Commonwealth Numbered Acts

THERAPEUTIC GOODS AMENDMENT ACT (NO. 2) 2000 NO. 56, 2000 - SCHEDULE 1

1 Subsection 3(1)

counterfeit has the meaning given by section 42E.

2 Subsection 3(1)

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

3 Subsection 20(1)

(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)

; 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

6 After Part 4A

Part 4B—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).

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)