Therapeutic Goods Act 1989

The Secretary is to cause to be maintained a register, to be known as the Australian Register of Therapeutic Goods, for the purpose of compiling information in relation to, and providing for evaluation of, therapeutic goods for use in humans.

Subject to subsection (3), the Register is to be kept in such form as the Secretary determines.

The Register is to contain these 5 parts:

a part for goods to be known as registered goods; and

a part for goods to be known as provisionally registered goods; and

a part for goods to be known as listed goods; and

a part for biologicals included in the Register under Part 3‑2A; and

a part for medical devices included in the Register under Chapter 4.

The regulations may prescribe:

the therapeutic goods, or the classes of therapeutic goods, that are required to be included in each part of the Register; and

the ways in which goods that are included in one part of the Register may be transferred, or may be required to be transferred, to another part of the Register; and

the ways in which goods that have been assigned a registration or listing number may be assigned a different registration or listing number; and

the ways in which a biological that has been assigned a number under subsection 32DB(2), 32DCB(2), 32DF(2) or 32DN(5) may be assigned a different number (which may be any combination of numbers and either or both of letters and symbols); and

the ways in which medical devices that have been assigned a device number may be assigned a different device number.