Therapeutic Goods (Charges) Act 1989

Act No. 22 of 1990 as amended

This compilation was prepared on 4 October 2002
taking into account amendments up to Act No. 25 of 2002

The text of any of those amendments not in force
on that date is appended in the Notes section

The operation of amendments that have been incorporated may be affected by application provisions that are set out in the Notes section

Prepared by the Office of Legislative Drafting,
Attorney‑General’s Department, Canberra

Contents

1 Short title [see Note 1]...........................

2 Commencement...............................

3 Incorporation.................................

4 Charges....................................

5 Regulations..................................

Notes 

An Act to impose an annual charge on the registration, listing and inclusion in the Register of therapeutic goods, and on the licensing of manufacturers of therapeutic goods

1  Short title [see Note 1]

  This Act may be cited as the Therapeutic Goods (Charges) Act 1989.

2  Commencement

  This Act commences on 1 July 1990.

3  Incorporation

 (1) The Therapeutic Goods Act 1989 is incorporated, and is to be read as one, with this Act.

 (2) However, for the purposes of this Act, if a suspension of a kind of medical device, or any medical devices of a particular kind, has effect under Chapter 4 of the Therapeutic Goods Act 1989, that kind of medical device is taken to be included in the Register under that Chapter.

4  Charges

 (1) Annual charges of such amounts as are prescribed are payable in respect of the registration or listing of therapeutic goods, other than grouped therapeutic goods, that is in force at any time during a financial year.

 (1A) If the registration or listing of one or more grouped therapeutic goods, being goods covered by a single registration or listing number, is in force at any time during a financial year, an annual charge of such amount as is prescribed is payable in respect of all of the registrations or listings concerned.

 (1B) Annual charges of such amounts as are prescribed are payable in respect of the inclusion of kinds of medical devices in the Register under Chapter 4 of the Therapeutic Goods Act that has effect at any time during a financial year.

 (2) An annual charge of such amount as is prescribed is payable in respect of a licence that is in force at any time during a financial year.

 (3) If:

 (a) goods are included in the Register under subsection 6A(3) of the Therapeutic Goods Act; and

 (b) the goods are so included for the purposes of a provision of a corresponding State law that provides for registration of therapeutic goods by the inclusion of the goods in the Register;

this section has effect as if the goods had been registered under Part 3‑2 of the Therapeutic Goods Act.

 (4) If:

 (a) goods are included in the Register under subsection 6A(3) of the Therapeutic Goods Act; and

 (b) the goods are so included for the purposes of a provision of a corresponding State law that provides for listing of therapeutic goods by the inclusion of the goods in the Register;

this section has effect as if the goods had been listed under Part 3‑2 of the Therapeutic Goods Act.

 (4A) If:

 (a) medical devices are included in the Register under subsection 6A(3) of the Therapeutic Goods Act; and

 (b) the devices are so included for the purposes of a provision of a corresponding State law that provides for the inclusion of devices in the Register;

this section has effect as if the devices had been included in the Register under Chapter 4 of the Therapeutic Goods Act.

 (5) If:

 (a) a licence is issued by the Secretary by virtue of subsection 6A(1) of the Therapeutic Goods Act; and

 (b) the licence is issued for the purposes of provisions of a corresponding State law that correspond to Part 3‑3 of the Therapeutic Goods Act;

this section has effect as if the licence had been issued under Part 3‑3 of the Therapeutic Goods Act.

 (6) In this section, Therapeutic Goods Act means the Therapeutic Goods Act 1989.

5  Regulations

 (1) The Governor‑General may make regulations, not inconsistent with this Act, prescribing the amounts of charges.

 (2) The regulations may prescribe different charges in relation to:

 (a) different classes of goods (including medical devices); or

 (b) in the case of annual licensing charges—different steps in the manufacture of goods.

 (3) The regulations shall provide that annual charges in respect of the registration or listing of therapeutic goods, or the inclusion of kinds of medical devices in the Register under Chapter 4 of the Therapeutic Goods Act 1989, are not payable by persons whose turnover of those goods or devices is of low volume and low value.

Notes to the Therapeutic Goods (Charges) Act 1989

Note 1

The Therapeutic Goods (Charges) Act 1989 as shown in this compilation comprises Act No. 22, 1990 amended as indicated in the Tables below.

Table of Acts

Table of Amendments