Conditions of use of biological for experimental purposes in humans
32CL Conditions of use of biological for experimental purposes in humans
The use by a person (the experimenter) for experimental purposes in humans of a biological that is the subject of an approval:
that is held by another person under subsection 32CK(1); and
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:
the preconditions on the use of the biological for those purposes;
the principles to be followed in the use of the biological for those purposes;
the monitoring of the use, and the results of the use, of the biological for those purposes;
the circumstances in which the experimenter must cease the use of the biological for those purposes.
There are criminal offences and a civil penalty related to the breach of a condition applicable under regulations made for the purposes of this section: see sections 32CP and 32CQ.
This provision refers to the regulations (specified in the regulations
). Made under this Act:
- Therapeutic Goods (Medical Devices) Regulations 2002 · under s 63
- Therapeutic Goods Regulations 1990 · under s 63
5 more instruments made under this Act are listed on the Act’s overview.
This Act’s bill:Second reading speech
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