Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulation 2015
 
Select Legislative Instrument No. 87, 2015
I, General the Honourable Sir Peter Cosgrove AK MC (Ret’d), Governor‑General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following regulation.
Dated 17 June 2015
Peter Cosgrove
Governor‑General
By His Excellency’s Command
Fiona Nash
Assistant Minister for Health
 
  
  
Contents
1............ Name................................................................................................... 1
2............ Commencement................................................................................... 1
3............ Authority............................................................................................. 1
4............ Schedules............................................................................................ 1
Schedule 1—Amendments                                                                                                2
Therapeutic Goods (Medical Devices) Regulations 2002                                   2
Therapeutic Goods Regulations 1990                                                                     3
 
1  Name
                   This is the Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulation 2015.
2  Commencement
             (1)  Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.
 
Commencement information

Column 1
Column 2
Column 3

Provisions
Commencement
Date/Details

1.  The whole of this instrument
1 July 2015.
1 July 2015

Note:          This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.
             (2)  Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.
3  Authority
                   This instrument is made under the Therapeutic Goods Act 1989.
4  Schedules
                   Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.
Schedule 1—Amendments
  
Therapeutic Goods (Medical Devices) Regulations 2002
1  Amendments of listed provisions
 
Amendments of fees

Item
Provision
Omit
Substitute

1
Paragraph 9.4(2)(b)
3 705
3 785

2
Schedule 5, item 1.1
920
940

3
Schedule 5, item 1.2, paragraph (a)
7 965
8 135

4
Schedule 5, item 1.2, paragraph (b)
8 020
8 190

5
Schedule 5, item 1.3, paragraph (a)
48 800
49 800

6
Schedule 5, item 1.3, paragraph (b)
37 600
38 400

7
Schedule 5, item 1.3A, paragraph (a)
27 500
28 100

8
Schedule 5, item 1.3A, paragraph (b)
58 700
59 900

9
Schedule 5, item 1.3A, paragraph (c)
14 300
14 600

10
Schedule 5, item 1.3A, paragraph (d)
3 460
3 535

11
Schedule 5, item 1.3A, paragraph (e)
37 900
38 700

12
Schedule 5, item 1.3A, paragraph (f)
24 200
24 700

13
Schedule 5, item 1.5, paragraphs (a) and (b)
1 210
1 235

14
Schedule 5, item 1.5, paragraphs (c) to (f)
940
960

15
Schedule 5, item 1.7
16 800
17 200

16
Schedule 5, item 1.8
330
335

17
Schedule 5, item 1.9, paragraph (a)
27 400
28 000

18
Schedule 5, item 1.9, paragraph (b)
54 000
55 100

19
Schedule 5, item 1.9, paragraph (c)
37 600
38 400

20
Schedule 5, item 1.9, paragraph (d)
26 200
26 800

21
Schedule 5, item 1.9, paragraph (e)
24 000
24 500

22
Schedule 5, item 1.9, paragraph (f)
20 500
20 900

23
Schedule 5, item 1.9A, paragraph (a)
27 500
28 100

24
Schedule 5, item 1.9A, paragraph (b)
58 700
59 900

25
Schedule 5, item 1.9A, paragraph (c)
14 300
14 600

26
Schedule 5, item 1.9A, paragraph (d)
3 460
3 535

27
Schedule 5, item 1.9A, paragraph (e)
37 900
38 700

28
Schedule 5, item 1.9A, paragraph (f)
24 200
24 700

29
Schedule 5, item 1.10, paragraph (a)
16 500
16 800

30
Schedule 5, item 1.10, paragraph (b)
32 500
33 200

31
Schedule 5, item 1.10, paragraph (c)
22 600
23 100

32
Schedule 5, item 1.10, paragraph (d)
14 300
14 600

33
Schedule 5, item 1.10, paragraph (e)
12 400
12 700

34
Schedule 5, item 1.12
380
390

35
Schedule 5, item 1.13
3 545
3 620

36
Schedule 5, item 1.14
6 500
6 640

37
Schedule 5, item 1.14A
6 330
6 465

38
Schedule 5, item 1.15
410
420

39
Schedule 5, item 1.17
940
960

40
Schedule 5, paragraph 2.1(b)
380
390

 
Therapeutic Goods Regulations 1990
2  At the end of subregulation 3(3)
Add:
                   ; (g)  Medicines, Poisons and Therapeutic Goods Act (NT);
                     (h)  Medicines, Poisons and Therapeutic Goods Regulations (NT).
3  Part 2 of Schedule 9 (after paragraph (bj) of table item 2)
Insert:
 
 
(bk) for an application relating to a medicine in relation to which an evaluation fee is payable under paragraph (bc) of item 4
1 035
4  Part 2 of Schedule 9 (paragraph (b) of the cell at table item 4, column 2)
After “paragraph (bb)”, insert “or (bc)”.
5  Part 2 of Schedule 9 (after paragraph (bb) of table item 4)
Insert:
 
 
(bc) an extension of indications that is the subject of an application to which regulation 16G applies
4 120
6  Amendments of listed provisions
 
Amendments of fees etc.

Item
Provision
Omit
Substitute

1
Paragraph 43AAJ(1)(b)
90 500
92 400

2
Paragraph 45(4A)(a)
10 095
10 300

3
Paragraph 45(4A)(b)
8 395
8 575

4
Paragraphs 45(4A)(c) and (ca)
8 120
8 290

5
Paragraph 45(4A)(d)
33 800
34 500

6
Paragraphs 45(4A)(e) and (f)
8 120
8 290

7
Paragraphs 45(9)(a) to (e)
5 050
5 155

8
Paragraphs 45(11)(a) to (e)
1 845
1 885

9
Schedule 9, Part 2, item 1A
430
440

10
Schedule 9, Part 2, item 1, paragraph (a)
1 595
1 630

11
Schedule 9, Part 2, item 1, paragraph (b)
19 900
20 300

12
Schedule 9, Part 2, item 1, paragraph (c)
16 800
17 200

13
Schedule 9, Part 2, item 1, paragraph (d)
2 530
2 585

14
Schedule 9, Part 2, item 2, paragraph (a)
1 445
1 475

15
Schedule 9, Part 2, item 2, paragraph (b)
1 350
1 380

16
Schedule 9, Part 2, item 2, paragraph (ba)
44 200
45 100

17
Schedule 9, Part 2, item 2, paragraph (bb)
14 700
15 000

18
Schedule 9, Part 2, item 2, paragraph (bc)
29 500
30 100

19
Schedule 9, Part 2, item 2, paragraph (bd)
26 300
26 900

20
Schedule 9, Part 2, item 2, subparagraph (be)(i)
8 775
8 960

21
Schedule 9, Part 2, item 2, subparagraph (be)(ii)
5 725
5 845

22
Schedule 9, Part 2, item 2, subparagraph (bf)(i)
17 600
18 000

23
Schedule 9, Part 2, item 2, subparagraph (bf)(ii)
11 500
11 700

24
Schedule 9, Part 2, item 2, paragraph (bg)
17 000
17 400

25
Schedule 9, Part 2, item 2, paragraph (bh)
2 785
2 845

26
Schedule 9, Part 2, item 2, paragraph (bi)
17 200
17 600

27
Schedule 9, Part 2, item 2, paragraph (bj)
1 015
1 035

28
Schedule 9, Part 2, item 2, paragraph (c)
4 025
4 110

29
Schedule 9, Part 2, item 2, paragraph (d)
2 015
2 060

30
Schedule 9, Part 2, item 2, paragraph (d)
11 700
11 900

31
Schedule 9, Part 2, item 2, paragraph (f)
635
650

32
Schedule 9, Part 2, item 2, paragraph (g)
1 350
1 380

33
Schedule 9, Part 2, item 2, paragraph (h)
675
690

34
Schedule 9, Part 2, item 2AA
615
630

35
Schedule 9, Part 2, item 2A, paragraph (a)
1 555
1 590

36
Schedule 9, Part 2, item 2A, paragraph (b)
1 445
1 475

37
Schedule 9, Part 2, item 2A, paragraph (c)
380
390

38
Schedule 9, Part 2, item 2A, paragraphs (d) to (g)
410
420

39
Schedule 9, Part 2, item 2AB
390
400

40
Schedule 9, Part 2, item 2AC
1 015
1 035

41
Schedule 9, Part 2, item 2B
5 050
5 155

42
Schedule 9, Part 2, item 2C
4 035
4 120

43
Schedule 9, Part 2, item 2CA
5 050
5 155

44
Schedule 9, Part 2, item 3, paragraph (a)
410
420

45
Schedule 9, Part 2, item 3, paragraph (b)
760
775

46
Schedule 9, Part 2, item 3AA
615
630

47
Schedule 9, Part 2, item 4, paragraph (a)
177 200
181 000

48
Schedule 9, Part 2, item 4, subparagraphs (aa)(i) and (ii)
59 100
60 400

49
Schedule 9, Part 2, item 4, subparagraph (aa)(iii)
118 000
120 500

50
Schedule 9, Part 2, item 4, paragraph (b)
105 300
107 500

51
Schedule 9, Part 2, item 4, subparagraph (bb)(i)
35 100
35 800

52
Schedule 9, Part 2, item 4, subparagraph (bb)(i)
22 700
23 200

53
Schedule 9, Part 2, item 4, subparagraph (bb)(ii)
35 100
35 800

54
Schedule 9, Part 2, item 4, subparagraph (bb)(ii)
22 700
23 200

55
Schedule 9, Part 2, item 4, subparagraph (bb)(iii)
70 100
71 600

56
Schedule 9, Part 2, item 4, subparagraph (bb)(iii)
45 800
46 800

57
Schedule 9, Part 2, item 4, paragraph (c)
67 600
69 000

58
Schedule 9, Part 2, item 4, paragraph (d)
11 200
11 400

59
Schedule 9, Part 2, item 4, paragraph (g)
68 500
70 000

60
Schedule 9, Part 2, item 4, paragraph (h)
4 035
4 120

61
Schedule 9, Part 2, item 5, paragraph (a)
9 665
9 870

62
Schedule 9, Part 2, item 5, subparagraph (b)(i)
9 665
9 870

63
Schedule 9, Part 2, item 5, subparagraph (b)(ii)
12 400
12 700

64
Schedule 9, Part 2, item 5, subparagraph (b)(iii)
17 000
17 400

65
Schedule 9, Part 2, item 5, subparagraph (b)(iv)
22 500
23 000

66
Schedule 9, Part 2, item 5, subparagraph (b)(v)
33 800
34 500

67
Schedule 9, Part 2, item 5, subparagraph (b)(vi)
45 100
46 100

68
Schedule 9, Part 2, item 5, subparagraph (b)(vii)
67 600
69 000

69
Schedule 9, Part 2, item 5, paragraph (c)
3 490
3 565

70
Schedule 9, Part 2, item 5, subparagraph (d)(i)
3 490
3 565

71
Schedule 9, Part 2, item 5, subparagraph (d)(ii)
12 400
12 700

72
Schedule 9, Part 2, item 5, subparagraph (d)(iii)
17 000
17 400

73
Schedule 9, Part 2, item 5, subparagraph (d)(iv)
22 500
23 000

74
Schedule 9, Part 2, item 5, subparagraph (d)(v)
33 800
34 500

75
Schedule 9, Part 2, item 5, subparagraph (d)(vi)
45 100
46 100

76
Schedule 9, Part 2, item 5, subparagraph (d)(vii)
67 600
69 000

77
Schedule 9, Part 2, item 5A, paragraphs (a) to (f)
5 050
5 155

78
Schedule 9, Part 2, item 5B
16 800
17 200

79
Schedule 9, Part 2, item 6, paragraph (a)
29 600
30 200

80
Schedule 9, Part 2, item 6, paragraphs (b), (c) and (ca)
20 200
20 600

81
Schedule 9, Part 2, item 6, paragraph (d)
33 800
34 500

82
Schedule 9, Part 2, item 6AA
360
370

83
Schedule 9, Part 2, item 6AB
635
650

84
Schedule 9, Part 2, item 6ABA
1 915
1 955

85
Schedule 9, Part 2, item 6AC
1 075
1 100

86
Schedule 9, Part 2, item 6AD, paragraph (a)
20 200
20 600

87
Schedule 9, Part 2, item 6AD, paragraph (b)
5 050
5 155

88
Schedule 9, Part 2, item 6A
1 350
1 380

89
Schedule 9, Part 2, item 6B
3 380
3 450

90
Schedule 9, Part 2, item 6C
7 350
7 505

91
Schedule 9, Part 2, item 6D, paragraph (a)
9 665
9 870

92
Schedule 9, Part 2, item 6D, paragraph (b)
12 400
12 700

93
Schedule 9, Part 2, item 6D, paragraph (c)
17 000
17 400

94
Schedule 9, Part 2, item 6D, paragraph (d)
22 500
23 000

95
Schedule 9, Part 2, item 6D, paragraph (e)
33 800
34 500

96
Schedule 9, Part 2, item 6D, paragraph (f)
45 100
46 100

97
Schedule 9, Part 2, item 6D, paragraph (g)
67 600
69 000

98
Schedule 9, Part 2, item 7, paragraph (a)
10 095
10 300

99
Schedule 9, Part 2, item 7, paragraphs (b), (c) and (ca)
8 395
8 575

100
Schedule 9, Part 2, item 7, paragraph (d)
33 800
34 500

101
Schedule 9, Part 2, item 7, paragraphs (e) and (f)
8 395
8 575

102
Schedule 9, Part 2, item 7A, paragraph (a)
9 665
9 870

103
Schedule 9, Part 2, item 7A, subparagraph (b)(i)
9 665
9 870

104
Schedule 9, Part 2, item 7A, subparagraph (b)(ii)
12 400
12 700

105
Schedule 9, Part 2, item 7A, subparagraph (b)(iii)
17 000
17 400

106
Schedule 9, Part 2, item 7A, subparagraph (b)(iv)
22 500
23 000

107
Schedule 9, Part 2, item 7A, subparagraph (b)(v)
33 800
34 500

108
Schedule 9, Part 2, item 7A, subparagraph (b)(vi)
45 100
46 100

109
Schedule 9, Part 2, item 7A, subparagraph (b)(vii)
67 600
69 000

110
Schedule 9, Part 2, item 7B, paragraph (a)
9 665
9 870

111
Schedule 9, Part 2, item 7B, subparagraph (b)(i)
9 665
9 870

112
Schedule 9, Part 2, item 7B, subparagraph (b)(ii)
12 400
12 700

113
Schedule 9, Part 2, item 7B, subparagraph (b)(iii)
17 000
17 400

114
Schedule 9, Part 2, item 7B, subparagraph (b)(iv)
22 500
23 000

115
Schedule 9, Part 2, item 7B, subparagraph (b)(v)
33 800
34 500

116
Schedule 9, Part 2, item 7B, subparagraph (b)(vi)
45 100
46 100

117
Schedule 9, Part 2, item 7B, subparagraph (b)(vii)
67 600
69 000

118
Schedule 9, Part 2, item 8
940
960

119
Schedule 9, Part 2, item 9, paragraph (a)
615
630

120
Schedule 9, Part 2, item 9, paragraph (b)
1 250
1 275

121
Schedule 9, Part 2, item 9AA
615
630

122
Schedule 9, Part 2, item 9AB
830
850

123
Schedule 9, Part 2, items 9AC and 9ACA
615
630

124
Schedule 9, Part 2, item 9AD, paragraph (a)
1 210
1 235

125
Schedule 9, Part 2, item 9AD, paragraph (b)
10 400
10 600

126
Schedule 9, Part 2, item 9AD, paragraph (c)
23 200
23 700

127
Schedule 9, Part 2, item 9AD, paragraph (d)
31 200
31 900

128
Schedule 9, Part 2, item 9AD, paragraph (e)
48 700
49 700

129
Schedule 9, Part 2, item 9AD, paragraph (f)
64 800
66 200

130
Schedule 9, Part 2, item 9AD, paragraph (g)
79 000
80 700

131
Schedule 9, Part 2, items 9B and 9C
16 800
17 200

132
Schedule 9, Part 2, item 10
155
160

133
Schedule 9, Part 2, items 14 and 14A
330
335

134
Schedule 9, Part 2, item 17, subparagraph (a)(i)
225
230

135
Schedule 9, Part 2, item 17, subparagraph (a)(ii)
275
280

136
Schedule 9, Part 2, item 17, subparagraph (a)(iii)
430
440

137
Schedule 9, Part 2, item 17, paragraph (b)
195
200

138
Schedule 9, Part 2, item 17A, subparagraph (a)(i)
1 105
1 130

139
Schedule 9, Part 2, item 17A, subparagraph (a)(ii)
585
595

140
Schedule 9, Part 2, item 17A, sub‑subparagraph (a)(iii)(A)
830
850

141
Schedule 9, Part 2, item 17A, sub‑subparagraph (a)(iii)(B)
235
240

142
Schedule 9, Part 2, item 17A, subparagraph (a)(iv)
400
410

143
Schedule 9, Part 2, item 17A, subparagraph (a)(v)
285
290

144
Schedule 9, Part 2, item 17A, sub‑subparagraph (a)(vi)(A)
225
230

145
Schedule 9, Part 2, item 17A, sub‑subparagraph (a)(vi)(B)
275
280

146
Schedule 9, Part 2, item 17A, sub‑subparagraph (a)(vi)(C)
430
440

147
Schedule 9, Part 2, item 17A, paragraph (b)
195
200

148
Schedule 9, Part 2, item 18
2 040
2 085

149
Schedule 9A, Part 2, items 1, 2 and 3
1 005
1 025

150
Schedule 9A, Part 2, item 4
66 800
68 200

151
Schedule 9A, Part 2, item 5
133 500
136 300

152
Schedule 9A, Part 2, item 6
217 000
221 600

153
Schedule 9A, Part 2, item 7
21 600
22 100

154
Schedule 9A, Part 2, item 8
1 005
1 025

155
Schedule 9A, Part 2, item 9
6 125
6 255

156
Schedule 9A, Part 2, item 10
16 100
16 400

157
Schedule 9A, Part 2, item 11
31 700
32 400

158
Schedule 9A, Part 2, item 12
19 900
20 300

159
Schedule 9A, Part 2, item 13
15 100
15 400

160
Schedule 9A, Part 2, item 14
615
630

161
Schedule 9A, Part 2, item 16
24 100
24 600

162
Schedule 9A, Part 2, item 17
315
320