Document ID: chunk:federal_register_of_legislation:C2010A00054:clause:1_32cj:p1
Version: federal_register_of_legislation:C2010A00054
Segment Type: clause
Provision Reference: sch 1 cl 32CJ (pt 1/2)
Character Range: 59139–61754

32CJ  Criminal offences and civil penalty for biologicals not conforming to standards etc.
 (1) This section applies if:
 (a) a biological is exempt under section 32CB; and
 (b) a person supplies a batch of the biologicals; and
 (c) the Secretary is satisfied that the biologicals included in that batch:
 (i) do not conform to a standard applicable to the biologicals; or
 (ii) are otherwise not fit to be used for their intended purposes.
 (2) The Secretary may, by written notice given to the person, require the person to take steps to recover the biologicals included in that batch (except any of those biologicals that cannot be recovered because they have been administered to, or applied in the treatment of, a person).
 (3) The notice may specify one or more of the following requirements:
 (a) the steps to be taken to recover the biologicals;
 (b) the manner in which the steps are to be taken;
 (c) a reasonable period within which the steps are to be taken.
 (4) The Secretary must, as soon as practicable after giving the notice, cause particulars of it to be published in the Gazette.

Notice is not a legislative instrument
 (5) A notice given under subsection (2) is not a legislative instrument.

Offences
 (6) A person commits an offence if:
 (a) the Secretary gives a notice to the person under subsection (2); and
 (b) the notice specifies a particular requirement mentioned in subsection (3); and
 (c) the person fails to comply with that requirement; and
 (d) either:
 (i) the use of any of the biologicals has resulted in, or will result in, harm or injury to any person; or
 (ii) the use of any of the biologicals, if any of the biologicals were used, would result in harm or injury to any person; and
 (e) the harm or injury has resulted, will result, or would result, because the person failed to comply with that requirement.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
 (7) A person commits an offence if:
 (a) the Secretary gives a notice to the person under subsection (2); and
 (b) the notice specifies a particular requirement mentioned in subsection (3); and
 (c) the person fails to comply with that requirement; and
 (d) the use of any of the biologicals, if any of the biologicals were used, would be likely to result in harm or injury to any person; and
 (e) the harm or injury would be likely to result because the person failed to comply with that requirement.
Penalty: 2,000 penalty units.
 (8) An offence against subsection (7) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
 (9) A person commits