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This is a Bill, not an Act. For current law, see the Acts databases.
1998-1999-2000
The Parliament
of the
Commonwealth of
Australia
HOUSE OF
REPRESENTATIVES
Presented and read a first
time
Therapeutic
Goods Amendment Bill (No. 2) 2000
No. ,
2000
(Health and Aged
Care)
A Bill for an Act to amend the
Therapeutic Goods Act 1989, and for related purposes
ISBN: 0642
429545
Contents
A Bill for an Act to amend the Therapeutic Goods Act
1989, and for related purposes
The Parliament of Australia enacts:
This Act may be cited as the Therapeutic Goods Amendment Act (No. 2)
2000.
This Act commences on the day on which it receives the Royal
Assent.
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repealed as set out in the applicable items in the Schedule concerned, and any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.
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:
(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.