Commonwealth Consolidated Acts

THERAPEUTIC GOODS ACT 1989 - SECT 9A

             (1)  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.

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

             (3)  The Register is to contain these 3 parts:

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

                     (b)  a part for goods to be known as listed goods; and

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

             (4)  The regulations may prescribe:

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

                     (b)  the ways in which:

                              (i)  goods that are included in the part of the Register relating to registered goods may be transferred, or may be required to be transferred, to the part of the Register for listed goods; and

                             (ii)  goods that are included in the part of the Register relating to listed goods may be transferred, or may be required to be transferred, to the part of the Register for registered goods; and

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

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

             (5)  The Minister may, by notice published in the Gazette :

                     (a)  require that specified therapeutic goods be included in the part of the Register for listed goods; and

                     (b)  specify the conditions subject to which such goods may be included in that part of the Register.

             (6)  If the regulations are amended to require any of those goods to be included in the part of the Register for listed or registered goods, then the Gazette notice ceases to have effect in respect of the goods included in the regulations.