Document ID: chunk:federal_register_of_legislation:C2024C00632:section:32cl
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 32CL
Character Range: 443476–444651

32CL  Conditions of use of biological for experimental purposes in humans
 (1) The use by a person (the experimenter) for experimental purposes in humans of a biological that is the subject of an approval:
 (a) that is held by another person under subsection 32CK(1); and
 (b) that covers the importation into Australia, or the supply in Australia, of the biological for use solely for experimental purposes in humans;
is subject to the conditions (if any) specified in the regulations relating to one or more of the following:
 (c) the preconditions on the use of the biological for those purposes;
 (d) the principles to be followed in the use of the biological for those purposes;
 (e) the monitoring of the use, and the results of the use, of the biological for those purposes;
 (f) the circumstances in which the experimenter must cease the use of the biological for those purposes.
 (2) A person commits an offence if:
 (a) the person does an act or omits to do an act; and
 (b) the act or omission results in the breach of a condition applicable under regulations made for the purposes of this section.
Penalty for contravention of this subsection: 60 penalty units.