The Parliament of the

Commonwealth of Australia

HOUSE OF REPRESENTATIVES

Presented and read a first time

Therapeutic Goods (Charges) Amendment Bill 2001

No. , 2001

(Health and Aged Care)

A Bill for an Act to amend the Therapeutic Goods (Charges) Act 1989, and for related purposes

ISBN: 0642 468230

Contents

A Bill for an Act to amend the Therapeutic Goods (Charges) Act 1989, and for related purposes

The Parliament of Australia enacts:

1 Short title This Act may be cited as the Therapeutic Goods (Charges) Amendment Act 2001.

2 Commencement This Act commences at the same time as Schedule 1 to the Therapeutic Goods Amendment (Medical Devices) Act 2001 commences.

3 Schedule(s) Each Act that is specified in a Schedule to this Act is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Act has effect according to its terms.

Schedule 1--Amendment of the Therapeutic Goods (Charges) Act 1989

1 Title

Omit "registration and listing", substitute "registration, listing and inclusion in the Register".

2 At the end of section 3

Add:

(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.

3 After subsection 4(1A)

Insert:

(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.

4 Subsections 4(3) and (4)

Omit "Part 3", substitute "Part 3-2".

5 After subsection 4(4)

Insert:

(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.

6 Subsection 4(5)

Omit "Part 4" (wherever occurring), substitute "Part 3-3".

7 Paragraph 5(2)(a)

After "of goods", insert "(including medical devices)".

8 Subsection 5(3)

After "therapeutic goods", insert ", or the inclusion of kinds of medical devices in the Register under Chapter 4 of the Therapeutic Goods Act 1989,".

9 Subsection 5(3)

After "those goods", insert "or devices".