an executive officer of a body corporate, see sections   54B and 54BA.

  (4)   A person commits an offence 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.

Penalty:   Imprisonment for 12 months or 1,000 penalty units, or both.

  (4A)   A person commits an offence 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.

Penalty:   100 penalty units.

  (4B)   An offence against subsection   (4A) is an offence of strict liability.

Defences

  (5)   Subsection   (1), (4) or (4A) does not apply if the defendant proves that the defendant was not the sponsor of the biological at the time of the supply.

Note:   A defendant bears a legal burden in relation to the matter in subsection   (5): see section   13.4 of the Criminal Code .

  (6)   Subsection   (1) does not apply if:

  (a)   harm or injury did not, will not, or is not likely to, directly result from:

  (i)   the quality, safety or efficacy of the biological; or

  (ii)   a matter relating to the labelling or packaging of the biological; or

  (iii)   the improper use of the biological; or

  (b)   harm or injury would not, or would not be likely to, directly result from:

  (i)   the quality, safety or efficacy of the biological; or

  (ii)   a matter relating to the labelling or packaging of the biological; or

  (iii)   the improper use of the biological.

Note:   A defendant bears an evidential burden in relation to the matters in subsection   (6): see subsection   13.3(3) of the Criminal Code .