Therapeutic Goods Amendment Act 2001

Administered by Department of Health, Disability and Ageing

Legislation au C2004A00781 In force Act

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No. 14, 2001

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

Contents

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

2 Commencement...............................

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

Schedule 1—Electronic lodgment facility for listing medicines

Therapeutic Goods Act 1989

Therapeutic Goods Amendment Act 2001

No. 14, 2001

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

[Assented to 22 March 2001]

The Parliament of Australia enacts:

1 Short title

This Act may be cited as the Therapeutic Goods Amendment Act 2001.

2 Commencement

(1) Subject to subsection (2), this Act commences on a day to be fixed by Proclamation.

(2) If this Act does not commence under subsection (1) within the period of 6 months beginning on the day on which it receives the Royal Assent, it commences on the first day after the end of that period.

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Each Act that is specified in a Schedule to this Act is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Act has effect according to its terms.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

Therapeutic Goods Act 1989

1 Subsection 3(1)

Insert:

export only medicine means a medicine that:

(a) is manufactured in Australia for export only, or imported into Australia for export only; and

(b) is listable goods only because it is so manufactured or imported (and not for any other reason).

2 Subsection 3(1)

Insert:

listable goods means therapeutic goods that are required:

(a) under the regulations; or

(b) by a notice published in the Gazette under subsection 17(5);

to be included in the part of the Register relating to listed goods.

3 Subsection 3(1)

Insert:

working day, for a person, means any day except:

(a) Saturday or Sunday; or

(b) a day that is a public holiday in the State or Territory in which the person is located.

4 Subsection 16(1)

After “therapeutic goods” (first occurring), insert “(other than medicine of the kind to which subsection (1A) applies)”.

5 After subsection 16(1)

Insert:

(1A) Medicines that are listable goods (other than export only medicines) are taken to be separate and distinct from other therapeutic goods if the medicines have:

(a) different active ingredients; or

(b) different quantities of active ingredients; or

(d) such other different characteristics as the regulations prescribe;

from the therapeutic goods.

6 After subsection 22(2)

Insert:

(2A) A person must not, in or in connection with a certification of any matter under subsection 26A(2), intentionally or recklessly make a statement that is false or misleading in a material particular.

Maximum penalty: 400 penalty units.

7 Paragraph 26(1)(j)

Repeal the paragraph, substitute:

(j) if the goods have been manufactured in Australia, or imported into Australia, solely for export—a relevant authority of the country to which the goods are to be exported has not confirmed its willingness to accept the goods and:

(i) the goods have been refused registration or listing for supply in Australia; or

(ii) the Secretary requires such a confirmation for a reason other than because the goods have been refused registration or listing; or

8 Paragraph 26A(1)(a)

Omit “therapeutic goods”, substitute “medicine”.

Note: The heading to section 26A is replaced by the heading “Listing of certain medicines”.

9 Paragraph 26A(1)(b)

Repeal the paragraph.

10 Paragraph 26A(1)(d)

Repeal the paragraph, substitute:

(d) the medicine is not export only medicine;

11 Subsection 26A(1)

Omit “is not to refuse to list the goods”, substitute “must list the medicine”.

12 Subsection 26A(2)

Repeal the subsection, substitute:

(2) The applicant must certify that:

(a) the medicine is eligible for listing; and

(b) the medicine is safe for the purposes for which it is to be used; and

(d) the medicine conforms to every standard (if any) applicable to the medicine and to every requirement (if any) relating to advertising applicable under the regulations; and

(e) if the medicine has been manufactured in Australia—each step in the manufacture of the medicine has been carried out by a person who is the holder of a licence to carry out that step granted under section 38; and

(f) the medicine complies with all prescribed quality or safety criteria; and

(g) the medicine does not contain substances that are prohibited imports for the purposes of the Customs Act 1901; and

(h) all the manufacturers of the medicine are nominated as manufacturers in the application; and

(i) the applicant has, with manufacturers of the medicine who are manufacturers of the prescribed kind, written agreements containing such matters as are prescribed; and

(j) the applicant holds information or evidence to support any claim that the applicant makes relating to the medicine; and

(k) the information included in or with the application is correct.

13 Subsection 26A(3)

Omit “goods”, substitute “medicine”.

14 Subparagraph 26A(4)(a)(i)

Omit “the goods are not therapeutic devices and”.

15 Subparagraph 26A(4)(a)(i)

Omit “goods” (second and third occurring), substitute “medicine”.

16 Subparagraph 26A(4)(a)(ii)

Omit “goods”, substitute “medicine”.

17 Paragraph 26A(4)(b)

Omit “goods”, substitute “medicine”.

18 At the end of subsection 26A(4)

Add:

; and (c) whether the applicant has complied with any requirements made by the Secretary under section 31 in relation to the manufacture or preparation of the medicine.

19 Subsection 26A(5)

Omit “therapeutic goods are”, substitute “a medicine is”.

20 Subsection 26A(5)

Omit “goods” (second and third occurring), substitute “medicine”.

21 Subsection 26A(6)

Omit “therapeutic goods”, substitute “a medicine”.

22 Subsection 26A(6)

Omit “goods” (second and third occurring), substitute “medicine”.

23 Paragraph 26A(7)(a)

Omit “therapeutic goods were”, substitute “a medicine was”.

24 Paragraph 26A(7)(b)

Omit “goods been made in Australia, they”, substitute “medicine been made in Australia, it”.

25 Subsection 26A(7)

Omit “goods” (third occurring), substitute “medicine”.

26 Subsection 26A(8)

Repeal the subsection.

27 Subsection 26A(9)

Omit “an applicant has been informed that therapeutic goods in respect of which an application was made are acceptable for listing”, substitute “a medicine has been listed under this section”.

28 Subsection 26A(9)

Omit “the goods” (wherever occurring), substitute “the medicine”.

29 After subsection 28(5)

Insert:

(5A) In addition to any conditions imposed under subsection (1), (3) or (5), the listing of a medicine under section 26A is subject to a condition that the person in relation to whom the medicine is listed will deliver a reasonable number of samples of the medicine if the Secretary so requests:

(a) within the period specified in the request; and

(b) in accordance with any other requirements specified in the request.

The period specified in the request must include at least 10 working days.

30 Paragraph 30(1)(e)

Omit “goods”, substitute “a medicine”.

31 After subsection 30(1)

Insert:

(1A) The Secretary may, by notice in writing given to a person in relation to whom a medicine is listed under section 26A, cancel the listing of the medicine if:

(a) the medicine is not eligible for listing; or

(b) the medicine is exempt; or

(c) there is a serious breach, involving the medicine, of the requirements relating to advertising applicable under the regulations, and the Secretary is satisfied that:

(i) the breach is significant; and

(ii) as a result of the breach, the presentation of the medicine is misleading to a significant extent.

(1B) However, paragraph (1A)(c) does not apply to medicines that are manufactured in Australia for export only, or are imported into Australia for export only.

(1C) The Secretary may, by notice in writing given to a person in relation to whom a medicine is listed under section 26A, cancel the listing of the medicine if:

(a) the Secretary, under section 31, gives to the person a notice requiring the person to give to the Secretary information or documents relating to the medicine; and

(b) the notice is given for the purposes of ascertaining whether the medicine should have been listed; and

32 Paragraph 30(2)(ba)

Omit “goods”, substitute “a medicine”.

33 Paragraph 30(2)(ba)

Omit “or (h)”, substitute “, (h), (i), (j) or (k)”.

34 Subsection 30(5)

Omit “subsection (1)”, substitute “subsection (1), (1A) or (1C)”.

35 At the end of section 31

Add:

(6) A person in relation to whom a medicine is listed under section 26A must not, in purported compliance with a notice under this section relating to the medicine, intentionally or recklessly provide information that is false or misleading in a material particular.

Maximum penalty: 400 penalty units.

36 Application of amendments

(1) The amendments made by this Schedule do not apply, and the Therapeutic Goods Act 1989 as in force immediately before the commencement of this Schedule continues to apply, in relation to any application made under that Act, before that commencement, for listing of therapeutic goods.

(2) However, the amendment made by item 5 of this Schedule applies, after that commencement, to therapeutic goods that were listed before that commencement.

(3) The amendment made by item 31 of this Schedule applies, after that commencement, to medicines listed under section 26A before that commencement.

[Minister’s second reading speech made in—

Senate on 7 December 2000

House of Representatives on 7 March 2001]

(197/00)

Overview

The Therapeutic Goods Amendment Act 2001 was enacted by the Parliament of Australia to amend the Therapeutic Goods Act 1989. This Act was introduced to address the need for updating and enhancing the regulatory framework governing the listing of medicines in Australia, ensuring that the therapeutic goods available to the public meet necessary safety, quality, and efficacy standards. A key policy objective of the Act is to streamline the process for listing certain medicines and to improve the efficiency of the therapeutic goods regulation by introducing an electronic lodgment facility. The Act aims to provide clearer definitions and requirements for the listing of medicines, ensuring that only those medicines that meet specific criteria and standards are listed for supply in Australia. The Therapeutic Goods Amendment Act 2001 introduces several amendments to the Therapeutic Goods Act 1989, including the establishment of an electronic lodgment facility for listing medicines, clearer definitions for terms such as "export only medicine" and "listable goods", and more stringent requirements for the certification of medicines. The Act also imposes penalties for making false or misleading statements in the context of medicine certification and listing. Furthermore, the Act mandates that certain medicines must be listed if they meet the specified criteria, and it outlines conditions under which a medicine's listing can be cancelled, such as non-compliance with advertising requirements or failure to provide requested information.

Scope and Application

The Therapeutic Goods Amendment Act 2001 amends the Therapeutic Goods Act 1989, primarily in relation to the listing of medicines and the electronic lodgment facility for listing medicines. The Act applies to persons and entities involved in the manufacture, import, supply, or advertisement of therapeutic goods, particularly medicines, in Australia. This includes pharmaceutical companies, healthcare professionals, and distributors of therapeutic goods. The Act's jurisdictional reach is Commonwealth-wide, ensuring a uniform approach to the regulation of therapeutic goods across Australia. The Act introduces specific definitions and requirements for listing certain medicines, including export-only medicines, and mandates that these medicines must be distinct from other therapeutic goods based on their active ingredients, quantities, dosage forms, or other characteristics as prescribed by regulations. The Act also imposes penalties for false or misleading statements made in the certification of matters under the listing process. Additionally, the Act introduces provisions for the electronic lodgment of applications for listing medicines and modifies the conditions under which a medicine can be listed or delisted, including provisions for the delivery of samples and the cancellation of listings for non-compliance or significant breaches of advertising requirements. The amendments made by this Act do not apply retroactively to applications made before its commencement but do apply to therapeutic goods listed before and medicines listed after the commencement of the Act.

Key Provisions

The Therapeutic Goods Amendment Act 2001 amends the Therapeutic Goods Act 1989 to introduce new provisions concerning the listing and certification of medicines, among other things. The Act makes specific changes to the definition of certain terms, including 'export only medicine', 'listable goods', and 'working day', and it introduces new criteria for distinguishing between listable medicines and other therapeutic goods (Schedule 1, items 1-3). Additionally, it modifies the conditions under which certain medicines can be listed (Schedule 1, items 4-12). Under the amended Act, the Secretary is required to list a medicine if it meets the specified criteria, and applicants must certify that the medicine is eligible for listing, safe, and compliant with all relevant standards and regulations (Schedule 1, items 11-12, 22-26A). The Act also requires that applicants provide samples of the medicine upon request and ensures that listed medicines are subject to certain conditions and can be cancelled if they fail to meet the eligibility criteria or if there is a significant breach of advertising requirements (Schedule 1, items 27-30, 31-36). The Act places the onus on the applicant to ensure that all information provided in the application is accurate and complete. The Act imposes several obligations on the parties or entities it governs. For instance, it requires that listable medicines be distinct from other therapeutic goods based on specific criteria, such as active ingredients or dosage form (Schedule 1, item 5). It mandates that applicants certify the eligibility and safety of medicines for listing and that they comply with all relevant standards and requirements (Schedule 1, items 11-12, 22-26A). Furthermore, the Act requires that applicants provide samples of listed medicines upon request and that they do not provide false or misleading information in their applications or in response to requests for information from the Secretary (Schedule 1, items 27-30, 31-36). The Act imposes penalties for non-compliance with its provisions. For example, it imposes a maximum penalty of 400 penalty units for making a false or misleading statement in a certification (Schedule 1, item 6). Similarly, it imposes a maximum penalty of 400 penalty units for intentionally or recklessly providing false or misleading information in response to a notice from the Secretary (Schedule 1, item 35). The Act also provides for the cancellation of the listing of medicines that fail to meet the eligibility criteria or that are the subject of a significant breach of advertising requirements (Schedule 1, items 28-30). These penalties and consequences serve to enforce compliance with the Act and to ensure the safety and efficacy of therapeutic goods in Australia.

Area of Law: Medical Law
Instrument: Act
Concepts: Commencement Provisions; Reporting & Disclosure Obligations; Prohibited Conduct

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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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