Federal Register of Legislation - Australian Government

Primary content

SLI 2013 No. 94 Regulations as made
This regulation amends the Therapeutic Goods (Charges) Regulations 1990, Therapeutic Goods (Medical Devices) Regulations 2002 and Therapeutic Goods Regulations 1990 to increase the fees and charges by 2.9 per cent.
Administered by: Health
Registered 03 Jun 2013
Tabling HistoryDate
Tabled HR05-Jun-2013
Tabled Senate17-Jun-2013
Date of repeal 02 Jul 2013
Repealed by Division 1 of Part 5A of the Legislative Instruments Act 2003
Table of contents.

Commonwealth Coat of Arms

 

 

Therapeutic Goods Legislation Amendment (Fees and Charges) Regulation 2013

 

Select Legislative Instrument No. 94, 2013

I, Professor Marie Bashir AC CVO, Administrator of the Government of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following regulation under the Therapeutic Goods Act 1989 and the Therapeutic Goods (Charges) Act 1989.

Dated 30 May 2013

Marie Bashir

Administrator

By Her Excellency’s Command

Shayne Neumann

Parliamentary Secretary for Health and Ageing

 

 

  

  


Contents

1............ Name of regulation.............................................................................. 1

2............ Commencement................................................................................... 1

3............ Authority............................................................................................. 1

4............ Schedule(s)......................................................................................... 1

Schedule 1—Amendments                                                                                                2

Therapeutic Goods (Charges) Regulations 1990                                                  2

Therapeutic Goods (Medical Devices) Regulations 2002                                   3

Therapeutic Goods Regulations 1990                                                                     4

 


1  Name of regulation

                   This regulation is the Therapeutic Goods Legislation Amendment (Fees and Charges) Regulation 2013.

2  Commencement

                   This regulation commences on 1 July 2013.

3  Authority

                   This regulation is made under the Therapeutic Goods Act 1989 and the Therapeutic Goods (Charges) Act 1989.

4  Schedule(s)

                   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 1Amendments

  

Therapeutic Goods (Charges) Regulations 1990

1  Amendments of listed provisions—charges

 

Amendments relating to charges

Item

Provision

Omit

Substitute

1

Subparagraph 3(1)(a)(i)

$1 280

$1 320

2

Subparagraph 3(1)(a)(ii)

$2 520

$2 590

3

Subparagraph 3(1)(a)(iii)

$1 440

$1 480

4

Subparagraph 3(1)(b)(i)

$6 250

$6 430

5

Subparagraph 3(1)(b)(ii)

$3 750

$3 860

6

Subparagraph 3(1)(c)(i)

$910

$940

7

Subparagraph 3(1)(c)(ii)

$1 280

$1 320

8

Subparagraph 3(1)(c)(iii)

$730

$750

9

Subparagraph 3(1A)(a)(i)

$1 280

$1 320

10

Subparagraph 3(1A)(a)(ii)

$2 520

$2 590

11

Subparagraph 3(1A)(a)(iii)

$1 440

$1 480

12

Subparagraph 3(1A)(b)(i)

$6 250

$6 430

13

Subparagraph 3(1A)(b)(ii)

$3 750

$3 860

14

Subparagraph 3(1A)(c)(i)

$910

$940

15

Subparagraph 3(1A)(c)(ii)

$1 280

$1 320

16

Subparagraph 3(1A)(c)(iii)

$730

$750

17

Paragraph 3(1AA)(a)

$580

$600

18

Paragraph 3(1AA)(b)

$5 810

$5 980

19

Paragraph 3(1B)(a)

$70

$80

20

Paragraph 3(1B)(b)

$580

$600

21

Paragraph 3(1B)(c)

$890

$920

22

Paragraph 3(1B)(d)

$1 150

$1 180

23

Paragraphs 3(2)(a) and (b)

$10 900

$11 200

24

Paragraphs 3(2)(c) to (h)

$5 600

$5 760

25

Subparagraph 3(2)(j)(i)

$140 600

$144 700

26

Subparagraph 3(2)(j)(ii)

$6 920

$7 120

27

Paragraphs 3(2)(ja) and (k)

$6 050

$6 230

28

Paragraph 3(2)(l)

$11 800

$12 100

29

Subregulation 3(3), note

$85 900

$88 400

 

Therapeutic Goods (Medical Devices) Regulations 2002

2  Amendments of listed provisions—fees

 

Amendments relating to fees

Item

Provision

Omit

Substitute

1

Paragraph 9.4 (2) (b)

$3 520

$3 620

2

Schedule 5, item 1.1

870

900

3

Schedule 5, item 1.2, paragraph (a)

7 560

7 780

4

Schedule 5, item 1.2, paragraph (b)

7 610

7 830

5

Schedule 5, item 1.3, paragraph (a)

46 400

47 700

6

Schedule 5, item 1.3, paragraph (b)

35 700

36 700

7

Schedule 5, item 1.3A, paragraph (a)

26 100

26 900

8

Schedule 5, item 1.3A, paragraph (b)

55 700

57 300

9

Schedule 5, item 1.3A, paragraph (c)

13 600

14 000

10

Schedule 5, item 1.3A, paragraph (d)

3 280

3 380

11

Schedule 5, item 1.3A, paragraph (e)

36 000

37 000

12

Schedule 5, item 1.3A, paragraph (f)

22 900

23 600

13

Schedule 5, item 1.5, paragraphs (a) and (b)

1 150

1 180

14

Schedule 5, item 1.5, paragraphs (c) to (f)

890

920

15

Schedule 5, item 1.7

15 900

16 400

16

Schedule 5, item 1.8

310

320

17

Schedule 5, item 1.9, paragraph (a)

26 000

26 800

18

Schedule 5, item 1.9, paragraph (b)

51 200

52 700

19

Schedule 5, item 1.9, paragraph (c)

35 700

36 700

20

Schedule 5, item 1.9, paragraph (d)

24 900

25 600

21

Schedule 5, item 1.9, paragraph (e)

22 700

23 400

22

Schedule 5, item 1.9, paragraph (f)

19 400

20 000

23

Schedule 5, item 1.9A, paragraph (a)

26 100

26 900

24

Schedule 5, item 1.9A, paragraph (b)

55 700

57 300

25

Schedule 5, item 1.9A, paragraph (c)

13 600

14 000

26

Schedule 5, item 1.9A, paragraph (d)

3 280

3 380

27

Schedule 5, item 1.9A, paragraph (e)

36 000

37 000

28

Schedule 5, item 1.9A, paragraph (f)

22 900

23 600

29

Schedule 5, item 1.10, paragraph (a)

15 600

16 100

30

Schedule 5, item 1.10, paragraph (b)

30 800

31 700

31

Schedule 5, item 1.10, paragraph (c)

21 500

22 100

32

Schedule 5, item 1.10, paragraph (d)

13 600

14 000

33

Schedule 5, item 1.10, paragraph (e)

11 800

12 100

34

Schedule 5, item 1.12

360

370

35

Schedule 5, item 1.13

3 360

3 460

36

Schedule 5, item 1.14

6 170

6 350

37

Schedule 5, item 1.14A

6 010

6 180

38

Schedule 5, item 1.15

390

400

39

Schedule 5, item 1.17

890

920

40

Schedule 5, paragraph 2.1(b)

$360

$370

 

Therapeutic Goods Regulations 1990

3  Amendments of listed provisions—fees and charges

 

Amendments relating to fees and charges

Item

Provision

Omit

Substitute

1

Paragraph 43AAJ (1)(b)

$85 900

$88 400

2

Paragraph 45(4A)(a)

$9 580

$9 860

3

Paragraph 45(4A)(b)

$7 970

$8 200

4

Paragraphs 45(4A)(c) and (ca)

$7 710

$7 930

5

Paragraph 45(4A)(d)

$32 100

$33 000

6

Paragraphs 45(4A)(e) and (f)

$7 710

$7 930

7

Paragraphs 45(9)(a) to (e)

$4 790

$4 930

8

Paragraphs 45(11)(a) to (e)

$1 750

$1 800

9

Regulation 45A

$14 000

$15 000

10

Schedule 9, Part 2, item 1A

410

420

11

Schedule 9, Part 2, item 1, paragraph (a)

1 520

1 560

12

Schedule 9, Part 2, item 1, paragraph (b)

18 900

19 400

13

Schedule 9, Part 2, item 1, paragraph (c)

15 900

16 400

14

Schedule 9, Part 2, item 1, paragraph (d)

2 400

2 470

15

Schedule 9, Part 2, item 2, paragraph (a)

1 370

1 410

16

Schedule 9, Part 2, item 2, paragraph (b)

1 280

1 320

17

Schedule 9, Part 2, item 2, paragraph (ba)

42 000

43 200

18

Schedule 9, Part 2, item 2, paragraph (bb)

14 000

14 400

19

Schedule 9, Part 2, item 2, paragraph (bc)

28 000

28 800

20

Schedule 9, Part 2, item 2, paragraph (bd)

25 000

25 700

21

Schedule 9, Part 2, item 2, subparagraph (be)(i)

8 330

8 570

22

Schedule 9, Part 2, item 2, subparagraph (be)(ii)

5 430

5 590

23

Schedule 9, Part 2, item 2, subparagraph (bf)(i)

16 700

17 200

24

Schedule 9, Part 2, item 2, subparagraph (bf)(ii)

10 900

11 200

25

Schedule 9, Part 2, item 2, paragraph (bg)

16 100

16 600

26

Schedule 9, Part 2, item 2, paragraph (bh)

2 640

2 720

27

Schedule 9, Part 2, item 2, paragraph (bi)

16 300

16 800

28

Schedule 9, Part 2, item 2, paragraph (bj)

960

990

29

Schedule 9, Part 2, item 2, paragraph (c)

3 820

3 930

30

Schedule 9, Part 2, item 2, paragraph (d)

1 910

1 970

31

Schedule 9, Part 2, item 2, paragraph (d)

11 100

11 400

32

Schedule 9, Part 2, item 2, paragraph (f)

600

620

33

Schedule 9, Part 2, item 2, paragraph (g)

1 280

1 320

34

Schedule 9, Part 2, item 2, paragraph (h)

640

660

35

Schedule 9, Part 2, item 2AA

580

600

36

Schedule 9, Part 2, item 2A, paragraph (a)

1 480

1 520

37

Schedule 9, Part 2, item 2A, paragraph (b)

1 370

1 410

38

Schedule 9, Part 2, item 2A, paragraph (c)

360

370

39

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

390

400

40

Schedule 9, Part 2, item 2AB

370

380

41

Schedule 9, Part 2, item 2AC

960

990

42

Schedule 9, Part 2, item 2B

4 790

4 930

43

Schedule 9, Part 2, item 2C

3 830

3 940

44

Schedule 9, Part 2, item 2CA

4 790

4 930

45

Schedule 9, Part 2, item 3, paragraph (a)

390

400

46

Schedule 9, Part 2, item 3, paragraph (b)

720

740

47

Schedule 9, Part 2, item 3AA

580

600

48

Schedule 9, Part 2, item 3AB

140

150

49

Schedule 9, Part 2, item 4, paragraph (a)

168 100

173 000

50

Schedule 9, Part 2, item 4, subparagraphs (aa)(i) and (ii)

56 100

57 700

51

Schedule 9, Part 2, item 4, subparagraph (aa)(iii)

112 000

115 200

52

Schedule 9, Part 2, item 4, paragraph (b)

99 900

102 800

53

Schedule 9, Part 2, item 4, sub‑subparagraph (bb)(i)(a)

33 300

34 300

54

Schedule 9, Part 2, item 4, sub‑subparagraph (bb)(i)(b)

21 600

22 200

55

Schedule 9, Part 2, item 4, sub‑subparagraph (bb)(ii)(a)

33 300

34 300

56

Schedule 9, Part 2, item 4, sub‑subparagraph (bb)(ii)(b)

21 600

22 200

57

Schedule 9, Part 2, item 4, sub‑subparagraph (bb)(iii)(a)

66 600

68 500

58

Schedule 9, Part 2, item 4, sub‑subparagraph (bb)(iii)(b)

43 400

44 700

59

Schedule 9, Part 2, item 4, paragraph (c)

64 100

66 000

60

Schedule 9, Part 2, item 4, paragraph (d)

10 600

10 900

61

Schedule 9, Part 2, item 4, paragraph (g)

65 000

66 900

62

Schedule 9, Part 2, item 4, paragraph (h)

3 830

3 940

63

Schedule 9, Part 2, item 5, paragraph (a)

9 170

9 440

64

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

9 170

9 440

65

Schedule 9, Part 2, item 5, subparagraph (b)(ii)

11 800

12 100

66

Schedule 9, Part 2, item 5, subparagraph (b)(iii)

16 100

16 600

67

Schedule 9, Part 2, item 5, subparagraph (b)(iv)

21 400

22 000

68

Schedule 9, Part 2, item 5, subparagraph (b)(v)

32 100

33 000

69

Schedule 9, Part 2, item 5, subparagraph (b)(vi)

42 800

44 000

70

Schedule 9, Part 2, item 5, subparagraph (b)(vii)

64 100

66 000

71

Schedule 9, Part 2, item 5, paragraph (c)

3 310

3 410

72

Schedule 9, Part 2, item 5, subparagraph (d)(i)

3 310

3 410

73

Schedule 9, Part 2, item 5, subparagraph (d)(ii)

11 800

12 100

74

Schedule 9, Part 2, item 5, subparagraph (d)(iii)

16 100

16 600

75

Schedule 9, Part 2, item 5, subparagraph (d)(iv)

21 400

22 000

76

Schedule 9, Part 2, item 5, subparagraph (d)(v)

32 100

33 000

77

Schedule 9, Part 2, item 5, subparagraph (d)(vi)

42 800

44 000

78

Schedule 9, Part 2, item 5, subparagraph (d)(vii)

64 100

66 000

79

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

4 790

4 930

80

Schedule 9, Part 2, item 5B

15 900

16 400

81

Schedule 9, Part 2, item 6, paragraph (a)

28 100

28 900

82

Schedule 9, Part 2, item 6, paragraphs (b), (c) and (ca)

19 100

19 700

83

Schedule 9, Part 2, item 6, paragraph (d)

32 100

33 000

84

Schedule 9, Part 2, item 6AA

340

350

85

Schedule 9, Part 2, item 6AB

600

620

86

Schedule 9, Part 2, item 6ABA

1 820

1 870

87

Schedule 9, Part 2, item 6AC

1 020

1 050

88

Schedule 9, Part 2, item 6AD, paragraph (a)

19 100

19 700

89

Schedule 9, Part 2, item 6AD, paragraph (b)

4 790

4 930

90

Schedule 9, Part 2, item 6A

1 280

1 320

91

Schedule 9, Part 2, item 6B

3 210

3 300

92

Schedule 9, Part 2, item 6C

6 980

7 180

93

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

9 170

9 440

94

Schedule 9, Part 2, item 6D, paragraph (b)

11 800

12 100

95

Schedule 9, Part 2, item 6D, paragraph (c)

16 100

16 600

96

Schedule 9, Part 2, item 6D, paragraph (d)

21 400

22 000

97

Schedule 9, Part 2, item 6D, paragraph (e)

32 100

33 000

98

Schedule 9, Part 2, item 6D, paragraph (f)

42 800

44 000

99

Schedule 9, Part 2, item 6D, paragraph (g)

64 100

66 000

100

Schedule 9, Part 2, item 7, paragraph (a)

9 580

9 860

101

Schedule 9, Part 2, item 7, paragraphs (b), (c) and (ca)

7 970

8 200

102

Schedule 9, Part 2, item 7, paragraph (d)

32 100

33 000

103

Schedule 9, Part 2, item 7, paragraphs (e) and (f)

7 970

8 200

104

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

9 170

9 440

105

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

9 170

9 440

106

Schedule 9, Part 2, item 7A, subparagraph (b)(ii)

11 800

12 100

107

Schedule 9, Part 2, item 7A, subparagraph (b)(iii)

16 100

16 600

108

Schedule 9, Part 2, item 7A, subparagraph (b)(iv)

21 400

22 000

109

Schedule 9, Part 2, item 7A, subparagraph (b)(v)

32 100

33 000

110

Schedule 9, Part 2, item 7A, subparagraph (b)(vi)

42 800

44 000

111

Schedule 9, Part 2, item 7A, subparagraph (b)(vii)

64 100

66 000

112

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

9 170

9 440

113

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

9 170

9 440

114

Schedule 9, Part 2, item 7B, subparagraph (b)(ii)

11 800

12 100

115

Schedule 9, Part 2, item 7B, subparagraph (b)(iii)

16 100

16 600

116

Schedule 9, Part 2, item 7B, subparagraph (b)(iv)

21 400

22 000

117

Schedule 9, Part 2, item 7B, subparagraph (b)(v)

32 100

33 000

118

Schedule 9, Part 2, item 7B, subparagraph (b)(vi)

42 800

44 000

119

Schedule 9, Part 2, item 7B, subparagraph (b)(vii)

64 100

66 000

120

Schedule 9, Part 2, item 8

890

920

121

Schedule 9, Part 2, item 9, paragraph (a)

580

600

122

Schedule 9, Part 2, item 9, paragraph (b)

1 190

1 220

123

Schedule 9, Part 2, item 9AA

580

600

124

Schedule 9, Part 2, item 9AB

790

810

125

Schedule 9, Part 2, items 9AC and 9ACA

580

600

126

Schedule 9, Part 2, item 9AD, paragraph (a)

1 150

1 180

127

Schedule 9, Part 2, item 9AD, paragraph (b)

9 920

10 200

128

Schedule 9, Part 2, item 9AD, paragraph (c)

22 100

22 700

129

Schedule 9, Part 2, item 9AD, paragraph (d)

29 600

30 500

130

Schedule 9, Part 2, item 9AD, paragraph (e)

46 300

47 600

131

Schedule 9, Part 2, item 9AD, paragraph (f)

61 500

63 300

132

Schedule 9, Part 2, item 9AD, paragraph (g)

74 900

77 100

133

Schedule 9, Part 2, items 9B and 9C

15 900

16 400

134

Schedule 9, Part 2, item 10

140

150

135

Schedule 9, Part 2, items 14 and 14A

310

320

136

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

210

220

137

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

260

270

138

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

410

420

139

Schedule 9, Part 2, item 17, subparagraph (a)(iv)

100

110

140

Schedule 9, Part 2, item 17, paragraph (b)

$180

190

141

Schedule 9, Part 2, item 17, paragraph (c)

100

110

142

Schedule 9, Part 2, item 17A, subparagraph (a)(i)

1 050

1 080

143

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

550

570

144

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

790

810

145

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

220

230

146

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

380

390

147

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

270

280

148

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

210

220

149

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

260

270

150

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

410

420

151

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

$180

190

152

Schedule 9, Part 2, item 18

1 930

1 990

153

Schedule 9A, Part 2, items 1, 2 and 3

$950

$980

154

Schedule 9A, Part 2, item 4

$63 400

$65 200

155

Schedule 9A, Part 2, item 5

$126 700

$130 400

156

Schedule 9A, Part 2, item 6

$205 900

$211 900

157

Schedule 9A, Part 2, item 7

$20 500

$21 100

158

Schedule 9A, Part 2, item 8

$950

$980

159

Schedule 9A, Part 2, item 9

$5 810

$5 980

160

Schedule 9A, Part 2, item 10

$15 300

$15 700

161

Schedule 9A, Part 2, item 11

$30 100

$31 000

162

Schedule 9A, Part 2, item 12

$18 900

$19 400

163

Schedule 9A, Part 2, item 13

$14 300

$14 700

164

Schedule 9A, Part 2, item 14

$580

$600

165

Schedule 9A, Part 2, item 16

$22 800

$23 500

166

Schedule 9A, Part 2, item 17

$300

$310