Therapeutic Goods Legislation Amendment Act 1998

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No. 34, 1998

Therapeutic Goods Legislation Amendment Act 1998

No. 34, 1998

An Act to amend the Therapeutic Goods Act 1989 and the Customs Act 1901

Contents

1 Short title..................................1

2 Commencement..............................1

3 Schedule(s).................................2

Schedule 1—Amendment of the Therapeutic Goods Act 1989 3

Schedule 2—Amendment of the Customs Act 1901 7

Therapeutic Goods Legislation Amendment Act 1998

No. 34, 1998

An Act to amend the Therapeutic Goods Act 1989 and the Customs Act 1901

[Assented to 17 April 1998]

The Parliament of Australia enacts:

1 Short title

This Act may be cited as the Therapeutic Goods Legislation Amendment Act 1998.

2 Commencement

This Act commences on the day on which it 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Each Act that is specified in a Schedule to this Act is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Act has effect according to its terms.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—Amendment of the Therapeutic Goods Act 1989

1 Subsection 3(1)

Insert:

protected information, in relation to therapeutic goods, has the meaning given by section 25A.

2 At the end of subsection 25(1)

Add:

Note: The Secretary must not use protected information when evaluating therapeutic goods for registration: see section 25A.

3 After section 25

Insert:

25A When the Secretary must not use protected information

(1) When evaluating therapeutic goods for registration, the Secretary must not use information about other therapeutic goods that is protected information.

(2) Information is protected information if:

(a) the information was given to the Secretary in relation to an application to register therapeutic goods (the new goods):

(i) not being therapeutic devices; and

(ii) consisting of, or containing, an active component; and

(b) the information is about the active component and is not available to the public; and

(i) no other therapeutic goods consisting of, or containing, that active component were included in the Register; and

(ii) no such therapeutic goods had been included in the Register at any time before then; and

(d) the new goods became registered on or after the commencement of this subsection; and

(e) 5 years have not passed since the day the new goods became registered; and

(f) the person in relation to whom the new goods are registered has not given the Secretary permission in writing for the Secretary to use the information.

(3) For the purposes of subsection (2), an active component, in relation to therapeutic goods, is a substance that is, or one of the substances that together are, primarily responsible for the biological or other effect identifying the goods as therapeutic goods.

(4) The use of protected information contrary to subsection (1) does not render the Commonwealth, the Secretary or a delegate of the Secretary liable to a person in respect of loss, damage or injury of any kind suffered by the person as a result of, or arising out of, the use of that information.

4 After subsection 30(4)

Insert:

(4A) The Secretary must, by notice in writing given to a person in relation to whom therapeutic goods are included in the Register, cancel the registration of the goods if the Secretary becomes aware that protected information was used when evaluating the goods for registration.

5 Paragraph 31(2)(d)

Repeal the paragraph, substitute:

(d) the method and place of manufacture or preparation of the goods and the procedures employed to ensure that proper standards are maintained in the manufacture and handling of the goods;

6 After subparagraph 38(1)(f)(ii)

Insert:

(iia) controls a body corporate (whether directly, or indirectly through one or more interposed entities) that has been convicted of an offence against this Act or a law of a State or Territory relating to therapeutic goods; or

(iib) controlled a body corporate (whether directly, or indirectly through one or more interposed entities) when the body committed an offence against this Act or a law of a State or Territory relating to therapeutic goods, and the body has been convicted of that offence; or

(iic) is controlled by another person (whether directly, or indirectly through one or more interposed entities) and that other person has been convicted of an offence against this Act or a law of a State or Territory relating to therapeutic goods; or

7 After paragraph 41(1)(a)

Insert:

(aa) the holder controls a body corporate (whether directly, or indirectly through one or more interposed entities) that has been convicted of an offence against this Act or a law of a State or Territory relating to therapeutic goods; or

(ab) the holder controlled a body corporate (whether directly, or indirectly through one or more interposed entities) when the body committed an offence against this Act or a law of a State or Territory relating to therapeutic goods, and the body has been convicted of that offence; or

(ac) the holder is controlled by another person (whether directly, or indirectly through one or more interposed entities) and that other person has been convicted of an offence against this Act or a law of a State or Territory relating to therapeutic goods; or

8 Subsection 61(8)

Omit “Therapeutic goods information”, substitute “Subject to section 25A, therapeutic goods information”.

9 After subsection 63(3)

Insert:

(3A) The regulations may provide for:

(a) the granting of a licence or permission to import or export therapeutic goods; and

(b) licences or permissions to import or export therapeutic goods to be subject to conditions or requirements; and

(d) the surrender of a licence or permission to import or export therapeutic goods; and

(e) the revocation of a licence or permission to import or export therapeutic goods.

Schedule 2—Amendment of the Customs Act 1901

1 Paragraphs 50(3)(a) and 112(2A)(a)

After “regulations”, insert “made under this Act or the Therapeutic Goods Act 1989”.

2 Paragraphs 50(3)(b) and 112(2A)(b)

Before “may make”, insert “in relation to licences or permissions granted as prescribed by regulations made under this Act—”.

[Minister's second reading speech made in—

House of Representatives on 3 December 1997

Senate on 9 March 1998]

(244/97)

Overview

The Therapeutic Goods Legislation Amendment Act 1998 No. 34 was enacted by the Parliament of Australia to address issues related to the confidentiality of information in the therapeutic goods industry. The primary aim was to protect information provided during the registration process for therapeutic goods, ensuring that proprietary information about active components in therapeutic goods remains confidential for a specified period. This legislation was introduced to safeguard the interests of innovators and manufacturers by preventing the misuse of sensitive information that could potentially undermine the competitive advantage derived from the registration process. By amending the Therapeutic Goods Act 1989 and the Customs Act 1901, the Act sought to establish clear guidelines on the use of protected information and to outline the consequences of its misuse, thereby fostering an environment conducive to innovation and fair competition within the therapeutic goods sector.

Scope and Application

The Therapeutic Goods Legislation Amendment Act 1998 No. 34, 1998 is an Act that amends both the Therapeutic Goods Act 1989 and the Customs Act 1901. This Act applies to persons and entities involved in the registration, manufacture, importation, exportation, and distribution of therapeutic goods. It specifically addresses the use of protected information in the evaluation of therapeutic goods for registration, ensuring that such information cannot be used unless specific conditions are met, such as the passage of five years since the goods were registered or written permission is given by the registrant. The Act also imposes obligations on persons who control a body corporate that has been convicted of an offence under this Act or related State or Territory laws. The Act's provisions extend nationally as it is a Commonwealth Act, thereby having jurisdiction across Australia. Subordinate instruments may further extend or restrict the application of the Act by detailing specific conditions or requirements for the import and export of therapeutic goods, as well as the management of related licences and permissions.

Key Provisions

The Therapeutic Goods Legislation Amendment Act 1998 (No. 34, 1998) makes significant amendments to the Therapeutic Goods Act 1989 and the Customs Act 1901. Under this Act, key sections include the addition of section 25A, which defines "protected information" in relation to therapeutic goods and prohibits the Secretary from using this information when evaluating applications for the registration of therapeutic goods (sections 25A(1) and 25A(2)). Information qualifies as "protected" if it pertains to an active component of a therapeutic good, is not publicly available, and meets several other specific conditions (section 25A(2)(a)-(f)). Additionally, section 30(4A) mandates that the Secretary cancel the registration of therapeutic goods if they become aware that protected information was used in their evaluation. The Act also modifies section 31(2)(d) to include new conditions regarding the method and place of manufacture and the procedures for maintaining manufacturing standards. Further, it updates section 38(1)(f) to include new grounds for refusing a licence or permit, such as controlling a body corporate convicted of an offence under the Act or related state or territory laws (section 38(1)(f)(iia)-(iic)). Similarly, section 41(1)(a) is amended to include new conditions for the cancellation of a licence or permit (section 41(1)(a)(aa)-(ac)). The Act also alters section 61(8) to subject "therapeutic goods information" to section 25A and adds new regulatory powers under section 63(3A) to include provisions for the granting, assigning, surrendering, and revoking of licences or permissions to import or export therapeutic goods. This Act imposes specific obligations on entities involved in the registration, manufacture, and import/export of therapeutic goods. For instance, the Secretary must strictly adhere to the prohibition on using protected information during the evaluation of therapeutic goods registration applications (section 25A(1)). Furthermore, the Secretary is obligated to cancel the registration of therapeutic goods if they discover that protected information was used in the evaluation process (section 30(4A)). Entities that manufacture therapeutic goods must ensure that their manufacturing methods and locations comply with the newly specified conditions in section 31(2)(d). Additionally, licence and permit holders are required to meet the updated conditions outlined in sections 38(1)(f)(iia)-(iic) and 41(1)(a)(aa)-(ac), which pertain to their control over entities involved in offences related to therapeutic goods. These obligations aim to maintain high standards in the therapeutic goods industry, ensuring both the quality and integrity of the products. The Therapeutic Goods Legislation Amendment Act 1998 also outlines specific consequences for breaches of its provisions. For example, while the Act prohibits the use of protected information during the evaluation of therapeutic goods, it explicitly states that the Commonwealth, the Secretary, or a delegate of the Secretary is not liable for any loss, damage, or injury resulting from the use of such information (section 25A(4)). However, section 30(4A) imposes a significant consequence by mandating the cancellation of the registration of therapeutic goods if the Secretary becomes aware that protected information was used in their evaluation. This cancellation can have serious ramifications for entities involved in the manufacture and distribution of therapeutic goods. Additionally, the new conditions for refusing or cancelling licences or permits under sections 38(1)(f)(iia)-(iic) and 41(1)(a)(aa)-(ac) introduce potential penalties for non-compliance, which may include the loss of regulatory permissions and the inability to legally import or export therapeutic goods. These provisions underscore the importance of adhering to the Act's requirements to avoid severe regulatory and legal consequences.

Area of Law: Medical Law
Instrument: Act
Concepts: Commencement Provisions; Repeal & Amendment; Licensing & Registration; Prohibited Conduct; Regulatory Standards

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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.

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