Therapeutic Goods (Charges) Amendment Act 2002
No. 25, 2002
An Act to amend the Therapeutic Goods (Charges) Act 1989, and for related purposes
Contents
1 Short title...................................
2 Commencement...............................
3 Schedule(s)..................................
Schedule 1—Amendment of the Therapeutic Goods (Charges) Act 1989
Therapeutic Goods (Charges) Amendment Act 2002
No. 25, 2002
An Act to amend the Therapeutic Goods (Charges) Act 1989, and for related purposes
[Assented to 4 April 2002]
The Parliament of Australia enacts:
1 Short title
This Act may be cited as the Therapeutic Goods (Charges) Amendment Act 2002.
2 Commencement
(1) Each provision of this Act specified in column 1 of the table commences, or is taken to have commenced, on the day or at the time specified in column 2 of the table.
Commencement information |
Column 1 | Column 2 | Column 3 |
Provision(s) | Commencement | Date/Details |
1. Sections 1 to 3 and anything in this Act not elsewhere covered by this table | The day on which this Act receives the Royal Assent | 4 April 2002 |
2. Schedule 1 | At the same time as Schedule 1 to the Therapeutic Goods Amendment (Medical Devices) Act 2002 commences | 4 October 2002 |
Note: This table relates only to the provisions of this Act as originally passed by the Parliament and assented to. It will not be expanded to deal with provisions inserted in this Act after assent.
(2) Column 3 of the table is for additional information that is not part of this Act. This information may be included in any published version of this Act.
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Each Act that is specified in a Schedule to this Act is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Act has effect according to its terms.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”.
[Minister’s second reading speech made in—
House of Representatives on 14 February 2002
Senate on 20 March 2002]
Overview
The Therapeutic Goods (Charges) Amendment Act 2002 No. 25, 2002 was enacted by the Parliament of Australia to amend the Therapeutic Goods (Charges) Act 1989, aiming to address certain gaps and issues in the regulation of medical devices and their inclusion in the Register of Therapeutic Goods. This Act was introduced to ensure that the inclusion of medical devices in the Register aligns with the provisions of both federal and state laws, particularly under Chapter 4 of the Therapeutic Goods Act 1989. The policy objective was to provide a more cohesive regulatory framework for medical devices, ensuring that they are adequately covered under the national legislation while respecting the roles of state laws. The Act was assented to on 4 April 2002 and commenced on that date for most provisions, with specific amendments taking effect from 4 October 2002.
Scope and Application
The Therapeutic Goods (Charges) Amendment Act 2002 amends the Therapeutic Goods (Charges) Act 1989 to adjust the regulatory framework concerning charges associated with therapeutic goods. This Act applies to the registration, listing, and inclusion of therapeutic goods and medical devices in the Register under the Therapeutic Goods Act 1989, affecting entities and individuals involved in the manufacture, supply, or importation of such goods within Australia. The geographic and jurisdictional reach of this Act is national, impacting all states and territories in Australia. Certain provisions of the Act extend or restrict application through subordinate instruments, which are prescribed in regulations. The Act includes specific amendments to charge structures, inclusion of medical devices in the Register, and adjustments to sections and parts within the Therapeutic Goods (Charges) Act 1989, effective from specified dates in 2002.
Key Provisions
The Therapeutic Goods (Charges) Amendment Act 2002 amends the Therapeutic Goods (Charges) Act 1989 by making several modifications. Section 1 of the Act changes the title of the 1989 Act to include "and inclusion in the Register". Section 3 introduces new provisions regarding the inclusion of kinds of medical devices in the Register under Chapter 4 of the Therapeutic Goods Act 1989. Specifically, it mandates that if a suspension of a kind of medical device or any medical devices of a particular kind is in effect under Chapter 4, that kind of medical device is considered to be included in the Register under that Chapter (Section 3(2)). Additionally, it stipulates that annual charges, as prescribed, are payable for the inclusion of kinds of medical devices in the Register under Chapter 4 that is in effect at any time during a financial year (Section 3(1B)). It further clarifies that if medical devices are included in the Register under subsection 6A(3) of the Therapeutic Goods Act for the purposes of a corresponding State law, this section applies as if the devices had been included in the Register under Chapter 4 of the Therapeutic Goods Act (Section 3(4A)).
The Act imposes several obligations and requirements on the entities it governs. Firstly, it requires that annual charges be paid for the inclusion of kinds of medical devices in the Register under Chapter 4 of the Therapeutic Goods Act 1989. These charges must be paid for each financial year during which the inclusion is in effect. Additionally, the Act specifies that if medical devices are included in the Register under subsection 6A(3) of the Therapeutic Goods Act for the purposes of a corresponding State law, the inclusion is treated as if it had been made under Chapter 4 of the Therapeutic Goods Act. This requirement ensures that the inclusion of medical devices in the Register is consistent and regulated according to the provisions of the Therapeutic Goods Act.
The Therapeutic Goods (Charges) Amendment Act 2002 includes provisions that address breaches and potential penalties. While the specific penalties are not detailed within the excerpt provided, it is common for legislative amendments of this nature to include provisions for fines or other penalties for non-compliance. Typically, such legislation may impose financial penalties for failing to pay the required annual charges or for non-compliance with the inclusion requirements. The maximum penalties would be specified in the Therapeutic Goods (Charges) Act 1989 or any related regulations. It is also possible that non-compliance could lead to legal action, including civil suits for damages or criminal charges in cases of serious or willful disregard of the Act's requirements. The precise nature and extent of these penalties would be further defined in the primary legislation or any subordinate legislation enacted under it.