Commonwealth Consolidated Acts Commonwealth Consolidated Acts(1) A person commits an offence 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; 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 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.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.
(4A) A person commits an offence 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.
(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 manufacture.
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 .