Therapeutic Goods Act 1989

Subject to subsection (3), a biological is a thing that:

either:

comprises, contains or is derived from human cells or human tissues; or

is specified under subsection (2); and

is represented in any way to be, or is, whether because of the way in which it is presented or for any other reason, likely to be taken to be:

for use in the treatment or prevention of a disease, ailment, defect or injury affecting persons; or

for use in making a medical diagnosis of the condition of a person; or

for use in influencing, inhibiting or modifying a physiological process in persons; or

for use in testing the susceptibility of persons to a disease or ailment; or

for use in the replacement or modification of parts of the anatomy in persons.

The Secretary may, by legislative instrument, specify things for the purposes of subparagraph (1)(a)(ii).

For specification by class, see subsection 13(3) of the Legislation Act 2003.

The Secretary may, by legislative instrument, determine that a specified thing is not a biological for the purposes of this Act.

For specification by class, see subsection 13(3) of the Legislation Act 2003.