Therapeutic Goods (Victoria) Act 2010
i
Therapeutic Goods (Victoria) Act 2010
No. 25 of 2010
TABLE OF PROVISIONS
Section Page
PART 1—PRELIMINARY 1
1 Purposes 1
2 Commencement 2
3 Definitions 2
4 Definitions in Commonwealth Act 6
5 Act to bind Crown 6
PART 2—APPLIED PROVISIONS 7
6 Application of Commonwealth therapeutic goods laws to
Victoria 7
7 Interpretation of Commonwealth therapeutic goods laws 7
PART 3—FUNCTIONS AND POWERS UNDER APPLIED
PROVISIONS 8
8 Functions and powers of Commonwealth Minister 8
9 Functions and powers of Commonwealth Secretary 8
10 Commonwealth may retain fees paid to Commonwealth
Secretary 8
11 Functions and powers of other persons 8
12 Delegation by Commonwealth Minister or Commonwealth
Secretary 9
13 Appointments under Commonwealth therapeutic goods laws 9
PART 4—ADMINISTRATIVE LAW MATTERS 10
14 Application of Commonwealth administrative laws to applied
provisions 10
15 Functions and powers conferred on Commonwealth officers
and authorities 10
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PART 5—OFFENCES AGAINST APPLIED PROVISIONS 12
16 Application of Commonwealth criminal laws to offences
against applied provisions 12
17 Functions and powers conferred on certain Commonwealth
officers and authorities relating to offences 12
18 No double jeopardy for offences against applied provisions 13
PART 6—PROVISIONS SPECIFIC TO VICTORIA 14
19 Power of Minister to exempt persons or goods by order 14
20 Hawking of therapeutic goods 15
21 Supply by vending machine 15
PART 7—CODES OF PRACTICE 17
22 Codes of Practice 17
23 Status of a Code of Practice 18
24 Procedure for making or adopting Codes of Practice 18
25 Commencement of Code of Practice 19
26 Availability of Codes of Practice 19
27 Code or matter etc. applied, adopted or incorporated in Code
to be laid before Parliament 20
28 Code may be disallowed by either House of Parliament 21
29 No liability if Code of Practice not available 21
30 Review by VCAT 21
PART 8—ENFORCEMENT—VICTORIAN PROVISIONS 23
Division 1—Authorised persons 23
31 Victorian authorised persons 23
32 Identity cards 23
33 Production of identity card when exercising powers 24
34 Victorian authorised persons subject to Victorian Secretary's
direction 24
Division 2—Enforcement powers of Victorian authorised persons 25
35 Offence-related searches and seizures with consent 25
36 Occupier to be given copy of consent 27
37 Search warrants 28
38 Announcement before entry on search warrant 30
39 Copy of search warrant to be given to occupier 30
40 General powers of Victorian authorised persons in relation to
premises 30
41 False or misleading information 32
42 Protection against self-incrimination 32
43 Receipt must be given for any thing seized 32
44 Copies of certain seized things to be given 33
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45 Use of equipment to examine or process things 34
46 Use or seizure of electronic equipment at premises 34
47 Return of seized documents or things 36
48 Court may extend period 36
49 Offence to hinder or obstruct Victorian authorised person 37
50 Entry to be reported to Victorian Secretary 37
51 Register of exercise of powers of entry 38
52 Complaints about exercise of powers 38
Division 3—Evidential and legal proceeding matters 38
53 Forfeiture 38
54 Conduct by officers, employees or agents 39
55 Offences by bodies corporate 41
56 Actions by firms and unincorporated association 41
PART 9—GENERAL 42
57 Regulations 42
58 Transitional provisions 43
PART 10—REPEALS AND CONSEQUENTIAL AMENDMENTS 44
59 Repeal of Therapeutic Goods (Victoria) Act 1994 44
60 Repeal of Part 10 44
═══════════════
ENDNOTES 45
INDEX 46
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1
Therapeutic Goods (Victoria) Act 2010 †
No. 25 of 2010
[Assented to 1 June 2010]
The Parliament of Victoria enacts:
PART 1—PRELIMINARY
1 Purposes
The main purposes of this Act are—
(a) to provide for the application of the
Therapeutic Goods Act 1989 of the
Commonwealth as a law of Victoria; and
(b) to provide for the regulation of therapeutic
goods in Victoria in circumstances where the
Commonwealth Act does not apply; and
Victoria
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(c) to repeal the Therapeutic Goods (Victoria)
Act 1994.
2 Commencement
(1) Subject to subsection (2), this Act comes into
operation on a day or days to be proclaimed.
(2) If a provision of this Act does not come into
operation before 1 February 2011, it comes into
operation on that day.
3 Definitions
In this Act—
applied provisions means the Commonwealth
therapeutic goods laws that apply as a law of
Victoria by virtue of section 6;
authorised person means—
(a) in relation to any provision of this Act,
a Victorian authorised person; or
(b) in relation to the applied provisions, an
authorised person within the meaning
of paragraph (a) of the definition of
authorised person in the
Commonwealth Act; or
(c) in relation to the Victorian provisions, a
member of the police force of Victoria;
Code of Practice means a Code of Practice made
or adopted under Part 7;
Commonwealth Act means the Therapeutic Goods
Act 1989 of the Commonwealth;
Commonwealth administrative laws means the
following Acts and regulations of the
Commonwealth—
(a) the Administrative Appeals Tribunal
Act 1975;
s. 2
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(b) the Freedom of Information Act 1982;
(c) the Ombudsman Act 1976;
(d) the Privacy Act 1988;
(e) any regulation made under an Act
referred to in paragraphs (a) to (d);
Commonwealth Department means the
Department of Health and Ageing or such
other Department of the Commonwealth as
is the relevant Department for the purposes
of the Commonwealth therapeutic goods
laws;
Commonwealth Minister means the Minister
responsible for administering the
Commonwealth therapeutic goods laws;
Commonwealth Secretary means the Secretary of
the Commonwealth Department;
Commonwealth therapeutic goods laws means—
(a) the Therapeutic Goods Act 1989 of the
Commonwealth; and
(b) any regulation, order or manufacturing
principle made and in force under the
Commonwealth Act;
exempt goods has the same meaning as it has in
the Commonwealth Act;
listed goods has the same meaning as it has in the
Commonwealth Act;
manufacturer's licence means a licence issued
and in force under the Commonwealth Act;
person includes an unincorporated association, a
firm and a partnership;
s. 3
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premises includes—
(a) a structure, building, aircraft, vehicle or
vessel; and
(b) a place (whether enclosed or built upon
or not); and
(c) a part of a thing referred to in
paragraph (a) or (b);
registered dentist means a person registered under
the Health Practitioner Regulation National
Law—
(a) to practise in the dental profession as a
dentist (other than as a student); and
(b) in the dentists division of that
profession;
registered goods has the same meaning as it has in
the Commonwealth Act;
registered medical practitioner means a person
registered under the Health Practitioner
Regulation National Law to practise in the
medical profession (other than as a student);
registered pharmacist means a person registered
under the Health Practitioner Regulation
National Law to practise in the pharmacy
profession (other than as a student);
sell includes—
(a) sell, whether by wholesale or retail; or
(b) barter or exchange; or
(c) dealing in, agreeing to sell, or offering
or exposing for sale; or
(d) keeping or having in possession for
sale; or
(e) sell by sending;
s. 3
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supply includes—
(a) sell, dispense or distribute; and
(b) supply, whether free of charge or
otherwise, by way of sample or
advertisement; and
(c) supply, whether free of charge or
otherwise, in the course of testing the
safety or efficacy on persons or
animals; and
(d) agree or offer to sell or distribute; and
(e) keep or have in possession for sale,
dispensing or distribution; and
(f) send, forward, deliver or receive for
sale, dispensing or distribution; and
(g) authorise, direct, cause, suffer, permit
or attempt any act referred to in
paragraphs (a) to (f);
supply by wholesale, in relation to goods,
means—
(a) supply of the goods for the purposes of
resupply; or
(b) supply of an ingredient for the purposes
of incorporation in the goods—
and includes supply of the goods in
wholesale quantities for use—
(c) in a public institution;
(d) in connection with the carrying on by
any person, in prescribed
circumstances, of any prescribed
activity;
therapeutic device has the same meaning as it has
in the Commonwealth Act;
s. 3
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therapeutic goods has the same meaning as it has
in the Commonwealth Act;
therapeutic use has the same meaning as it has in
the Commonwealth Act;
Victorian authorised person means a person
authorised by the Victorian Secretary under
Part 8;
Victorian provisions means the provisions of the
Act in Parts 1, 6, 7, 8, 9 and 10;
Victorian Secretary means the Secretary within
the meaning of the Public Health and
Wellbeing Act 2008.
4 Definitions in Commonwealth Act
(1) Words and expressions used in the
Commonwealth Act and in this Act have the same
meanings in this Act as they have in the
Commonwealth Act.
(2) Subsection (1) does not apply to the extent that the
context or subject matter otherwise indicates or
requires.
5 Act to bind Crown
This Act binds the Crown not only in right of
Victoria but also, so far as the legislative power of
the Parliament permits, the Crown in all its other
capacities.
__________________
s. 4
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Part 2—Applied Provisions
Therapeutic Goods (Victoria) Act 2010
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PART 2—APPLIED PROVISIONS
6 Application of Commonwealth therapeutic goods
laws to Victoria
(1) The Commonwealth therapeutic goods laws, as in
force for the time being and as modified by or
under this Part, apply as a law of Victoria.
(2) Those Commonwealth therapeutic goods laws so
apply as if they extended to—
(a) things done or omitted to be done by persons
who are not corporations; and
(b) things done or omitted to be done in the
course of trade and commerce within the
limits of Victoria.
(3) Regulations under this Act may modify the
Commonwealth therapeutic goods laws for the
purposes of this section.
7 Interpretation of Commonwealth therapeutic goods
laws
(1) The Acts Interpretation Act 1901 of the
Commonwealth, as in force for the time being—
(a) applies as a law of Victoria in relation to the
interpretation of the applied provisions; and
(b) so applies as if the applied provisions were
an Act of the Commonwealth or regulations
or orders under a Commonwealth Act, as the
case requires.
(2) The Interpretation of Legislation Act 1984 does
not apply to the applied provisions.
__________________
s. 6
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Part 3—Functions and Powers Under Applied Provisions
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8
PART 3—FUNCTIONS AND POWERS UNDER APPLIED
PROVISIONS
8 Functions and powers of Commonwealth Minister
The Commonwealth Minister has the same
functions and powers under the applied provisions
as that Minister has under the Commonwealth
therapeutic goods laws as those laws apply to the
Commonwealth.
9 Functions and powers of Commonwealth Secretary
(1) The Commonwealth Secretary has the same
functions and powers under the applied provisions
as that Secretary has under the Commonwealth
therapeutic goods laws as those laws apply to the
Commonwealth.
(2) Without limiting subsection (1), the
Commonwealth Secretary has the function of
including goods in the Australian Register of
Therapeutic Goods kept under the applied
provisions and is authorised to cancel the
inclusion of goods in that Register in accordance
with the applied provisions.
10 Commonwealth may retain fees paid to
Commonwealth Secretary
The Commonwealth may retain fees paid to, or
recovered by, the Commonwealth Secretary in
respect of the performance or exercise of
functions or powers conferred on the
Commonwealth Secretary by the applied
provisions.
11 Functions and powers of other persons
An authorised person, authorised officer or
official analyst appointed under the
Commonwealth therapeutic goods laws has the
same functions and powers under the applied
s. 8
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provisions as that person, officer or analyst has
under the Commonwealth therapeutic goods laws
as those laws apply to the Commonwealth.
12 Delegation by Commonwealth Minister or
Commonwealth Secretary
Any delegation by the Commonwealth Minister or
the Commonwealth Secretary under section 57 of
the Commonwealth Act is taken to extend to, and
have effect for the purposes of, the corresponding
provision of the applied provisions.
13 Appointments under Commonwealth therapeutic
goods laws
The appointment of a person to an office or
position under a provision of the Commonwealth
therapeutic goods laws is taken to extend to, and
have effect for the purposes of, the applied
provisions.
__________________
s. 12
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Part 4—Administrative Law Matters
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No. 25 of 2010
10
PART 4—ADMINISTRATIVE LAW MATTERS
14 Application of Commonwealth administrative laws
to applied provisions
(1) The Commonwealth administrative laws apply as
laws of Victoria to any matter arising in relation to
the applied provisions as if the applied provisions
were a law of the Commonwealth and not a law of
Victoria.
(2) For the purposes of a law of Victoria, a matter
arising in relation to the applied provisions—
(a) is taken to be a matter arising in relation to
laws of the Commonwealth in the same way
as it would if the applied provisions were a
law of the Commonwealth; and
(b) is taken not to be a matter arising in relation
to laws of Victoria.
(3) Subsection (2) has effect for the purposes of a law
of Victoria except as prescribed by the
regulations.
(4) Any provision of a Commonwealth administrative
law applying because of this section that purports
to confer jurisdiction on a federal court is taken
not to have that effect.
15 Functions and powers conferred on Commonwealth
officers and authorities
(1) A Commonwealth administrative law applying
because of section 14 that confers on a
Commonwealth officer or authority a function or
power also confers on the officer or authority the
same function or power in relation to a matter
arising in relation to the applied provisions.
s. 14
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(2) In performing a function, or exercising a power,
conferred by this section, a Commonwealth
officer or authority must act as nearly as is
practicable as the officer or authority would in
performing or exercising the same function or
power under the Commonwealth administrative
law.
(3) A function or power conferred on a
Commonwealth officer or authority because of
this section cannot be performed or exercised by
an officer or authority of Victoria.
__________________
s. 15
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Part 5—Offences Against Applied Provisions
Therapeutic Goods (Victoria) Act 2010
No. 25 of 2010
12
PART 5—OFFENCES AGAINST APPLIED PROVISIONS
16 Application of Commonwealth criminal laws to
offences against applied provisions
(1) The relevant Commonwealth laws apply as laws
of Victoria in relation to any offence committed
against the applied provisions as if the applied
provisions were a law of the Commonwealth and
not a law of Victoria.
(2) For the purposes of a law of Victoria, an offence
against the applied provisions—
(a) is taken to be an offence against the laws of
the Commonwealth in the same way as if the
applied provisions were a law of the
Commonwealth; and
(b) is taken not to be an offence against the laws
of Victoria.
(3) Subsection (2) has effect for the purposes of a law
of Victoria except as prescribed by the
regulations.
17 Functions and powers conferred on certain
Commonwealth officers and authorities relating to
offences
(1) A provision of the applied provisions applying
because of section 16 that confers on a
Commonwealth officer or authority a function or
power in relation to an offence against the
Commonwealth therapeutic goods laws also
confers on the officer or authority the same
function or power in relation to an offence against
the corresponding provision of the applied
provisions.
(2) In performing a function, or exercising a power,
conferred by subsection (1), the Commonwealth
officer or authority must act as nearly as is
s. 16
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practicable as the officer or authority would act in
performing or exercising the same function or
power in relation to an offence against the
corresponding provision of the Commonwealth
therapeutic goods laws.
18 No double jeopardy for offences against applied
provisions
If—
(a) an act or omission is both an offence against
the applied provisions and an offence against
the Commonwealth therapeutic goods laws;
and
(b) the offender has been punished for that
offence under the Commonwealth
therapeutic goods laws—
the offender is not liable to be punished for that
offence under the applied provisions.
__________________
s. 18
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Part 6—Provisions Specific to Victoria
Therapeutic Goods (Victoria) Act 2010
No. 25 of 2010
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PART 6—PROVISIONS SPECIFIC TO VICTORIA
19 Power of Minister to exempt persons or goods by
order
(1) Subject to subsection (3), the Minister, by order
published in the Government Gazette, may
exempt—
(a) any person or class of persons specified in
the order from—
(i) all the Victorian provisions; or
(ii) any Victorian provisions specified in
the order; or
(b) any goods or class of goods specified in the
order from—
(i) all Victorian provisions; or
(ii) any Victorian provisions specified in
the order.
(2) Subject to subsection (3), the Minister, by order
published in the Government Gazette, may declare
that goods are exempt goods for the purposes of
any Victorian provisions when those goods are
used, advertised or presented for supply in the
way specified in the order.
(3) The Minister must not make an order under this
section unless he or she is satisfied that making
the order is in the interests of public health.
(4) An order under this section is subject to the
conditions, if any, specified in the order.
s. 19
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20 Hawking of therapeutic goods
(1) Subject to subsection (2), a person must not,
without the written consent of the Victorian
Secretary, knowingly supply therapeutic goods in
a street or from house to house.
Penalty: 10 penalty units.
(2) Subsection (1) does not apply to the supply by
free distribution of clinical samples of therapeutic
goods to a registered medical practitioner,
registered pharmacist, registered dentist or
veterinary practitioner if—
(a) the supply is by a person licensed to
manufacture or supply by wholesale
therapeutic goods; and
(b) the goods are supplied to the registered
medical practitioner, registered pharmacist,
registered dentist or veterinary practitioner
personally or by post in a letter or parcel
addressed to him or her.
21 Supply by vending machine
(1) A person must not, without the written consent of
the Victorian Secretary, knowingly install a
vending machine for the supply of therapeutic
goods, whether in premises under the person's
control or elsewhere.
Penalty: 10 penalty units.
(2) A person must not, without the written consent of
the Victorian Secretary, knowingly supply
therapeutic goods by means of a vending machine,
whether in premises under the person's control or
elsewhere.
Penalty: 10 penalty units.
s. 20
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(3) A person must not, without the written consent of
the Victorian Secretary, knowingly permit a
vending machine for the supply of therapeutic
goods to be installed on premises owned or
occupied by that person.
Penalty: 10 penalty units.
(4) A person must not, without the written consent of
the Victorian Secretary, knowingly permit
therapeutic goods to be placed in a vending
machine under that person's control.
Penalty: 10 penalty units.
__________________
s. 21
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Part 7—Codes of Practice
Therapeutic Goods (Victoria) Act 2010
No. 25 of 2010
17
PART 7—CODES OF PRACTICE
22 Codes of Practice
(1) The Victorian Secretary may make or adopt Codes
of Practice in accordance with this Part.
(2) A Code of Practice must be approved by the
Minister before it is made or adopted.
(3) A Code of Practice may apply, adopt or
incorporate any matter contained in any
document, code, standard, rule, specification or
method formulated, issued, prescribed or
published by any authority or body whether—
(a) wholly or partially or as amended by the
Code of Practice; or
(b) as formulated, issued, prescribed or
published at the time the Code of Practice is
made or adopted or at any time before then;
or
(c) as formulated, issued, prescribed or
published from time to time.
(4) If a Code of Practice has applied, adopted or
incorporated any matter contained in any
document, code, standard, rule, specification or
method as formulated, issued, prescribed or
published from time to time and that document,
code, standard, rule, specification or method is at
any time amended, until the Victorian Secretary
causes notice to be published in the Government
Gazette of that amendment, the document, code,
standard, rule, specification or method is to be
taken not to have been so amended.
s. 22
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(5) A Code of Practice may—
(a) confer a discretionary authority or impose a
duty on a specified person or body or a
specified class of persons and bodies;
(b) leave any matter or thing to be from time to
time determined, applied, dispensed with or
regulated by the Victorian Secretary;
(c) authorise an authorised person to enforce the
Code of Practice.
23 Status of a Code of Practice
A Code of Practice is a subordinate instrument for
the purposes of the Interpretation of Legislation
Act 1984 except section 32 of that Act.
24 Procedure for making or adopting Codes of Practice
(1) Before the Victorian Secretary makes or adopts a
Code of Practice, the Victorian Secretary must
give a notice stating—
(a) the purpose and general purport of the
proposed Code of Practice;
(b) where a copy of the proposed Code of
Practice can be obtained or inspected;
(c) in the case of the proposed making of a Code
of Practice, that any person may make a
submission on the proposed Code of Practice
to the Victorian Secretary within the period
specified in the notice.
(2) In the case of the proposed making of a Code of
Practice, the Victorian Secretary must—
(a) allow at least 28 days after the day on which
a notice is given under subsection (1) for the
making of submissions; and
s. 23
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(b) if, after considering any submissions made,
the Victorian Secretary determines to make
the Code of Practice, give a notice stating
that the Victorian Secretary intends to make
the Code of Practice.
(3) A notice under this section must be—
(a) published in the Government Gazette; and
(b) published in a daily newspaper generally
circulating in Victoria; and
(c) sent to bodies or organisations that the
Victorian Secretary considers are likely to be
affected by the proposed Code of Practice.
25 Commencement of Code of Practice
A Code of Practice or a provision of a Code of
Practice comes into operation—
(a) on the day on which the Code of Practice is
approved by the Minister; or
(b) on such later day as is expressed in the Code
of Practice as the day on which the Code of
Practice or a provision of the Code comes
into operation.
26 Availability of Codes of Practice
(1) Upon the making or adoption of a Code of
Practice, the Victorian Secretary must cause to be
published in the Government Gazette notice of—
(a) the making or adoption of the Code of
Practice; and
(b) the date of commencement of the Code of
Practice; and
(c) the place where copies of the Code of
Practice may be obtained.
s. 25
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(2) A notice published under subsection (1) or
a notice of an amendment published under
section 22(4) must include a statement that the
Code of Practice, any incorporated document or
any amendment to an incorporated document
(as the case may be) may be inspected at the
office of the Victorian Secretary specified in the
notice.
27 Code or matter etc. applied, adopted or
incorporated in Code to be laid before Parliament
(1) The Minister must cause a copy of a Code of
Practice that is made or adopted under section 22
and of the notice of its making or adoption to be
laid before each House of Parliament within
7 sitting days of that House after the notice is
published in the Government Gazette.
(2) If the Code of Practice has applied, adopted or
incorporated any matter contained in any
document, code, standard, rule, specification or
method as formulated, issued, prescribed or
published, the Minister must include that applied,
adopted or incorporated matter in the material
laid before each House of Parliament under this
section.
(3) If the Code of Practice has applied, adopted or
incorporated any matter contained in any
document, code, standard, rule, specification or
method as formulated, issued, prescribed or
published and that document, code, standard, rule,
specification or method is at any time amended,
the Minister must cause a copy of the amendment
and of the notice of amendment under section
22(4) to be laid before each House of Parliament
within 7 sitting days of that House after the notice
under section 22(4) is published in the
Government Gazette.
s. 27
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28 Code may be disallowed by either House of
Parliament
(1) A Code of Practice may be disallowed in whole or
in part by either House of Parliament.
(2) Part 5 of the Subordinate Legislation Act 1994
applies to a Code of Practice as if—
(a) a reference in that Part to a "statutory rule"
were a reference to the Code of Practice; and
(b) a reference in section 23(1)(c) of that Act to
"section 15(1)" were a reference to section
27(1) of this Act.
(3) A reference to a Code of Practice in this section
includes a reference to any amendment of a Code
of Practice.
29 No liability if Code of Practice not available
A person must not be prejudicially affected or
made subject to any liability under a Code of
Practice if it is proved that at the relevant time—
(a) notice of the Code of Practice had not been
published in the Government Gazette; or
(b) a copy of the Code of Practice and any
incorporated matter was not available for
inspection.
30 Review by VCAT
(1) A person whose interests are affected by a
decision of the Victorian Secretary under this Part
may apply to VCAT for review of the decision.
(2) An application for review must be made within
28 days after the later of—
(a) the day on which the decision is made;
(b) if, under the Victorian Civil and
Administrative Tribunal Act 1998, the
person requests a statement of reasons for the
s. 28
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decision, the day on which the statement of
reasons is given to the person or the person is
informed under section 46(5) of that Act that
a statement of reasons will not be given.
__________________
s. 30
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Part 8—Enforcement—Victorian provisions
Therapeutic Goods (Victoria) Act 2010
No. 25 of 2010
23
PART 8—ENFORCEMENT—VICTORIAN PROVISIONS
Division 1—Authorised persons
31 Victorian authorised persons
(1) The Victorian Secretary may authorise any
employee under Part 3 of the Public
Administration Act 2004 to be a Victorian
authorised person to exercise powers under this
Act or a specified provision or provisions of this
Act if the Secretary believes the person has the
appropriate training, qualifications, knowledge or
experience to be appointed as an authorised
person.
(2) An authorisation under subsection (1) must be in
writing.
32 Identity cards
(1) The Victorian Secretary must ensure that each
Victorian authorised person is issued with an
identity card that—
(a) contains a photograph of the person; and
(b) states the full name of the person to whom it
is issued; and
(c) states that the person is a Victorian
authorised person for the purposes of this
Act or a specified provision or provisions of
this Act, as the case requires.
(2) In any proceedings under this Act, other than
under the applied provisions, an identity card
purporting to be issued to a person by the
Victorian Secretary under this Part is evidence of
the authorisation of that person as a Victorian
authorised person.
s. 31
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(3) If a person ceases to be a Victorian authorised
person, the person must return the person's
identity card to the Victorian Secretary as soon as
practicable after ceasing to be a Victorian
authorised person.
33 Production of identity card when exercising powers
(1) A Victorian authorised person must produce his or
her identity card for inspection at any time—
(a) before exercising a power or function under
this Act; or
(b) if asked to do so by any person at any time
during the exercise of a power or function
under this Act.
(2) If a Victorian authorised person proposes to
exercise a power or functions under this Act and
fails to produce on demand his or her identity
card, the person is not authorised to exercise those
powers or functions in relation to the person
making the demand.
34 Victorian authorised persons subject to Victorian
Secretary's direction
(1) The Victorian Secretary may give a direction to a
Victorian authorised person in relation to the
Victorian authorised person's performance or
exercise of a function or power under this Act.
(2) A direction under subsection (1) may be of a
general nature or may relate to a specified matter
or specified class of matter.
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Division 2—Enforcement powers of Victorian authorised
persons
35 Offence-related searches and seizures with consent
(1) A Victorian authorised person may only exercise
powers under this section if he or she has
reasonable grounds for suspecting that there is on
any premises a particular thing that may be
evidence of the commission of an offence against
the Victorian provisions.
(2) A Victorian authorised person may—
(a) enter any part of a premises that is generally
open to the public during reasonable
business hours without the consent of the
occupier (if any) of the premises; and
(b) exercise the powers set out in this section
and section 40.
(3) Subject to subsection (4), with the consent in
writing of the occupier of the premises, a
Victorian authorised person may—
(a) enter the premises and search for a thing
referred to in subsection (1) without applying
for a search warrant; and
(b) exercise the powers set out in this section
and section 40.
(4) A Victorian authorised person must not enter and
search any premises with the consent of the
occupier unless, before the occupier consents to
that entry, the Victorian authorised person has—
(a) produced his or her identity card for
inspection; and
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(b) informed the occupier—
(i) of the purpose of the search; and
(ii) that the occupier may refuse to give
consent to the entry and search or to the
seizure of anything found during the
search; and
(iii) that the occupier may refuse to consent
to the taking of any sample of goods or
any copy or extract from a document
found on the premises during the
search; and
(iv) that anything seized or taken during the
search with the consent of the occupier
may be used in evidence in
proceedings.
(5) If the consent is given, the Victorian authorised
person may ask the occupier to sign an
acknowledgment of the consent.
(6) The acknowledgment must state—
(a) that the occupier or apparent occupier (as the
case requires) has been informed—
(i) of the purpose of the entry; and
(ii) that the occupier or apparent occupier is
not required to consent; and
(b) the purpose of the entry; and
(c) that the occupier or apparent occupier gives
the Victorian authorised person consent to
enter the place and exercise powers under
this Part; and
(d) the time and date the consent was given.
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(7) For the purpose of asking the occupier of
residential premises for consent to enter, the
Victorian authorised person, without the
occupier's consent or a warrant may—
(a) enter land around the residential premises to
an extent that is reasonable to contact the
occupier; or
(b) enter part of the premises the Victorian
authorised person reasonably considers
members of the public ordinarily are allowed
to enter when they wish to contact the
occupier.
(8) If a thing referred to in subsection (1) is found
during a search under this section, the Victorian
authorised person may—
(a) inspect any thing on the premises;
(b) inspect, and make copies of, or take extracts
from, the thing;
(c) seize the thing if the Victorian authorised
person believes on reasonable grounds that
it—
(i) may be evidence of the commission of
an offence against the Victorian
provisions; or
(ii) is necessary to seize it in order to
prevent its concealment, loss or
destruction.
36 Occupier to be given copy of consent
(1) An occupier who consents in writing to the entry
and search of the occupier's premises, including
residential premises under section 35, must be
given a copy of the signed consent immediately.
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(2) In any proceeding, if a written consent is not
produced to the court, it must be presumed, until
the contrary is proved, that the occupier did not
consent to the entry and search.
37 Search warrants
(1) A Victorian authorised person may apply to a
magistrate for the issue of a search warrant in
relation to premises if the Victorian authorised
person believes on reasonable grounds that there
is, or may be within the next 72 hours, a particular
thing (including a document) at the premises that
may afford evidence of the commission of an
offence against the Victorian provisions.
(2) If a magistrate is satisfied that there are reasonable
grounds to believe that a particular kind of thing
which may be evidence of a contravention of the
Victorian provisions is on the premises, he or she
may issue a search warrant in accordance with the
Magistrates' Court Act 1989 authorising a
specified Victorian authorised person and any
other specified person or persons—
(a) to enter the premises with any necessary
equipment; and
(b) to do all or any of the following—
(i) search for or seize;
(ii) secure against interference;
(iii) examine, inspect and make copies of, or
take extracts from—
a particular kind of thing or things specified
or described in the warrant which the
Victorian authorised person reasonably
believes to be connected with the alleged
contravention.
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(3) The search warrant must state—
(a) the offence suspected; and
(b) the premises to be searched; and
(c) a description of the thing for which the
search is to be made; and
(d) the purpose of the search and nature of the
alleged contravention; and
(e) any conditions to which the warrant is
subject; and
(f) whether entry is authorised to be made at any
time of the day or night or only during
particular hours; and
(g) that the warrant authorises entry on only one
occasion; and
(h) when the warrant ceases to have effect,
which must be no more than 7 days after it is
issued.
(4) Subject to subsection (5), a search warrant must
be issued in accordance with the Magistrates'
Court Act 1989 and must be in the form
prescribed under that Act.
(5) Despite section 78 of the Magistrates' Court Act
1989, a search warrant under this section must not
authorise a Victorian authorised person to arrest a
person.
(6) Except as provided by this Act, the rules to be
observed with respect to search warrants under the
Magistrates' Court Act 1989 extend and apply to
warrants issued under this section.
s. 37
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38 Announcement before entry on search warrant
(1) Before executing a search warrant, the Victorian
authorised person named in the warrant, or a
person assisting the Victorian authorised person,
must—
(a) announce that he or she is authorised by the
search warrant to enter the premises; and
(b) give any person at the premises an
opportunity to allow that entry.
(2) Despite subsection (1), a Victorian authorised
person, or person assisting the Victorian
authorised person, need not comply with that
subsection if he or she believes on reasonable
grounds that immediate entry to the premises is
needed to ensure—
(a) the safety of any person; or
(b) that the effective execution of the search
warrant is not frustrated.
39 Copy of search warrant to be given to occupier
If an occupier is present at the premises when a
search warrant is being executed, the Victorian
authorised person must—
(a) identify himself or herself to that person by
producing his or her identity card for
inspection; and
(b) give that person a copy of the execution copy
of the search warrant.
40 General powers of Victorian authorised persons in
relation to premises
(1) Subject to subsection (2), a Victorian authorised
person who enters premises (including a public
place) under section 35 or pursuant to a search
warrant issued under this Part has the following
powers—
s. 38
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(a) to search any part of the premises;
(b) to inspect, examine, take measures of, or
conduct tests (including by the taking of
samples) concerning any thing in or on the
premises that relates to therapeutic goods or
to vending machines;
(c) to take extracts from, and make copies of,
any documents relating to therapeutic goods
or vending machines in or on the premises;
(d) if the Victorian authorised person was only
authorised to enter the premises because the
occupier of the premises consented to the
entry, to require the occupier to—
(i) answer any questions put by that
authorised person; and
(ii) produce any books, records or
documents requested by that authorised
person; and
(e) if the Victorian authorised person was
authorised to enter the premises by a search
warrant under this Part, to require any person
in or on the premises to—
(i) answer any questions put by that
authorised person; and
(ii) produce any books, records or
documents requested by that authorised
person;
(f) to take into or onto the premises any
equipment and materials that the Victorian
authorised person requires for the purpose of
exercising powers in relation to the premises.
(2) Subsection (1) has effect subject to any terms or
conditions of a search warrant issued under
section 37.
s. 40
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41 False or misleading information
(1) A person must not, in response to a request or
requirement under section 40(1)(d) or 40(1)(e),
give information that the person knows to be false
or misleading in a material detail.
Penalty: 20 penalty units.
(2) A person must not, in response to a request or
requirement under section 40(1)(d) or 40(1)(e)
produce a document that the person knows to be
false or misleading in a material detail without—
(a) indicating the respect in which it is false or
misleading; and
(b) if practicable, providing correct information.
Penalty: 20 penalty units.
42 Protection against self-incrimination
(1) It is a reasonable excuse for a natural person to
refuse or fail to give information or do any other
thing that the person is required to do by or under
this Part, if the giving of the information or the
doing of that other thing would tend to incriminate
the person.
(2) Despite subsection (1), it is not a reasonable
excuse for a natural person to refuse or fail to
produce a document that the person is required to
produce by or under this Part, if the production of
the document would tend to incriminate the
person.
43 Receipt must be given for any thing seized
(1) A Victorian authorised person must not seize a
thing apparently in the possession or custody of a
person unless the Victorian authorised person
completes and gives to the person a receipt for the
thing seized that—
(a) identifies the thing; and
s. 41
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(b) states the name of the Victorian authorised
person and the reason why the thing is being
seized.
(2) A Victorian authorised person must leave the
receipt with, or post it to, the owner of the
premises from which the thing was seized if the
Victorian authorised person is unable to discover
the identity of—
(a) the lawful owner of a thing seized; or
(b) the person from whose custody a thing is
seized.
44 Copies of certain seized things to be given
(1) Subject to subsection (2), if a Victorian authorised
person seizes—
(a) a document; or
(b) a thing that can be readily copied; or
(c) a storage device containing information that
can be readily copied—
the Victorian authorised person, as soon as is
practicable after the seizure, must give a copy of
the thing or information to—
(d) the owner; or
(e) the person from whom the document, thing
or device was seized.
(2) Subsection (1) does not apply—
(a) to a document, thing or device moved under
section 45(2); or
(b) if the Victorian authorised person is unable
to discover the identity of the lawful owner
or person from whom any document, thing
or device is seized.
s. 44
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45 Use of equipment to examine or process things
(1) A Victorian authorised person may bring on to
any premises (including a public place) any
equipment reasonably necessary for the
examination or processing of things found at the
premises in order to determine whether they are
things that may be seized.
(2) Things referred to in subsection (1) may be moved
to another place so that the examination or
processing can be carried out in order to
determine whether they are things that may be
seized if—
(a) it is not practicable to examine or process the
things at the premises; or
(b) the occupier of the premises consents in
writing.
(3) A Victorian authorised person, or a person
assisting that authorised person, may operate
equipment already at the premises to carry out the
examination or processing of a thing found at the
premises in order to determine whether it is a
thing that may be seized, if the Victorian
authorised person or person assisting believes on
reasonable grounds that—
(a) the equipment is suitable for the examination
or processing; and
(b) the examination or processing can be carried
out without damage to the equipment or the
thing.
46 Use or seizure of electronic equipment at premises
(1) If—
(a) a thing found at a premises is or includes a
disk, tape or other information storage
device; and
s. 45
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(b) equipment at the premises may be used with
the disk, tape or other information storage
device; and
(c) an authorised person believes on reasonable
grounds that the information stored on the
disk, tape or other information storage device
is relevant to determine whether the
Victorian provisions have been
contravened—
the Victorian authorised person or a person
assisting that authorised person may operate, or
may require the occupier or an employee of the
occupier to operate, the equipment to access the
information.
(2) If a Victorian authorised person or a person
assisting that authorised person finds that a disk,
tape or other information storage device at the
premises contains information of the kind referred
to in subsection (1)(c), the Victorian authorised
person—
(a) may put the information in documentary
form and seize the documents so produced;
or
(b) may copy the information to another disk,
tape or other information storage device and
remove that disk, tape or other information
storage device from the premises; or
(c) if it is not practicable to put the information
in documentary form or to copy the
information, may seize the disk, tape or other
information storage device and the
equipment that enables the information to be
accessed.
s. 46
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(3) A Victorian authorised person or a person
assisting that authorised person must not operate
or seize equipment for the purpose referred to in
this section unless the Victorian authorised person
or person assisting believes on reasonable grounds
that the operation or seizure of the equipment can
be carried out without damage to the equipment.
47 Return of seized documents or things
(1) If a Victorian authorised person seizes a document
or other thing under this Part, he or she must take
reasonable steps to return the document or thing to
the person from whom it was seized if the reason
for its seizure no longer exists.
(2) If the document or thing has not been returned
within 3 months after it was seized, the Victorian
authorised person must take reasonable steps to
return it unless—
(a) proceedings for the purpose for which the
document or thing was kept have started
within that 3 month period and those
proceedings (including any appeal) have not
been completed; or
(b) the Magistrates' Court makes an order under
section 48 extending the period for which the
document or thing may be kept.
48 Court may extend period
(1) A Victorian authorised person may apply to the
Magistrates' Court for an extension of the period
during which the seized thing may be retained.
(2) An application under subsection (1) may be
made—
(a) within 3 months after seizing a thing; or
(b) if an extension has been granted under this
section, within that extended period.
s. 47
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(3) The Magistrates' Court may order the extension of
the period during which a seized thing may be
retained if satisfied that retention of the thing is
necessary—
(a) for the purposes of an investigation into
whether an offence has been committed; or
(b) to enable evidence of an offence to be
obtained for the purposes of a prosecution.
(4) The Magistrates' Court may adjourn an
application to enable notice of the application to
be given to any person.
49 Offence to hinder or obstruct Victorian authorised
person
A person must not, without reasonable excuse,
hinder or obstruct a Victorian authorised person
who is exercising a power under this Part.
Penalty: 60 penalty units.
50 Entry to be reported to Victorian Secretary
(1) Within 7 days after exercising a power to enter
premises under this Part, a Victorian authorised
person must report the exercise of the power to the
Victorian Secretary.
(2) The report must include all relevant details of the
entry including particulars of—
(a) the purpose, time and place of the entry; and
(b) the things done while on the premises,
including details of things seized, copies
made and extracts taken; and
(c) when the Victorian authorised person left the
premises.
s. 49
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51 Register of exercise of powers of entry
The Victorian Secretary must keep a register
containing the particulars of all reports made
under section 50.
52 Complaints about exercise of powers
(1) A person may complain to the Victorian Secretary
about the exercise of a power by a Victorian
authorised person under this Part.
(2) The Victorian Secretary must—
(a) investigate the complaint; and
(b) provide a written report to the complainant
on the results of the investigation.
Division 3—Evidential and legal proceeding matters
53 Forfeiture
(1) If a court convicts a person of an offence against
the Victorian provisions in relation to any
therapeutic goods—
(a) the court may order that the goods be
forfeited to the State; and
(b) if an order referred to in paragraph (a) is
made, the goods become the property of the
State.
(2) If goods are forfeited under an order referred to in
subsection (1), the Victorian Secretary may cause
notice of the forfeiture to be published in the
Government Gazette.
(3) Goods forfeited under an order referred to in
subsection (2) are to be disposed of in such
manner as the Victorian Secretary directs.
s. 51
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54 Conduct by officers, employees or agents
(1) If, in any proceeding under the Victorian
provisions, it is necessary to establish the state of
mind of a body corporate in relation to particular
conduct, it is sufficient to show—
(a) that the conduct was engaged in by an officer
of that body corporate within the scope of
the officer's actual or apparent authority and
the officer had that state of mind; or
(b) that the conduct was engaged in by an agent
of the body corporate and—
(i) the agent acted at the specific direction
or with the specific consent or
agreement of the body corporate; and
(ii) the agent had that state of mind; and
(iii) the body corporate was aware of the
agent's state of mind when the conduct
was engaged in.
(2) For the purposes of any proceeding under the
Victorian provisions, any conduct engaged in on
behalf of a body corporate is deemed to have been
engaged in also by the body corporate if the
conduct was engaged in by—
(a) an officer of the body corporate within the
scope of the officer's actual or apparent
authority; or
(b) any other person at the specific direction or
with the specific consent or agreement of an
officer of the body corporate, if the giving of
the direction, consent or agreement is within
the scope of the actual or apparent authority
of the officer.
(3) If, in any proceeding under the Victorian
provisions, it is necessary to establish the state of
mind of a person other than a body corporate in
s. 54
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40
relation to particular conduct, it is sufficient to
show—
(a) that the conduct was engaged in by an
employee of that person within the scope of
the employee's actual or apparent authority
and the employee had that state of mind; or
(b) that the conduct was engaged in by an agent
of the person and—
(i) the agent acted at the specific direction
or with the specific consent or
agreement of the person; and
(ii) the agent had that state of mind; and
(iii) the person was aware of the agent's
state of mind when the conduct was
engaged in.
(4) For the purposes of any proceeding under the
Victorian provisions, any conduct engaged in on
behalf of a person other than a body corporate
(the principal) is deemed to have been engaged in
also by the principal if the conduct was engaged in
by—
(a) an employee of the principal within the
scope of the employee's actual or apparent
authority; or
(b) any other person at the specific direction or
with the specific consent or agreement of an
employee of the principal, if the giving of the
direction, consent or agreement is within the
scope of the actual or apparent authority of
the employee.
(5) A reference in this section to the state of mind of a
person includes a reference to the knowledge,
intention, opinion, belief or purpose of the person
and the person's reasons for the intention, opinion,
belief or purpose.
s. 54
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55 Offences by bodies corporate
(1) If a body corporate contravenes any provision of
the Victorian provisions, each officer of the body
corporate is taken to have contravened the same
provision if the officer knowingly authorised or
permitted the contravention.
(2) A person may be proceeded against and convicted
under a provision in accordance with subsection
(1) whether or not the body corporate has been
proceeded against under that provision.
(3) Nothing in this section affects any liability
imposed on a body corporate for an offence
committed by the body corporate against the
Victorian provisions.
56 Actions by firms and unincorporated association
If the Victorian provisions provide that a person,
being a firm or an unincorporated association, is
guilty of an offence, that reference to the person—
(a) in the case of a partnership, is to be read as a
reference to each member of the partnership;
and
(b) in the case of any other unincorporated body,
is to be read as a reference to each member
of the committee of management of the
body.
__________________
s. 55
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Part 9—General
Therapeutic Goods (Victoria) Act 2010
No. 25 of 2010
42
PART 9—GENERAL
57 Regulations
(1) The Governor in Council may make regulations
for or with respect to—
(a) prohibiting or regulating the supply of
therapeutic goods of a specified class or
classes;
(b) the inspection of premises, stocks, books,
documents and records;
(c) prohibiting the supply of therapeutic goods
by prescribed self-service methods;
(d) providing for the disposal of things seized
under the Victorian provisions;
(e) prescribing penalties not exceeding
20 penalty units for any contravention of the
regulations;
(f) any other matter or thing required or
permitted by this Act to be prescribed or
necessary to be prescribed to give effect to
this Act.
(2) The regulations may—
(a) be of general or limited application;
(b) differ according to differences in time, place
or circumstance;
(c) apply, adopt or incorporate by reference any
document formulated or published by a
person or body, either—
(i) without modification or as modified by
the regulations; or
(ii) as formulated or published on or before
the date when the regulations are made;
or
s. 57
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(iii) as formulated or published from time to
time;
(d) confer a discretionary authority or impose a
duty on a specified person or class of
persons.
58 Transitional provisions
(1) On and from the commencement of section 59, a
person authorised by the Victorian Secretary
under section 7 of the Therapeutic Goods
(Victoria) Act 1994 is taken to be an authorised
person within the meaning of this Act.
(2) Despite the repeal of the Therapeutic Goods
(Victoria) Act 1994 an order made by the
Minister under section 9 of that Act and in force
immediately before its repeal is taken to be an
order made under section 19.
(3) Despite the repeal of the Therapeutic Goods
(Victoria) Act 1994 a written consent under
section 16 or section 17 of that Act and in force
immediately before its repeal is taken to be—
(a) in the case of a written consent under
section 16 of that Act, a written consent
under section 20;
(b) in the case of a written consent under
section 17 of that Act, a written consent
under section 21.
__________________
s. 58
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Part 10—Repeals and Consequential Amendments
Therapeutic Goods (Victoria) Act 2010
No. 25 of 2010
44
PART 10—REPEALS AND CONSEQUENTIAL
AMENDMENTS
59 Repeal of Therapeutic Goods (Victoria) Act 1994
The Therapeutic Goods (Victoria) Act 1994 is
repealed.
60 Repeal of Part 10
This Part is repealed on 1 February 2012.
Note
The repeal of this Part of this Act does not affect the continuing
operation of the amendments made by it (see section 15(1) of the
Interpretation of Legislation Act 1984).
═══════════════
See:
Act No.
79/1994.
Reprint No. 1
as at
11 May 1999
and
amending
Act Nos
67/2001,
74/2004,
46/2008 and
7/2009.
LawToday:
www.
legislation.
vic.gov.au
s. 59
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45
ENDNOTES
† Minister's second reading speech—
Legislative Assembly: 25 March 2010
Legislative Council: 15 April 2010
The long title for the Bill for this Act was "A Bill for an Act to repeal the
Therapeutic Goods (Victoria) Act 1994, to provide for the application
of the Therapeutic Goods Act 1989 of the Commonwealth as a law of
Victoria, to provide for continued controls over therapeutic goods not
covered by the Commonwealth Act and for other purposes."
Endnotes
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INDEX
Subject Section
Actapplied provisions (def.) 3
commencement 2
Crown bound by 5
definitions in Commonwealth Act 4
purposes 1
regulations 57
repeal of Part 10 60
repeal of Therapeutic Goods (Victoria) Act 1994 59
transitional provisions 58
Authorised persons
authorisation 31
complaints against 52
definition 3
identity cards 32, 33
obstruction, hindrance of 49
reports of entry 50
search, seizure powers 35–40, 43–48
subject to Victorian Secretary's direction 34
Victorian authorised persons (def.) 3
Bodies corporate 54, 55
Codes of Practice
approval 22
availability 26, 29
commencement 25
definition 3
disallowance 28
laid before Parliament 27
liability 29
making 24
review by VCAT 30
status 23
Commonwealth Act (def.) 3
Commonwealth administrative laws
application to applied provisions 14
conferral of functions, powers under 15
definition 3
Commonwealth Minister 3, 8, 12
Commonwealth Secretary 3, 9, 10, 12
Commonwealth therapeutic goods laws
application of Commonwealth criminal laws 16, 17
application to Victoria 6
appointment of persons under 13
conferral of functions, powers regarding 17
definition 3
functions, powers of persons appointed under 11
interpretation 7
no double jeopardy 18
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Subject Section
Definitions 3, 4
Exempt goods 3, 19
Forfeiture 53
Listed goods (def.) 3
Manufacturers' licences (def.) 3
Minister
powers regarding
Codes of Practice 22, 25, 27
exemption of persons, goods 19
Occupiers 35, 36, 39, 40, 45,
46
Offences and penalties
against applied provisions 16, 18
by bodies corporate 55
by firms, unincorporated associations 56
false, misleading information 41
hawking of therapeutic goods 20
hindrance, obstruction of Victorian authorised
persons 49
no double jeopardy 18
supply by vending machine 21
Premises 3, 40
Registered goods (def.) 3
Regulations 6, 57
Search, seizure
entry with or without consent 35, 36
general powers on entry 40
reports, register of entry 50, 51
return of seized documents, things 47
search warrants 37–39
seizure 43, 44, 46–48
use of equipment 45, 46
Self-incrimination
protection from 42
Sell (def.) 3
Supply 3, 20, 21
Supply by wholesale (def.) 3
Therapeutic devices (def.) 3
Therapeutic goods (def.) 3
Therapeutic use (def.) 3
Transitional provisions 58
VCAT 30
Vending machines 21, 40
Victorian authorised persons See Authorised persons
Victorian Secretary
definition 3
powers, duties regarding
authorised persons 31, 32, 34, 51, 52
Codes of Practice 22, 24, 26
notice, disposal of forfeited goods 53
supply of therapeutic goods 20, 21
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