Therapeutic Goods Amendment Act (No. 2) 2006

Administered by Department of Health, Disability and Ageing

Legislation au C2006A00002 In force Act

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Therapeutic Goods Amendment Act (No. 2) 2006

 

No. 2, 2006

 

 

 

 

 

An Act to amend the Therapeutic Goods Act 1989, and for related purposes

 

 

Contents

1 Short title

2 Commencement

3 Schedule(s)

Schedule 1—Amendment of the Therapeutic Goods Act 1989

 

 

 

Therapeutic Goods Amendment Act (No. 2) 2006

No. 2, 2006

 

 

 

An Act to amend the Therapeutic Goods Act 1989, and for related purposes

[Assented to 1 March 2006]

The Parliament of Australia enacts:

1  Short title

  This Act may be cited as the Therapeutic Goods Amendment Act (No. 2) 2006.

2  Commencement

 (1) Each provision of this Act specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

 

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.

1 March 2006

2.  Schedule 1

A single day to be fixed by Proclamation.

However, if any of the provision(s) do not commence within the period of 6 months beginning on the day on which this Act receives the Royal Assent, they commence on the first day after the end of that period.

3 April 2006

(see F2006L00889)

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 contains additional information that is not part of this Act. Information in this column may be added to or edited 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  Each Act that is specified in a Schedule to this Act is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Act has effect according to its terms.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 Act 1989

 

1  Paragraph 25(4)(d)

Repeal the paragraph, substitute:

 (d) if the decision is to register the goods:

 (i) notify the applicant in writing that the goods will be included in the Register if the applicant gives the Secretary either the certificate required under subsection 26B(1) or a notice (in accordance with a form approved, in writing, by the Secretary) that a certificate under that subsection is not required in relation to the application; and

 (ii) include the goods in the Register and give the applicant a certificate of registration if the applicant gives the Secretary either the certificate required under subsection 26B(1) or a notice (in accordance with a form approved, in writing, by the Secretary) that a certificate under that subsection is not required in relation to the application.

2  Subsection 25(4) (second sentence)

Repeal the sentence, substitute:

To avoid doubt, if the applicant gives the Secretary the certificate required under subsection 26B(1) or a notice that a certificate under that subsection is not required in relation to the application, the Secretary must include the goods in the Register under subparagraph (d)(ii) without inquiring into the correctness of the certificate or the notice.

3  At the end of subsection 25(4A)

Add “or a notice given under subparagraph (4)(d)(ii)”.

4  Paragraph 26(1)(aa)

Repeal the paragraph, substitute:

 (aa) if goods are not therapeutic devices—the application is accompanied by either:

 (i) the certificate required under subsection 26B(1); or

 (ii) a notice (in accordance with a form approved, in writing, by the Secretary) that a certificate under that subsection is not required in relation to the application; and

5  Paragraph 26(1A)(b)

Repeal the paragraph, substitute:

 (b) the application is accompanied by either:

 (i) the certificate required under subsection 26B(1); or

 (ii) a notice that a certificate under that subsection is not required in relation to the application; and

6  At the end of subsection 26(1A)

Add “or the notice”.

7  At the end of subsection 26(1B)

Add “or a notice given under subparagraph (1)(aa)(ii)”.

8  Paragraph 26A(1)(b)

Repeal the paragraph, substitute:

 (b) the application is accompanied by either:

 (i) the certificate required under subsection 26B(1); or

 (ii) a notice (in accordance with a form approved, in writing, by the Secretary) that a certificate under that subsection is not required in relation to the application; and

9  Paragraph 26A(1A)(b)

Repeal the paragraph, substitute:

 (b) the application is accompanied by either:

 (i) the certificate required under subsection 26B(1); or

 (ii) a notice that a certificate under that subsection is not required in relation to the application; and

10  At the end of subsection 26A(1A)

Add “or the notice”.

11  At the end of subsection 26A(1B)

Add “or a notice given under subparagraph (1)(b)(ii)”.

12  Before subsection 26B(1)

Insert:

 (1A) A certificate is required under subsection (1) in relation to an application for registration or listing of therapeutic goods only if:

 (a) the applicant is required to submit evidence or information to establish the safety or efficacy of the goods as part of the process of applying for registration or listing; and

 (b) in order to satisfy that requirement, the applicant relies (in whole or in part) on evidence or information that another person submitted to the Secretary:

 (i) to establish the safety or efficacy of other therapeutic goods that have already been registered or listed; and

 (ii) as part of the process of applying for the registration or listing of those other goods.

13  Subsection 26B(1)

Omit “certificate required by”, substitute “certificate required under”.

14  After section 26B

Insert:

26BA  Approved form for notices

  An approval of a form for a notice for the purposes of subsection 25(4), 26(1) or 26A(1) may require or permit the notice to be given in accordance with specified software requirements:

 (a) on a specified kind of data processing device; or

 (b) by way of a specified kind of electronic transmission.

15  Application

The amendments made by this Schedule apply to applications for registration or listing of therapeutic goods that are made on or after the day on which this Schedule commences.

 

 

 [Minister’s second reading speech made in—

House of Representatives on 14 September 2005

Senate on 7 November 2005]

(152/05)

 

Overview

The Therapeutic Goods Amendment Act (No. 2) 2006 was enacted by the Parliament of Australia to amend the Therapeutic Goods Act 1989. The primary objective of this Act is to streamline the process of registering therapeutic goods by modifying the conditions under which certain certificates are required, thus aiming to expedite the inclusion of these goods into the Therapeutic Goods Register. The Act introduces provisions to allow for the acceptance of notices in lieu of specific certificates when the safety or efficacy of therapeutic goods has already been established by another party. This change is intended to reduce administrative burdens and enhance the efficiency of the regulatory process. The Act came into effect on 1 March 2006, with specific amendments to the Therapeutic Goods Act 1989 commencing on 3 April 2006.

Scope and Application

The Therapeutic Goods Amendment Act (No. 2) 2006 amends the Therapeutic Goods Act 1989 to introduce changes regarding the certification process for applications for the registration or listing of therapeutic goods. The Act applies to the Commonwealth of Australia and affects all applications for the registration or listing of therapeutic goods made on or after the day the Act's Schedule commences. The Act introduces provisions that specify when a certificate is required under subsection 26B(1) of the Therapeutic Goods Act 1989, allowing an applicant to provide a notice instead of a certificate under certain conditions. It also mandates that the Secretary must include the goods in the Register without inquiring into the correctness of the certificate or the notice if the applicant provides either the required certificate or a notice that a certificate is not required. The Act provides for the approval of forms for notices to be given in accordance with specified software requirements, allowing for electronic transmission or data processing devices. The Act does not specify any exclusions, exemptions, or thresholds, and its application may be extended or restricted through subordinate instruments.

Key Provisions

The Therapeutic Goods Amendment Act (No. 2) 2006 amends the Therapeutic Goods Act 1989, introducing new requirements and procedures for the registration and listing of therapeutic goods. The key amendments concern the documentation that must accompany an application for the registration or listing of therapeutic goods, as well as the process by which such applications are handled by the Secretary. Specifically, section 1 of Schedule 1 introduces new provisions for the registration of goods, requiring the Secretary to notify the applicant in writing if the goods will be included in the Register (subsection 1(d)). This notification is contingent upon the applicant providing either the required certificate under subsection 26B(1) or a notice that such a certificate is not required. The Secretary must then include the goods in the Register and provide the applicant with a certificate of registration, provided the required documentation is submitted (subsection 1(ii)). The obligations imposed by the Act require applicants for the registration or listing of therapeutic goods to submit either the certificate required under subsection 26B(1) or a notice stating that such a certificate is not required. This requirement applies to both applications for registration and listing of therapeutic goods, as well as for applications related to therapeutic devices. The Act also mandates that the Secretary include the goods in the Register and issue a certificate of registration upon receipt of the required documentation, without inquiring into the correctness of the certificate or notice. This streamlined process aims to facilitate the timely registration and listing of therapeutic goods. Failure to comply with the requirements set out in the Act may result in civil or criminal penalties, depending on the nature and severity of the breach. For instance, providing false or misleading information in an application for registration or listing of therapeutic goods could result in fines or imprisonment under section 32DA of the Therapeutic Goods Act 1989. The maximum penalties for such offences can be substantial, reflecting the importance of ensuring the safety and efficacy of therapeutic goods available in the Australian market. It is therefore crucial for applicants to adhere strictly to the documentation and procedural requirements stipulated in the Act.

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Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.