Therapeutic Goods Amendment Act 2007
No. 140, 2007
An Act to amend the law relating to therapeutic goods, and for related purposes
Contents
1 Short title
2 Commencement
3 Schedule(s)
Schedule 1—Amendments
Part 1—Therapeutic Goods Act 1989
Part 2—Other Acts
Therapeutic Goods Amendment Act (No. 1) 2006
Therapeutic Goods Amendment (Medical Devices) Act 2002
Therapeutic Goods Amendment Act 2007
No. 140, 2007
An Act to amend the law relating to therapeutic goods, and for related purposes
[Assented to 14 September 2007]
The Parliament of Australia enacts:
1 Short title
This Act may be cited as the Therapeutic Goods Amendment Act 2007.
2 Commencement
This Act commences, or is taken to have commenced, on 3 October 2007.
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Each Act that is specified in a Schedule to this Act is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Act has effect according to its terms.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—Amendments
Part 1—Therapeutic Goods Act 1989
1 Subsection 9B(2)
Repeal the subsection, substitute:
(2) The registration or listing of any other medical device is taken to be cancelled at the time shown in the table:
Time of cancellation of registration or listing |
| Circumstances | Time |
1 | That kind of medical device is included in the Register under Chapter 4 before 4 October 2007 because of an application finally determined before that day | When that kind of medical device is included in the Register under Chapter 4 |
2 | An effective application for a conformity assessment certificate relating to that kind of medical device is made, but not finally determined, before 4 October 2007 | The end of 30 days after the application is finally determined or, if the application lapses, the later of the following times (or either of them if they are the same): (a) the time the application lapses; (b) the start of 4 October 2007 |
3 | An effective application to include that kind of medical device in the Register under Chapter 4 is made, but not finally determined, before 4 October 2007, and item 2 does not apply | Whichever one of the following times applies, or the earlier of them: (a) the time that kind of medical device is included in the Register under Chapter 4 (even if that time is before 4 October 2007); (b) the time the application is finally determined, if the application is unsuccessful when it is finally determined; or, if the application lapses, the later of the following times (or either of them if they are the same): (c) the time the application lapses; (d) the start of 4 October 2007 |
4 | None of items 1, 2 and 3 applies | The start of 4 October 2007 |
Note: 4 October 2007 is the fifth anniversary of the day Chapter 4 commenced.
(2A) For the purposes of subsection (2), an application is finally determined at the first time both the following conditions are met:
(a) a decision has been made under Part 4‑4 or 4‑5 whether or not to grant the conformity assessment certificate or include the kind of medical device in the Register (as appropriate);
(b) there is no longer any possibility of a change in the outcome of the decision in terms of the grant (or not) of the conformity assessment certificate or the inclusion (or not) of the kind of medical device in the Register.
For the purposes of paragraph (b), ignore any possibility of a discretion being exercised, after the period has ended, to extend a period for seeking review by a tribunal or court of the decision or for starting other proceedings (including appeals) arising out of the application, the decision or the review.
Note: In certain circumstances a decision may be taken to have been made under Part 4‑4 or Part 4‑5. For example, see section 41EH.
2 Chapter 3 (note to heading)
Repeal the note, substitute:
Note: This Chapter still applies to medical devices while they are registered or listed goods. Section 9B automatically cancels the registration or listing of those goods over time.
3 Chapter 4 (note to heading)
Repeal the note, substitute:
Note: This Chapter does not apply, and Chapter 3 (Medicines and other therapeutic goods that are not medical devices) still applies, to medical devices that are registered or listed goods. Section 9B automatically cancels the registration or listing of those goods over time.
Part 2—Other Acts
Therapeutic Goods Amendment Act (No. 1) 2006
4 Subsection 2(1) (table item 5)
Repeal the item.
5 Schedule 1 (Act heading after item 157)
Repeal the heading.
6 Item 158 of Schedule 1
Repeal the item.
Therapeutic Goods Amendment (Medical Devices) Act 2002
7 Subsection 2(1) (table item 3)
Repeal the item.
8 Schedule 2
Repeal the Schedule.
[Minister’s second reading speech made in—
Senate on 20 June 2007
House of Representatives on 16 August 2007]
Overview
The Therapeutic Goods Amendment Act 2007, enacted by the Parliament of Australia and assented to on 14 September 2007, was designed to amend the existing laws concerning therapeutic goods. This Act aims to refine and enhance the regulatory framework governing therapeutic goods in Australia, ensuring they meet safety, quality, and efficacy standards. By addressing certain legislative gaps and updating existing provisions, the Act seeks to better protect public health and safety by ensuring that therapeutic goods available in the market are appropriately regulated.
The policy objective behind this Act is to provide a more streamlined and effective regulatory system for therapeutic goods, which includes medicines, medical devices, and other therapeutic goods. By making precise amendments to the Therapeutic Goods Act 1989 and related Acts, the 2007 Amendment Act ensures that the registration and listing processes for medical devices are more clearly defined and effectively managed. This includes the automatic cancellation of the registration or listing of certain medical devices under specific circumstances, thereby ensuring that only those devices meeting current safety and efficacy standards remain on the market.
Scope and Application
The Therapeutic Goods Amendment Act 2007 is an Act of the Parliament of Australia that seeks to amend the law relating to therapeutic goods, which includes a broad range of products such as medicines, medical devices, and blood and blood components, intended for use in diagnosing, treating, mitigating, or preventing diseases or medical conditions in humans or animals. This Act applies to all individuals and entities involved in the manufacture, supply, importation, or distribution of therapeutic goods within Australia. It covers all types of therapeutic goods, ensuring that they meet the safety, quality, and efficacy standards set by the Therapeutic Goods Administration (TGA). The Act's geographic reach is national, as it pertains to the entire Commonwealth of Australia. The Act does not explicitly state exclusions or exemptions but modifies existing provisions to refine the regulatory framework around therapeutic goods. The scope of application is further extended through subordinate instruments such as regulations and guidelines issued by the TGA, which provide detailed rules and standards for the implementation of the Act.
Key Provisions
The Therapeutic Goods Amendment Act 2007 (the "Act") amends the Therapeutic Goods Act 1989 (the "TGA") and other related Acts, introducing several changes to the regulation of therapeutic goods in Australia. The Act repeals and replaces subsection 9B(2) of the TGA, which concerns the cancellation of registration or listing of medical devices (section 1). Specifically, it modifies the circumstances under which the registration or listing of medical devices is deemed to be cancelled. For example, the Act now states that the registration or listing of a medical device will be cancelled at the end of 30 days after an application for a conformity assessment certificate is finally determined if the application was made before 4 October 2007 but not finally determined by that date (section 1(2)(2)). Additionally, the Act makes minor amendments to other Acts, such as repealing certain items in the Therapeutic Goods Amendment Act (No. 1) 2006 and the Therapeutic Goods Amendment (Medical Devices) Act 2002 (sections 4, 7).
The Act imposes several obligations and requirements on the parties involved in the regulation of therapeutic goods. Firstly, it mandates that medical devices which were registered or listed before 4 October 2007 will have their registration or listing automatically cancelled under specific circumstances (section 1). Secondly, it requires that effective applications for conformity assessment certificates and registrations must be made and finally determined within specified timeframes to avoid automatic cancellation (section 1(2)). These provisions ensure that the regulation of medical devices is consistent and that devices which do not meet the required standards are not allowed to remain on the market.
The Act also includes provisions regarding offences, penalties, and consequences for breaches. While the Act itself does not explicitly state the penalties for non-compliance, the Therapeutic Goods Act 1989, which the Act amends, provides for a range of civil and criminal penalties for breaches of its provisions. For instance, offences related to the supply of therapeutic goods that do not comply with standards can result in fines of up to $1,100,000 for corporations and $220,000 for individuals, as well as imprisonment for up to five years (section 24AA of the TGA). These penalties serve as a deterrent against non-compliance and ensure that the regulation of therapeutic goods in Australia is effectively enforced.