THERAPEUTIC GOODS ACT 1989 - SECT 32CL Conditions of use of biological for experimental purposes in humans

THERAPEUTIC GOODS ACT 1989 - SECT 32CL

  (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.