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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 2000
CONTENTS
Part 1 -- Preliminary
1. Short title 2
2. Commencement 2
3. Objects of Act (Cwlth s. 4) 2
4. Interpretation (Cwlth s. 3) 2
5. Act to bind Crown (Cwlth s. 5) 10
6. This Act in addition to other written laws relating to
therapeutic goods 10
7. Authorised persons (Cwlth s. 7A) 10
8. Secretary may approve or authorise the supply of
certain therapeutic goods (Cwlth s. 19) 10
9. Power of Minister to exempt 12
10. Kits (Cwlth s. 7B) 13
11. Power to obtain information with respect to
therapeutic goods (Cwlth s. 8) 14
Part 2 -- Standards
12. Compliance with standards (Cwlth s. 14) 16
13. Consent may be subject to conditions etc. (Cwlth s.
15) 16
Part 3 -- Australian register of therapeutic
goods
Division 1 -- Preliminary
14. Therapeutic goods and gazetted groups (Cwlth s. 16) 17
15. Offences relating to manufacture and supply of
therapeutic goods (Cwlth s. 20) 18
page i
138--1
Therapeutic Goods (Western Australia) Bill 2000
Contents
16. Offence relating to supply of unregistered or unlisted
goods (Cwlth s. 21) 19
17. Hawking of therapeutic goods 20
18. Supply by automatic machine 20
19. General offences relating to this Part (Cwlth s. 22) 20
20. Offence to supply therapeutic goods for use in humans
after expiry date, unless authorised by the
Commissioner 23
21. Offence to use certain therapeutic devices without
authority 23
22. False statements in applications for registration
(Cwlth s. 22A) 23
Division 2 -- Registration and listing
23. Applications generally (Cwlth s. 23) 24
24. Applications for registration (Cwlth s. 24) 24
25. When evaluation fee due for payment (Cwlth s. 24A) 26
26. Payment of evaluation fee by instalments (Cwlth s.
24B) 26
27. Recovery of evaluation fee (Cwlth s. 24C) 26
28. Reduction of evaluation fee where evaluation not
completed within prescribed period (Cwlth s. 24D) 26
29. Deemed refusal of application (Cwlth s. 24E) 27
30. Evaluation and registration of therapeutic goods
(Cwlth s. 25) 28
31. When the Secretary must not use protected
information (Cwlth s. 25A) 31
32. Registration of therapeutic device to which
conformity assessment certificate applies (Cwlth s.
25B) 33
33. Listing of therapeutic goods (Cwlth s. 26) 34
34. Listing of therapeutic devices to which conformity
assessment certificate applies (Cwlth s. 26AA) 37
35. Listing of certain types of therapeutic goods (Cwlth s.
26A) 38
36. Registration or listing number (Cwlth s. 27) 41
37. Conditions on registration or listing (Cwlth s. 28) 41
38. Duration of registration or listing (Cwlth s. 29) 43
39. Notification of adverse effects etc. of goods (Cwlth s.
29A) 43
page ii
Therapeutic Goods (Western Australia) Bill 2000
Contents
40. Notification of adverse effects etc. where application
withdrawn or lapses (Cwlth s. 29B) 44
41. Cancellation of registration or listing (Cwlth s. 30) 44
42. Recovery of wrongly supplied therapeutic goods
(Cwlth s. 30A) 47
43. Recovery etc. of registered or listed goods not
conforming to standards (Cwlth s. 30B) 48
Division 3 -- General
44. Secretary may require information (Cwlth s. 31) 49
45. Commissioner may obtain information about certain
substances and goods 52
46. Inspection and variation of entries in Register (Cwlth
s. 32) 52
47. Publication of list of goods on Register (Cwlth s. 33) 54
Part 4 -- Manufacturing of therapeutic
goods
48. Offences relating to manufacturing and licences
(Cwlth s. 35) 55
49. Application for licence (Cwlth s. 37) 55
50. Grant of licence (Cwlth s. 38) 56
51. Term of licence (Cwlth s. 39) 59
52. Conditions of licences (Cwlth s. 40) 59
53. Revocation and suspension of licences (Cwlth s. 41) 60
54. Publication of list of manufacturers etc. (Cwlth s. 42) 62
Part 5 -- Wholesalers to comply with code of
practice
55. Wholesalers to comply with wholesaling code of
practice 64
Part 6 -- Payment of charges
56. By whom charges payable (Cwlth s. 43) 65
57. Time for payment of charges (Cwlth s. 44) 65
58. Recovery of charges 66
page iii
Therapeutic Goods (Western Australia) Bill 2000
Contents
Part 7 -- Entry, searches and warrants
59. Definitions in this Part (Cwlth s. 45A) 67
60. Searches to monitor compliance with Act (Cwlth s.
46) 67
61. Searches of certain premises to monitor compliance
with Act (Cwlth s. 46A) 68
62. Searches and seizures on public health grounds
(Cwlth s. 46B) 70
63. Searches and seizures related to offences (Cwlth s. 47) 71
64. General powers of authorised persons in relation to
premises (Cwlth s. 48) 72
65. Details of warrants to be given to occupier etc. (Cwlth
s. 48A) 73
66. Announcement before entry (Cwlth s. 48B) 73
67. Use of electronic equipment at premises (Cwlth s.
48C) 74
68. Compensation for damage to electronic equipment
(Cwlth s. 48D) 76
69. Copies of seized things to be provided (Cwlth s. 48E) 77
70. Occupier entitled to be present during search (Cwlth s.
48F) 77
71. Receipts for things seized under warrant (Cwlth s.
48G) 78
72. Retention of seized things (Cwlth s. 48H) 78
73. Magistrate may permit a thing to be retained (Cwlth s.
48J) 79
74. Monitoring warrants (Cwlth s. 49) 80
75. Offence related warrants (Cwlth s. 50) 81
76. Offence related warrants by telephone (Cwlth s. 51) 82
77. Offences relating to warrants (Cwlth s. 51B) 84
Part 8 -- Miscellaneous
78. Identity cards (Cwlth s. 52) 86
79. Indictable offences and forfeiture (Cwlth s. 54) 86
80. Time for bringing prosecutions (Cwlth s. 54A) 87
81. Evidentiary certificate of Commissioner 87
82. Evidentiary certificates of the Secretary (Cwlth s.
56A) 88
83. Provisions relating to evidentiary certificates 89
page iv
Therapeutic Goods (Western Australia) Bill 2000
Contents
84. Conduct by directors, servants and agents (Cwlth s.
55) 90
85. Judicial notice (Cwlth s. 56) 91
86. Delegation by Secretary (Cwlth s. 57) 91
87. Delegation by Commissioner 92
88. Offences under this Act and the Commonwealth Act 92
89. Review of decisions (Cwlth s. 60) 93
90. Regulations (Cwlth s. 63) 93
Part 9 -- Consequential amendments and
transitional provisions
91. Health Act 1911 amended 95
92. Health Amendment Act 1987 amended 96
93. Health (Drugs and Allied Substances)
Regulations 1961 are repealed. 96
94. Transitional arrangements for Part 4 96
95. Transitional arrangements for goods required to be
registered or listed 97
Defined Terms
page v
Western Australia
LEGISLATIVE ASSEMBLY
Therapeutic Goods (Western Australia) Bill
2000
A Bill for
An Act to promote and facilitate the development of a national
system of controls relating to the quality, safety, efficacy and timely
availability of therapeutic goods, and for that purpose to make
provision in Western Australia for the implementation of controls
forming part of such a system complementary, and additional, to the
provision made by the Therapeutic Goods Act 1989 of the
Commonwealth and, as a consequence, to repeal or amend various
written laws.
The Parliament of Western Australia enacts as follows:
page 1
Therapeutic Goods (Western Australia) Bill 2000
Part 1 Preliminary
s. 1
Part 1 -- Preliminary
1. Short title
This Act may be cited as the Therapeutic Goods (Western
Australia) Act 2000.
5 2. Commencement
This Act comes into operation on a day fixed by proclamation.
3. Objects of Act (Cwlth s. 4)
The objects of this Act are --
(a) to promote and facilitate the development of a national
10 system of controls relating to the quality, safety, efficacy
and timely availability of therapeutic goods;
(b) to make provision in Western Australia for the
implementation of controls forming part of such a
system complementary, and additional, to the provision
15 made by the Commonwealth Act.
4. Interpretation (Cwlth s. 3)
(1) In this Act --
"advertisement", in relation to therapeutic goods, includes any
statement, pictorial representation or design, however
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
20 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
page 2
Therapeutic Goods (Western Australia) Bill 2000
Preliminary Part 1
s. 4
therapeutic goods are listed under Part 5 of the
Commonwealth Act;
"annual registration charge" means an amount equal to the
amount of the charge payable by a person in relation to
5 whom therapeutic goods are registered under Part 5 of the
Commonwealth Act;
"authorised person" means --
(a) in relation to any provision of this Act, a person
authorised under section 7(1) or (2) to exercise
10 powers under that provision; or
(b) in relation to a provision of Part 7--
(i) a member of the Police Force of Western
Australia; or
(ii) a member of the Australian Federal Police;
15 "automatic machine" means a machine or mechanical device
used or capable of being used for the purposes of selling or
supplying goods without the personal manipulation or
attention of the seller or supplier, or an agent or employee
of the seller or supplier at the time of that sale or supply;
20 "Commissioner" has the same meaning as it has for the
purposes of the Health Act 1911;
"Commonwealth Act" means the Therapeutic Goods Act 1989
of the Commonwealth;
"Commonwealth Department" means the Department of
25 Health and Aged Care or such other Department of the
Commonwealth as is the relevant Department for the
purposes of the Commonwealth Act;
"Commonwealth Minister" means the Minister administering
the Commonwealth Act;
30 "Commonwealth regulations" means the regulations for the
time being in force under the Commonwealth Act;
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Therapeutic Goods (Western Australia) Bill 2000
Part 1 Preliminary
s. 4
"exempt goods" means --
(a) in relation to a provision of Part 3, therapeutic goods
that are exempt from the operation of Part 3 of the
Commonwealth Act;
5 (b) in relation to a provision of Part 4, therapeutic goods
that are exempt from the operation of Part 4 of the
Commonwealth Act; and
(c) in relation to any provision of this Act, therapeutic
goods that are exempt for the purposes of that
10 provision because of an order under section 9 where
the goods are used, advertised or presented for supply
in the way specified in the order;
"exempt person" means --
(a) in relation to therapeutic goods, a person exempt
15 from the operation of Part 4 of the Commonwealth
Act in relation to those goods; or
(b) in relation to any provision of this Act, a person
exempt from that provision because of an order under
section 9;
20 "gazetted kits group" means a group of kits identified in an
order made under section 16(3A) of the Commonwealth
Act or section 14(4) of this Act;
"gazetted therapeutic devices group" means a group of
therapeutic devices identified in an order made under
25 section 16(3) of the Commonwealth Act or section 14(3) of
this Act;
"gazetted therapeutic goods group" means a group of
therapeutic goods identified in an order made under
section 16(2) of the Commonwealth Act or section 14(2) of
30 this Act;
page 4
Therapeutic Goods (Western Australia) Bill 2000
Preliminary Part 1
s. 4
"grouped therapeutic goods" means therapeutic goods
included in --
(a) a gazetted therapeutic goods group;
(b) a gazetted therapeutic devices group; or
5 (c) a gazetted kits group;
"licence" means a licence under Part 4;
"listable devices" means therapeutic devices that are required
under this Act or the Commonwealth Act to be included in
the part of the Register for listed goods;
10 "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
the goods under section 27 of the Commonwealth Act or
15 section 36 of this Act;
"protected information" has the meaning given in
section 31(2);
"Register" means the Australian Register of Therapeutic Goods
maintained under section 17 of the Commonwealth Act;
20 "registered goods" means therapeutic goods that are included
in the part of the Register for goods known as registered
goods;
"registration number", in relation to registered goods, means
any combination of numbers, symbols and letters assigned
25 to the goods under section 27 of the Commonwealth Act or
section 36 of this Act;
"Secretary" means the Secretary to the Commonwealth
Department;
"sponsor", in relation to therapeutic goods, means a person
30 who, in Western Australia, manufactures the goods, or
arranges for another person to manufacture the goods, for
page 5
Therapeutic Goods (Western Australia) Bill 2000
Part 1 Preliminary
s. 4
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,
5 on behalf of another person who, at the time of the
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 --
10 (a) is specified in an order under section 10 of the
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 --
15 (i) in the case of goods for use in humans, the
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;
20 "supply" includes --
(a) supply by way of sale, exchange, gift, lease, loan,
hire or hire-purchase;
(b) supply, whether free of charge or otherwise, by way
of sample or advertisement;
25 (c) supply, whether free of charge or otherwise, in the
course of testing the safety or efficacy of therapeutic
goods in persons or animals; and
(d) supply by way of administration to, or application in
the treatment of, a person or animal;
page 6
Therapeutic Goods (Western Australia) Bill 2000
Preliminary Part 1
s. 4
"therapeutic device" means therapeutic goods consisting of an
instrument, apparatus, appliance, material or other article
(whether for use alone or in combination), together with
any accessories or software required for its proper
5 functioning, which does not achieve its principal intended
action by pharmacological, chemical, immunological or
metabolic means though it may be assisted in its function
by such means, but the expression does not include
therapeutic goods declared under the Commonwealth Act
10 not to be therapeutic devices;
"therapeutic goods" means goods --
(a) that are represented in any way to be, or that are,
whether because of the way in which the goods are
presented or for any other reason, likely to be taken
15 to be --
(i) for therapeutic use;
(ii) for use as an ingredient or component in the
manufacture of therapeutic goods; or
(iii) for use as a container or part of a container for
20 goods of the kind referred to in
subparagraph (i) or (ii); or
(b) included in a class of goods the sole or principal use
of which is, or ordinarily is, a therapeutic use or a use
of a kind referred to in paragraph (a)(ii) or (iii),
25 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
order in force under that section or under an order
30 under section 9 of this Act;
(d) goods in respect of which such an order is in force,
being an order that declares the goods not to be
page 7
Therapeutic Goods (Western Australia) Bill 2000
Part 1 Preliminary
s. 4
therapeutic goods when used, advertised or presented
for supply in the way specified in the order where the
goods are used, advertised or presented for supply in
that way;
5 (e) goods for which there is a prescribed standard in the
Australian New Zealand Food Standards Code as
defined in section 3(1) of the Australia New Zealand
Food Authority Act 1991 of the Commonwealth; or
(f) goods which, in Australia or New Zealand, have a
10 tradition of use as foods for humans in the form in
which they are presented;
"therapeutic use" means use in or in connection with --
(a) preventing, diagnosing, curing or alleviating a
disease, ailment, defect or injury in persons or
15 animals;
(b) influencing, inhibiting or modifying a physiological
process in persons or animals;
(c) testing the susceptibility of persons or animals to a
disease or ailment;
20 (d) influencing, controlling or preventing conception in
persons;
(e) testing for pregnancy in persons; or
(f) the replacement or modification of parts of the
anatomy in persons or animals.
25 (2) For the purposes of this Act --
(a) therapeutic goods are to be taken to be for use in
animals if --
(i) the goods bear a name or description that
indicates, or is likely to give the impression, that
30 the goods are intended for use in animals and are
not intended for use in humans; or
page 8
Therapeutic Goods (Western Australia) Bill 2000
Preliminary Part 1
s. 4
(ii) the goods are otherwise represented, or otherwise
purport, to be intended for use in animals and not
intended for use in humans;
and
5 (b) therapeutic goods are to be taken to be for use in
humans if they are not solely for use in animals.
(3) 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,
10 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;
(b) if a name applied to the goods is the same as the name
15 applied to other therapeutic goods that are supplied in
Western Australia where those other goods contain
additional or different therapeutically active ingredients;
(c) if the label of the goods does not declare the presence of
a therapeutically active ingredient;
20 (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.
25 (4) A word or expression used in this Act has the same meaning as
in the Commonwealth Act unless --
(a) this Act gives it another meaning; or
(b) the contrary intention appears in some other way.
(5) Notes in this Act are provided to assist understanding and do not
30 form part of this Act.
page 9
Therapeutic Goods (Western Australia) Bill 2000
Part 1 Preliminary
s. 5
5. Act to bind Crown (Cwlth s. 5)
(1) This Act binds the Crown in right of Western Australia and, so
far as the legislative power of Parliament permits, the Crown in
all its other capacities.
5 (2) Nothing in this Act renders the Crown in any of its capacities
liable to be prosecuted for an offence.
6. This Act in addition to other written laws relating to
therapeutic goods
If another written law relates to therapeutic goods that law
10 applies in addition to this Act, unless a written law expressly
provides otherwise.
7. Authorised persons (Cwlth s. 7A)
(1) The Commissioner may, in writing, authorise any person to
exercise powers under a specified provision of this Act.
15 (2) A person who is an authorised person under the Commonwealth
Act in respect of a provision of that Act is authorised to exercise
powers under the corresponding provision of this Act.
(3) In subsection (2) --
"corresponding provision" in relation to a section of the
20 Commonwealth Act referred to in the heading to a section
of this Act, means that section of this Act, unless otherwise
prescribed.
8. Secretary may approve or authorise the supply of certain
therapeutic goods (Cwlth s. 19)
25 (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
page 10
Therapeutic Goods (Western Australia) Bill 2000
Preliminary Part 1
s. 8
(b) for use solely for experimental purposes in humans.
(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
5 be made for the supply of the therapeutic goods to which
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
10 to in subsection (1)(a), must be accompanied by such
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) --
15 (i) must be made in writing;
(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
20 amount equal to the evaluation fee prescribed for
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
25 within 28 days of making the decision and, in the case of a
decision not to grant the approval, of the reasons for the
decision.
page 11
Therapeutic Goods (Western Australia) Bill 2000
Part 1 Preliminary
s. 9
(5) The Secretary may, in writing, authorise an approved medical
practitioner to supply --
(a) specified therapeutic goods for use in the treatment of
humans; or
5 (b) a specified class of such goods,
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.
10 (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 --
15 "approved medical practitioner" means a medical practitioner
registered under the Medical Act 1894 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
20 under subsection (5) does not render the Commonwealth, the
State, the Secretary or a delegate of the Secretary liable to a
person in respect of loss, 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.
25 9. Power of Minister to exempt
(1) The Minister may, by order published in the Gazette --
(a) exempt --
(i) any person or class of persons; or
(ii) any goods or class of goods,
page 12
Therapeutic Goods (Western Australia) Bill 2000
Preliminary Part 1
s. 10
specified in the order from all provisions of this Act, or
from such provisions of this Act as are specified in the
order; or
(b) declare that goods are exempt goods for the purposes of
5 a provision of this Act when those goods are used,
advertised or presented for supply in the way specified
in the order.
(2) An order under this section is subject to such conditions, if any,
as are specified in the order.
10 10. Kits (Cwlth s. 7B)
(1) A package and therapeutic goods in the package together
constitute a kit for the purposes of this Act if --
(a) the package and the therapeutic goods are for use as a unit;
(b) each item of the therapeutic goods consists of goods that
15 are registered or listed or are therapeutic goods that are
exempt from the operation of Part 3 of the
Commonwealth Act; and
(c) the package and therapeutic goods do not constitute a
composite pack.
20 (2) A package and therapeutic goods in the package together
constitute a composite pack if --
(a) the therapeutic goods are of 2 or more kinds;
(b) the package does not contain any therapeutic devices;
(c) the therapeutic goods are for administration as a single
25 treatment or as a single course of treatment; and
(d) it is necessary that the therapeutic goods be combined
before administration or that they be administered in a
particular sequence.
page 13
Therapeutic Goods (Western Australia) Bill 2000
Part 1 Preliminary
s. 11
(3) To avoid doubt, it is declared that a kit constitutes therapeutic
goods.
11. Power to obtain information with respect to therapeutic
goods (Cwlth s. 8)
5 (1) The Secretary may, by notice in writing given to a person who
has supplied in Western Australia --
(a) therapeutic goods; or
(b) goods in relation to which the Secretary is considering
making a declaration under section 7 of the
10 Commonwealth Act,
request the person to give to an officer of the Commonwealth
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
15 use or labelling of the goods or concerning advertising material
relating to the goods.
(2) A notice under subsection (1) may require the information to be
given --
(a) in writing; or
20 (b) in accordance with specified software requirements --
(i) on a specified kind of data processing device; or
(ii) by way of a specified kind of electronic
transmission.
(3) A person must not, without reasonable excuse, fail to comply
25 with a notice given to the person under subsection (1).
(4) A person must not, in purported compliance with a notice under
subsection (1), make a statement that is false or misleading in a
material particular if the person knows, or ought reasonably to
page 14
Therapeutic Goods (Western Australia) Bill 2000
Preliminary Part 1
s. 11
know, that the statement is false or misleading in a material
particular.
Penalty: $10 000.
page 15
Therapeutic Goods (Western Australia) Bill 2000
Part 2 Standards
s. 12
Part 2 -- Standards
12. Compliance with standards (Cwlth s. 14)
(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: $25 000.
(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. (Cwlth s. 15)
(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) A person who breaches a condition of such a consent commits
20 an offence.
Penalty: $15 000.
page 16
Therapeutic Goods (Western Australia) Bill 2000
Australian register of therapeutic goods Part 3
Preliminary Division 1
s. 14
Part 3 -- Australian register of therapeutic goods
Division 1 -- Preliminary
14. Therapeutic goods and gazetted groups (Cwlth s. 16)
(1) For the purposes of this Part, therapeutic goods are to be taken
5 to be separate and distinct from other therapeutic goods if they
have --
(a) a different formulation, composition or design
specification;
(b) a different strength or size (disregarding pack size);
10 (c) a different dosage form or model;
(d) a different name;
(e) different indications;
(f) different directions for use; or
(g) a different type of container (disregarding container
15 size).
(2) The Secretary may, by order published in the Commonwealth of
Australia Gazette, determine that a group of therapeutic goods
(not being therapeutic devices) identified in the order is a
gazetted therapeutic goods group because the goods within the
20 group have common characteristics.
(3) The Secretary may, by order published in the Commonwealth of
Australia Gazette, determine that a group of therapeutic goods
(being therapeutic devices) identified in the order is a gazetted
therapeutic devices group because the goods within the
25 group --
(a) have common characteristics; and
(b) have been produced by the same manufacturer.
page 17
Therapeutic Goods (Western Australia) Bill 2000
Part 3 Australian register of therapeutic goods
Division 1 Preliminary
s. 15
(4) The Secretary may, by order published in the Commonwealth of
Australia Gazette, determine that a group of kits identified in the
order is a gazetted kits group.
(5) An order under subsection (2), (3) or (4) may make provision
5 for or in relation to a matter by applying, adopting or
incorporating, with or without modification, a document as in
force from time to time, if the document is --
(a) published by the Commonwealth Department (whether
in electronic form or otherwise);
10 (b) available for sale to the public; and
(c) available for inspection (whether by using a visual
display unit or otherwise) by the public at offices of the
Commonwealth Department specified by the Secretary
in the order.
15 (6) The Secretary may, by order published in the Commonwealth of
Australia Gazette, amend or revoke an order made under this
section.
15. Offences relating to manufacture and supply of therapeutic
goods (Cwlth s. 20)
20 (1) A person must not --
(a) manufacture in Western Australia therapeutic goods for
use in humans; or
(b) supply therapeutic goods in Western Australia for use in
humans;
25 unless --
(c) the goods are registered goods or listed goods in relation
to the person;
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(d) the goods are exempt goods or are the subject of an
approval or authority under section 19 of the
Commonwealth Act or section 8 of this Act; or
(e) the goods are the subject of an approval under
5 section 19A of the Commonwealth Act.
Penalty: $25 000.
(2) It is a defence to a prosecution under subsection (1) if the
defendant proves that the defendant was not a sponsor of the goods
at the time of the manufacture or supply, as the case may be.
10 (3) A person in relation to whom therapeutic goods are registered or
listed must not supply those goods in 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
15 prescribed under the Commonwealth Act; or
(b) the goods are devices that are listed goods.
Penalty: $10 000.
16. Offence relating to supply of unregistered or unlisted goods
(Cwlth s. 21)
20 A person must not supply in Western Australia therapeutic goods
for use in humans (other than 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;
(b) the goods are exempt goods or are the subject of an
25 approval or authority under section 19 of the
Commonwealth Act or under section 8 of this Act; or
(c) the goods are the subject of an approval under
section 19A of the Commonwealth Act.
Penalty: $15 000.
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17. Hawking of therapeutic goods
A person must not supply unsolicited therapeutic goods in a
street, by mail or from house to house other than in accordance
with --
5 (a) the written approval of the Commissioner; or
(b) the regulations.
Penalty: $1 000.
18. Supply by automatic machine
(1) Subject to the regulations, a person must not whether in
10 premises under his or her control or elsewhere --
(a) install an automatic machine for the supply of
therapeutic goods; or
(b) supply therapeutic goods by means of an automatic
machine.
15 (2) Subject to the regulations, a person must not permit an
automatic machine for the supply of therapeutic goods to be
installed on premises owned or occupied by that person.
(3) Subject to the regulations, a person must not permit therapeutic
goods to be placed in an automatic machine under that person's
20 control.
Penalty: $1 000.
19. General offences relating to this Part (Cwlth s. 22)
(1) A person must not set out or cause to be set out, on a container
or package that contains therapeutic goods or on a label of
25 goods of that kind, a number that purports to be the registration
number or listing number of the goods in relation to a particular
person if the number is not that number and the person knows,
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or ought reasonably to know, that the number is not that
number.
(2) A person must not, in or in connection with an application for
listing of therapeutic goods make a statement that is false or
5 misleading in a material particular if the person knows, or ought
reasonably to know, that the statement is false or misleading in
a material particular.
(3) A person in relation to whom therapeutic goods are registered or
listed must not breach a condition of the registration or listing of
10 the goods.
(4) A person must not --
(a) represent therapeutic goods that the person knows, or
ought reasonably to know, are not included in the
Register as being so included;
15 (b) represent therapeutic goods that the person knows, or
ought reasonably to know, are not exempt goods as
being exempt goods;
(c) represent therapeutic goods that the person knows, or
ought reasonably to know, are included in one part of
20 the Register as being included in the other part of the
Register;
(d) represent therapeutic goods that the person knows, or
ought reasonably to know, are not the subject of an
approval or authority under section 19 of the
25 Commonwealth Act or section 8 of this Act, as being the
subject of such an approval of authority; or
(e) represent therapeutic goods that the person knows, or
ought reasonably to know, are not the subject of an
approval under section 19A of the Commonwealth Act
30 as being the subject of such an approval.
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(5) A person, being the sponsor of therapeutic goods that are
included in the Register, must not, by any means, advertise the
goods for an indication other than those that the person knows,
or ought reasonably to know, are accepted in relation to the
5 inclusion of the goods in the Register.
(6) A person must not make a claim, by any means, that the person
or another person can arrange the supply of therapeutic goods
(not being exempt goods) that the person knows, or ought
reasonably to know, are not registered goods or listed goods.
10 (7) A person must not breach a condition of --
(a) an exemption applicable under regulations made for the
purposes of section 18(1) of the Commonwealth Act;
(b) an approval under section 19 of the Commonwealth Act;
(c) an approval under section 19A of the Commonwealth
15 Act; or
(d) an approval under section 8 of this Act.
(8) A person to whom an authority under section 19(5) of the
Commonwealth Act or under section 8(5) of this Act has been
granted must not supply the therapeutic goods to which the
20 authority relates except in accordance with --
(a) the authority; and
(b) any regulations made for the purpose of section 19(7) of
the Commonwealth Act.
(9) A person must not use therapeutic goods that the person knows,
25 or ought reasonably to know, are not either exempt goods, listed
goods, registered goods or goods the subject of an approval
under section 19A of the Commonwealth Act --
(a) for use in the treatment of another person; or
(b) for use solely for experimental purposes in humans,
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except in accordance with an approval or authority under
section 19 of the Commonwealth Act or under section 8 of this
Act.
Penalty: $10 000.
5 20. Offence to supply therapeutic goods for use in humans after
expiry date, unless authorised by the Commissioner
A person must not supply therapeutic goods for use in humans
after the expiry date that is, in accordance with a standard that is
applicable to the goods, stated on or in relation to the goods,
10 other than in accordance with the written approval of the
Commissioner.
Penalty: $2 000.
21. Offence to use certain therapeutic devices without authority
A person must not use a therapeutic device of a type prescribed
15 for the purposes of this section other than in accordance with an
authorisation given by the Commissioner in accordance with the
regulations.
Penalty: $5 000.
22. False statements in applications for registration
20 (Cwlth s. 22A)
A person must not, in or in connection with an application for
registration of therapeutic goods, make a statement that is false
or misleading in a material particular if the person knows, or
ought reasonably to know, that the statement is false or
25 misleading in a material particular.
Penalty: $40 000.
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Division 2 -- Registration and listing
23. Applications generally (Cwlth s. 23)
(1) An application for registration or listing of therapeutic goods
must --
5 (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.
10 (2) An application is not effective unless --
(a) an application fee of an amount equal to the prescribed
application fee under section 23 of the Commonwealth
Act has been paid;
(b) the applicant has delivered to the office to which the
15 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
to the office to which the application was made a
20 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 --
(a) on a specified kind of data processing device; or
25 (b) by way of a specified kind of electronic transmission.
24. Applications for registration (Cwlth s. 24)
(1) Where an application is made for the registration of therapeutic
goods in accordance with section 23 and the goods are goods
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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
5 applicant in respect of the evaluation of the goods for
registration, and the Secretary must notify each such applicant
of the amount of the evaluation fee.
(2) Subject to section 28 of this Act, an application for registration
of therapeutic goods lapses if --
10 (a) any part of the evaluation fee payable in respect of those
goods remains unpaid at the end of the period of
2 months after the day on which the amount became due
and payable;
(b) the application contains information that is inaccurate or
15 misleading in a material particular;
(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 44 of this Act, is inaccurate or
20 misleading in a material particular; or
(d) the applicant fails to comply with a requirement under
section 44 of this Act to give information consisting of
individual patient data in relation to the goods.
(3) In this section --
25 "individual patient data", in relation to therapeutic goods,
means information, derived from clinical 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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25. When evaluation fee due for payment (Cwlth s. 24A)
Subject to sections 26 and 28, an evaluation fee under
section 24 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.
26. Payment of evaluation fee by instalments (Cwlth s. 24B)
(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 24 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 24 of this Act in
20 circumstances of that kind by instalments.
(3) Subsection (2) does not limit the generality of subsection (1).
27. Recovery of evaluation fee (Cwlth s. 24C)
An evaluation fee under section 24 may be recovered by the
Commonwealth as a debt due to the Commonwealth.
25 28. Reduction of evaluation fee where evaluation not completed
within prescribed period (Cwlth s. 24D)
(1) This section applies to an application under section 23 of this
Act in relation to therapeutic goods for the evaluation of which
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s. 29
a period is prescribed under section 63(2)(da) of the
Commonwealth Act.
(2) Nothing in section 24, 25 or 26 of this Act requires the
applicant to pay more than three-quarters of the evaluation fee
5 before the completion of the evaluation of the goods.
(3) If the evaluation is not completed within the period referred to
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
10 section 24 of the Commonwealth Act, would have been the
evaluation fee.
(4) If --
(a) the evaluation is completed within the period referred to
in subsection (1); and
15 (b) part of the evaluation fee is unpaid when the evaluation
is completed,
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
20 to be taken to be completed when the applicant is notified
according to section 30(3)(a) of the Secretary's decision on the
application.
29. Deemed refusal of application (Cwlth s. 24E)
(1) This section applies in the case of an application under
25 section 23 of this Act in relation to therapeutic goods for the
evaluation of which a period is prescribed under
section 63(2)(da) of the Commonwealth Act.
(2) If the evaluation is not completed within the period referred to
in subsection (1), the applicant may give the Secretary written
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s. 30
notice that the applicant wishes to treat the application as having
been refused.
(3) A notice under subsection (2) may be given at any time before
the evaluation is completed.
5 (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.
30. Evaluation and registration of therapeutic goods
(Cwlth s. 25)
10 (1) Where --
(a) an application is made for the registration of therapeutic
goods in relation to a person in accordance with section 23
of this Act;
(b) there is no part of an evaluation fee under section 24 of
15 this Act in 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
20 the Secretary under section 44 of this Act in relation to
the goods,
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
25 satisfactorily established;
(e) whether the presentation of the goods is acceptable;
(f) whether the goods conform to any standard applicable to
the goods, or any requirements relating to advertising
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applicable to goods of that kind under the
Commonwealth regulations;
(g) if a step in the manufacture of the goods has been
carried out outside Australia, whether the manufacturing
5 and quality control procedures used in the manufacture
of the goods are acceptable;
(h) if the goods have been manufactured in Western
Australia, whether the goods have been manufactured in
accordance with Part 4 of the Commonwealth Act or
10 Part 4 of this Act;
(i) whether the goods contain substances that are prohibited
imports for the purposes of the Customs Act 1901 of the
Commonwealth; and
(j) such other matters (if any) as the Secretary considers
15 relevant.
Note: The Secretary must not use protected information when evaluating
therapeutic goods for registration: see section 31 of this Act.
(2) In making a decision for the purposes of subsection (1)(g), the
matters that may be taken into account include --
20 (a) whether the applicant has provided --
(i) if the goods are not therapeutic devices and a
step in the manufacture of the goods has been
carried out in a country that is a member of the
European Community, a conformity assessment
25 certificate in relation to the goods; or
(ii) in any other case, an acceptable form of evidence
from a relevant overseas authority establishing
that the manufacture of the goods is of an
acceptable standard;
30 and
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s. 30
(b) whether the applicant has agreed to provide, where the
Secretary considers inspection of the manufacturing
procedures used in the manufacture of the goods to be
necessary --
5 (i) funds for the carrying out of that inspection by
the Commonwealth Department; and
(ii) evidence that the manufacturer has agreed to
such an inspection.
(3) An evaluation under this section of goods in relation to which a
10 period has been prescribed under section 63(2)(da) of the
Commonwealth Act must be completed within that period.
(4) If therapeutic goods are exempt from the operation of Part 4 of
the Commonwealth Act or Part 4 of this Act or a person is
exempt from the operation of either or both of those Parts in
15 relation to the manufacture of the goods, subsection (1) has
effect, in relation to the goods, as if paragraph (h) were omitted.
(5) If a person is exempt from the operation of Part 4 of the
Commonwealth Act or Part 4 of this Act in relation to a step in
the manufacture of therapeutic goods, subsection (1) has effect,
20 in relation to the goods, as if the reference in paragraph (h) to
those Parts were a reference to those Parts to the extent that they
apply to that person in relation to the manufacture of the goods.
(6) A decision for the purposes of paragraph (1)(g) may also take
into account any information provided to the Secretary by a
25 health authority of a Convention country and relating to --
(a) the general standards of manufacturing practice of a
particular manufacturer; or
(b) the specific standards of manufacture or control adopted
by a particular manufacturer in relation to particular
30 goods.
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(7) For the purposes of subsection (6), a Convention country is a
country that is a party to the Mutual Recognition Convention.
(8) Information referred to in subsection (6) and provided in
accordance with the Mutual Recognition Convention is to be
5 treated as equivalent to information obtained as a result of an
inspection under Part 4 of this Act.
(9) After therapeutic goods have been evaluated for registration, the
Secretary must --
(a) notify the applicant in writing of his or her decision on
10 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
15 registration.
(10) The registration of therapeutic goods commences on the day
specified for the purpose in the certificate of registration.
(11) The failure to complete an evaluation within the period
mentioned in subsection (3) does not render the
20 Commonwealth, the State, the Secretary or a delegate of the
Secretary liable to a person in respect of loss, damage or injury
of any kind caused by, or arising out of, the failure.
31. When the Secretary must not use protected information
(Cwlth s. 25A)
25 (1) If evaluating therapeutic goods for registration, the Secretary
must not use information about other therapeutic goods that is
protected information.
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(2) In this section --
"protected information", in relation to therapeutic goods,
means --
(a) that the information is protected information within
5 the meaning of the Commonwealth Act; or
(b) that --
(i) the information was given by the Secretary in
relation to an application to register
therapeutic goods (the "new goods") to which
10 this Act applies --
(I) not being therapeutic devices; and
(II) consisting of, or containing, an active
component;
(ii) the information is about the active component
15 and is not available to the public;
(iii) when the application to register the new goods
was lodged --
(I) no other therapeutic goods consisting
of, or containing, that active
20 component were included in the
Register; and
(II) no such therapeutic goods had been
included in the Register at any time
before then;
25 (iv) 5 years have not passed since the goods
became registered; and
(v) the person in relation to whom the new goods
are registered has not given the Secretary
permission in writing for the Secretary to use
30 the information.
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(3) For the purposes of subsection (2) --
"active component", in relation to therapeutic goods, means a
substance that is, or one of the substances that together are,
primarily responsible for the biological or other effect
5 identifying the goods as therapeutic goods.
(4) The use of protected information contrary to subsection (1) does
not render the Commonwealth, the State, the Secretary or a
delegate of the Secretary liable to a person in respect of loss,
damage or injury of any kind suffered as a result of, or arising
10 out of, the use of that information.
32. Registration of therapeutic device to which conformity
assessment certificate applies (Cwlth s. 25B)
(1) If --
(a) an application is made in accordance with section 23 for
15 the registration of a therapeutic device in relation to a
person; and
(b) the applicant gives to the Secretary a conformity
assessment certificate as to the matters that would
require evaluation under section 30(1) if that section
20 applied in relation to the device,
then the Secretary must register the device unless the Secretary
considers that the device may compromise the health or safety
of users.
(2) The Secretary must notify the applicant in writing of his or her
25 decision on the application within 28 days of the making of the
decision and, if the Secretary decides not to register the device,
the notice must contain the reasons for that decision.
(3) If the Secretary decides to register the device, the Secretary
must --
30 (a) include the device in the Register; and
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s. 33
(b) give to the applicant a certificate of registration.
(4) The registration of the device commences on the day specified
for the purpose in the certificate of registration.
33. Listing of therapeutic goods (Cwlth s. 26)
5 (1) If --
(a) an application is made in accordance with section 23 of
this Act for the listing of therapeutic goods in relation to
a person;
(b) the applicant has complied with any requirements made
10 by the Secretary under section 44 of this Act in relation
to the goods; and
(c) the goods are not goods which may be listed under
section 35 of this Act,
then, subject to section 34 of this Act, the Secretary must not
15 refuse to list the goods in relation to the person unless the
Secretary is satisfied that --
(d) the goods are not eligible for listing;
(e) the goods are not safe for the purposes for which they
are to be used;
20 (f) the presentation of the goods is unacceptable;
(g) the goods do not conform to a standard applicable to the
goods or to a requirement relating to advertising
applicable to goods of that kind under the
Commonwealth regulations;
25 (h) if a step in the manufacture of the goods (not being
therapeutic devices other than devices prescribed under
the Commonwealth Act) for the purposes of
section 26(1)(g) of the Commonwealth Act has been
carried out outside Australia, the manufacturing and
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quality control procedures used in the manufacture of
the goods are not acceptable;
(i) if the goods have been manufactured in Western
Australia, the goods have been manufactured contrary to
5 Part 4 of the Commonwealth Act or Part 4 of this Act;
(j) the goods do not comply with quality or safety criteria
prescribed under the Commonwealth Act; or
(k) the goods contain substances that are prohibited imports
for the purposes of the Customs Act 1901 of the
10 Commonwealth.
(2) In making a decision for the purposes of subsection (1)(h), the
matters that may be taken into account include --
(a) whether the applicant has provided --
(i) if the goods are not therapeutic devices and a
15 step in the manufacture of the goods has been
carried out in a country that is a member of the
European Community, a conformity assessment
certificate in relation to the goods; or
(ii) in any other case, an acceptable form of evidence
20 from a relevant overseas authority establishing
that the manufacture of the goods is of an
acceptable standard;
and
(b) whether the applicant has agreed to provide, where the
25 Secretary considers inspection of the manufacturing
procedures used in the manufacture of the goods to be
necessary --
(i) funds for the carrying out of that inspection by
the Commonwealth Department; and
30 (ii) evidence that the manufacturer has agreed to
such an inspection.
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(3) If therapeutic goods are exempt from the operation of Part 4 of
the Commonwealth Act or Part 4 of this Act or a person is
exempt from the operation of either or both of those Parts in
relation to the manufacture of the goods, subsection (1) has
5 effect, in relation to the goods, as if paragraph (i) were omitted.
(4) If a person is exempt from the operation of Part 4 of the
Commonwealth Act or Part 4 of this 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 (i) to
10 those Parts were a reference to those Parts to the extent that they
apply to that person in relation to the manufacture of the goods.
(5) A decision for the purposes of subsection (1)(h) may also take
into account any information provided to the Secretary by a
health authority of a Convention country and relating to --
15 (a) the general standards of manufacturing practice of a
particular manufacturer; or
(b) the specific standards of manufacture or control adopted
by a particular manufacturer in relation to particular
goods.
20 (6) For the purposes of subsection (5), a Convention country is a
country that is a party to the Mutual Recognition Convention.
(7) Information referred to in subsection (5) and provided in
accordance with the Mutual Recognition Convention is to be
treated as equivalent to information obtained as a result of an
25 inspection under Part 4 of this Act.
(8) 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.
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(9) As soon as practicable after an applicant has been informed that
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
5 the goods commences on the day specified for the purpose in
the certificate.
34. Listing of therapeutic devices to which conformity
assessment certificate applies (Cwlth s. 26AA)
(1) If --
10 (a) an application is made in accordance with section 23 for
the listing of a therapeutic device in relation to a person;
and
(b) the applicant gives to the Secretary a conformity
assessment certificate as to the matters specified in
15 section 33(1)(d) to (k) in relation to the device,
then the Secretary must list the device in relation to the person
unless the Secretary considers that the device may compromise
the health or safety of users.
(2) The Secretary must notify the applicant in writing of his or her
20 decision within 28 days of the making of the decision and if the
Secretary decides not to list the device, the notice must contain
the reasons for that decision.
(3) If the Secretary decides to list the device, the Secretary must --
(a) include the device in the Register; and
25 (b) give to the applicant a certificate of listing.
(4) The listing of the device commences on the day specified for the
purpose in the certificate of listing.
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35. Listing of certain types of therapeutic goods (Cwlth s. 26A)
(1) If --
(a) an application is made in accordance with section 23 of
this Act for the listing of therapeutic goods in relation to
5 a person;
(b) the applicant has complied with any requirements made
by the Secretary under section 44 of this Act in relation
to the goods;
(c) the requirements of subsection (2) and, where
10 applicable, subsection (3) have been complied with; and
(d) the goods are not --
(i) therapeutic devices; or
(ii) device kits within the meaning of the regulations
made for the purposes of section 26A(1)(d)(iv)
15 of the Commonwealth Act,
then the Secretary is not to refuse to list the goods in relation to
the person.
(2) The applicant must certify that --
(a) the goods are eligible for listing;
20 (b) the goods are safe for the purpose for which they are to
be used;
(c) the presentation of the goods is not unacceptable;
(d) the goods conform to every standard, if any, applicable
to the goods and to every requirement, if any, relating to
25 advertising applicable under the regulations made under
the Commonwealth Act or this Act;
(e) if the goods have been manufactured in Western
Australia, each step in the manufacturing process has
been carried out by a person who is the holder of a
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s. 35
licence to carry out that step granted under section 38 of
the Commonwealth Act or section 50 of this Act;
(f) the goods comply with all quality of safety criteria
prescribed under the Commonwealth Act;
5 (g) the goods do not contain substances that are prohibited
imports for the purposes of the Customs Act 1901 of the
Commonwealth; and
(h) the information included in or with the application is
correct.
10 (3) If a step in the manufacture of the goods has been carried out
outside Australia, the Secretary must have certified, prior to the
application being made, that the manufacturing and quality
control procedures used in each such step are acceptable.
(4) In deciding whether so to certify for the purposes of subsection (3),
15 the matters that may be taken into account include --
(a) whether the applicant has provided --
(i) if the goods are not therapeutic devices and a
step in the manufacture of the goods has been
carried out in a country that is a member of the
20 European Community, a conformity assessment
certificate in relation to the goods; or
(ii) in any other case, an acceptable form of evidence
from a relevant overseas authority establishing
that the manufacture of the goods is of an
25 acceptable standard;
and
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(b) whether the applicant has agreed to provide, if the
Secretary considers inspection of the manufacturing
procedures used in the manufacture of the goods to be
necessary --
5 (i) funds for the carrying out of that inspection by
the Department; and
(ii) evidence that the manufacturer has agreed to
such an inspection.
(5) If therapeutic goods are exempt from the operation of Part 4 of
10 the Commonwealth Act or Part 4 of this Act or a person is
exempt from either or both of those Parts in relation to the
manufacture of the goods, subsection (2) has effect, in relation
to the goods, as if paragraph (e) were omitted.
(6) If a person ("the manufacturer") is exempt from the operation
15 of Part 4 of the Commonwealth Act or Part 4 of this Act in
relation to a step in the manufacture of therapeutic goods,
subsection (2) has effect in relation to the goods, as if the
reference in paragraph (e) to a person who is the holder of a
licence were a reference to the manufacturer to the extent those
20 Parts apply to the manufacture of the goods.
(7) 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.
25 (8) As soon as practicable after an applicant has been informed that
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
30 the certificate.
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s. 36
36. Registration or listing number (Cwlth s. 27)
(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.
5 (2) Where the Secretary includes grouped therapeutic goods in the
Register, the Secretary is to assign a single, unique registration
or listing number to the grouped therapeutic goods.
37. Conditions on registration or listing (Cwlth s. 28)
(1) Where the Secretary includes therapeutic goods in the Register
10 in relation to a person the Secretary may, in writing, impose
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;
(b) the custody, use, supply, disposal or destruction of the
15 goods;
(c) the keeping of records relating to the goods;
(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
20 thinks appropriate.
(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.
25 (4) The Secretary's power under subsection (3) may be exercised at
the request of the person concerned or of the Secretary's own
motion.
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(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
imminent risk of death, serious illness or serious injury,
5 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.
(6) In addition to any conditions imposed under subsection (1) or
10 (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 --
(i) to enter, at any reasonable time, premises at
15 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
20 (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.
(7) If --
25 (a) in, or in connection with, an application for the listing of
therapeutic goods, a claim is made by the applicant in
relation to the goods; and
(b) the claim is included in the Register in respect of the
goods,
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then the listing of the goods is subject to the following
conditions --
(c) a condition that the sponsor of the goods had, at the time
when the claim was made, information or evidence that
5 supported the claim and complied with the requirements,
if any, of the Commonwealth regulations;
(d) a condition that the sponsor retains the information or
evidence at all times while the goods remain listed; and
(e) a condition that, at any time while the goods remain
10 listed, the sponsor will, if asked by the Secretary, give
information or evidence to the Secretary.
38. Duration of registration or listing (Cwlth s. 29)
Where goods are included in the Register in relation to a person,
the goods remain so included until their registration or listing is
15 cancelled under this Part.
39. Notification of adverse effects etc. of goods (Cwlth s. 29A)
(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
20 information to the Secretary in writing.
Penalty: $40 000.
(2) The information with which subsection (1) is concerned is
information of the following kinds:
(a) information that contradicts information already
25 furnished by the person under this Act;
(b) information that indicates that the use of the goods in
accordance with the recommendations for their use may
have an unintended harmful effect;
(c) information that indicates that the goods, when used in
30 accordance with the recommendations for their use, may
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s. 40
not be as effective as the application for registration of
the goods or information already furnished by the person
under this Act suggests.
40. Notification of adverse effects etc. where application
5 withdrawn or lapses (Cwlth s. 29B)
(1) If an application for registration of goods is withdrawn or
lapses, the Secretary may give the applicant written notice
requiring the applicant --
(a) to inform the Secretary in writing whether the applicant
10 is aware of any information of a kind mentioned in
section 39(2) relating to the goods; and
(b) if the applicant is aware of such information, to give the
information to the Secretary in writing.
(2) Notice under subsection (1) may be given within 14 days after
15 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 person.
(4) A person must not, in purporting to comply with a notice under
subsection (1), provide information that is false or misleading in
20 a material particular if the person knows, or ought reasonably to
know, that the information is false or misleading in a material
particular.
Penalty: $40 000.
41. Cancellation of registration or listing (Cwlth s. 30)
25 (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 --
(a) it appears to the Secretary that failure to cancel the
registration or listing would create an imminent risk of
30 death, serious illness or serious injury;
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(b) the goods become exempt goods;
(c) the person requests in writing the cancellation of the
registration or listing;
(d) the goods contain substances that are prohibited imports
5 for the purposes of the Customs Act 1901 of the
Commonwealth; or
(e) in the case of goods listed under section 35, it appears to
the Secretary that any of the certifications under
section 35(2)(a), (e) or (g) are incorrect.
10 (2) Subject to subsection (3), 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 --
(a) it appears to the Secretary that the quality, safety or
15 efficacy of the goods is unacceptable;
(b) the goods have changed so that they have become
separate and distinct from the goods as so included;
(c) in the case of goods listed under section 35, it appears to
the Secretary that any of the certifications under section
20 35(2)(b), (c), (d), (f) or (h) are incorrect;
(d) the sponsor has refused or failed to comply with a
condition to which the inclusion of the goods is subject;
(e) the person has contravened section 39(1) in relation to
the goods;
25 (f) the goods become required to be included in the other
part of the Register;
(g) the goods do not conform to a standard applicable to the
goods or to a requirement relating to advertising
applicable to goods of that kind under the
30 Commonwealth regulations or regulations made under
this Act; or
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(h) the annual registration or listing charge is not paid
within 28 days after it becomes payable.
(3) Where the Secretary proposes to cancel the registration or
listing of goods in relation to a person under subsection (2)
5 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
to cancel that registration or listing and set out the
reasons for that proposed action; and
10 (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
subsection (3)(b), the Secretary is not to make a decision
15 relating to the cancellation until the Secretary has taken the
submissions into account.
(5) The Secretary must, by notice in writing given to a person in
relation to whom therapeutic goods are included in the Register,
cancel the registration of the goods if the Secretary becomes
20 aware that protected information was used when evaluating the
goods for registration.
(6) Where the Secretary cancels the registration or listing of goods
in relation to a person, the goods cease to be registered or
listed --
25 (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
notice.
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(7) Where the Secretary cancels the registration or listing of goods
in relation to a person, the Secretary --
(a) may, in writing, impose on the person one or both of the
following requirements --
5 (i) to inform the public, or a specified class of
persons, in the specified manner and within such
reasonable period as is specified, of the
cancellation;
(ii) to take steps to recover any of the goods that
10 have been distributed;
and
(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
15 cancellation.
(8) A person who refuses or fails to comply with a requirement
under subsection (7)(a) commits an offence.
Penalty: $10 000.
42. Recovery of wrongly supplied therapeutic goods
20 (Cwlth s. 30A)
(1) This section applies if --
(a) any person supplies therapeutic goods; and
(b) the goods are not registered goods, listed goods, exempt
goods, goods that are the subject of an approval or
25 authority under section 19 of the Commonwealth Act or
under section 8 of this Act, goods that are the subject of
an approval under section 19A of the Commonwealth
Act or an exemption under section 9 of this Act.
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(2) The Secretary may, in writing, impose on the sponsor of the
goods one or both of the following requirements --
(a) to inform the public or a specified class of persons, in
the specified manner and within such reasonable period
5 as is specified, that the goods have been wrongly
supplied;
(b) to take steps to recover any of the goods that have been
distributed.
(3) The Secretary must cause to be published in the Commonwealth
10 of Australia Gazette, as soon as practicable after imposing such
a requirement, a notice setting out particulars of the
requirement.
(4) A person who refuses or fails to comply with a requirement
under subsection (2) commits an offence.
15 Penalty: $10 000.
43. Recovery etc. of registered or listed goods not conforming to
standards (Cwlth s. 30B)
(1) This section applies if --
(a) therapeutic goods of a particular type are included in the
20 Register in relation to a person;
(b) any person supplies a batch of goods of that kind;
(c) the Secretary is satisfied that the goods included in that
batch do not conform to a standard applicable to goods
of that kind; and
25 (d) the Secretary is not aware that any other goods of that
kind supplied by the person within the previous
6 months have failed to conform to that standard or
another standard applicable to goods of that kind.
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(2) The Secretary may, in writing, impose on the sponsor of the
goods one or both of the following requirements --
(a) to inform the public or a specified class of persons, in
the specified manner and within such reasonable period
5 as is specified, that the goods included in that batch do
not conform to a standard applicable to goods of that
kind;
(b) to take steps to recover the goods included in that batch,
except those goods that cannot be recovered because
10 they have been administered to, or applied in the
treatment of a person or animal.
(3) The Secretary must cause to be published in the Commonwealth of
Australia Gazette, as soon as practicable after imposing such a
requirement, a notice setting out particulars of the requirement.
15 (4) A person who refuses or fails to comply with a requirement
under subsection (2) commits an offence.
Penalty: $10 000.
(5) This section does not stop the Secretary from taking action
under section 41.
20 Division 3 -- General
44. Secretary may require information (Cwlth s. 31)
(1) The Secretary may, by notice in writing given to a person who
is an applicant for the registration of therapeutic goods or in
relation to whom therapeutic goods are registered, require the
25 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 --
(a) the formulation of the goods;
30 (b) the composition of the goods;
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s. 44
(c) the design specifications of the goods;
(d) the quality of the goods;
(e) the method and place of manufacture or preparation of
the goods and the procedures employed to ensure that
5 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
which they are to be used;
10 (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;
(j) any other matter prescribed by the Commonwealth
15 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
to whom therapeutic goods are listed, require the person to give
20 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 --
(a) the formulation of the goods;
25 (b) the composition of the goods;
(c) the design specifications of the goods;
(d) the method and place of manufacture or preparation of
the goods and the procedures employed to ensure that
proper standards are maintained in the manufacture and
30 handling of the goods;
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General Division 3
s. 44
(e) the presentation of the goods;
(f) the safety of the goods for the purposes for which they
are to be used;
(g) the conformity of the goods to a standard applicable to
5 the goods, or to a requirement relating to advertising
applicable to goods of that kind under the
Commonwealth regulations or regulations made under
this Act;
(h) any other matter prescribed by the Commonwealth
10 regulations for the purposes of section 31(2)(h) of the
Commonwealth Act in relation to goods of that kind.
(3) A notice under this section requiring information or documents
to be given may specify that the form in which the information
or document is to be given is in accordance with specified
15 software requirements --
(a) on a specified kind of data processing device; or
(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
20 notice given to the person under this section.
Penalty: $10 000.
(5) A person in relation to whom therapeutic goods are registered or
listed must not, in purporting to comply with a notice under this
section, give information that is false or misleading in a material
25 particular if the person knows, or ought reasonably to know,
that the information is false or misleading in a material
particular.
Penalty: $10 000.
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s. 45
45. Commissioner may obtain information about certain
substances and goods
(1) The Commissioner may, by notice served on a person who
manufactures in, imports into or supplies in Western Australia
5 any therapeutic goods, require the person to give to the
Commissioner, or to another person specified in the notice, such
information about the goods as is requested in the notice.
(2) A person must comply with a notice within such time, being not
less than 14 days after the notice is served, as is specified in the
10 notice, unless the person has a reasonable excuse for not doing
so.
(3) A notice may be served on a person even if the person has
previously given information to the Commissioner about the
goods.
15 (4) A person must not, in purporting to comply with a notice, give
information that is false or misleading in a material particular if
the person knows, or ought reasonably to know, that the
information is false or misleading in a material particular.
Penalty: $2 000.
20 46. Inspection and variation of entries in Register (Cwlth s. 32)
(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.
(2) If a person makes such a request, the Secretary must send to the
25 person a copy of so much, if any, of that entry as is contained in
any computer database maintained by the Commonwealth
Department for purposes connected with the administration of
this Act, other than any part of that entry that was supplied in
confidence by another person.
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General Division 3
s. 46
(3) If the person makes such a request, then, instead of providing a
copy of an entry to the person, the Secretary may, if the request
is for the provision of the copy in an electronic form, provide
the information contained in the entry --
5 (a) on a data processing device; or
(b) by way of electronic transmission.
(4) The Secretary may, following a request by a person in relation
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
10 goods if the entry contains information that is incomplete or
incorrect.
(5) Where --
(a) the person in relation to whom therapeutic goods are
registered or listed has asked the Secretary to vary
15 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
class of persons for whom the goods are suitable or to
add a warning or precaution, being a warning or
20 precaution that does not include any comparison of the
goods with any other therapeutic goods by reference to
quality, safety or efficacy,
the Secretary must vary the entry in accordance with the
request.
25 (6) 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
relates to the goods;
30 (b) subsection (4) does not apply to the request; and
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Division 3 General
s. 47
(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
to be used,
5 the Secretary may vary the entry in accordance with the request.
(7) In this section --
"product information", in relation to therapeutic goods, means
information relating to the safe and effective use of the
goods, including information regarding the usefulness and
10 limitations of the goods.
47. Publication of list of goods on Register (Cwlth s. 33)
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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Manufacturing of therapeutic goods Part 4
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Part 4 -- Manufacturing of therapeutic goods
48. Offences relating to manufacturing and licences
(Cwlth s. 35)
(1) A person must not, at premises in Western Australia, carry out a
5 step in the manufacture of therapeutic 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
10 under Part 4 of the Commonwealth Act that authorises
the carrying out of that step in relation to the goods at
those premises.
Penalty: $25 000.
(2) A person who is the holder of a licence must not breach a
15 condition of the licence.
Penalty: $15 000.
(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 false or misleading in a material
20 particular if the person knows, or ought reasonably to know,
that it is false or misleading in a material particular.
Penalty: $10 000.
49. Application for licence (Cwlth s. 37)
(1) An application for a licence must --
25 (a) be made in writing in accordance with a form approved
by the Secretary;
(b) identify the therapeutic goods or classes of therapeutic
goods that the applicant proposes to manufacture;
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(c) identify the manufacturing premises that will be used in
the manufacture of those goods;
(d) identify the steps in the manufacture of those goods that
the applicant proposes to carry out under the licence;
5 (e) state the names, qualifications and experience of the
persons who are to have control of the production of the
goods and of the quality control measures that are to be
employed;
(f) be delivered to an office of the Commonwealth
10 Department specified in the form; and
(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.
15 (2) The Secretary may, by notice in writing given to an applicant
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;
20 or
(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
25 premises.
50. Grant of licence (Cwlth s. 38)
(1) Where --
(a) a person has made an application to carry out steps in
the manufacture of therapeutic goods at particular
30 manufacturing premises;
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(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;
5 (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
(d) the person has complied with any requirements made by
10 the Secretary under section 49(2) of this Act in relation
to the application,
the Secretary must grant the person a licence to carry out those
steps at those premises unless --
(e) the Secretary is satisfied that --
15 (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;
(f) the person --
20 (i) has had a licence granted to the person under this
Act or the Commonwealth Act revoked;
(ii) has been convicted of an offence against this
Act, the Commonwealth Act or a law of another
State or Territory relating to therapeutic goods;
25 (iii) controls a body corporate, whether directly or
indirectly through one or more interposed
entities, that has been convicted of an offence
against this Act, the Commonwealth Act or a law
of a State or Territory relating to therapeutic
30 goods;
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(iv) controlled a body corporate, whether directly or
indirectly through one or more interposed
entities, when the body committed an offence
against this Act, the Commonwealth Act or a law
5 of a State or Territory relating to therapeutic
goods for which the body has been convicted;
(v) is controlled by another person, whether directly
or indirectly through one or more interposed
entities, and that other person has been convicted
10 of an offence against this Act, the
Commonwealth Act or a law of a State or
Territory relating to therapeutic goods; or
(vi) has failed on more than one occasion to observe
the manufacturing principles in connection with
15 the manufacture of therapeutic goods.
(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 subsection (1)(f) if, in the opinion of the
Secretary, special circumstances make it appropriate to do so.
20 (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
for the refusal.
25 (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.
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51. Term of licence (Cwlth s. 39)
A licence commences on the day specified in the licence and
remains in force until it is revoked or suspended.
52. Conditions of licences (Cwlth s. 40)
5 (1) A licence may be granted subject to --
(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
10 (b) such other conditions relating to the manufacture of the
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.
15 (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
imminent risk of death, serious illness or serious injury,
on the day on which the notice is given to the person; or
20 (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
(2), each licence is, except as otherwise specified in the licence,
25 subject to the conditions that the holder of the licence will --
(a) ensure that the goods conform to any standard
applicable to the goods;
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(b) allow an authorised person --
(i) to enter, at any reasonable time, the
manufacturing premises to which the licence
relates; and
5 (ii) while on those premises, to inspect those premises,
any therapeutic goods manufactured at 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
10 photographs of those premises, goods or processes;
(c) where an authorised person enters premises as
mentioned in paragraph (b)(i), answer questions relating
to procedures carried out at the premises and require
employees at those premises to do so;
15 (d) if requested to do so by an authorised person --
(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
20 (ii) produce to the person for examination any batch
samples kept by the holder;
and
(e) comply with such other conditions (if any) as are
specified in the Commonwealth regulations for the
25 purposes of section 40 of the Commonwealth Act.
53. Revocation and suspension of licences (Cwlth s. 41)
(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 --
30 (a) the holder has been convicted of an offence against this
Act or the Commonwealth Act;
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Manufacturing of therapeutic goods Part 4
s. 53
(b) the holder controls a body corporate, whether directly or
indirectly through one or more interposed entities, that
has been convicted of an offence against this Act, the
Commonwealth Act or a law of a State or Territory
5 relating to therapeutic goods;
(c) the holder controlled a body corporate, whether directly
or indirectly through one or more interposed entities,
when the body committed an offence against this Act,
the Commonwealth Act or a law of a State or Territory
10 relating to therapeutic goods for which the body has
been convicted;
(d) the holder is controlled by another person, whether
directly or indirectly through one or more interposed
entities, and that other person has been convicted of an
15 offence against this Act, the Commonwealth Act or a
law of a State or Territory relating to therapeutic goods;
(e) the holder has breached a condition of the licence;
(f) the holder has failed to observe the manufacturing
principles;
20 (g) the holder requests in writing that the licence be revoked
or suspended, as the case may be;
(h) the holder ceases to carry on the business of
manufacturing the goods to which the licence relates; or
(i) the annual licensing charge, or any applicable inspection
25 fees, have not been paid within 28 days after they
become payable.
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(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
5 imminent risk of death, serious illness or serious injury --
(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
10 result of a failure to pay the annual licensing charge or
an applicable inspection fee, give the holder an
opportunity to make, within such reasonable time as is
specified in the notice, submissions to the Secretary in
relation to the proposed action.
15 (3) Where the holder makes submissions in accordance with
subsection (2)(b), the Secretary is not to make a decision
relating to the revocation or suspension of the licence before
taking into account the submissions.
(4) A licence may be revoked even if the licence is suspended.
20 (5) Where a licence is suspended, the Secretary may, by notice in
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
25 in the Commonwealth of Australia Gazette as soon as
practicable after the decision is made.
54. Publication of list of manufacturers etc. (Cwlth s. 42)
The Secretary may, from time to time and in such manner as the
Secretary determines, publish a list of the persons who are
30 licensed under this Part, the classes of goods to which the
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Manufacturing of therapeutic goods Part 4
s. 54
licences relate, the steps of manufacture that the licences
authorise and the addresses of the manufacturing premises to
which the licences relate.
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Part 5 Wholesalers to comply with code of practice
s. 55
Part 5 -- Wholesalers to comply with code of practice
55. Wholesalers to comply with wholesaling code of practice
(1) A person who is engaged in the supply by wholesale of
therapeutic goods for human use must ensure that the
5 recommendations and requirements of the Wholesaling Code of
Practice are complied with.
Penalty: $10 000.
(2) In this section --
"supply by wholesale" --
10 (a) means supply for the purposes of resale; and
(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
15 or industry for use only in connection with that
profession, business, trade or industry, but not
for resale.
"Wholesaling Code of Practice" means the code of practice
entitled Code of Good Wholesaling Practice for
20 Therapeutic Goods for Human Use, published by the
Commonwealth Government, as in force from time to time.
(3) Nothing in this section affects the operation of any other
provision of this Act in relation to the supply of therapeutic
goods.
25
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Therapeutic Goods (Western Australia) Bill 2000
Payment of charges Part 6
s. 56
Part 6 -- Payment of charges
56. By whom charges payable (Cwlth s. 43)
(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.
57. Time for payment of charges (Cwlth s. 44)
10 (1) An annual registration charge or annual listing charge for a
financial year relating to therapeutic goods other than grouped
therapeutic goods becomes payable --
(a) if the year is the financial year (in this subsection called
the "first year") during which the registration or listing
15 of the therapeutic goods concerned commenced, on that
commencement; or
(b) if the year is a later financial year, on the anniversary of
that commencement or, if the Secretary has, by notice in
writing given before the end of the first year to the
20 person in relation to whom the therapeutic goods
concerned are registered or listed, specified another day
as being the day on which the charge becomes payable,
on the specified day or on an anniversary of that day, as
the case requires.
25 (2) An annual registration charge or annual listing charge for a
financial year relating to grouped therapeutic goods becomes
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.
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(3) An annual licensing charge for a financial year becomes 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
5 annual registration charge, annual listing charge or an annual
licensing charge is payable, vary the day on which the charge is
payable.
58. Recovery of charges
An annual registration charge, annual listing charge or annual
10 licensing charge may be recovered by the Commonwealth as a
debt due to the Commonwealth.
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Therapeutic Goods (Western Australia) Bill 2000
Entry, searches and warrants Part 7
s. 59
Part 7 -- Entry, searches and warrants
59. Definitions in this Part (Cwlth s. 45A)
In this Part, unless the contrary intention appears --
"evidential material" means --
5 (a) any thing with respect to which an offence against
this Act has been committed or is suspected, on
reasonable grounds, to have been committed;
(b) any thing as to which there are reasonable grounds
for suspecting that it will afford evidence as to the
10 commission of any such offence; or
(c) any thing as to which there are reasonable grounds
for suspecting that it is intended to be used for the
purpose of committing any such offence;
"occupier" , in relation to premises, includes a person present
15 at the premises who is in apparent control of the premises;
"seize" includes secure against interference;
"thing" includes a substance, and a thing in electronic or
magnetic form.
60. Searches to monitor compliance with Act (Cwlth s. 46)
20 (1) Subject to subsections (2) and (3), an authorised person may, for
the purpose of finding out whether this Act or the regulations
have been complied with --
(a) enter any premises; and
(b) exercise the powers set out in section 64(1).
25 (2) The authorised person must not enter the premises unless --
(a) the occupier of the premises has consented to the entry;
or
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Part 7 Entry, searches and warrants
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(b) the entry is made under a warrant issued under
section 74.
(3) An authorised person is not entitled to exercise any powers
under subsection (1) in relation to the premises if --
5 (a) the occupier of the premises has required the authorised
person to produce his or her identity card for inspection
by the occupier; and
(b) the authorised person fails to comply with the
requirement.
10 61. Searches of certain premises to monitor compliance with
Act (Cwlth s. 46A)
(1) An authorised person may, subject to subsections (2) and (3),
and to the extent that it is reasonably necessary for the purpose
of finding out whether this Act or the regulations have been
15 complied with, enter premises to which this section applies and
do any of the following --
(a) search the premises and any thing on the premises;
(b) inspect, examine, take measurements of, or conduct
tests, including by the taking of samples, concerning,
20 any thing in the premises that relates to therapeutic
goods;
(c) take photographs, including video recordings, or make
sketches of the premises or any thing on the premises;
(d) inspect any book, record, or document on the premises.
25 (2) An authorised person must not, under subsection (1), enter
premises that are a residence unless --
(a) the occupier of the premises has consented to the entry;
or
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(b) the premises are used for commercial purposes in
relation to therapeutic goods, in addition to residential
purposes.
(3) An authorised person is not entitled to exercise any powers
5 under subsection (1) in relation to premises if --
(a) the occupier of the premises has required the authorised
person to produce his or her identity card for inspection
by the occupier;
(b) the authorised person fails to comply with the
10 requirement.
(4) This section applies to --
(a) premises of a person --
(i) who has been granted an approval or authority
under section 19 of the Commonwealth Act or
15 under section 8 of this Act, or an exemption
under section 9 of this Act;
(ii) who has been granted approval under
section 19A of the Commonwealth Act; or
(iii) in relation to whom therapeutic goods are
20 registered or listed,
being premises connected with the manufacture or
supply of therapeutic goods or the keeping of records
relating to the manufacture or supply of therapeutic
goods;
25 (b) premises to which the person in relation to whom
therapeutic goods are registered or listed, or the sponsor
of the goods, must allow access as a condition of the
registration or listing of the therapeutic goods; and
(c) premises in relation to which a licence has been granted
30 under Part 4 of the Commonwealth Act or Part 4 of this
Act for the manufacture of therapeutic goods, or
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Therapeutic Goods (Western Australia) Bill 2000
Part 7 Entry, searches and warrants
s. 62
premises at which records are kept in relation to such
information.
62. Searches and seizures on public health grounds
(Cwlth s. 46B)
5 (1) Subject to subsection (2), if an authorised person has reasonable
grounds for suspecting that --
(a) there may be on any premises a particular thing in
respect of which this Act or the regulations have not
been complied with; and
10 (b) it is necessary in the interests of public health to exercise
powers under this section in order to avoid an imminent
risk of death, serious illness or serious injury,
the authorised person may, to the extent that it is reasonably
necessary for the purpose of avoiding an imminent risk of death,
15 serious illness or serious injury, enter the premises and do any
of the following --
(c) search the premises for the thing;
(d) if the authorised person finds the thing on the premises,
seize it.
20 (2) An authorised person is not entitled to exercise any powers
under subsection (1) in relation to premises if --
(a) the occupier of the premises has required the authorised
person to produce his or her identity card for inspection
by the occupier; and
25 (b) the authorised person fails to comply with the
requirement.
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Entry, searches and warrants Part 7
s. 63
63. Searches and seizures related to offences (Cwlth s. 47)
(1) Subject to subsections (2) and (3), if an authorised person has
reasonable grounds for suspecting that there may be evidential
material on any premises, the authorised person may --
5 (a) enter the premises;
(b) exercise the powers set out in subsection (4) and
section 64(1); and
(c) if the authorised person finds the thing on the premises,
seize it.
10 (2) The authorised person must not enter the premises unless --
(a) the occupier of the premises has consented to the entry;
or
(b) the entry is made under a warrant issued under
section 75.
15 (3) An authorised person is not entitled to exercise any powers
under subsection (1) in relation to premises if --
(a) the occupier of the premises has required the authorised
person to produce his or her identity card for inspection
by the occupier; and
20 (b) the authorised person fails to comply with the
requirement.
(4) If --
(a) in the course of searching, in accordance with a warrant,
for a particular thing, an authorised person finds another
25 thing that the authorised person believes on reasonable
grounds to be evidential material; and
(b) the authorised person believes, on reasonable grounds,
that it is necessary to seize that other thing in order to
prevent its concealment, loss or destruction, or its use in
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Part 7 Entry, searches and warrants
s. 64
committing, continuing or repeating an offence against
this Act,
the warrant is taken to authorise the authorised person to seize
that other thing.
5 64. General powers of authorised persons in relation to
premises (Cwlth s. 48)
(1) The powers an authorised person may exercise under
sections 60(1)(b) and 63(1)(b) are as follows --
(a) to search the premises and any thing on the premises;
10 (b) to inspect, examine, take measurements of, or conduct
tests, including by the taking of samples, concerning any
thing on the premises that relates to therapeutic goods;
(c) to take photographs, including video recordings, or
make sketches of the premises or any thing on the
15 premises;
(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
20 person; and
(ii) produce any book, record or document requested
by the authorised person;
(e) if the authorised person was authorised to enter the
premises by a warrant under section 74 or 75, to require
25 any person on or in the premises to --
(i) answer any questions put by the authorised
person; and
(ii) produce any book, record or document requested
by the authorised person;
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s. 65
(f) to inspect any book, record or document on the
premises;
(g) to take extracts from or make copies of any such book,
record or document;
5 (h) to take onto the premises such equipment and materials
as the authorised person requires for the purpose of
exercising powers in relation to the premises.
(2) A person must not, without reasonable excuse, refuse or fail to
comply with a requirement under subsection (1)(e).
10 Penalty: $3 000.
(3) 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.
65. Details of warrants to be given to occupier etc.
15 (Cwlth s. 48A)
(1) If a warrant in relation to premises is being executed and the
occupier of the premises or another person who apparently
represents the occupier is present at the premises, the authorised
person must make available to that person a copy of the warrant.
20 (2) The authorised person must identify himself or herself to that
person.
(3) The copy of the warrant referred to in subsection (1) need not
include the signature of the magistrate who issued the warrant.
66. Announcement before entry (Cwlth s. 48B)
25 (1) An authorised person must, before entering the premises under a
warrant --
(a) announce that he or she is authorised to enter the
premises; and
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Part 7 Entry, searches and warrants
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(b) give any person at the premises an opportunity to allow
entry to the premises.
(2) An authorised person is not required to comply with
subsection (1) if he or she believes on reasonable grounds that
5 immediate entry to the premises is required to ensure --
(a) the safety of a person; or
(b) that the effective execution of the warrant is not
frustrated.
67. Use of electronic equipment at premises (Cwlth s. 48C)
10 (1) The authorised person may operate electronic equipment at the
premises to see whether evidential material is accessible by
doing so if he or she believes on reasonable grounds that the
operation of the equipment can be carried out without damage
to the equipment.
15 (2) If the authorised person, after operating the equipment, finds
that evidential material is accessible by doing so, he or she
may --
(a) seize the equipment and any disk, tape or other
associated device;
20 (b) if the material can, by using facilities at the premises, be
put in documentary form, operate the facilities to put the
material in that form and seize the documents so
produced; or
(c) if the material can be transferred to a disk, tape or other
25 storage device that --
(i) is brought to the premises; or
(ii) is at the premises and the use of which for the
purpose has been agreed to in writing by the
occupier of the premises,
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s. 67
operate the equipment or other facilities to copy the
material to the storage device and take the storage
device from the premises.
(3) An authorised person may seize equipment under
5 subsection (2)(a) only if --
(a) it is not practicable to put the material in documentary
form as mentioned in subsection (2)(b) or to copy the
material as mentioned in subsection (2)(c); or
(b) possession by the occupier of the equipment could
10 constitute an offence.
(4) If the authorised person believes on reasonable grounds that --
(a) evidential material may be accessible by operating
electronic equipment at the premises;
(b) expert assistance is required to operate the equipment;
15 and
(c) if he or she does not take action under this subsection,
the material may be destroyed, altered or otherwise
interfered with,
he or she may do whatever is necessary to secure the equipment,
20 whether by locking it up, placing a guard or otherwise.
(5) The authorised person must give notice to the occupier of the
premises of his or her intention to secure equipment and of the
fact that the equipment may be secured for up to 24 hours.
(6) The equipment may be secured --
25 (a) for a period not exceeding 24 hours; or
(b) until the equipment has been operated by the expert,
whichever occurs first.
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Therapeutic Goods (Western Australia) Bill 2000
Part 7 Entry, searches and warrants
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(7) If the authorised person believes on reasonable grounds that the
expert assistance will not be available within 24 hours, he or she
may apply to the magistrate for an extension of that period.
(8) The authorised person must give notice to the occupier of the
5 premises of his or her intention to apply for an extension, and
the occupier is entitled to be heard in relation to the application.
68. Compensation for damage to electronic equipment
(Cwlth s. 48D)
(1) If --
10 (a) damage is caused to equipment as a result of it being
operated as mentioned in section 67; and
(b) the damage was caused as a result of --
(i) insufficient care being exercised in selecting the
person who was to operate the equipment; or
15 (ii) insufficient care being exercised by the person
operating the equipment,
compensation for the damage is payable to the owner of
the equipment.
(2) Compensation is payable out of the Consolidated Fund, which is
20 to the necessary extent appropriated accordingly.
(3) In determining the amount of compensation payable, regard is
to be had to whether the occupier of the premises and his or her
employees and agents, if they were available at the time, had
provided any warning or guidance as to the operation of the
25 equipment that was appropriate in the circumstances.
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s. 69
69. Copies of seized things to be provided (Cwlth s. 48E)
(1) Subject to subsection (2), if an authorised person seizes, under a
warrant relating to premises --
(a) a document, film, computer file or other thing that can
5 be readily copied; or
(b) a storage device the information in which can be readily
copied,
the authorised person must, if requested to do so by the occupier
of the premises or another person who apparently represents the
10 occupier and who is present when the warrant is executed, give
a copy of the thing or the information to that person as soon as
practicable after the seizure.
(2) Subsection (1) does not apply if --
(a) the thing that has been seized or taken was seized or
15 taken under section 67(2)(b) or (c); or
(b) possession by the occupier of the document, film,
computer file, thing or information could constitute an
offence.
70. Occupier entitled to be present during search (Cwlth s. 48F)
20 (1) If a warrant in relation to premises is being executed and the
occupier of the premises or another person who apparently
represents the occupier is present at the premises, the person is
entitled to observe the search being conducted.
(2) The right to observe the search being conducted ceases if the
25 person impedes the search.
(3) This section does not prevent 2 or more areas of the premises
being searched at the same time.
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71. Receipts for things seized under warrant (Cwlth s. 48G)
(1) If a thing is seized under this Part, the authorised person must
provide a receipt for the thing.
(2) If 2 or more things are seized or moved, they may be covered in
5 the one receipt.
72. Retention of seized things (Cwlth s. 48H)
(1) Subject to any contrary order of a court, if an authorised person
seizes a thing under this Part, an authorised person must return
it if --
10 (a) the reason for its seizure no longer exists or it is decided
that it is not to be used in evidence; or
(b) subject to subsection (2), the period of 90 days after its
seizure ends,
whichever first occurs, unless the thing is forfeited or forfeitable
15 under this Act or the Commonwealth Act.
(2) At the end of the 90 days specified in subsection (l)(b) an
authorised person must take reasonable steps to return the thing
to the person from whom it was seized, unless --
(a) proceedings in respect of which the thing may afford
20 evidence were instituted before the end of the 90 days
and have not been completed, including an appeal to a
court in relation to those proceedings;
(b) an authorised person may retain the thing because of an
order under section 73; or
25 (c) an authorised person is otherwise authorised (by a law,
or an order of a court, of the Commonwealth or of a
State or Territory) to retain, destroy or dispose of the
thing.
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Entry, searches and warrants Part 7
s. 73
(3) The thing may be returned under subsection (2) either
unconditionally or on such terms and conditions --
(a) as the Commissioner sees fit, if the thing is seized by a
person authorised under section 7(1) or a member of the
5 Police Force of Western Australia; or
(b) as the Secretary sees fit in any other case.
73. Magistrate may permit a thing to be retained (Cwlth s. 48J)
(1) An authorised person may apply to a magistrate for an order that
he or she may retain the thing for a further period if --
10 (a) before the end of 90 days after the seizure; or
(b) before the end of a period previously specified in an
order of a magistrate under this section,
proceedings in respect of which the thing may afford evidence
have not commenced.
15 (2) If the magistrate is satisfied that it is necessary for an authorised
person to continue to retain the thing --
(a) for the purposes of an investigation as to whether an
offence against this Act has been committed; or
(b) to enable evidence of an offence against this Act to be
20 secured for the purposes of a prosecution,
the magistrate may order that an authorised person may retain
the thing for the period, not exceeding 3 years, specified in the
order.
(3) Before making the application, the authorised person must --
25 (a) take reasonable steps to discover who has an interest in
the retention of the thing; and
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(b) if it is practicable to do so, notify each person whom the
authorised person believes to have such an interest of
the proposed application.
74. Monitoring warrants (Cwlth s. 49)
5 (1) An authorised person may apply to a justice for a warrant under
this section in relation to premises.
(2) Subject to subsection (3), a justice may issue the warrant if
satisfied, by information on oath, that it is reasonably necessary
that one or more authorised persons should have access to the
10 premises for the purpose of finding out whether the
requirements of this Act are being complied with.
(3) A justice is not to issue a warrant unless the authorised person
or some other person has given to the justice, either orally or by
affidavit, such further information (if any) as the justice requires
15 concerning the grounds on which the issue of the warrant is
being sought.
(4) The warrant must --
(a) authorise one or more authorised persons, whether or
not named in the warrant, with such assistance and by
20 such force as is necessary and reasonable --
(i) to enter the premises; and
(ii) to exercise the powers set out in section 64(1) in
relation to the premises;
(b) state whether the entry is authorised to be made at any
25 time of the day or night or during specified hours of the
day or night;
(c) specify the day (not more than 6 months after the issue
of the warrant) on which the warrant ceases to have
effect; and
30 (d) state the purpose for which the warrant is issued.
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s. 75
75. Offence related warrants (Cwlth s. 50)
(1) An authorised person may apply to a justice for a warrant under
this section in relation to premises.
(2) Subject to subsection (3), a justice may issue the warrant if
5 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 evidential material.
(3) A justice must not issue a warrant unless the authorised person
or some other person has given to the justice, either orally or by
10 affidavit, such further information (if any) as the justice requires
concerning the grounds on which the issue of the warrant is
sought.
(4) The warrant must --
(a) name one or more authorised persons;
15 (b) authorise the persons so named, with such assistance
and by such force as is necessary and reasonable --
(i) to enter the premises;
(ii) to exercise the powers set out in sections 63(4)
and 64(1); and
20 (iii) to seize the evidential material;
(c) 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;
(d) specify the day (not more than one week after the issue
25 of the warrant) on which the warrant ceases to have
effect; and
(e) state the purpose for which the warrant is issued.
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76. Offence related warrants by telephone (Cwlth s. 51)
(1) If, in an urgent case, an authorised person considers it necessary
to do so, the person may apply to a magistrate by telephone for
a warrant under section 75 in relation to premises.
5 (2) Before applying for a warrant, the person must prepare an
information of the kind mentioned in section 75(2) in relation to
the premises that sets out the grounds on which the warrant is
sought.
(3) If it is necessary to do so, the person may apply for the warrant
10 before the information is sworn.
(4) If the magistrate is satisfied --
(a) after having considered the terms of the information;
and
(b) after having received such further information (if any) as
15 the magistrate requires concerning the grounds on which
the issue of the warrant is being sought,
that there are reasonable grounds for issuing the warrant, the
magistrate may complete and sign the same warrant that could
be issued under section 75 if the application had been made
20 under that section.
(5) If the magistrate completes and signs the warrant --
(a) the magistrate must --
(i) tell the authorised person what the terms of the
warrant are;
25 (ii) tell the authorised person the day on which and
the time at which the warrant was signed;
(iii) tell the authorised person the day, not more than
one week after the magistrate completes and
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signs the warrant, on which the warrant ceases to
have effect; and
(iv) record on the warrant the reasons for granting the
warrant;
5 and
(b) the authorised person must --
(i) complete a form of warrant in the same terms as
the warrant completed and signed by the
magistrate; and
10 (ii) write on the form the name of the magistrate and
the day on which and the time at which the
warrant was signed.
(6) The authorised person must also, not later that the day after the
day of expiry or execution of the warrant, whichever is the
15 earlier, send to the magistrate --
(a) the form of the warrant completed by the person; and
(b) the information referred to in subsection (2), which must
have been duly sworn.
(7) When the magistrate receives those documents, the magistrate
20 must --
(a) attach them to the warrant that the magistrate completed
and signed; and
(b) deal with them in the way in which the magistrate would
have dealt with the information if the application had
25 been made under section 75.
(8) A form of warrant duly completed under subsection (5) is
authority for any entry, search, seizure or other exercise of a
power that the warrant signed by the magistrate authorises.
page 83
Therapeutic Goods (Western Australia) Bill 2000
Part 7 Entry, searches and warrants
s. 77
(9) If --
(a) it is material, in any proceedings, for a court to be
satisfied that an exercise of power was authorised by
this section; and
5 (b) the warrant signed by the magistrate authorising the
exercise of the power is not produced in evidence,
the court must assume, unless the contrary is proved, that the
exercise of the power was not authorised by such a warrant.
(10) A reference in this Part to a warrant under section 75 includes a
10 reference to a warrant signed by a magistrate under this section.
77. Offences relating to warrants (Cwlth s. 51B)
(1) A person must not, in an application for a warrant, make a
statement that is false or misleading in a material particular if
the person knows, or ought reasonably to know, that the
15 statement is false or misleading in a material particular.
Penalty: Imprisonment for 2 years.
(2) A person must not --
(a) state in a document that purports to be a form of warrant
under section 76 the name of the magistrate unless that
20 magistrate issued the warrant;
(b) state on a form of warrant under that section a matter
that, to the person's knowledge, departs in a material
particular from the form authorised by the magistrate;
(c) purport to execute, or present to another person, a
25 document that purports to be a form of warrant under
that section that the first mentioned person knows --
(i) has not been approved by a magistrate under that
section; or
page 84
Therapeutic Goods (Western Australia) Bill 2000
Entry, searches and warrants Part 7
s. 77
(ii) to depart in a material particular from the terms
authorised by the magistrate under that section;
or
(d) give to a magistrate a form of warrant under that section
5 that is not the form of warrant that the person purported
to execute.
Penalty: Imprisonment for 2 years.
page 85
Therapeutic Goods (Western Australia) Bill 2000
Part 8 Miscellaneous
s. 78
Part 8 -- Miscellaneous
78. Identity cards (Cwlth s. 52)
(1) The Commissioner is to ensure that each person authorised by
him or her as an authorised person for the purposes of this Act is
5 issued with an identity card that incorporates a recent
photograph of the person.
(2) Where a person ceases to be an authorised person referred to in
subsection (1), the person must, as soon as practicable after so
ceasing, return the person's identity card to the Commissioner.
10 Penalty: $1 000.
79. Indictable offences and forfeiture (Cwlth s. 54)
(1) An offence against section 22, 39 or 40 is an indictable offence.
(2) Despite subsection (1), a court of summary jurisdiction may
hear and determine proceedings in respect of an offence referred
15 to in subsection (1) if the court is satisfied that it is appropriate
to do so and the defendant and the prosecutor consent.
(3) Where a court of summary jurisdiction convicts a person of an
offence referred to in subsection (1), the penalty that the court
may impose is a fine not exceeding $2 000.
20 (4) 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.
(5) Where goods are so forfeited, the Commissioner may cause
25 notice of the forfeiture to be published in the Gazette.
(6) Goods forfeited under an order referred to in subsection (2) are
to be disposed of in such manner as the Commissioner directs.
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Therapeutic Goods (Western Australia) Bill 2000
Miscellaneous Part 8
s. 80
80. Time for bringing prosecutions (Cwlth s. 54A)
Proceedings for an offence against this Act may be commenced
within 3 years after the alleged commission of the offence, but
not later.
5 81. Evidentiary certificate of Commissioner
(1) In any legal proceedings under this Act, a certificate purporting
to be signed by the Commissioner as to any of the matters set
out in subsection (2) is evidence and, in the absence of evidence
to the contrary, is proof of the facts stated in the certificate.
10 (2) The Commissioner may certify as to the following --
(a) a person was or was not, at a date specified in the
certificate --
(i) the holder of a licence under this Act;
(ii) the holder of a licence under the Poisons
15 Act 1964; or
(iii) exempt, or of a class of person who were
exempt, under section 9 from such provision or
provisions of this Act as are specified in the
certificate;
20 (b) at a date specified in the certificate, there were no
exemptions under section 9 applying to goods specified
in the certificate;
(c) at the date specified in the certificate, there was no
authorisation given by the Commissioner under
25 section 20 applying to goods specified in the certificate;
or
(d) at a date specified in the certificate, there was no
authorisation given by the Commissioner under
section 21 applying to therapeutic devices specified in
30 the certificate.
page 87
Therapeutic Goods (Western Australia) Bill 2000
Part 8 Miscellaneous
s. 82
82. Evidentiary certificates of the Secretary (Cwlth s. 56A)
(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 were no
section 18 exemptions under the Commonwealth Act
applying to goods specified in the certificate;
10 (b) that at a date specified in the certificate, there were no
section 19 approvals or authorisations under the
Commonwealth Act granted in respect of goods
specified in the certificate;
(c) that at a date specified in the certificate, there were no
15 approvals or authorisations under section 8 granted in
respect of goods specified in the certificate;
(d) that at a date specified in the certificate, there was no
exemption in effect under section 9;
(e) that at a date specified in the certificate, there was no
20 consent given by the Secretary under section 12
applying to goods specified in the certificate;
(f) that at the date specified in the certificate, there were no
section 19A exemptions under the Commonwealth Act
applying to goods specified in the certificate;
25 (g) that goods are or are not included in the Register;
(h) specifying the period that goods specified in the
certificate were included in the Register, including any
conditions applying to the registration or listing of those
goods;
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Therapeutic Goods (Western Australia) Bill 2000
Miscellaneous Part 8
s. 83
(i) that at a date specified in the certificate, the registration
or listing of goods specified in the certificate has been
cancelled;
(j) that at a date specified in the certificate, no section 7
5 order under the Commonwealth Act has been issued in
respect of goods specified in the certificate;
(k) 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,
10 including any conditions applying to the licence.
83. Provisions relating to evidentiary certificates
(1) A certificate under this section or section 81 or 82 may relate to
more than one of the matters referred to in the section.
(2) In proceedings for an offence against section 17, a certificate
15 purported to be signed by the Commissioner to the effect that --
(a) the Commissioner did not approve the supply that is the
subject of the proceedings; or
(b) the Commissioner approved that supply subject to the
conditions specified in the certificate,
20 is evidence and, in the absence of evidence to the contrary, is
proof of the facts stated in the certificate.
(3) In proceedings for an offence against this Act, a document
purporting to be a certificate given under this section or
section 81 or 82 is, unless the contrary is proved, taken to be
25 such a certificate and to have been duly given.
page 89
Therapeutic Goods (Western Australia) Bill 2000
Part 8 Miscellaneous
s. 84
84. Conduct by directors, servants and agents (Cwlth s. 55)
(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 --
5 (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
(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
10 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
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
15 reasonable precautions and exercised due diligence to avoid the
conduct.
(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
20 to show that --
(a) the conduct was engaged in by a servant or agent of the
person within the scope of his or her actual or apparent
authority; and
(b) the servant or agent had the state of mind.
25 (4) Any conduct engaged in on behalf of a person other than a body
corporate (in this subsection called the "employer") by a
servant 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
30 engaged in also by the employer unless the employer establishes
page 90
Therapeutic Goods (Western Australia) Bill 2000
Miscellaneous Part 8
s. 85
that he or she took reasonable precautions and exercised due
diligence to avoid the conduct.
(5) Where --
(a) a person other than a body corporate is convicted of an
5 offence; and
(b) the person would not have been convicted of the offence
if subsections (3) and (4) had not been enacted,
the person is not liable to be punished by imprisonment for that
offence.
10 (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
(b) the person's reasons for the intention, opinion, belief or
15 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
Commonwealth, of a State or of a Territory.
20 (8) A reference in this section to engaging in conduct includes a
reference to failing or refusing to engage in conduct.
85. Judicial notice (Cwlth s. 56)
All courts are to take judicial notice of the British
Pharmacopoeia and of the British Pharmacopoeia (Veterinary).
25 86. Delegation by Secretary (Cwlth s. 57)
(1) The Secretary may by signed instrument delegate the
performance of any function of the Secretary under this Act,
other than this power of delegation, to any person to whom the
page 91
Therapeutic Goods (Western Australia) Bill 2000
Part 8 Miscellaneous
s. 87
Secretary may delegate any powers under section 57 of the
Commonwealth Act.
(2) A delegation may be general or as otherwise provided in the
instrument of delegation.
5 (3) A delegate performing a function under this section is to be
taken to do so in accordance with the terms of the delegation
unless the contrary is shown.
87. Delegation by Commissioner
(1) The Commissioner may by signed instrument delegate to a
10 person the performance of any function of the Commissioner
under this Act other than this power of delegation.
(2) A delegation may be general or as otherwise provided in the
instrument of delegation.
(3) A delegate performing a function under this section is to be
15 taken to do so in accordance with the terms of the delegation
unless the contrary is shown.
88. Offences under this Act and the Commonwealth Act
If --
(a) an act or omission constitutes an offence under this Act
20 and the Commonwealth Act; and
(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.
page 92
Therapeutic Goods (Western Australia) Bill 2000
Miscellaneous Part 8
s. 89
89. Review of decisions (Cwlth s. 60)
(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.
90. Regulations (Cwlth s. 63)
(1) The Governor may make regulations prescribing all matters that
are required or permitted by this Act to be prescribed or are
15 necessary or convenient to be prescribed for giving effect to the
purposes of this Act.
(2) Without limiting subsection (1), regulations may be made --
(a) prohibiting or regulating the advertising of therapeutic
goods, including the form and content of advertisements
20 and the manner in which advertisements may be
published or displayed;
(b) with respect to labelling, sampling, examination, testing
and analysis of therapeutic goods;
(c) prescribing conditions to be complied with in respect of
25 the preparation, dispensing, storage, packing, handling,
carriage and delivery of therapeutic goods;
(d) prohibiting or regulating the supply of therapeutic goods
of a specified class or classes;
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Therapeutic Goods (Western Australia) Bill 2000
Part 8 Miscellaneous
s. 90
(e) with respect to the inspection of premises, stocks, books,
documents and records;
(f) regulating the circumstances in which therapeutic goods,
or therapeutic goods of a specified class or classes, may
5 be supplied by automatic machines, or automatic
machines of a particular type or types;
(g) providing for authorisations to be given by the
Commissioner for the use of therapeutic devices
prohibited under section 21;
10 (h) prohibiting the supply of therapeutic goods by
prescribed self-service methods;
(i) with respect to the unsolicited distribution of therapeutic
goods, in accordance with section 17, including the
persons who may distribute the goods, the persons, or
15 classes of persons, to whom distribution may be made
and the method of distribution;
(j) providing for the disposal of things seized under the
Act;
(k) providing that a contravention of a regulation constitutes
20 an offence and prescribing penalties not exceeding
$2 000 for any such contravention;
(l) prescribing fees in respect of matters under this Act or
the regulations.
(3) The regulations may apply, adopt or incorporate by reference
25 any document formulated or published by a person or body,
either --
(a) without modification or as modified by the regulations;
(b) as formulated or published on or before the date when
the regulations are made; or
30 (c) as formulated or published from time to time.
page 94
Therapeutic Goods (Western Australia) Bill 2000
Consequential amendments and transitional provisions Part 9
s. 91
Part 9 -- Consequential amendments and
transitional provisions
91. Health Act 1911 amended
(1) This section amends the Health Act 1911*.
5 (2) Section 3(1) is amended as follows:
(a) by deleting the definitions of "Drug", "the Drug
Advisory Committee", "Therapeutic substance", and
"Therapeutic use";
(b) in the definition of "Trade description" by deleting "or
10 drug".
(3) Section 5(5) is amended by deleting "and drugs".
(4) Section 5(6) is amended by deleting "or drug" in each place
where it occurs.
(5) The heading to Part VIIA is amended by deleting ", drugs,
15 medicines, disinfectants, therapeutic substances".
(6) The provisions specified in the Table to this subsection are
repealed.
Table
Section 202 Part VIIA Division 7
Part VIIA Division 5 Section 246D(1)
Part VII Division 6 Section 377(10)
(7) Schedule 5 is amended as follows:
20 (a) under the heading "Part I" by deleting ",225(1), 238(3)
and (5)";
(b) under the heading "Part II" by deleting ",224(2),
227(13)";
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Therapeutic Goods (Western Australia) Bill 2000
Part 9 Consequential amendments and transitional provisions
s. 92
(c) under the heading "Part IV" by deleting ",223(1),
225(2), 227(2), 231(2), 234(1) and 240(1)";
(d) under the heading "Part VI" by deleting ",221(1), 222,
236(1), 241(1)";
5 (e) under the heading "Part VII" by deleting ",228(2),
237(2), 238(1)".
[* Reprinted as at 31 March 2000.]
92. Health Amendment Act 1987 amended
Sections 4(d), 83 and 90 of the Health Amendment Act 1987*
10 are repealed.
[* Act No. 80 of 1987.]
93. Health (Drugs and Allied Substances) Regulations 1961 are
repealed.
The Health (Drugs and Allied Substances) Regulations 1961 are
15 repealed.
94. 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
Australia if, before the commencement of this section, the
20 person was carrying out that step in relation to goods of that
kind at those premises.
(2) Where --
(a) this section applies to a step in the manufacture of
therapeutic goods in relation to a person in relation to
25 premises; and
(b) the Secretary is not aware of the person having been
convicted of an offence against a law of the
page 96
Therapeutic Goods (Western Australia) Bill 2000
Consequential amendments and transitional provisions Part 9
s. 95
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 48(1) does not apply to the carrying out of that step by
5 the person in relation to goods of that kind at those premises
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
10 premises; and
(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 49 and within
4 months after the commencement of this section,
15 section 48(1) does not apply to the carrying out of that step by
the person in relation to goods of that kind at those premises
until the application is determined.
95. Transitional arrangements for goods required to be
registered or listed
20 (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 --
25 (a) this section applies to therapeutic goods in relation to a
person;
(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
page 97
Therapeutic Goods (Western Australia) Bill 2000
Part 9 Consequential amendments and transitional provisions
s. 95
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
5 goods of that kind into Australia otherwise than in
accordance with regulations in force under the Customs
Act 1901 of the Commonwealth,
section 15(1) and (3) do not apply to goods of that kind in
relation to the person during the period of 4 months after that
10 commencement.
(3) If --
(a) this section applies to therapeutic goods in relation to a
person; and
(b) the person makes an application in accordance with
15 section 23 for registration or listing of goods of that kind
within 4 months after the commencement of this section,
then --
(c) section 15(1) does not apply to goods of that kind in
relation to the person during the period of 6 months after
20 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
of that 6 month period; and
(d) section 15(3) does not apply to goods of that kind in
25 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
published in the Commonwealth of Australia Gazette
before the end of that 12 month period.
30 (4) If, on an application referred to in subsection (3), goods have
been registered without having been evaluated, the Secretary
page 98
Therapeutic Goods (Western Australia) Bill 2000
Consequential amendments and transitional provisions Part 9
s. 95
may, if he or she thinks it appropriate, give the person in
relation to whom the goods are registered written notice that the
goods are to be evaluated to determine whether they should
continue to be registered.
5 (5) A person who makes an application referred to in subsection (3)
is not required to pay --
(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
10 goods, a fee for the evaluation of the goods for
registration,
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
15 the Commonwealth regulations in relation to an application
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 --
20 (a) section 30 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
25 evaluation fee under section 24 were a reference
to a fee payable under subsection (5) of this
section;
(b) sections 25, 26 and 27 have effect as if any reference in
those sections to section 24 were a reference to
30 subsection (5) of this section; and
(c) sections 28 and 29 do not apply.
page 99
Therapeutic Goods (Western Australia) Bill 2000
Part 9 Consequential amendments and transitional provisions
s. 95
(7) If, on an application referred to in subsection (3), goods have
been listed without consideration of the matters mentioned in
section 33(1)(d) to (k), the Secretary may, if he or she thinks it
appropriate, give the person in relation to whom the goods are
5 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 33 applies as if
the person in relation to whom the goods are listed were an
applicant for the listing of the goods.
10
page 100
Therapeutic Goods (Western Australia) Bill 2000
Defined Terms
Defined Terms
[This is a list of terms defined and the provisions where they are defined.
The list is not part of the law.]
Defined Term Provision(s)
active component .......................................................................................31(3)
advertisement .............................................................................................. 4(1)
annual licensing charge ............................................................................... 4(1)
annual listing charge.................................................................................... 4(1)
annual registration charge............................................................................ 4(1)
approved medical practitioner...................................................................... 8(7)
authorised person ........................................................................................ 4(1)
automatic machine....................................................................................... 4(1)
Commissioner ............................................................................................. 4(1)
Commonwealth Act..................................................................................... 4(1)
Commonwealth Department ........................................................................ 4(1)
Commonwealth Minister ............................................................................. 4(1)
Commonwealth regulations ......................................................................... 4(1)
corresponding provision .............................................................................. 7(3)
decision......................................................................................................89(1)
employer ....................................................................................................84(4)
evidential material .......................................................................................... 59
exempt goods .............................................................................................. 4(1)
exempt person ............................................................................................. 4(1)
first year................................................................................................ 57(1)(a)
gazetted kits group ...................................................................................... 4(1)
gazetted therapeutic devices group............................................................... 4(1)
gazetted therapeutic goods group ................................................................. 4(1)
grouped therapeutic goods ........................................................................... 4(1)
individual patient data ................................................................................24(3)
licence......................................................................................................... 4(1)
listable devices ............................................................................................ 4(1)
listed goods ................................................................................................. 4(1)
listing number ............................................................................................. 4(1)
new goods ..................................................................................................31(2)
occupier ......................................................................................................... 59
product information....................................................................................46(7)
protected information ........................................................................ 4(1), 31(2)
Register....................................................................................................... 4(1)
registered goods .......................................................................................... 4(1)
registration number ..................................................................................... 4(1)
page 101
Therapeutic Goods (Western Australia) Bill 2000
Defined Terms
Secretary..................................................................................................... 4(1)
seize............................................................................................................... 59
sponsor ....................................................................................................... 4(1)
standard ...................................................................................................... 4(1)
supply ......................................................................................................... 4(1)
supply by wholesale ...................................................................................55(2)
the manufacturer ........................................................................................35(6)
therapeutic device........................................................................................ 4(1)
therapeutic goods......................................................................................... 4(1)
therapeutic use ............................................................................................ 4(1)
thing .............................................................................................................. 59
Wholesaling Code of Practice................................................................ 55(2)(ii)
page 102
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