Therapeutic Goods Amendment Act (No. 2) 2000

Administered by Department of Health, Disability and Ageing

Legislation au C2004A00648 In force Act

Legislation content

 

 

 

 

Therapeutic Goods Amendment Act (No. 2) 2000

 

No. 56, 2000

 

 

 

 

Therapeutic Goods Amendment Act (No. 2) 2000

 

No. 56, 2000

 

 

 

 

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

 

 

Contents

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

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

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

Schedule 1—Therapeutic Goods Act 1989

 

Therapeutic Goods Amendment Act (No. 2) 2000

No. 56, 2000

 

 

 

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

[Assented to 30 May 2000]

The Parliament of Australia enacts:

1  Short title

  This Act may be cited as the Therapeutic Goods Amendment Act (No. 2) 2000.

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  Each Act that is specified in a Schedule to this Act is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Act has effect according to its terms.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

 

1  Subsection 3(1)

Insert:

counterfeit has the meaning given by section 42E.

2  Subsection 3(1)

Insert:

Therapeutic Goods Advertising Code has the meaning given by the regulations.

3  Subsection 20(1)

Repeal the subsection, substitute:

 (1) A person is guilty of an offence if:

 (a) the person intentionally:

 (i) imports into Australia therapeutic goods for use in humans; or

 (ii) exports from Australia therapeutic goods for use in humans; or

 (iii) manufactures in Australia therapeutic goods for use in humans; or

 (iv) supplies in Australia therapeutic goods for use in humans; and

 (b) none of the following subparagraphs applies in relation to the goods:

 (i) the goods are registered goods or listed goods in relation to the person;

 (ii) the goods are exempt goods;

 (iii) the goods are the subject of an approval or authority under section 19;

 (iv) the goods are the subject of an approval under section 19A.

 (1AA) An offence against subsection (1) is punishable on conviction by a fine not more than 240 penalty units.

4  At the end of subsection 30(1)

Add:

 ; or (f) both of the following apply:

 (i) under the regulations, an authority constituted by or under the regulations gives a direction to, or makes a requirement of, the person in relation to an advertisement of the goods to ensure that advertising complies with the Therapeutic Goods Advertising Code;

 (ii) the person does not comply with the direction or requirement.

5  Application

The amendment of section 30 of the Therapeutic Goods Act 1989 by this Schedule applies to directions given, and requirements made, of persons after the commencement of the amendment.

6  After Part 4A

Insert:

Part 4B—Counterfeit therapeutic goods

 

42E  Offence of dealing with counterfeit therapeutic goods

 (1) A person is guilty of an offence if:

 (a) the person intentionally:

 (i) manufactures goods in Australia; or

 (ii) supplies goods in Australia; or

 (iii) imports goods into Australia; or

 (iv) exports goods from Australia; and

 (b) the goods are therapeutic goods; and

 (c) the goods are counterfeit and the person knows that fact or is reckless as to whether that fact exists.

 (2) Goods are counterfeit if any of the following contain a false representation of a matter listed in subsection (3):

 (a) the label or presentation of the goods;

 (b) any document or record relating to the goods or their manufacture;

 (c) any advertisement for the goods.

 (3) The matters are as follows:

 (a) the identity or name of the goods;

 (b) the formulation, composition or design specification of the goods or of any ingredient or component of them;

 (c) the presence or absence of any ingredient or component of the goods;

 (d) the strength or size of the goods (other than the size of any pack in which the goods are contained);

 (e) the strength or size of any ingredient or component of the goods;

 (f) the sponsor, source, manufacturer or place of manufacture of the goods.

 (4) An offence against this section is punishable on conviction by imprisonment for not more than 5 years, a fine not more than 500 penalty units or both.

Note: Subsection 4B(3) of the Crimes Act 1914 lets a court fine a body corporate up to 5 times the maximum amount the court can fine an individual.

 (5) To avoid doubt, a term that is defined in subsection 3(1) in relation to therapeutic goods and used in this section in relation to goods has in this section the meaning given by subsection 3(1).

42F  Customs treatment of counterfeit therapeutic goods

Imported counterfeit therapeutic goods

 (1) If the Secretary notifies the Chief Executive Officer of Customs in writing that the Secretary wishes the Customs Act 1901 to apply to an import of counterfeit therapeutic goods, that Act has effect as if the goods included in the import were goods described as forfeited to the Crown under section 229 of that Act because they were prohibited imports within the meaning of that Act.

Exported counterfeit therapeutic goods

 (2) If the Secretary notifies the Chief Executive Officer of Customs in writing that the Secretary wishes the Customs Act 1901 to apply to an export of counterfeit therapeutic goods, that Act has effect as if the goods included in the export were goods described as forfeited to the Crown under section 229 of that Act because they were prohibited exports within the meaning of that Act.

 

 

(26/00)


 

[Minister’s second reading speech made in—

House of Representatives on 9 March 2000

Senate on 9 May 2000]

 

 

 

 

Overview

The Therapeutic Goods Amendment Act (No. 2) 2000, enacted by the Parliament of Australia, was introduced to address the issue of counterfeit therapeutic goods and to enhance the regulatory framework governing the advertising of therapeutic goods. This legislation amends the Therapeutic Goods Act 1989, aiming to ensure that therapeutic goods available in Australia are safe, of high quality, and accurately represented. The policy objective of this Act is to provide stricter penalties for the manufacture, supply, import, and export of counterfeit therapeutic goods, as well as to enforce compliance with advertising standards for therapeutic goods, thereby protecting public health and safety. The Act introduces new offences related to the dealing of counterfeit therapeutic goods and outlines the customs treatment for such goods, providing a robust legal framework to combat the illicit trade of counterfeit products. Additionally, it addresses the advertising of therapeutic goods, imposing penalties for non-compliance with advertising codes, thereby ensuring that therapeutic goods are marketed truthfully and responsibly.

Scope and Application

The Therapeutic Goods Amendment Act (No. 2) 2000 amends the Therapeutic Goods Act 1989 to introduce new regulations and penalties regarding the importation, exportation, manufacture, and supply of therapeutic goods within Australia. The Act applies to individuals and entities involved in any of these activities with therapeutic goods, which are defined broadly to include medicines, medical devices, and other health-related products. It applies nationwide, covering all states and territories within Australia, and aims to strengthen the regulation of these goods to protect public health. The Act introduces new offences for dealing with counterfeit therapeutic goods and imposes penalties for non-compliance with advertising regulations designed to ensure the safety and efficacy of therapeutic goods. These amendments extend the application of the Therapeutic Goods Act 1989 to cover new aspects of therapeutic goods regulation, including stricter penalties for violations and specific measures targeting counterfeit goods. The Act's provisions are designed to be enforced through subordinate instruments, which may include regulations and directions issued by relevant authorities under the amended Act.

Key Provisions

The Therapeutic Goods Amendment Act (No. 2) 2000 amends the Therapeutic Goods Act 1989 by introducing new definitions and requirements. Section 3(1) of the Therapeutic Goods Act 1989 now includes definitions for "counterfeit" and "Therapeutic Goods Advertising Code." Section 20(1) is repealed and replaced with a new subsection that outlines the offence of importing, exporting, manufacturing, or supplying therapeutic goods in Australia without the necessary registration, listing, approval, or exemption (subsection 20(1)). The new subsection (1AA) specifies that this offence is punishable by a fine not exceeding 240 penalty units. Additionally, section 30(1) is amended to include a new subsection (1f), which makes it an offence to fail to comply with directions or requirements made under the regulations to ensure advertising complies with the Therapeutic Goods Advertising Code (subsection 30(1f)). This amendment applies to directions given and requirements made after the commencement of the amendment (subsection 30(1)). The Act imposes obligations on individuals and entities to ensure that they comply with the Therapeutic Goods Act 1989 and associated regulations. Individuals and entities must ensure that any therapeutic goods they import, export, manufacture, or supply in Australia are either registered, listed, exempt, or approved as required by the Act. They must also comply with any directions or requirements made under the regulations to ensure advertising complies with the Therapeutic Goods Advertising Code. Failure to comply with these obligations can result in criminal penalties. There are significant penalties and consequences for breaches of the Therapeutic Goods Act 1989 as amended by this Act. Section 20(1) creates an offence for importing, exporting, manufacturing, or supplying therapeutic goods in Australia without the necessary registration, listing, approval, or exemption. This offence is punishable by a fine not exceeding 240 penalty units. Section 30(1f) creates an additional offence for failing to comply with directions or requirements to ensure advertising complies with the Therapeutic Goods Advertising Code, with similar penalties. Section 42E creates a more serious offence for dealing with counterfeit therapeutic goods. This offence is punishable by imprisonment for up to 5 years, a fine not exceeding 500 penalty units, or both. The definition of "counterfeit" includes goods with false representations in their label, documents, or advertisements. The Act also allows for the forfeiture of counterfeit goods under the Customs Act 1901 if the Secretary notifies the Chief Executive Officer of Customs. This Act aims to strengthen the regulation of therapeutic goods in Australia by clarifying definitions, introducing new offences, and increasing penalties for breaches. By doing so, it seeks to protect public health and safety by ensuring that only safe and effective therapeutic goods are available on the market.

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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.