Therapeutic Goods Amendment (2011 Measures No. 1) Act 2011

Administered by Department of Health, Disability and Ageing

Legislation au C2011A00077 In force Act

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Therapeutic Goods Amendment (2011 Measures No. 1) Act 2011

 

No. 77, 2011

 

 

 

 

 

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

 

 

Contents

1 Short title

2 Commencement

3 Schedule(s)

Schedule 1—Amendments

Therapeutic Goods Act 1989

 

 

 

Therapeutic Goods Amendment (2011 Measures No. 1) Act 2011

No. 77, 2011

 

 

 

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

[Assented to 25 July 2011]

The Parliament of Australia enacts:

1  Short title

  This Act may be cited as the Therapeutic Goods Amendment (2011 Measures No. 1) Act 2011.

2  Commencement

  This Act commences on the day after this Act receives the Royal Assent.

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  Each Act that is specified in a Schedule to this Act is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Act has effect according to its terms.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

 

Therapeutic Goods Act 1989

1  Subsections 9D(6) to (8)

Repeal the subsections, substitute:

Form and manner of requests

 (6) The Secretary may, by writing:

 (a) approve a form for particular kinds of requests under this section; and

 (b) approve the manner of making particular kinds of requests under this section.

 (7) If:

 (a) the Secretary has approved a form for, and the manner of making, a kind of request under this section; and

 (b) either:

 (i) the kind of request is one under subsection (3) and which, under the regulations, must be decided within 175 or 255 working days; or

 (ii) the kind of request is one prescribed by the regulations for the purposes of this subparagraph;

then a request of that kind is not effective unless:

 (c) the request is in accordance with that form; and

 (d) the request contains the information required by that form; and

 (e) the request is made in that manner; and

 (f) any prescribed application fee has been paid.

2  Subsection 24(2)

Omit “Subject to section 24D, an”, substitute “An”.

3  Section 24A

Omit “sections 24B and 24D”, substitute “section 24B”.

4  Subsections 24D(2) to (6)

Repeal the subsections, substitute:

 (2) If:

 (a) the applicant has paid the whole of the evaluation fee; and

 (b) the evaluation is completed, but not within the period referred to in subsection (1);

then 25% of the evaluation fee must be refunded to the applicant.

 (3) For the purposes of subsection (2), the evaluation is taken to be completed when the applicant is notified under subsection 25(4) of the Secretary’s decision on the evaluation.

Note: The heading to section 24D is altered by omitting “Reduction” and substituting “Refund”.

5  Paragraphs 31(1B)(b) and (1C)(b)

Omit “pre‑submission form”, substitute “pre‑submission planning form”.

6  Application

(1) The amendment made by item 1 applies in relation to requests made on or after the commencement of that item.

(2) The amendments made by items 2 to 4 apply in relation to applications made under section 23 of the Therapeutic Goods Act 1989 on or after the commencement of those items.

(3) The amendment made by item 5 applies in relation to notices given on or after the commencement of that item.

7  Transitional—approved forms

An approval in force under subsection 9D(6) of the Therapeutic Goods Act 1989 immediately before the commencement of this item continues in force on and after that commencement as if it were an approval in force under paragraph 9D(6)(a) of that Act.

8  Transitional—registration or listing conditions

(1) If:

 (a) on or after the day on which this item commences, the first instrument made under subsection 28(2) of the principal Act takes effect; and

 (b) immediately before that first instrument takes effect, a condition on the registration or listing of therapeutic goods was in force under subsection 28(2B) of the principal Act; and

 (c) either:

 (i) if that condition was in force because of subitem 57(3) of Schedule 7 to the amending Act—that condition was imposed in writing under subsection 28(1) of the principal Act (as in force at any time before 25 January 2010) and was described as a standard condition; or

 (ii) in any other case—that condition was imposed by notice in writing under subsection 28(2B) of the principal Act and was described as a standard condition;

then that condition ceases to be in force at the time that first instrument takes effect.

Note 1: If, immediately before that first instrument takes effect, multiple conditions on the registration or listing of therapeutic goods were in force under subsection 28(2B) of the principal Act, this item has a separate application in relation to each of those conditions.

Note 2: Section 12 of the Legislative Instruments Act 2003 deals with when a legislative instrument takes effect.

(2) Subitem 57(1) of Schedule 7 to the amending Act is subject to an instrument under subsection 28(2) of the principal Act providing that specified conditions apply only to a specified class of therapeutic goods that are registered or listed on or after that instrument takes effect.

(3) In this item:

amending Act means the Therapeutic Goods Amendment (2009 Measures No. 1) Act 2009.

principal Act means the Therapeutic Goods Act 1989.

 

 

[Minister’s second reading speech made in—

House of Representatives on 23 March 2011

Senate on 14 June 2011]

(41/11)

 

Overview

The Therapeutic Goods Amendment (2011 Measures No. 1) Act 2011 was enacted by the Parliament of Australia to amend the Therapeutic Goods Act 1989 and address certain issues related to the regulation of therapeutic goods. The Act was designed to refine the regulatory framework for therapeutic goods in Australia, focusing on improving the efficiency of the approval and evaluation processes. One of the key policy objectives behind this legislation was to enhance the effectiveness and transparency of the regulatory processes, thereby ensuring that therapeutic goods meet the necessary safety, quality, and efficacy standards. The Act provides for the amendment of specific provisions in the Therapeutic Goods Act 1989, including changes to the form and manner of making requests, adjustments to the refund process for evaluation fees, and modifications to the terminology used in pre-submission planning. These amendments aim to streamline the regulatory processes and improve the overall management of therapeutic goods in Australia.

Scope and Application

The Therapeutic Goods Amendment (2011 Measures No. 1) Act 2011 amends the Therapeutic Goods Act 1989, impacting the form and manner of requests for therapeutic goods, the process for evaluation fee refunds, and the terminology used in pre-submission planning forms. The Act applies to any person or entity making requests or applications for the evaluation or registration of therapeutic goods in Australia. The amendments are effective for requests, applications, and notices made on or after the commencement of the respective sections. The Act extends to the entire Commonwealth of Australia and any subordinate instruments or regulations made under the authority of the Act will further define or refine its application. Notably, the Act includes transitional provisions to ensure that any forms or conditions approved before the commencement of the Act continue to have effect, subject to any changes specified in the new legislation.

Key Provisions

The Therapeutic Goods Amendment (2011 Measures No. 1) Act 2011 amends the Therapeutic Goods Act 1989 (TGA) in several significant ways, as outlined in Schedule 1. Firstly, it revises the form and manner of requests for certain therapeutic goods, allowing the Secretary to approve both the form and the manner of making particular types of requests under section 9D (subsections 9D(6) to (8)). For instance, if the Secretary has approved a form and manner for a specific kind of request, the request will not be effective unless it adheres to the approved form, contains the required information, is made in the approved manner, and includes any prescribed application fee. Secondly, the Act simplifies the application process for therapeutic goods by omitting references to sections 24B and 24D in section 24A, and by altering the heading of section 24D from "Reduction" to "Refund" to reflect the change in its purpose (subsections 24D(2) to (6)). Additionally, it updates the terminology by replacing "pre-submission form" with "pre-submission planning form" in paragraphs 31(1B)(b) and (1C)(b). The amended Act imposes several obligations on parties or entities it governs. For example, it mandates that requests for therapeutic goods must comply with any approved forms and manners specified by the Secretary, and that applicants must pay the requisite application fees. It also requires that if an evaluation of an application is completed beyond the stipulated period, the applicant is entitled to a refund of 25% of the evaluation fee. Furthermore, the Act requires that any conditions on the registration or listing of therapeutic goods cease to be in force upon the effect of the first instrument made under section 28(2) of the principal Act. There are potential civil and criminal consequences for breaches of this Act. For instance, non-compliance with the form and manner requirements for requests could render those requests ineffective, potentially delaying the approval process for therapeutic goods. Failure to adhere to the new refund provisions might result in disputes between applicants and the Secretary. Additionally, if any legislative instruments or conditions are not properly managed or updated as per the Act's requirements, this could lead to legal challenges or enforcement actions. The maximum penalties for breaches are not explicitly stated in the Act but may be found in the Therapeutic Goods Act 1989 or other relevant legislation.

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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.