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This is a Bill, not an Act. For current law, see the Acts databases.
Western Australia
Therapeutic Goods (Western Australia) Bill
1999
CONTENTS
Part 1 -- Preliminary
1. Purpose 2
2. Commencement 2
3. Definitions 2
4. Definitions in Commonwealth Act 9
5. Interpretation 10
6. Act to bind Crown 11
7. Authorised persons 11
8. Secretary may approve or authorise the supply of
certain therapeutic goods 11
9. Power of Minister to exempt 13
10 . Kits 14
11 . Power to obtain information with respect to
therapeutic goods 14
Part 2 -- Standards
12 . Compliance with standards 16
13 . Consent may be subject to conditions etc. 16
Part 3 -- Australian Register of Therapeutic
Goods
Division 1 -- Preliminary
14 . Offences by sponsors 17
15 . Offence relating to supply of unregistered or unlisted
goods 17
16 . Hawking of therapeutic goods 18
17 . Supply by vending machine 18
page i
88--1
Therapeutic Goods (Western Australia) Bill 1999
Contents
18 . General offences relating to this Part 19
19 . False statements in applications for registration 21
Division 2 -- Registration and Listing
20 . Applications generally 21
21 . Applications for registration 22
22 . When evaluation fee due for payment 23
23 . Payment of evaluation fee by instalments 23
24 . Recovery of evaluation fee 23
25 . Reduction of evaluation fee where evaluation not
completed within prescribed period 23
26 . Deemed refusal of application 24
27 . Evaluation of therapeutic goods 25
28 . Listing of therapeutic goods 27
29 . Registration or listing number 28
30 . Conditions on registration or listing 28
31 . Duration of registration or listing 30
32 . Notification of adverse effects etc. of goods 30
33 . Notification of adverse effects etc. where application
withdrawn or lapses 31
34 . Cancellation of registration or listing 31
Division 3 -- General
35 . Secretary may require information 34
36 . Inspection and variation of entries in Register 36
37 . Publication of list of goods on Register 37
Part 4 -- Manufacturing of Therapeutic
Goods
38 . Offences relating to manufacturing and licences 38
39 . Application for licence 38
40 . Grant of licence 39
41 . Term of licence 41
42 . Conditions of licences 41
43 . Revocation and suspension of licences 43
44 . Publication of list of manufacturers etc 44
Part 5 -- Licences to Supply by Wholesale
45 . Definition and application of Part 45
46 . Offences relating to supply by wholesale and licences 45
47 . Application for licence 46
page ii
Therapeutic Goods (Western Australia) Bill 1999
Contents
48 . Grant of licence 47
49 . Term of licence 48
50 . Renewal of licence 48
51 . Conditions of licences 49
52 . Revocation and suspension of licences 50
53 . Publication of list of wholesale suppliers 52
Part 6 -- Payment of Charges
54 . By whom charges payable 53
55 . Time for payment of charges 53
56 . Recovery of charges 54
Part 7 -- Miscellaneous
57 . Monitoring compliance with Act 55
58 . Entry and search of premises-evidence of offences 55
59 . General powers of authorised persons in relation to
premises 57
60 . Monitoring warrants 58
61 . Offence related warrants 59
62 . Identity cards 60
63 . Offences 61
64 . Evidentiary certificate of Commissioner of Health 61
65 . Evidentiary certificates of the Secretary 62
66 . Conduct by directors, servants and agents 62
67 . Judicial notice 64
68 . Delegation 64
69 . Offences under this Act and the Commonwealth Act 64
70 . Review of decisions excluding decisions under Part 5 65
71 . Review by Supreme Court 65
72 . Regulations 65
Part 8 -- Consequential Amemndments and
Transitional Provisions
73 . Amendments to the Health Act 1911 67
74 . Amendments to the Poisons Act 1964 67
75 . Transitional arrangements for Part 4 67
76 . Transitional arrangements for Part 5 68
77 . Transitional arrangements for goods required to be
registered or listed 69
page iii
Western Australia
LEGISLATIVE ASSEMBLY
(Introduced by Ms McHale, MLA)
Therapeutic Goods (Western Australia) Bill
1999
A Bill for
An Act to make provision for the implementation in Western Australia of
controls relating to Western Australian therapeutic goods complementary
to the provision made by the Therapeutic Goods Act 1989 of the
Commonwealth.
The Parliament of Western Australia enacts as follows:
page 1
Therapeutic Goods (Western Australia) Bill 1999
Part 1 Preliminary
s. 1
Part 1 -- Preliminary
1. Purpose
The purpose of this Act is to promote and facilitate the
development of a national system of controls relating to the
5 quality, safety, efficacy and timely availability of therapeutic
goods, and for that purpose, to make provision for the
implementation in Western Australia of controls relating to
Western Australian therapeutic goods complementary to the
provision made by the Therapeutic Goods Act 1989 of the
10 Commonwealth.
2. Commencement
(1) Section 1 and this section come into operation on the day on
which this Act receives the Royal Assent.
(2) Subject to sub-sections (3) and (4), the remaining provisions of
15 this Act come into operation on a day or days to be proclaimed.
(3) If a provision referred to in sub-section (2) (other than section
16, 17 or Part 5) does not come into operation within the period
of 6 months beginning on, and including, the day on which this
Act receives the Royal Assent, it comes into operation on the
20 first day after the end of that period.
(4) If section 16, 17 or Part 5 of this Act do not come into operation
within the period of 12 months beginning on, and including, the
day on which this Act receives the Royal Assent, those
provisions come into operation on the first day after the end of
25 that period.
3. Definitions
In this Act --
"advertisement", in relation to therapeutic goods, includes any
statement, pictorial representation or design, however
page 2
Therapeutic Goods (Western Australia) Bill 1999
Preliminary Part 1
s. 3
made, that is intended, whether directly or indirectly, to
promote the use or supply of the goods;
"annual licensing charge" means an amount equal to the
amount of the charge payable by the holder of the licence
5 to which the charge relates under Part 5 of the
Commonwealth Act;
"annual listing charge" means an amount equal to the amount
of the charge payable by a person in relation to whom
therapeutic goods are listed under Part 5 of the
10 Commonwealth Act;
"annual registration charge" means an amount equal to the
amount of the charge payable by a person in relation to
whom therapeutic goods are registered under Part 5 of the
Commonwealth Act;
15 "authorised person" means --
(a) in relation to any provision of this Act --
(i) a person authorised by the Commissioner of
Health or
(ii) an authorised person within the meaning of
20 paragraph (a) of the definition of "authorised
person" in the Commonwealth Act; or
(b) in relation to a provision of Part 7 --
(i) a member of the police force of Western
Australia; or
25 (ii) a member of the Australian Federal Police;
"British Pharmacopoeia" has the same meaning as in the
Commonwealth Act;
"British Pharmacopoeia (Veterinary)" has the same meaning
as in the Commonwealth Act;
30 "Commissioner of Health" means the Commissioner of Health
referred to in the Health Legislation Administration Act
1984.
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Therapeutic Goods (Western Australia) Bill 1999
Part 1 Preliminary
s. 3
"Commonwealth Act" means the Therapeutic Goods Act 1989
of the Commonwealth;
"Commonwealth Department" means the Department of
Human Services and Health or such other Department of
5 the Commonwealth as is the relevant Department for the
purposes of the Commonwealth Act;
"Commonwealth Minister" means the Minister administering
the Commonwealth Act;
"Commonwealth regulations" means the regulations for the
10 time being in force under the Commonwealth Act;
"data processing device" means any article or material (for
example, a disc) from which information is capable of
being reproduced with or without the aid of any other
article or device;
15 "directions for use", in relation to therapeutic goods, includes
information on --
(a) appropriate doses of the goods; and
(b) the method of administration or use of the goods; and
(c) the frequency and duration of treatment for each
20 indication of the goods; and
(d) the use of the goods by persons of particular ages or
by persons having particular medical conditions;
"exempt goods" --
(a) in relation to a provision of Part 3, means therapeutic
25 goods that are exempt from the operation of Part 3 of
the Commonwealth Act;
(b) in relation to a provision of Part 4, means therapeutic
goods that are exempt from the operation of Part 4 of
the Commonwealth Act;
30 (c) in relation to any provision of this Act, means
therapeutic goods that are exempt for the purposes of
that provision because of an Order under section 9 of
this Act where the goods are used, advertised or
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Therapeutic Goods (Western Australia) Bill 1999
Preliminary Part 1
s. 3
presented for supply in the way specified in the
Order;
"exempt person", in relation to therapeutic goods, means --
(a) a person exempt from the operation of Part 4 of the
5 Commonwealth Act in relation to those goods; or
(b) in relation to a provision of this Act, a person exempt
from that provision because of an Order under
section 9;
"indications", in relation to therapeutic goods, means the
10 specific therapeutic uses of the goods;
"label", in relation to therapeutic goods, means a display of
printed information --
(a) on or attached to the goods;
(b) on or attached to a container or primary pack in
15 which the goods are supplied; or
(c) supplied with such a container or pack;
"licence" means a licence under Part 4 or Part 5;
"listable devices" means therapeutic devices that are required
under this Act or the Commonwealth Act to be included in
20 the part of the Register for listed goods;
"listed goods" means therapeutic goods that are included in the
part of the Register for goods known as listed goods;
"listing number", in relation to listed goods, means any
combination of numbers, symbols and letters assigned to
25 the goods under section 29 of this Act or section 27 of the
Commonwealth Act;
"manufacture", in relation to therapeutic goods, means --
(a) to produce the goods; or
(b) to engage in any part of the process of producing the
30 goods or of bringing the goods to their final state,
including engaging in the processing, assembling,
packaging, labelling, storage, sterilising, testing or
page 5
Therapeutic Goods (Western Australia) Bill 1999
Part 1 Preliminary
s. 3
releasing for supply of the goods or of any
component or ingredient of the goods as part of that
process;
"manufacturing premises" means premises (including
5 premises that comprise 2 or more sites) --
(a) that are for use in the manufacture of a particular kind
of therapeutic goods; and
(b) at which the same persons have control of the
management of the production of the goods and the
10 procedures for quality control;
"manufacturing principles" means the principles for the time
being having effect under section 36 of the Commonwealth
Act;
"premises" includes --
15 (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);
"presentation", in relation to therapeutic goods, means the way
in which the goods are presented for supply, and includes
20 matters relating to the name of the goods, the labelling and
packaging of the goods and any advertising or other
informational material associated with the goods;
"primary pack", in relation to therapeutic goods, means the
complete pack in which the goods, or the goods and their
25 container, are to be supplied to consumers;
"quality", in relation to therapeutic goods, includes the
composition, strength, potency, stability, sterility, purity,
bioburden, design, construction and performance
characteristics of the goods;
30 "Register" means the Australian Register of Therapeutic Goods
maintained under section 17 of the Commonwealth Act;
"registered goods" means therapeutic goods included in the
part of the Register for goods known as registered goods;
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Therapeutic Goods (Western Australia) Bill 1999
Preliminary Part 1
s. 3
"registration number", in relation to registered goods, means
any combination of numbers, symbols and letters assigned
to the goods under section 29 of this Act or under
section 27 of the Commonwealth Act;
5 "Secretary" means the Secretary to the Commonwealth
Department;
"sponsor", in relation to therapeutic goods, means a person
who, in Western Australia, manufactures the goods, or
arranges for another person to manufacture the goods, for
10 supply (whether in Western Australia or elsewhere) but
does not include a person who --
(a) manufactures the goods; or
(b) arranges the manufacture of the goods,
on behalf of another person who, at the time of the
15 manufacture or arrangements, is a resident of, or is carrying
on business in, Western Australia;
"standard", in relation to therapeutic goods, means a standard
that --
(a) is specified in an order under section 10 of the
20 Commonwealth Act that is applicable to the goods in
accordance with section 13 of that Act; or
(b) if no such order is so applicable to the goods but the
goods are the subject of a monograph in --
(i) in the case of goods for use in humans, the
25 British Pharmacopoeia; or
(ii) in the case of goods for use in animals, the
British Pharmacopoeia (Veterinary),
is constituted by the statements in that monograph;
"supply" includes --
30 (a) supply by way of sale, exchange, gift, lease, loan,
hire or hire-purchase; and
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Therapeutic Goods (Western Australia) Bill 1999
Part 1 Preliminary
s. 3
(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 of therapeutic
5 goods in persons or animals; and
(d) supply by way of administration to, or application in
the treatment of, a person or animal;
"therapeutic device" means therapeutic goods consisting of an
instrument, apparatus, appliance, material or other article
10 (whether for use alone or in combination), together with
any accessories or software required for its proper
functioning, which does not achieve its principal intended
action by pharmacological, chemical, immunological or
metabolic means though it may be assisted in its function
15 by such means, but the expression does not include
therapeutic goods declared under the Commonwealth Act
not to be therapeutic devices;
"therapeutic goods" means goods --
(a) that are represented in any way to be, or that are,
20 whether because of the way in which the goods are
presented or for any other reason, likely to be taken
to be --
(i) for therapeutic use; or
(ii) for use as an ingredient or component in the
25 manufacture of therapeutic goods; or
(iii) for use as a container or part of a container for
goods of the kind referred to in sub-paragraph
(i) or (ii); or
(b) included in a class of goods the sole or principal use
30 of which is, or ordinarily is, a therapeutic use or a use
of a kind referred to in paragraph (a)(ii) or (iii);
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Therapeutic Goods (Western Australia) Bill 1999
Preliminary Part 1
s. 4
and includes goods declared to be therapeutic goods under
an order in force under section 7 of the Commonwealth
Act, but does not include --
(c) goods declared not to be therapeutic goods under an
5 order in force under that section or under an Order
under section 9 of this Act; or
(d) goods in respect of which such an order is in force,
being an order that declares the goods not to be
therapeutic goods when used, advertised or presented
10 for supply in the way specified in the order where the
goods are used, advertised or presented for supply in
that way; or
(e) foods;
"therapeutic use" means use in or in connection with --
15 (a) preventing, diagnosing, curing or alleviating a
disease, ailment, defect or injury in persons or
animals; or
(b) influencing, inhibiting or modifying a physiological
process in persons or animals; or
20 (c) testing the susceptibility of persons or animals to a
disease or ailment; or
(d) influencing, controlling or preventing conception in
persons; or
(e) testing for pregnancy in persons; or
25 (f) the replacement or modification of parts of the
anatomy in persons or animals.
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
30 Commonwealth Act.
(2) Subsection (1) does not apply to the extent that the context or
subject-matter otherwise indicates or requires.
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Therapeutic Goods (Western Australia) Bill 1999
Part 1 Preliminary
s. 5
5. Interpretation
(1) For the purposes of this Act --
(a) therapeutic goods are to be taken to be for use in
animals if --
5 (i) the goods bear a name or description that
indicates, or is likely to give the impression, that
the goods are intended for use in animals and are
not intended for use in humans; or
(ii) the goods are otherwise represented, or otherwise
10 purport, to be intended for use in animals and not
intended for use in humans; and
(b) therapeutic goods are to be taken to be for use in
humans if they are not solely for use in animals.
(2) The Commissioner of Health must, at least once in each year,
15 cause to be published in the Government Gazette a list of the
names of all persons who are, at the time of publication, persons
authorised by the Commissioner of Health as authorised persons
for the purposes of this Act.
(3) The provisions of this Act are in addition to, and not in
20 substitution for, the provisions of any other Act that relate to
therapeutic goods.
(4) For the purposes of this Act, the presentation of therapeutic
goods is unacceptable if it is capable of being misleading or
confusing as to the content or proper use of the goods and,
25 without limiting the previous words in this subsection, the
presentation of therapeutic goods is unacceptable --
(a) if it states or suggests that the goods have ingredients,
components or characteristics that they do not have; or
(b) if a name applied to the goods is the same as the name
30 applied to other therapeutic goods that are supplied in
Western Australia where those other goods contain
page 10
Therapeutic Goods (Western Australia) Bill 1999
Preliminary Part 1
s. 6
additional or different therapeutically active ingredients;
or
(c) if the label of the goods does not declare the presence of
a therapeutically active ingredient; or
5 (d) if a form of presentation of the goods may lead to unsafe
use of the goods or suggests a purpose that is not in
accordance with conditions applicable to the supply of
the goods in Western Australia; or
(e) in prescribed cases.
10 6. Act to bind Crown
This Act binds the Crown not only in right of Western Australia
but also, so far as the legislative power of the Parliament
permits, the Crown in all its other capacities.
7. Authorised persons
15 The Commissioner of Health may, in writing, authorise any of
the following persons to exercise powers under a specified
provision of this Act --
(a) an employee in the public service;
(b) an officer of the Commonwealth Department or of
20 another Department of the Commonwealth or of an
authority of the Commonwealth, being a Department or
authority that has functions relating to health matters or
law enforcement matters.
8. Secretary may approve or authorise the supply of certain
25 therapeutic goods
(1) The Secretary may, by notice in writing, grant an approval to a
person to supply specified therapeutic goods that are not either
exempt goods or goods included in the Register --
(a) for use in the treatment of another person; or
30 (b) for use solely for experimental purposes in humans.
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Therapeutic Goods (Western Australia) Bill 1999
Part 1 Preliminary
s. 8
(2) An approval under subsection (1) --
(a) is subject to the conditions specified in the approval; and
(b) may include a condition relating to the charges that may
be made for the supply of the therapeutic goods to which
5 the approval relates.
(3) An application for an approval must be made to the Secretary
and --
(a) in the case of an application for use of the kind referred
to in subsection (1)(a), must be accompanied by such
10 information relating to the goods that the Secretary
requires; and
(b) in the case of an application for use of the kind referred
to in subsection (1)(b) --
(i) must be made in writing; and
15 (ii) must be accompanied by such information
relating to the goods that the Secretary requires;
and
(iii) must be accompanied by a fee which is an
amount equal to the evaluation fee prescribed for
20 the purposes of section 19(2)(b)(iii) of the
Commonwealth Act.
(4) If an application for an approval is made, the Secretary must
notify the applicant of his or her decision on the application
within 28 days of making the decision and, in the case of a
25 decision not to grant the approval, of the reasons for the
decision.
(5) The Secretary may, in writing, authorise an approved medical
practitioner to supply --
(a) specified therapeutic goods for use in the treatment of
30 humans; or
(b) a specified class of such goods,
page 12
Therapeutic Goods (Western Australia) Bill 1999
Preliminary Part 1
s. 9
to the class or classes of recipients specified in the authority,
being a class or classes of recipients to whom therapeutic goods
of that kind may be supplied in accordance with an authority
under section 19(5) of the Commonwealth Act.
5 (6) An authority given under subsection (5) may authorise supply in
the same circumstances as the circumstances in which the
holder of an authority under section 19(5) of the
Commonwealth Act may supply therapeutic goods.
(7) In this section, "approved medical practitioner" means a
10 registered medical practitioner of a class eligible to be given an
authority under section 19(5) of the Commonwealth Act.
(8) The giving of an approval under subsection (1) or an authority
under sub-section (5) does not render the State, the Secretary or
a delegate of the Secretary liable to a person in respect of loss,
15 damage or injury of any kind suffered by a person as a result of,
or arising out of, the use of therapeutic goods by that person or
another person.
9. Power of Minister to exempt
(1) The Minister may, by Order published in the Government
20 Gazette --
(a) exempt --
(i) any person or class of persons; or
(ii) any goods or class of goods,
specified in the Order from all provisions of this Act, or
25 from such provisions of this Act as are specified in the
Order; or
(b) declare that goods are exempt goods for the purposes of
a provision of this Act when those goods are used,
advertised or presented for supply in the way specified
30 in the Order.
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Therapeutic Goods (Western Australia) Bill 1999
Part 1 Preliminary
s. 10
(2) An Order under subsection (1) is subject to such conditions, if
any, as are specified in the Order.
10. Kits
(1) A package and therapeutic goods in the package together
5 constitute a kit for the purposes of this Act if --
(a) the package and the therapeutic goods are for use as a
unit; and
(b) each item of the therapeutic goods consists of goods that
are registered or listed or are exempt goods in relation to
10 Part 3 of the Commonwealth Act; and
(c) the package and therapeutic goods do not constitute a
composite pack.
(2) A package and therapeutic goods in the package together
constitute a composite pack if --
15 (a) the therapeutic goods are of 2 or more kinds; and
(b) the package does not contain any therapeutic devices;
and
(c) the therapeutic goods are for administration as a single
treatment or as a single course of treatment; and
20 (d) it is necessary that the therapeutic goods be combined
before administration or that they be administered in a
particular sequence.
(3) To avoid doubt, it is declared that a kit constitutes therapeutic
goods.
25 11. Power to obtain information with respect to therapeutic
goods
(1) The Secretary may, by notice in writing given to a person who
has supplied in Western Australia --
(a) therapeutic goods; or
page 14
Therapeutic Goods (Western Australia) Bill 1999
Preliminary Part 1
s. 11
(b) goods in relation to which the Secretary is considering
making a declaration under section 7 of the
Commonwealth Act,
request the person to give to an officer of the Commonwealth
5 Department identified in the notice, within such reasonable
period as is specified in the notice, information required by the
notice concerning the composition, indications, directions for
use or labelling of the goods or concerning advertising material
relating to the goods.
10 (2) A notice under subsection (1) may require the information to be
given --
(a) in writing; or
(b) in accordance with specified software requirements --
(i) on a specified kind of data processing device; or
15 (ii) by way of a specified kind of electronic
transmission.
(3) A person must not, without reasonable excuse, fail to comply
with a notice given to the person under this section.
(4) A person must not, in purported compliance with a notice under
20 this section, knowingly or recklessly provide information that is
false or misleading in a material particular.
Penalty: $6 000.
page 15
Therapeutic Goods (Western Australia) Bill 1999
Part 2 Standards
s. 12
Part 2 -- Standards
12. Compliance with standards
(1) Except with the consent in writing of the Secretary under this
section or section 14 of the Commonwealth Act, a person must
5 not supply therapeutic goods for use in Western Australia if the
goods do not conform with a standard applicable to the goods.
Penalty: $24 000.
(2) The Secretary must, as soon as practicable after making a
decision to give a consent under this section, cause particulars
10 of the decision to be published in the Commonwealth of
Australia Gazette.
(3) The Secretary must, within 28 days after making a decision to
refuse to give a consent under this section, notify the applicant
in writing of the decision and of the reasons for the decision.
15 13. Consent may be subject to conditions etc.
(1) The consent of the Secretary under section 12 may be given --
(a) unconditionally or subject to conditions; or
(b) in respect of particular goods or classes of goods.
(2) Where a person breaches a condition of such a consent, the
20 person is guilty of an offence.
Penalty: $12 000.
page 16
Therapeutic Goods (Western Australia) Bill 1999
Australian Register of Therapeutic Part 3
Preliminary Division 1
s. 14
Part 3 -- Australian Register of Therapeutic Goods
Division 1 -- Preliminary
14. Offences by sponsors
(1) A person who is the sponsor of therapeutic goods must not
5 knowingly or recklessly --
(a) manufacture the goods for supply in Western Australia
for use in humans; or
(b) supply the goods in Western Australia for use in
humans,
10 unless --
(c) the goods are registered goods or listed goods in relation
to the person; or
(d) the goods are exempt goods or are the subject of an
approval or authority under section 19 of the
15 Commonwealth Act or an approval or authority under
section 8 of this Act.
Penalty: $24 000.
(2) A person in relation to whom therapeutic goods are registered or
listed must not knowingly or recklessly supply those goods in
20 Western Australia unless --
(a) the registration number or listing number of the goods is
set out on the label of the goods in the manner
prescribed under the Commonwealth Act; or
(b) the goods are devices that are listed goods.
25 Penalty: $6 000.
15. Offence relating to supply of unregistered or unlisted goods
A person must not knowingly or recklessly supply in Western
Australia therapeutic goods for use in humans (other than
page 17
Therapeutic Goods (Western Australia) Bill 1999
Part 3 Australian Register of Therapeutic
Division 1 Preliminary
s. 16
listable devices), being goods of which the person is not a
sponsor, to another person unless --
(a) the goods are registered goods or listed goods; or
(b) the goods are exempt goods or are the subject of an
5 approval or authority under section 19 of the
Commonwealth Act or an approval or authority under
section 8 of this Act.
Penalty: $12 000.
16. Hawking of therapeutic goods
10 (1) A person must not, without the written consent of the
Commissioner of Health, supply therapeutic goods in a street or
from house to house.
Penalty: $1 000.
(2) Subsection (1) does not apply to the supply by free distribution
15 of clinical samples of therapeutic goods to a registered medical
practitioner, pharmacist, 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
20 practitioner, pharmacist, dentist or veterinary
practitioner personally or by post in a letter or parcel
addressed to him or her.
17. Supply by vending machine
(1) A person must not, without the written consent of the
25 Commissioner of Health, whether in premises under his or her
control or elsewhere --
(a) install a vending machine for the supply of therapeutic
goods; or
(b) supply therapeutic goods by means of a vending
30 machine.
Penalty: $1 000.
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Therapeutic Goods (Western Australia) Bill 1999
Australian Register of Therapeutic Part 3
Preliminary Division 1
s. 18
(2) A person must not, without the written consent of the
Commissioner of Health, permit a vending machine for the
supply of therapeutic goods to be installed on premises owned
or occupied by him or her.
5 Penalty: $1 000.
(3) A person must not, without the written consent of the
Commissioner of Health, permit therapeutic goods to be placed
in a vending machine under his or her control.
Penalty: $1 000.
10 18. General offences relating to this Part
(1) A person must not knowingly or recklessly set out or cause to
be set out, on a container or package that contains therapeutic
goods or on a label of goods of that kind, a number that purports
to be the registration number or listing number of the goods in
15 relation to a particular person if the number is not that number.
(2) A person must not, in or in connection with an application for
listing of therapeutic goods, knowingly or recklessly make a
statement that is false or misleading in a material particular.
(3) A person in relation to whom therapeutic goods are registered or
20 listed must not knowingly or recklessly breach a condition of
the registration or listing of the goods.
(4) A person must not knowingly or recklessly --
(a) represent therapeutic goods that are not included in the
Register as being so included; or
25 (b) represent therapeutic goods that are not exempt goods as
being exempt goods; or
(c) represent therapeutic goods that are included in one part
of the Register as being included in the other part of the
Register.
30 (5) A person, being the sponsor of therapeutic goods that are
included in the Register, must not, by any means, knowingly or
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Therapeutic Goods (Western Australia) Bill 1999
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Division 1 Preliminary
s. 18
recklessly advertise the goods for an indication other than those
accepted in relation to the inclusion of the goods in the Register.
(6) A person must not knowingly or recklessly make a claim, by
any means, that the person or another person can arrange the
5 supply of therapeutic goods (not being exempt goods) that are
not registered goods or listed goods.
(7) A person must not knowingly or recklessly breach a condition
of --
(a) an exemption applicable under regulations made for the
10 purposes of section 18(1) of the Commonwealth Act; or
(b) an approval under section 19 of the Commonwealth Act;
or
(c) an approval under section 8; or
(d) an exemption under section 9.
15 (8) A person to whom an authority under section 19(5) of the
Commonwealth Act or under section 8 of this Act has been
granted must not supply the therapeutic goods to which the
authority relates except in accordance with --
(a) the authority; and
20 (b) any regulations made for the purpose of section 19(7) of
the Commonwealth Act.
(9) A person must not knowingly or recklessly use therapeutic
goods that are not either exempt goods or goods included in the
Register --
25 (a) for use in the treatment of another person; or
(b) for use solely for experimental purposes in humans,
except in accordance with an approval or authority under
section 19 of the Commonwealth Act or under section 8 of this
Act.
30 Penalty: $6 000.
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19. False statements in applications for registration
A person must not, in or in connection with an application for
registration of therapeutic goods, knowingly or recklessly make
a statement that is false or misleading in a material particular.
5 Penalty: $40 000.
Division 2 -- Registration and Listing
20. Applications generally
(1) An application for registration or listing of therapeutic goods
must --
10 (a) be made in accordance with a form approved, in writing,
by the Secretary or in such other manner as is approved,
in writing, by the Secretary; and
(b) be delivered to an office of the Commonwealth
Department specified by the Secretary.
15 (2) An application is not effective unless --
(a) an application fee of an amount equal to the application
fee prescribed under the Commonwealth regulations in
respect of an application under section 23 of the
Commonwealth Act has been paid; and
20 (b) the applicant has delivered to the office to which the
application was made such information, in a form
approved, in writing, by the Secretary, as will allow the
determination of the application; and
(c) if the Secretary so requires, the applicant has delivered
25 to the office to which the application was made a
reasonable number of samples of the goods.
(3) An approval of a form may require or permit an application or
information to be given in accordance with specified software
requirements --
30 (a) on a specified kind of data processing device; or
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s. 21
(b) by way of a specified kind of electronic transmission.
21. Applications for registration
(1) Where an application is made for the registration of therapeutic
goods in accordance with section 20 and the goods are goods
5 that are required to be registered, a fee of an amount equal to the
fee specified in or determined in accordance with the
Commonwealth regulations in relation to an application under
section 24 of the Commonwealth Act is payable by the
applicant in respect of the evaluation of the goods for
10 registration, and the Secretary must notify each such applicant
of the amount of the evaluation fee.
(2) Subject to section 25, an application for registration of
therapeutic goods lapses if --
(a) any part of the evaluation fee payable in respect of those
15 goods remains unpaid at the end of the period of
2 months after the day on which the amount became due
and payable; or
(b) the application contains information that is inaccurate or
misleading in a material particular; or
20 (c) information given to the Secretary by, or on behalf of,
the applicant in connection with the application,
including information given for the purpose of a
requirement under section 35, is inaccurate or
misleading in a material particular; or
25 (d) the applicant fails to comply with a requirement under
section 35 to give information consisting of individual
patient data in relation to the goods.
(3) In this section, "individual patient data", in relation to
therapeutic goods, means information, derived from clinical
30 trials, relating to individuals before, during and after the
administration of the goods to those individuals, including, but
not limited to, demographic, biochemical and haematological
information.
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s. 22
22. When evaluation fee due for payment
Subject to sections 23 and 25, an evaluation fee under
section 21 payable by an applicant is due and payable on the
day on which the applicant is notified of the amount of the
5 evaluation fee.
23. Payment of evaluation fee by instalments
(1) If the Commonwealth regulations provide for the payment of an
evaluation fee to be made by instalments under section 24B of
the Commonwealth Act, the evaluation fee under section 21 of
10 this Act may be made by such instalments and at such times as
are ascertained in accordance with those Commonwealth
regulations, and the evaluation fee is due and payable
accordingly.
(2) If the Commonwealth regulations referred to in subsection (1)
15 provide that a person is not allowed to pay an evaluation fee by
instalments if any part of an instalment of that or any other
evaluation fee payable by the person was unpaid immediately
after the time when it became due for payment, a person is not
allowed to pay an evaluation fee under section 21 in
20 circumstances of that kind by instalments.
(3) Subsection (2) does not limit the generality of subsection (1).
24. Recovery of evaluation fee
An evaluation fee under section 21 may be recovered by the
Commonwealth as a debt due to the Commonwealth.
25 25. Reduction of evaluation fee where evaluation not completed
within prescribed period
(1) This section applies to an application under section 20 in
relation to therapeutic goods for the evaluation of which a
period is prescribed under section 63(2)(da) of the
30 Commonwealth Act.
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(2) Nothing in section 21, 22 or 23 requires the applicant to pay
more than three-quarters of the evaluation fee before the
completion of the evaluation of the goods.
(3) If the evaluation is not completed within the period referred to
5 in subsection (1), this Act has effect as if the evaluation fee
were reduced to three-quarters of the fee that, under the
Commonwealth regulations in relation to an application under
section 24 of the Commonwealth Act, would have been the
evaluation fee.
10 (4) If --
(a) the evaluation is completed within the period referred to
in subsection (1); and
(b) part of the evaluation fee under section 21 is unpaid
when the evaluation is completed,
15 that part becomes due and payable on the completion of the
evaluation.
(5) For the purposes of subsections (2), (3) and (4), the evaluation is
to be taken to be completed when the applicant is notified
according to section 27(5) of the Secretary's decision on the
20 application.
26. Deemed refusal of application
(1) This section applies in the case of an application under
section 20 in relation to therapeutic goods for the evaluation of
which a period is prescribed under section 63(2)(da) of the
25 Commonwealth Act.
(2) If, at the end of the period referred to in subsection (1), the
evaluation has not been completed, the applicant may give the
Secretary written notice that the applicant wishes to treat the
application as having been refused.
30 (3) A notice under subsection (2) may be given at any time before
the evaluation is completed.
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Therapeutic Goods (Western Australia) Bill 1999
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(4) If a notice has been given, this Act has effect as if the Secretary
had decided not to register the goods the subject of the
application.
27. Evaluation of therapeutic goods
5 (1) Where --
(a) an application is made for the registration of therapeutic
goods in relation to a person in accordance with section
20; and
(b) there is no part of an evaluation fee under section 21 in
10 respect of those goods that --
(i) is due and payable by the person; and
(ii) remains unpaid; and
(c) the person has complied with any requirements made by
the Secretary under section 35 in relation to the goods,
15 the goods are to be evaluated for registration having regard
to --
(d) whether the quality, safety and efficacy of the goods for
the purposes for which they are to be used have been
satisfactorily established; and
20 (e) whether the presentation of the goods is acceptable; and
(f) whether the goods conform to any standard applicable to
the goods, or any requirements relating to advertising
applicable to goods of that kind under the
Commonwealth regulations; and
25 (g) if the goods have been manufactured in Western
Australia, whether the goods have been manufactured in
accordance with Part 4 of the Commonwealth Act; and
(h) whether the goods contain substances that are prohibited
imports for the purposes of the Customs Act 1901 of the
30 Commonwealth; and
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Therapeutic Goods (Western Australia) Bill 1999
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s. 27
(i) such other matters (if any) as the Secretary considers
relevant.
(2) An evaluation under this section of goods in relation to which a
period has been prescribed under section 63(2)(da) of the
5 Commonwealth Act must be completed within that period.
(3) If therapeutic goods are exempt from the operation of Part 4 of
the Commonwealth Act or a person is exempt from the
operation of that Part in relation to the manufacture of the
goods, subsection (1) has effect, in relation to the goods, as if
10 paragraph (g) were omitted.
(4) If a person is exempt from the operation of Part 4 of the
Commonwealth Act in relation to a step in the manufacture of
therapeutic goods, subsection (1) has effect, in relation to the
goods, as if the reference in paragraph (g) to Part 4 were a
15 reference to that Part to the extent that it applies to that person
in relation to the manufacture of the goods.
(5) After therapeutic goods have been evaluated for registration, the
Secretary must --
(a) notify the applicant in writing of his or her decision on
20 the evaluation within 28 days of the making of the
decision and, in the case of a decision not to register the
goods, of the reasons for the decision; and
(b) if the decision is to register the goods, include the goods
in the Register and give the applicant a certificate of
25 registration.
(6) The registration of therapeutic goods commences on the day
specified for the purpose in the certificate of registration.
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28. Listing of therapeutic goods
(1) Where --
(a) an application is made for the listing of therapeutic
goods in relation to a person in accordance with
5 section 20; and
(b) the person has complied with any requirements made by
the Secretary under section 35 in relation to the goods,
the Secretary must not refuse to list the goods in relation to the
person unless the Secretary is satisfied that --
10 (c) the goods are not eligible for listing; or
(d) the goods are not safe for the purposes for which they
are to be used; or
(e) the presentation of the goods is unacceptable; or
(f) the goods do not conform to a standard applicable to the
15 goods or to a requirement relating to advertising
applicable to goods of that kind under the
Commonwealth regulations; or
(g) if the goods have been manufactured in Western
Australia, the goods have been manufactured contrary to
20 Part 4 of the Commonwealth Act; or
(h) the goods do not comply with quality or safety criteria
prescribed under the Commonwealth Act; or
(i) the goods contain substances that are prohibited imports
for the purposes of the Customs Act 1901 of the
25 Commonwealth.
(2) If therapeutic goods are exempt from the operation of Part 4 of
the Commonwealth Act or a person is exempt from the
operation of that Part in relation to the manufacture of the
goods, sub-section (1) has effect, in relation to the goods, as if
30 paragraph (g) were omitted.
(3) If a person is exempt from the operation of Part 4 of the
Commonwealth Act in relation to a step in the manufacture of
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Therapeutic Goods (Western Australia) Bill 1999
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s. 29
therapeutic goods, subsection (1) has effect, in relation to the
goods, as if the reference in paragraph (g) to Part 4 were a
reference to that Part to the extent that it applies to that person
in relation to the manufacture of the goods.
5 (4) Where an application is made, the Secretary must notify the
applicant in writing of his or her decision on the application
within 28 days of the making of the decision and, in the case of
a decision not to list the goods, of the reasons for the decision.
(5) As soon as practicable after an applicant has been informed that
10 therapeutic goods in respect of which an application was made
are acceptable for listing, the Secretary must give to the
applicant a certificate of listing of the goods, and the listing of
the goods commences on the day specified for the purpose in
the certificate.
15 29. Registration or listing number
(1) Where the Secretary includes therapeutic goods (other than
grouped therapeutic goods) in the Register, the Secretary is to
assign a unique registration or listing number to the goods.
(2) Where the Secretary includes grouped therapeutic goods in the
20 Register, the Secretary is to assign a single, unique registration
or listing number to the grouped therapeutic goods.
30. Conditions on registration or listing
(1) Where the Secretary includes therapeutic goods in the Register
in relation to a person the Secretary may, in writing, impose
25 conditions on the registration or listing of those goods.
(2) Conditions referred to in subsection (1) may relate to --
(a) the manufacture of the goods; or
(b) the custody, use, supply, disposal or destruction of the
goods; or
30 (c) the keeping of records relating to the goods; or
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Therapeutic Goods (Western Australia) Bill 1999
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Registration and Listing Division 2
s. 30
(d) matters dealt with in, or matters additional to matters
dealt with in, standards applicable to the goods; or
(e) such other matters relating to the goods as the Secretary
thinks appropriate.
5 (3) The Secretary may, by notice in writing given to the person in
relation to whom therapeutic goods are registered or listed,
impose new conditions on the registration or listing or vary or
remove existing conditions.
(4) The Secretary's power under subsection (3) may be exercised at
10 the request of the person concerned or of the Secretary's own
motion.
(5) The imposition or variation of a condition under subsection (3)
takes effect --
(a) if the notice states that the action is necessary to prevent
15 imminent risk of death, serious illness or serious injury,
on the day on which the notice is given to the person; or
(b) in any other case, on the day specified for the purpose in
the notice, being a day not earlier than 28 days after the
notice is given to the person.
20 (6) In addition to any conditions imposed under subsection (1) or
(3), the registration or listing of therapeutic goods is subject to
the conditions that the person in relation to whom the goods are
registered or listed will --
(a) allow an authorised person --
25 (i) to enter, at any reasonable time, premises at
which the person deals with the goods; and
(ii) while on those premises, to inspect those
premises and therapeutic goods at those premises
and to take samples of goods of that kind; and
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s. 31
(b) if requested to do so by an authorised person, produce to
the person such documents relating to the goods as the
person requires and allow the person to copy the
documents.
5 31. Duration of registration or listing
Where goods are included in the Register in relation to a person,
the goods remain so included until their registration or listing is
cancelled under this Part.
32. Notification of adverse effects etc. of goods
10 (1) As soon as a person in relation to whom therapeutic goods are
registered becomes aware of information of a kind mentioned in
subsection (2) relating to the goods, the person must give the
information to the Secretary in writing.
Penalty: $40 000.
15 (2) The information with which subsection (1) is concerned is
information of the following kinds --
(a) information that contradicts information already
furnished by the person under this Act;
(b) information that indicates that the use of the goods in
20 accordance with the recommendations for their use may
have an unintended harmful effect;
(c) information that indicates that the goods, when used in
accordance with the recommendations for their use, may
not be as effective as the application for registration of
25 the goods or information already furnished by the person
under this Act suggests.
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Therapeutic Goods (Western Australia) Bill 1999
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Registration and Listing Division 2
s. 33
33. Notification of adverse effects etc. where application
withdrawn or lapses
(1) If an application for registration of goods is withdrawn or
lapses, the Secretary may give the applicant written notice
5 requiring the applicant --
(a) to inform the Secretary in writing whether the applicant
is aware of any information of a kind mentioned in
section 32(2) relating to the goods; and
(b) if the applicant is aware of such information, to give the
10 information to the Secretary in writing.
(2) Notice under subsection (1) may be given within 14 days after
an application is withdrawn or lapses.
(3) A person must comply with the requirements of a notice under
subsection (1) within 30 days after the notice is given to the
15 person.
Penalty: $40 000.
(4) A person must not, in purported compliance with a notice under
subsection (1), knowingly or recklessly give information that is
false or misleading in a material particular.
20 Penalty: $40 000.
34. Cancellation of registration or listing
(1) The Secretary may, by notice in writing given to a person in
relation to whom therapeutic goods are included in the Register,
cancel the registration or listing of the goods if --
25 (a) it appears to the Secretary that failure to cancel the
registration or listing would create an imminent risk of
death, serious illness or serious injury; or
(b) the goods become exempt goods; or
(c) the person requests in writing the cancellation of the
30 registration or listing; or
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s. 34
(d) the goods contain substances that are' prohibited
imports for the purposes of the Customs Act 1901 of the
Commonwealth.
(2) Subject to subsection (3), the Secretary may, by notice in
5 writing given to a person in relation to whom therapeutic goods
are included in the Register, cancel the registration or listing of
the goods if --
(a) it appears to the Secretary that the quality, safety or
efficacy of the goods is unacceptable; or
10 (b) the goods have changed so that they have become
separate and distinct from the goods as so included; or
(c) the sponsor has refused or failed to comply with a
condition to which the inclusion of the goods is subject;
or
15 (d) the person has contravened section 32(1) in relation to
the goods; or
(e) the goods become required to be included in the other
part of the Register; or
(f) the goods do not conform to a standard applicable to the
20 goods or to a requirement relating to advertising
applicable to goods of that kind under the
Commonwealth regulations; or
(g) the annual registration or listing charge is not paid
within 28 days after it becomes payable.
25 (3) Where the Secretary proposes to cancel the registration or
listing of goods in relation to a person under subsection (2)
otherwise than as a result of a failure to pay the annual
registration or listing charge, the Secretary must --
(a) inform the person in writing that the Secretary proposes
30 to cancel that registration or listing and set out the
reasons for that proposed action; and
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Therapeutic Goods (Western Australia) Bill 1999
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Registration and Listing Division 2
s. 34
(b) give the person a reasonable opportunity to make
submissions to the Secretary in relation to the proposed
action.
(4) Where a person makes submissions in accordance with
5 subsection (3)(b), the Secretary is not to make a decision
relating to the cancellation until the Secretary has taken the
submissions into account.
(5) Where the Secretary cancels the registration or listing of goods
in relation to a person, the goods cease to be registered or
10 listed --
(a) if the cancellation is effected under subsection (1), on
the day on which the notice of cancellation is given to
the person; or
(b) in any other case, on such later day as is specified in the
15 notice.
(6) Where the Secretary cancels the registration or listing of goods
in relation to a person, the Secretary --
(a) may, in writing, require the person --
(i) to inform the public, or a specified class of
20 persons, in the specified manner and within such
reasonable period as is specified, of the
cancellation; or
(ii) to take steps to recover any of the goods that
have been distributed; and
25 (b) must cause to be published in the Commonwealth of
Australia Gazette, as soon as practicable after the
cancellation, a notice setting out particulars of the
cancellation.
(7) A person who knowingly or recklessly refuses or fails to
30 comply with a requirement under subsection (6)(a) is guilty of
an offence.
Penalty: $6 000.
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Therapeutic Goods (Western Australia) Bill 1999
Part 3 Australian Register of Therapeutic
Division 3 General
s. 35
Division 3 -- General
35. Secretary may require information
(1) The Secretary may, by notice in writing given to a person who
is an applicant for the registration of therapeutic goods or in
5 relation to whom therapeutic goods are registered, require the
person to give to the Secretary, within such reasonable time as
is specified in the notice and in such form as is specified in the
notice, information or documents relating to one or more of the
following --
10 (a) the formulation of the goods;
(b) the composition of the goods;
(c) the design specifications of the goods;
(d) the quality of the goods;
(e) the method and place of manufacture or preparation of
15 the goods and the procedures employed to ensure that
proper standards are maintained in the manufacture and
handling of the goods;
(f) the presentation of the goods;
(g) the safety and efficacy of the goods for the purposes for
20 which they are to be used;
(h) the conformity of the goods to a requirement relating to
advertising applicable to goods of that kind under the
Commonwealth regulations;
(i) the regulatory history of the goods in another country;
25 (j) any other matter prescribed by the Commonwealth
regulations for the purposes of section 31(1)(k) of the
Commonwealth Act in relation to goods of that kind.
(2) The Secretary may, by notice in writing given to a person who
is an applicant for the listing of therapeutic goods or in relation
30 to whom therapeutic goods are listed, require the person to give
to the Secretary, within such reasonable time as is specified in
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Therapeutic Goods (Western Australia) Bill 1999
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General Division 3
s. 35
the notice, information or documents relating to one or more of
the following --
(a) the formulation of the goods;
(b) the composition of the goods;
5 (c) the design specifications of the goods;
(d) the manufacture of the goods;
(e) the presentation of the goods;
(f) the safety of the goods for the purposes for which they
are to be used;
10 (g) the conformity of the goods to a standard applicable to
the goods, or to a requirement relating to advertising
applicable to goods of that kind under the
Commonwealth regulations;
(h) any other matter prescribed by the Commonwealth
15 regulations for the purposes of section 31(2)(h) of the
Commonwealth Act in relation to goods of that kind.
(3) An approval of a form may require or permit information to be
given in accordance with specified software requirements --
(a) on a specified kind of data processing device; or
20 (b) by way of a specified kind of electronic transmission.
(4) A person in relation to whom therapeutic goods are registered or
listed must not, without reasonable excuse, fail to comply with a
notice given to the person under this section.
Penalty: $6 000.
25 (5) A person in relation to whom therapeutic goods are registered or
listed must not, in purported compliance with a notice under this
section, knowingly or recklessly provide information that is
false or misleading in a material particular.
Penalty: $6 000.
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s. 36
36. Inspection and variation of entries in Register
(1) A person in relation to whom therapeutic goods are registered or
listed may make a written request to the Secretary for a copy of
the entry in the Register in relation to the goods and, where such
5 a request is made, the Secretary must send a copy of that entry
to a person (other than any part of that entry that was supplied in
confidence by another person).
(2) If a person makes such a request, then, instead of providing a
copy of an entry to the person, the Secretary may, if the request
10 is for the provision of the copy in an electronic form, provide
the information contained in the entry --
(a) on a data processing device; or
(b) by way of electronic transmission.
(3) The Secretary may, following a request by a person in relation
15 to whom therapeutic goods are registered or listed or of his or
her own motion, vary the entry in the Register in relation to the
goods if the entry contains information that is incomplete or
incorrect.
(4) Where --
20 (a) the person in relation to whom therapeutic goods are
registered or listed has asked the Secretary to vary
product information included in the entry in the Register
that relates to the goods; and
(b) the only effect of the variation would be to reduce the
25 class of persons for whom the goods are suitable or to
add a warning or precaution, being a warning or
precaution that does not include any comparison of the
goods with any other therapeutic goods by reference to
quality, safety or efficacy,
30 the Secretary must vary the entry in accordance with the
request.
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General Division 3
s. 37
(5) Where --
(a) the person in relation to whom therapeutic goods are
registered or listed has asked the Secretary to vary
information included in the entry in the Register that
5 relates to the goods; and
(b) subsection (4) does not apply to the request; and
(c) the Secretary is satisfied that the variation requested
does not indicate any reduction in the quality, safety or
efficacy of the goods for the purposes for which they are
10 to be used,
the Secretary may vary the entry in accordance with the request.
(6) In this section, "product information", in relation to therapeutic
goods, means information relating to the safety and effective
use of the goods, including information regarding the usefulness
15 and limitations of the goods.
37. Publication of list of goods on Register
The Secretary must publish a list of the therapeutic goods
included in the Register not less than once every 12 months.
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Therapeutic Goods (Western Australia) Bill 1999
Part 4 Manufacturing of Therapeutic Goods
s. 38
Part 4 -- Manufacturing of Therapeutic Goods
38. Offences relating to manufacturing and licences
(1) A person must not, at premises in Western Australia, knowingly
or recklessly carry out a step in the manufacture of therapeutic
5 goods for supply for use in humans unless --
(a) the goods are exempt goods or the person is an exempt
person in relation to the manufacture of the goods; or
(b) the person is the holder of a licence under this Part or
under Part 4 of the Commonwealth Act that authorises
10 the carrying out of that step in relation to the goods at
those premises.
Penalty: $24 000.
(2) A person who is the holder of a licence must not knowingly or
recklessly breach a condition of the licence.
15 Penalty: $12 000.
(3) A person must not, in or in connection with an application for a
licence to manufacture therapeutic goods for use in humans,
make a statement that is, to the person's knowledge, false or
misleading in a material particular.
20 Penalty: $6 000.
39. Application for licence
(1) An application for a licence must --
(a) be made in writing in accordance with a form approved
by the Secretary; and
25 (b) identify the therapeutic goods or classes of therapeutic
goods that the applicant proposes to manufacture; and
(c) identify the manufacturing premises that will be used in
the manufacture of those goods; and
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Therapeutic Goods (Western Australia) Bill 1999
Manufacturing of Therapeutic Goods Part 4
s. 40
(d) identify the steps in the manufacture of those goods that
the applicant proposes to carry out under the licence;
and
(e) state the names, qualifications and experience of the
5 persons who are to have control of the production of the
goods and of the quality control measures that are to be
employed; and
(f) be delivered to an office of the Commonwealth
Department specified in the form; and
10 (g) be accompanied by an application fee of an amount
equal to the application fee prescribed under the
Commonwealth regulations in respect of an application
under section 37 of the Commonwealth Act.
(2) The Secretary may, by notice in writing given to an applicant
15 for a licence, require the applicant --
(a) to give to the Secretary, within such reasonable time as
is specified in the notice, such further information
concerning the application as is specified in the notice;
or
20 (b) to allow an authorised person, at any reasonable time
specified in the notice, to inspect the premises,
equipment, processes and facilities that will be used in
the manufacture of the goods, or other goods on those
premises.
25 40. Grant of licence
(1) Where --
(a) a person has made an application to carry out steps in
the manufacture of therapeutic goods at particular
manufacturing premises; and
30 (b) an application fee of an amount equal to the application
fee prescribed under the Commonwealth regulations in
respect of an application under section 37 of the
Commonwealth Act has been paid; and
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Therapeutic Goods (Western Australia) Bill 1999
Part 4 Manufacturing of Therapeutic Goods
s. 40
(c) fees of an amount equal to any applicable inspection
fees prescribed under the Commonwealth regulations in
respect of the grant of a licence under section 38 of the
Commonwealth Act have been paid; and
5 (d) the person has complied with any requirements made by
the Secretary under section 39(2) in relation to the
application,
the Secretary must grant the person a licence to carry out those
steps at those premises unless --
10 (e) the Secretary is satisfied that --
(i) the person will be unable to comply with the
manufacturing principles; or
(ii) the premises are not satisfactory for the
manufacture of the goods; or
15 (f) the person --
(i) has had a licence granted to the person under this
Act or the Commonwealth Act revoked; or
(ii) has been convicted of an offence against this
Act, the Commonwealth Act or a law of another
20 State or Territory relating to therapeutic goods;
or
(iii) has failed on more than one occasion to observe
the manufacturing principles in connection with
the manufacture of therapeutic goods.
25 (2) Despite subsection (1)(f), the Secretary may grant a licence to a
person who, apart from this subsection, could not be granted a
licence because of sub-section (1)(f) if, in the opinion of the
Secretary, special circumstances make it appropriate to do so.
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Therapeutic Goods (Western Australia) Bill 1999
Manufacturing of Therapeutic Goods Part 4
s. 41
(3) Where the Secretary grants or refuses to grant a licence to a
person, the Secretary must --
(a) give the person written notice of the decision; and
(b) in the case of a refusal, include in the notice the reasons
5 for the refusal.
(4) Where the Secretary grants a licence, the Secretary must cause
particulars of the decision to be published in the Commonwealth
of Australia Gazette as soon as is practicable after the decision
is made.
10 41. Term of licence
A licence commences on the day specified in the licence and
remains in force until it is revoked or suspended.
42. Conditions of licences
(1) A licence may be granted subject to --
15 (a) conditions designed to ensure that the holder of the
licence manufactures the goods in accordance with the
manufacturing principles and any standards applicable
to the goods; and
(b) such other conditions relating to the manufacture of the
20 goods as the Secretary thinks appropriate.
(2) The Secretary may, by notice in writing given to the holder of a
licence, impose new conditions on the licence or vary or remove
existing conditions.
(3) The imposition or variation of a condition under subsection (2)
25 takes effect --
(a) if the notice states that the action is necessary to prevent
imminent risk of death, serious illness or serious injury,
on the day on which the notice is given to the person; or
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Therapeutic Goods (Western Australia) Bill 1999
Part 4 Manufacturing of Therapeutic Goods
s. 42
(b) in any other case, on the day specified for the purpose in
the notice, being a day not earlier than 28 days after the
notice is given to the person.
(4) In addition to any conditions imposed under subsection (1) or
5 (2), each licence is, except as otherwise specified in the licence,
subject to the conditions that the holder of the licence will --
(a) ensure that the goods conform to any standard
applicable to the goods; and
(b) allow an authorised person --
10 (i) to enter, at any reasonable time, the
manufacturing premises to which the licence
relates; and
(ii) while on those premises, to inspect those
premises, any therapeutic goods manufactured at
15 those premises and processes relating to that
manufacture, and to take samples of goods of
that kind and, with the agreement of the holder,
to take photographs of those premises, goods or
processes; and
20 (c) where an authorised person enters premises as
mentioned in paragraph (b)(i), require the holder or his
or her employees at those premises to answer questions
relating to procedures carried out at the premises; and
(d) if requested to do so by an authorised person --
25 (i) produce to the person such documents relating to
the manufacture of therapeutic goods
manufactured at those premises as the person
requires and allow the person to copy the
documents; or
30 (ii) produce to the person for examination any batch
samples kept by the holder; and
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Therapeutic Goods (Western Australia) Bill 1999
Manufacturing of Therapeutic Goods Part 4
s. 43
(e) comply with such other conditions (if any) as are
specified in the Commonwealth regulations for the
purposes of section 40 of the Commonwealth Act.
43. Revocation and suspension of licences
5 (1) Subject to subsection (2), the Secretary may, by notice in
writing given to the holder of a licence, revoke the licence, or
suspend the licence for a period specified in the notice, if --
(a) the holder has been convicted of an offence against this
Act or the Commonwealth Act; or
10 (b) the holder has breached a condition of the licence; or
(c) the holder has failed to observe the manufacturing
principles; or
(d) the holder requests in writing that the licence be revoked
or suspended, as the case may be; or
15 (e) the holder ceases to carry on the business of
manufacturing the goods to which the licence relates; or
(f) the annual licensing charge, or any applicable inspection
fees, have not been paid within 28 days after they
become payable.
20 (2) Where the Secretary proposes to revoke a licence or suspend a
licence otherwise than at the request of the holder of the licence,
the Secretary must, unless the Secretary considers that failure to
revoke or suspend the licence immediately would create an
imminent risk of death, serious illness or serious injury --
25 (a) by notice in writing given to the holder, inform the
holder of the action that the Secretary proposes to take
and of the reasons for that proposed action; and
(b) except where the proposed action is to be taken as a
result of a failure to pay the annual licensing charge or
30 an applicable inspection fee, give the holder an
opportunity to make, within such reasonable time as is
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Therapeutic Goods (Western Australia) Bill 1999
Part 4 Manufacturing of Therapeutic Goods
s. 44
specified in the notice, submissions to the Secretary in
relation to the proposed action.
(3) Where the holder makes submissions in accordance with
subsection (2)(b), the Secretary is not to make a decision
5 relating to the revocation of suspension of the licence before
taking into account the submissions.
(4) A licence may be revoked notwithstanding that the licence is
suspended.
(5) Where a licence is suspended, the Secretary may, by notice in
10 writing given to the holder of the licence, revoke the
suspension.
(6) Where the Secretary revokes or suspends a licence, the
Secretary must cause particulars of the decision to be published
in the Commonwealth of Australia Gazette as soon as
15 practicable after the decision is made.
44. Publication of list of manufacturers etc.
The Secretary may, from time to time and in such manner as the
Secretary determines, publish a list of the persons who are
licensed under this Part, the classes of goods to which the
20 licences relate, the steps of manufacture that the licences
authorise and the addresses of the manufacturing premises to
which the licences relate.
page 44
Therapeutic Goods (Western Australia) Bill 1999
Licences to Supply by Wholesale Part 5
s. 45
Part 5 -- Licences to Supply by Wholesale
45. Definition and application of Part
(1) In this Part, "supply by wholesale" --
(a) means supply for the purposes of resale; and
5 (b) includes supply in wholesale quantities of therapeutic
goods for use --
(i) in a public institution; or
(ii) in connection with a profession, business, trade
or industry for use only in connection with that
10 profession, business, trade or industry, but not
for resale.
(2) Nothing in this Part affects the operation of any other Part in
relation to the supply of therapeutic goods.
46. Offences relating to supply by wholesale and licences
15 (1) A person must not, in Western Australia, supply by wholesale
therapeutic goods for use in humans unless --
(a) the person is the holder of a licence under this Part that
authorises supply by wholesale of the goods; or
(b) the therapeutic goods are exempt goods for the purposes
20 of Parts 3 or 4 or under section 9 or the person is an
exempt person in relation to supply by wholesale of
those goods; or
(c) the person is licensed under section 35 of the
Commonwealth Act in respect of the goods or class of
25 goods described in that licence; or
(d) the person is the holder of a licence granted under
section 24 of the Poisons Act 1964 and prescribed by
regulation for the purposes of this subsection; or
(e) the supply by the person is a supply by wholesale that is
30 authorised under the Poisons Act 1964 and is to be
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Therapeutic Goods (Western Australia) Bill 1999
Part 5 Licences to Supply by Wholesale
s. 47
regarded as a sale or supply in the lawful practice of that
person's profession as a pharmacist.
Penalty: $10 000.
(2) A person who is the holder of a licence must not knowingly or
5 recklessly breach a condition of the licence.
Penalty: $10 000.
(3) A person must not, in or in connection with an application for a
licence to supply by wholesale therapeutic goods for use in
humans, make a statement that is, to the person's knowledge,
10 false or misleading in a material particular.
Penalty: $ 6 000.
(4) In this section, "therapeutic goods" does not include therapeutic
devices unless they are prescribed by the regulations as
therapeutic goods to which this section applies.
15 47. Application for licence
(1) An application for a licence to supply by wholesale must --
(a) be made in writing to the Commissioner of Health in
accordance with a form approved by the Commissioner
of Health; and
20 (b) identify the therapeutic goods or classes of therapeutic
goods that the applicant proposes to supply by
wholesale; and
(c) identify the premises that will be used in the storage,
handling and supply of those goods; and
25 (d) identify the measures proposed for the control of the
storage, handling and supply of the goods and the stock
control measures that are to be employed; and
(e) be accompanied by the prescribed application fee.
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Therapeutic Goods (Western Australia) Bill 1999
Licences to Supply by Wholesale Part 5
s. 48
(2) The Commissioner of Health may, by notice in writing given to
an applicant for a licence, require the applicant --
(a) to give to the Commissioner of Health, within such
reasonable time as is specified in the notice, such further
5 information concerning the application as is specified in
the notice; or
(b) to allow an authorised person, at any reasonable time
specified in the notice, to inspect the premises,
equipment, processes and facilities proposed to be used
10 by the applicant in the course of the business of supply
by wholesale of therapeutic goods.
48. Grant of licence
(1) Where --
(a) a person has made an application for a licence to supply
15 therapeutic goods by wholesale; and
(b) the prescribed application fee has been paid; and
(c) any applicable prescribed inspection fees in respect of
the grant of a licence have been paid; and
(d) the person has complied with any requirements made by
20 the Commissioner of Health under section 47(2) in
relation to the application,
the Commissioner of Health must grant the person a licence to
supply by wholesale therapeutic goods of the class specified in
the licence if satisfied --
25 (e) that the premises are satisfactory for the handling,
storage or supply of goods of that class; and
(f) as to the matters referred to in section 47(1)(d); and
(g) the person --
(i) has not been the holder of a licence granted
30 under this Act or the Commonwealth Act that
has been revoked; and
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Therapeutic Goods (Western Australia) Bill 1999
Part 5 Licences to Supply by Wholesale
s. 49
(ii) has not been convicted of an offence against this
Act, the Commonwealth Act or a law of another
State or Territory relating to therapeutic goods.
(2) The Commissioner of Health may grant a licence to a person
5 who could not be granted a licence because the person --
(a) has had a licence granted to the person under this Act or
the Commonwealth Act revoked; or
(b) has been convicted of an offence against this Act, the
Commonwealth Act or a law of another State or
10 Territory relating to therapeutic goods,
if, in the opinion of the Commissioner of Health, special
circumstances make it appropriate to do so.
(3) Where the Commissioner of Health grants or refuses to grant a
licence to a person, the Commissioner of Health must --
15 (a) give the person written notice of the decision; and
(b) in the case of a refusal, include in the notice the reasons
for the refusal.
49. Term of licence
A licence commences on the day specified in the licence and
20 remains in force for 12 months from that date.
50. Renewal of licence
(1) An application for renewal of a licence --
(a) may be made up to one month before the expiry of the
current licence; and
25 (b) must be made in writing and be accompanied by the
prescribed renewal fee.
(2) Subject to this Act and the regulations, on application under
subsection (1), the Commissioner of Health, in his or her
discretion, may renew the licence.
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Therapeutic Goods (Western Australia) Bill 1999
Licences to Supply by Wholesale Part 5
s. 51
(3) A renewed licence remains in force for 12 months from the
expiry of the previous licence.
51. Conditions of licences
(1) A licence may be granted subject to --
5 (a) conditions designed to ensure that the holder of the
licence supplies the therapeutic goods of the class
specified in the licence in accordance with appropriate
prescribed standards of hygiene, storage, handling and
monitoring controls applicable to goods of that class;
10 and
(b) such other conditions relating to supply by wholesale of
goods of that class as the Commissioner of Health thinks
appropriate.
(2) The Commissioner of Health may, by notice in writing given to
15 the holder of a licence, impose new conditions on the licence or
vary or remove existing conditions.
(3) The imposition or variation of a condition under subsection (2)
takes effect --
(a) if the notice states that the action is necessary to prevent
20 imminent risk of death, serious illness or serious injury,
on the day on which the notice is given to the person; or
(b) in any other case, on the day specified for the purpose in
the notice, being a day not earlier than 28 days after the
notice is given to the person.
25 (4) In addition to any conditions imposed under subsection (1) or
(2), each licence is, except as otherwise specified in the licence,
subject to the conditions that the holder of the licence will --
(a) ensure that goods of the class specified in the licence
conform to any standard applicable to goods of that
30 class; and
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Therapeutic Goods (Western Australia) Bill 1999
Part 5 Licences to Supply by Wholesale
s. 52
(b) allow an authorised person --
(i) to enter, at any reasonable time, the premises to
which the licence relates; and
(ii) while on those premises, to inspect those
5 premises, any therapeutic goods handled, stored
at or supplied from those premises and processes
relating to that supply, and to take samples of
goods of that kind and, with the agreement of the
holder, to take photographs of those premises,
10 goods or processes; and
(c) where an authorised person enters premises as
mentioned in paragraph (b)(i), require the holder or his
or her employees at those premises to answer questions
relating to procedures carried out at the premises; and
15 (d) if requested to do so by an authorised person, produce to
the person such documents relating to the handling,
storage or supply of therapeutic goods at those premises
as the person requires and allow the person to copy the
documents; and
20 (e) comply with the prescribed conditions (if any).
52. Revocation and suspension of licences
(1) Subject to subsection (2), the Commissioner of Health may, by
notice in writing given to the holder of a licence, revoke the
licence, or suspend the licence for a period specified in the
25 notice, if --
(a) the holder has been convicted of an offence against this
Act or the Commonwealth Act; or
(b) the holder has breached a condition of the licence; or
(c) the holder requests in writing that the licence be revoked
30 or suspended, as the case may be; or
(d) the holder ceases to carry on the business of supplying
by wholesale the goods to which the licence relates; or
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Therapeutic Goods (Western Australia) Bill 1999
Licences to Supply by Wholesale Part 5
s. 52
(e) the prescribed licence renewal fee and any applicable
prescribed inspection fees, have not been paid within
28 days after they become payable.
(2) Where the Commissioner of Health proposes to revoke a licence
5 or suspend a licence otherwise than at the request of the holder
of the licence, the Commissioner of Health must, unless the
Commissioner of Health considers that failure to revoke or
suspend the licence immediately would create an imminent risk
of death, serious illness or serious injury --
10 (a) by notice in writing given to the holder, inform the
holder of the action that the Commissioner of Health
proposes to take and of the reasons for that proposed
action; and
(b) except where the proposed action is to be taken as a
15 result of a failure to pay the prescribed licence renewal
fee or an applicable prescribed inspection fee, give the
holder an opportunity to make, within such reasonable
time as is specified in the notice, submissions to the
Commissioner of Health in relation to the proposed
20 action.
(3) Where the holder makes submissions in accordance with
subsection (2)(b), the Commissioner of Health is not to make a
decision relating to the revocation of suspension of the licence
before taking into account the submissions.
25 (4) A licence may be revoked notwithstanding that the licence is
suspended.
(5) Where a licence is suspended, the Commissioner of Health may,
by notice in writing given to the holder of the licence, revoke
the suspension.
30 (6) Where the Commissioner of Health revokes or suspends a
licence, the Commissioner of Health must cause particulars of
the decision to be published in the Government Gazette as soon
as practicable after the decision is made.
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Therapeutic Goods (Western Australia) Bill 1999
Part 5 Licences to Supply by Wholesale
s. 53
53. Publication of list of wholesale suppliers
The Commissioner of Health may, from time to time and in
such manner as the Commissioner of Health determines, publish
a list of the persons who are licensed under this Part, the classes
5 of goods to which the licences relate and the addresses of the
premises to which the licences relate.
page 52
Therapeutic Goods (Western Australia) Bill 1999
Payment of Charges Part 6
s. 54
Part 6 -- Payment of Charges
54. By whom charges payable
(1) An annual registration charge is payable by the person in
relation to whom therapeutic goods are registered.
5 (2) An annual listing charge is payable by the person in relation to
whom therapeutic goods are listed.
(3) An annual licensing charge is payable by the holder of a licence
under Part 4.
55. Time for payment of charges
10 (1) An annual registration charge or annual listing charge for a
financial year relating to therapeutic goods other than grouped
therapeutic goods is payable on the day of the commencement
of the registration or listing of the therapeutic goods and on each
anniversary of that day.
15 (2) An annual registration charge or annual listing charge for a
financial year relating to grouped therapeutic goods is payable
by a person on the day specified in relation to those grouped
therapeutic goods in a written notice given by the Secretary to
the person.
20 (3) An annual licensing charge for a financial year is payable on the
day on which the licence commenced and on each anniversary
of that day.
(4) The Secretary may, by agreement with the person by whom an
annual registration charge, annual listing charge or an annual
25 licensing charge is payable, vary the day on which the charge is
payable.
(5) In this section, "grouped therapeutic goods" has the same
meaning as in the Commonwealth Act.
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Therapeutic Goods (Western Australia) Bill 1999
Part 6 Payment of Charges
s. 56
56. Recovery of charges
An annual registration charge, annual listing charge or annual
licensing charge may be recovered by the Commonwealth as a
debt due to the Commonwealth.
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Therapeutic Goods (Western Australia) Bill 1999
Miscellaneous Part 7
s. 57
Part 7 -- Miscellaneous
57. Monitoring compliance with Act
(1) Subject to subsection (2), an authorised person may, for the
purpose of finding out whether the requirements of this Act are
5 being complied with --
(a) enter premises; and
(b) exercise the powers set out in section 59(1) in relation to
the premises.
(2) An authorised person must not enter premises, or exercise a
10 power under subsection (1) in relation to the premises, unless --
(a) the occupier of the premises consents to the entry or the
exercise of the power; or
(b) a warrant under section 60 authorises the entry or the
exercise of the power.
15 58. Entry and search of premises--evidence of offences
(1) Subject to subsection (3), if an authorised person has reasonable
grounds for suspecting that there is in or on premises a
particular thing (in this section called the "evidence") that may
afford evidence of the commission of an offence against this
20 Act, the authorised person may --
(a) enter the premises; and
(b) exercise the powers set out in section 59(1) in relation to
the premises.
(2) If the authorised person enters the premises and finds the
25 evidence, the following provisions have effect --
(a) the authorised person may seize the evidence;
(b) the authorised person may keep the evidence for 90 days
or, if a prosecution for an offence against this Act in the
commission of which the evidence may have been used
30 or otherwise involved is instituted within that period,
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Therapeutic Goods (Western Australia) Bill 1999
Part 7 Miscellaneous
s. 58
until the completion of the proceedings for the offence
and of any appeal from the decision in relation to the
proceedings;
(c) if the evidence is a book, record or document, while the
5 authorised person has possession of the book, record or
document, the authorised person must allow the book,
record or document to be inspected at any reasonable
time by a person who would be entitled to inspect it if it
were not in the authorised person's possession.
10 (3) The authorised person must not enter the premises, or exercise a
power in relation to the premises under subsection (1), unless --
(a) the occupier of the premises consents to the entry or the
exercise of the power; or
(b) a warrant under section 61 issued in relation to the
15 evidence authorises the entry or the exercise of the
power.
(4) If, in the course of searching the premises under subsection (1)
pursuant to a warrant under section 61, the authorised person --
(a) finds a thing that the authorised person believes, on
20 reasonable grounds, to be a thing (other than the
evidence) that will afford evidence of the commission of
the offence mentioned in subsection (1) or of another
offence against this Act; and
(b) believes, on reasonable grounds, that it is necessary to
25 seize the thing to prevent --
(i) its concealment, loss or destruction; or
(ii) its use in committing, continuing or repeating the
offence mentioned in subsection (1) or the other
offence,
30 subsection (2) applies to the thing as if it were the evidence.
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Therapeutic Goods (Western Australia) Bill 1999
Miscellaneous Part 7
s. 59
(5) An authorised person may, before the end of the period
mentioned in subsection (2)(b), apply to a magistrate for an
extension of that period.
(6) A person who would be entitled to possession of the evidence if
5 it had not been seized is entitled to make representations to the
magistrate about the application.
(7) The magistrate may extend the period if satisfied that it is
necessary to do so in order that an authorised person may have a
reasonable opportunity of completing the investigation of an
10 offence against this Act.
(8) The period may not be extended --
(a) after it has ended; or
(b) so that it exceeds 3 years.
(9) Where the period referred to in subsection (2)(b) has been
15 extended, a reference in subsection (5), (7) or (8) to that period
is a reference to that period as extended.
59. General powers of authorised persons in relation to
premises
(1) The powers an authorised person may exercise under
20 section 57(1)(b) or 58(1)(b) in relation to premises are as
follows --
(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
25 thing in or on the premises that relates to therapeutic
goods;
(c) to take extracts from, and make copies of, any
documents relating to therapeutic goods in or on the
premises;
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Therapeutic Goods (Western Australia) Bill 1999
Part 7 Miscellaneous
s. 60
(d) if the 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 the authorised
5 person; and
(ii) produce any books, records or documents
requested by the authorised person; and
(e) if the authorised person was authorised to enter the
premises by a warrant under section 60 or 61, to require
10 any person in or on the premises to --
(i) answer any questions put by the authorised
person; and
(ii) produce any books, records or documents
requested by the authorised person;
15 (f) to take into or onto the premises such equipment and
materials as the authorised person requires for the
purpose of exercising powers in relation to the premises.
(2) Subsection (1) has effect subject to sections 57(2) and 58(3).
(3) A person must not, without reasonable excuse, refuse or fail to
20 comply with a requirement under subsection (1)(e).
Penalty: $3 000.
(4) It is a reasonable excuse for a person to refuse or fail to answer
a question or produce a document if answering the question, or
producing the document, would tend to incriminate the person.
25 60. Monitoring warrants
(1) An authorised person may apply to a magistrate for a warrant
under this section in relation to premises.
(2) Subject to subsection (3), the magistrate may issue the warrant
if the magistrate satisfied, by information on oath, that it is
30 reasonably necessary that the authorised person should have
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Therapeutic Goods (Western Australia) Bill 1999
Miscellaneous Part 7
s. 61
access to the premises for the purpose of finding out whether the
requirements of this Act are being complied with.
(3) The magistrate must not issue the warrant unless the authorised
person or some other person has given to the magistrate, either
5 orally or by affidavit, such further information (if any) as the
magistrate requires concerning the grounds on which the issue
of the warrant is being sought.
(4) The warrant must --
(a) authorise an authorised person (whether or not named in
10 the warrant), with such assistance and by such force as
is necessary and reasonable --
(i) to enter the premises; and
(ii) to exercise the powers set out in section 59(1) in
relation to the premises; and
15 (b) state whether the entry is authorised to be made at any
time of the day or night or during specified hours of the
day or night; and
(c) specify the day (not more than 6 months after the issue
of the warrant) on which the warrant ceases to have
20 effect; and
(d) state the purpose for which the warrant is issued.
61. Offence related warrants
(1) An authorised person may apply to a magistrate for a warrant
under this section in relation to premises.
25 (2) Subject to subsection (3), the magistrate may issue the warrant
if the magistrate is satisfied, by information on oath, that there
are reasonable grounds for suspecting that there is, or there may
be within the next 72 hours, in or on the premises a particular
thing (in this section called the "evidence") that may afford
30 evidence of the commission of an offence against this Act.
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Therapeutic Goods (Western Australia) Bill 1999
Part 7 Miscellaneous
s. 62
(3) The magistrate must not issue the warrant unless the authorised
person or some other person has given to the magistrate, either
orally or by affidavit, such further information (if any) as the
magistrate requires concerning the grounds on which the issue
5 of the warrant is sought.
(4) The warrant must --
(a) state the name of the authorised person; and
(b) authorise the authorised person, with such assistance and
by such force as is necessary and reasonable --
10 (i) to enter the premises; and
(ii) to exercise the powers set out in section 59(1);
and
(iii) to seize the evidence; and
(c) state whether the entry is authorised to be made at any
15 time of the day or night or during specified hours of the
day or night; and
(d) specify the day (not more than one week after the issue
of the warrant) on which the warrant ceases to have
effect; and
20 (e) state the purpose for which the warrant is issued.
62. Identity cards
(1) The Commissioner of Health is to ensure that each person
authorised by him or her as an authorised person for the
purposes of this Act is issued with an identity card that
25 incorporates a recent photograph of the person.
(2) Where an authorised person referred to in subsection (1) enters
premises otherwise than under a warrant, the authorised person
must, if requested to do so by any person at those premises,
produce his or her identity card for inspection by that person.
30 (3) Where a person ceases to be an authorised person referred to in
subsection (1), the person must, as soon as practicable after so
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Therapeutic Goods (Western Australia) Bill 1999
Miscellaneous Part 7
s. 63
ceasing, return the person's identity card to the Commissioner
of Health.
Penalty: $100.
63. Offences
5 (1) An offence against section 19, 32, or 33 is an indictable offence.
(2) If a court convicts a person of an offence against this Act in
relation to any therapeutic goods, the court may order that the
goods be forfeited to the State and, where such an order is
made, the goods become the property of the State.
10 (3) Where goods are so forfeited, the Commissioner of Health may
cause notice of the forfeiture to be published in the Government
Gazette.
(4) Goods forfeited under an order referred to in subsection (2) are
to be disposed of in such manner as the Commissioner of Health
15 directs.
(5) A prosecution in respect of an indictable offence against this
Act may be commenced at any time within 3 years after the
commission of the offence.
64. Evidentiary certificate of Commissioner of Health
20 In any legal proceedings under this Act, a certificate purporting
to be signed by the Commissioner of Health stating that a
person was or was not, at a date specified in the certificate --
(a) the holder of a licence under this Act; or
(b) the holder of a licence under section 24 of the Poisons
25 Act 1964; or
(c) a person to whom, in his or her profession as a
pharmacist, an authorisation under the Poisons Act 1964
applied,
is evidence, and in the absence of evidence to the contrary, is
30 proof of the facts stated in the certificate.
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Therapeutic Goods (Western Australia) Bill 1999
Part 7 Miscellaneous
s. 65
65. Evidentiary certificates of the Secretary
(1) In any legal proceedings under this Act, a certificate purporting
to be signed by the Secretary as to any of the matters set out in
subsection (2) is evidence, and in the absence of evidence to the
5 contrary, is proof of the facts stated in the certificate.
(2) The Secretary may certify as to the following --
(a) that at a date specified in the certificate, there are no
section 18 exemptions under the Commonwealth Act
applying to goods;
10 (b) that at a date specified in the certificate, there are no
section 19 approvals or authorisations under the
Commonwealth Act granted in respect of the goods;
(c) that goods are or are not included in the Register;
(d) specifying the period that goods were included in the
15 Register, including any conditions applying to the
registration or listing of goods;
(e) that at a date specified in the certificate, the registration
or listing of goods has been cancelled;
(f) that at a date specified in the certificate, no section 7
20 order under the Commonwealth Act has been issued in
respect of the goods;
(g) that at a date specified in the certificate, a licence to
manufacture under Part 4 of this Act or the
Commonwealth Act has or has not been issued,
25 including any conditions applying to the licence.
66. Conduct by directors, servants and agents
(1) Where, in proceedings for an offence against this Act, it is
necessary to establish the state of mind of a body corporate in
relation to particular conduct, it is sufficient to show --
30 (a) that the conduct was engaged in by a director, servant or
agent of the body corporate within the scope of his or
her actual or apparent authority; and
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Miscellaneous Part 7
s. 66
(b) that the director, servant or agent had the state of mind.
(2) Any conduct engaged in or on behalf of a body corporate by a
director, servant or agent of the body corporate within the scope
of his or her actual or apparent authority is to be taken, for the
5 purposes of a prosecution for an offence against this Act, to
have been engaged in also by the body corporate unless the
body corporate establishes that the body corporate took
reasonable precautions and exercised due diligence to avoid the
conduct.
10 (3) Where, in proceedings for an offence against this Act, it is
necessary to establish the state of mind of a person other than a
body corporate in relation to particular conduct, it is sufficient
to show that --
(a) the conduct was engaged in by a servant or agent of the
15 person within the scope of his or her actual or apparent
authority; and
(b) the servant or agent had the state of mind.
(4) Any conduct engaged in on behalf of a person other than a body
corporate (in this subsection called the "employer") by a servant
20 or agent of the employer within the scope of his or her actual or
apparent authority is to be taken, for the purposes of a
prosecution for an offence against this Act, to have been
engaged in also by the employer unless the employer establishes
that he or she took reasonable precautions and exercised due
25 diligence to avoid the conduct.
(5) Where --
(a) a person other than a body corporate is convicted of an
offence; and
(b) the person would not have been convicted of the offence
30 if subsections (3) and (4) had not been enacted,
the person is not liable to be punished by imprisonment for that
offence.
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Part 7 Miscellaneous
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(6) A reference in subsection (1) or (3) to the state of mind of a
person includes a reference to --
(a) the knowledge, intention, opinion, belief or purpose of
the person; and
5 (b) the person's reasons for the intention, opinion, belief or
purpose.
(7) A reference in this section to a director of a body corporate
includes a reference to a constituent member of a body
corporate incorporated for a public purpose by a law of the
10 Commonwealth, of a State or of a Territory.
(8) A reference in this section to engaging in conduct includes a
reference to failing or refusing to engage in conduct.
67. Judicial notice
All courts are to take judicial notice of the British
15 Pharmacopoeia and of the British Pharmacopoeia (Veterinary).
68. Delegation
The Secretary may delegate any of his or her powers under this
Act, other than this power of delegation, to a person to whom
the Secretary may, under section 57 of the Commonwealth Act,
20 delegate any of his or her powers under that Act.
69. Offences under this Act and the Commonwealth Act
If --
(a) an act or omission constitutes an offence under this Act
and the Commonwealth Act; and
25 (b) the offender has been punished for that offence under
the Commonwealth Act,
the offender is not liable to be punished for the offence under
this Act.
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Therapeutic Goods (Western Australia) Bill 1999
Miscellaneous Part 7
s. 70
70. Review of decisions excluding decisions under Part 5
(1) In this section --
"decision" has the same meaning as in the Administrative
Appeals Tribunal Act 1975 of the Commonwealth.
5 (2) A person --
(a) whose interests are affected by a decision of the
Secretary or of a delegate of the Secretary under
section 8, section 12, Part 3 or Part 4; and
(b) who is dissatisfied with that decision,
10 may make an application to the Commonwealth Administrative
Appeals Tribunal for review of that decision.
71. Review by Supreme Court
(1) A person whose interests are affected by a decision of the
Commissioner of Health under Part 5 may apply to the Supreme
15 Court for review of the decision.
(2) An application for review must be made within 28 days after the
day on which the decision is made.
72. Regulations
(1) The Governor may make regulations for or with respect to --
20 (a) prohibiting or regulating the advertising of therapeutic
goods, including the form and content of advertisements
and the manner in which advertisements may be
published or displayed;
(b) labelling, sampling, examination, testing and analysis of
25 therapeutic goods;
(c) conditions to be complied with in respect of the
preparation, dispensing, storage, packing, handling,
carriage and delivery of therapeutic goods;
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Part 7 Miscellaneous
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(d) prohibiting or regulating the supply of therapeutic goods
of a specified class or classes;
(e) fees payable under Part 5;
(f) the inspection of premises, stocks, books, documents
5 and records;
(g) prohibiting the supply of therapeutic goods by
prescribed self-service methods;
(h) providing for the disposal of things seized under the
Act;
10 (i) prescribing penalties not exceeding $2 000 for any
contravention of the regulations;
(j) 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.
15 (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
20 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
25 (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.
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Therapeutic Goods (Western Australia) Bill 1999
Consequential Amendments and Transitional Provisions Part 8
s. 73
Part 8 -- Consequential Amendments and Transitional
Provisions
73. Amendments to the Health Act 1911
(1) Section 3 of the Health Act 1911 is amended in the definition of
5 "drug" by inserting after "includes" the following --
"
a drug that is a listed or registered therapeutic good within the
meaning of the Therapeutic Goods Act (Western Australia) 1999 or
the Therapeutic Goods Act 1989 of the Commonwealth,
10 ".
(2) Section 223 of the Health Act 1911 is amended by inserting
after subsection (2) the following --
"
(3) In any prosecution under subsection (1)(a) it shall be a
15 good defence that the therapeutic substance is a listed
or registered therapeutic good within the meaning of
the Therapeutic Goods Act (Western Australia) 1999 or
the Therapeutic Goods Act 1989 of the
Commonwealth.
20 ".
(3) Division 7 of Part VIIA of the Health Act 1911 is repealed.
74. Amendments to the Poisons Act 1964
Section 6(1) of the Poisons Act 1964 is amended by inserting
after "Misuse of Drugs Act 1981" the following --
25 " and the Therapeutic Goods Act 1999 ".
75. Transitional arrangements for Part 4
(1) This section applies to a step in the manufacture of therapeutic
goods in relation to a person in relation to premises in Western
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Therapeutic Goods (Western Australia) Bill 1999
Part 8 Consequential Amendments and Transitional Provisions
s. 76
Australia if, before the commencement of this section, the
person was carrying out that step in relation to goods of that
kind at those premises.
(2) Where --
5 (a) this section applies to a step in the manufacture of
therapeutic goods in relation to a person in relation to
premises; and
(b) the Secretary is not aware of the person having been
convicted of an offence against a law of the
10 Commonwealth, of a State or of an internal Territory in
respect of goods of that kind during the period of 2 years
ending on the commencement of this section,
section 38(1) does not apply to the carrying out of that step by
the person in relation to goods of that kind at those premises
15 during the period of 4 months after that commencement.
(3) Where --
(a) this section applies to a step in the manufacture of
therapeutic goods in relation to a person in relation to
premises; and
20 (b) the person makes an application for a licence to carry
out that step in relation to goods of that kind at those
premises in accordance with section 39 and within
4 months after the commencement of this section,
section 38(1) does not apply to the carrying out of that step by
25 the person in relation to goods of that kind at those premises
until the application is determined.
76. Transitional arrangements for Part 5
(1) Section 46(1) does not apply to the supply by wholesale of
therapeutic goods by a person who, during the whole period of
30 6 months before the commencement of this section, was
engaged in the supply by wholesale of therapeutic goods of that
kind.
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Therapeutic Goods (Western Australia) Bill 1999
Consequential Amendments and Transitional Provisions Part 8
s. 77
(2) A person to whom subsection (1) applies may make application
for a licence to supply by wholesale therapeutic goods in
accordance with section 47 and, if the person makes an
application within 6 months after the commencement of this
5 section, section 46(1) does not apply to the supply by wholesale
of therapeutic goods of that kind by that person until the
application is determined.
77. Transitional arrangements for goods required to be
registered or listed
10 (1) This section applies to therapeutic goods in relation to a person
if, immediately before the commencement of this section, the
person was a sponsor supplying goods of that kind in Western
Australia for use in humans.
(2) If --
15 (a) this section applies to therapeutic goods in relation to a
person; and
(b) the Secretary is not aware of the person having been
convicted of an offence against a law of the
Commonwealth, of a State or of an internal Territory in
20 respect of goods of that kind during the period of 2 years
ending on the commencement of this section; and
(c) if the goods are imported goods, the Secretary is not
aware of the person having, during that period, imported
goods of that kind into Australia otherwise than in
25 accordance with regulations in force under the Customs
Act 1901 of the Commonwealth,
sections 14(1) and (2) do not apply to goods of that kind in
relation to the person during the period of 3 months after that
commencement.
30 (3) If --
(a) this section applies to therapeutic goods in relation to a
person; and
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Therapeutic Goods (Western Australia) Bill 1999
Part 8 Consequential Amendments and Transitional Provisions
s. 77
(b) the person makes an application in accordance with
section 20 for registration or listing of goods of that kind
within 3 months after the commencement of this section,
then --
5 (c) section 14(1) does not apply to goods of that kind in
relation to the person during the period of 6 months after
that commencement or before the end of such longer
period as the Secretary specifies by notice published in
the Commonwealth of Australia Gazette before the end
10 of that 6 month period; and
(d) section 14(2) does not apply to goods of that kind in
relation to the person during the period of 12 months
after that commencement or before the end of such
longer period as the Secretary specifies by notice
15 published in the Commonwealth of Australia Gazette
before the end of that 12 month period.
(4) If, on an application under subsection (3), goods have been
registered without having been evaluated, the Secretary may, if
he or she thinks it appropriate, give the person in relation to
20 whom the goods are registered written notice that the goods are
to be evaluated to determine whether they should continue to be
registered.
(5) A person who makes an application in accordance with
subsection (3) is not required to pay --
25 (a) any application fee for the registration or listing of the
goods to which the application relates; or
(b) in the case of an application for the registration of
goods, a fee for the evaluation of the goods for
registration,
30 but if the goods are later evaluated to determine whether the
goods should continue to be registered, a fee that is an amount
equal to the fee specified in or determined in accordance with
the Commonwealth regulations in relation to an application
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Therapeutic Goods (Western Australia) Bill 1999
Consequential Amendments and Transitional Provisions Part 8
s. 77
under section 24 of the Commonwealth Act is payable in
respect of that evaluation.
(6) In relation to an evaluation conducted for the purposes of this
section --
5 (a) section 27 has effect as if --
(i) the person in respect of whom the goods are
registered were an applicant for the registration
of the goods; and
(ii) the reference in subsection (1)(b) to an
10 evaluation fee under section 21 were a reference
to a fee payable under subsection (5) of this
section; and
(b) sections 22, 23 and 24 have effect as if any reference in
those sections to section 21 were a reference to sub-
15 section (5) of this section; and
(c) sections 25 and 26 do not apply.
(7) If, on an application under subsection (3), goods have been
listed without consideration of the matters mentioned in section
28(1)(c) to (i), the Secretary may, if he or she thinks it
20 appropriate, give the person in relation to whom the goods are
listed written notice that the Secretary intends to determine
whether the goods should continue to be listed.
(8) If notice is given under subsection (7), section 28 applies as if
the person in relation to whom the goods are listed were an
25 applicant for the listing of the goods.
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