Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulation 2016 (Cth)

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Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulation 2016

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 05 May 2016

Peter Cosgrove

Governor‑General

By His Excellency’s Command

Sussan Ley

Minister for Health

Contents

1Name

This is the Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulation 2016.

2Commencement
  1. (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 2016.

1 July 2016

Note: This table relates only to the provisions of this instrument as originally made.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.

  1. (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.

3Authority

This instrument is made under the Therapeutic Goods Act 1989.

4Schedules

Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.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 (Medical Devices) Regulations 2002

1

Amendments of listed provisions

Amendments of fees

Item

Provision

Omit

Substitute

1

Paragraph 9.4(2)(b)

3 785

3 870

2

Schedule 5, item 1.1

940

960

3

Schedule 5, item 1.2, paragraph (a)

8 135

8 320

4

Schedule 5, item 1.2, paragraph (b)

8 190

8 375

5

Schedule 5, item 1.3, paragraph (a)

49 800

50 900

6

Schedule 5, item 1.3, paragraph (b)

38 400

39 300

7

Schedule 5, item 1.3A, paragraph (a)

28 100

28 700

8

Schedule 5, item 1.3A, paragraph (b)

59 900

61 200

9

Schedule 5, item 1.3A, paragraph (c)

14 600

14 900

10

Schedule 5, item 1.3A, paragraph (d)

3 535

3 615

11

Schedule 5, item 1.3A, paragraph (e)

38 700

39 600

12

Schedule 5, item 1.3A, paragraph (f)

24 700

25 300

13

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

1 235

1 265

14

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

960

980

15

Schedule 5, item 1.7

17 200

17 600

16

Schedule 5, item 1.8

335

345

17

Schedule 5, item 1.9, paragraph (a)

28 000

28 600

18

Schedule 5, item 1.9, paragraph (b)

55 100

56 300

19

Schedule 5, item 1.9, paragraph (c)

38 400

39 300

20

Schedule 5, item 1.9, paragraph (d)

26 800

27 400

21

Schedule 5, item 1.9, paragraph (e)

24 500

25 100

22

Schedule 5, item 1.9, paragraph (f)

20 900

21 400

23

Schedule 5, item 1.9A, paragraph (a)

28 100

28 700

24

Schedule 5, item 1.9A, paragraph (b)

59 900

61 200

25

Schedule 5, item 1.9A, paragraph (c)

14 600

14 900

26

Schedule 5, item 1.9A, paragraph (d)

3 535

3 615

27

Schedule 5, item 1.9A, paragraph (e)

38 700

39 600

28

Schedule 5, item 1.9A, paragraph (f)

24 700

25 300

29

Schedule 5, item 1.10, paragraph (a)

16 800

17 200

30

Schedule 5, item 1.10, paragraph (b)

33 200

33 900

31

Schedule 5, item 1.10, paragraph (c)

23 100

23 600

32

Schedule 5, item 1.10, paragraph (d)

14 600

14 900

33

Schedule 5, item 1.10, paragraph (e)

12 700

13 000

34

Schedule 5, item 1.12

390

400

35

Schedule 5, item 1.13

3 620

3 700

36

Schedule 5, item 1.14

6 640

6 790

37

Schedule 5, item 1.14A

6 465

6 610

38

Schedule 5, item 1.14B

59 900

61 200

39

Schedule 5, item 1.14C

14 600

14 900

40

Schedule 5, item 1.15

420

430

41

Schedule 5, item 1.17

960

980

42

Schedule 5, paragraph 2.1(b)

390

400

Therapeutic Goods Regulations 1990

  1. 2

    Clause 1 of Schedule 9A (definition of major variation)

After “the following”, insert “, other than a change that would result in the biological becoming separate and distinct from other biologicals”.

  1. 3

    Clause 1 of Schedule 9A (paragraph (b) of the definition of major variation)

Repeal the paragraph.

  1. 4

    Clause 1 of Schedule 9A (definition of minor variation)

Repeal the definition, substitute:

minor variation, for a biological, means a change to the entry of the biological in the Register that requires the evaluation of quality and manufacturing information, other than a change that is a major variation for the biological or that would result in the biological becoming separate and distinct from other biologicals.

  1. 5

    Part 2 of Schedule 9A (cell at table item 8, column headed “Matter”)

Repeal the cell, substitute:

Application under subsection 9D(3AA) or (3A) of the Act to vary the entry of a biological in the Register

6

Part 2 of Schedule 9A (after table item 8)

Insert:

8A

Evaluation of an application under subsection 9D(3AA) of the Act to vary the entry of a biological in the Register

$6 395 for each evaluation

  1. 7

    Part 2 of Schedule 9A (cell at table item 9, column headed “Matter”)

Repeal the cell, substitute:

Evaluation of an application under subsection 9D(3A) of the Act to vary the entry of a Class 2 biological in the Register

  1. 8

    Part 2 of Schedule 9A (cell at table item 10, column headed “Matter”)

Repeal the cell, substitute:

Evaluation of an application under subsection 9D(3A) of the Act to vary the entry of a Class 3 or Class 4 biological in the Register, if the variation is a minor variation

  1. 9

    Part 2 of Schedule 9A (cell at table item 11, column headed “Matter”)

Repeal the cell, substitute:

Evaluation of an application under subsection 9D(3A) of the Act to vary the entry of a Class 3 or Class 4 biological in the Register, if the variation is a major variation

10

Amendments of listed provisions

Amendments of fees etc.

Item

Provision

Omit

Substitute

1

Paragraph 43AAJ(1)(b)

92 400

94 500

2

Paragraph 45(4A)(a)

10 300

10 500

3

Paragraph 45(4A)(b)

8 575

8 770

4

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

8 290

8 475

5

Paragraph 45(4A)(d)

34 500

35 300

6

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

8 290

8 475

7

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

5 155

5 270

8

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

1 885

1 925

9

Schedule 9, Part 2, item 1A

440

450

10

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

1 630

1 665

11

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

20 300

20 800

12

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

17 200

17 600

13

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

2 585

2 645

14

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

1 475

1 510

15

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

1 380

1 410

16

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

45 100

46 100

17

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

15 000

15 300

18

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

30 100

30 800

19

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

26 900

27 500

20

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

8 960

9 160

21

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

5 845

5 975

22

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

18 000

18 400

23

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

11 700

12 000

24

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

17 400

17 800

25

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

2 845

2 910

26

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

17 600

18 000

27

Schedule 9, Part 2, item 2, paragraphs (bj) and (bk)

1 035

1 060

28

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

4 110

4 200

29

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

2 060

2 105

30

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

11 900

12 200

31

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

650

665

32

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

1 380

1 410

33

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

690

705

34

Schedule 9, Part 2, item 2AA

630

645

35

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

1 590

1 625

36

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

1 475

1 510

37

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

390

400

38

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

420

430

39

Schedule 9, Part 2, item 2AB

400

410

40

Schedule 9, Part 2, item 2AC

1 035

1 060

41

Schedule 9, Part 2, item 2B

5 155

5 270

42

Schedule 9, Part 2, item 2C

4 120

4 215

43

Schedule 9, Part 2, item 2CA

5 155

5 270

44

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

420

430

45

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

775

790

46

Schedule 9, Part 2, item 3AA

630

645

47

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

181 000

185 100

48

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

60 400

61 800

49

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

120 500

123 200

50

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

107 500

109 900

51

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

35 800

36 600

52

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

23 200

23 700

53

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

35 800

36 600

54

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

23 200

23 700

55

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

71 600

73 200

56

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

46 800

47 900

57

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

4 120

4 200

58

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

69 000

70 600

59

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

11 400

11 700

60

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

70 000

71 600

61

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

4 120

4 215

62

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

9 870

10 100

63

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

9 870

10 100

64

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

12 700

13 000

65

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

17 400

17 800

66

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

23 000

23 500

67

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

34 500

35 300

68

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

46 100

47 100

69

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

69 000

70 600

70

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

3 565

3 645

71

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

3 565

3 645

72

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

12 700

13 000

73

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

17 400

17 800

74

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

23 000

23 500

75

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

34 500

35 300

76

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

46 100

47 100

77

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

69 000

70 600

78

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

5 155

5 270

79

Schedule 9, Part 2, item 5B

17 200

17 600

80

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

30 200

30 900

81

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

20 600

21 100

82

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

34 500

35 300

83

Schedule 9, Part 2, item 6AA

370

380

84

Schedule 9, Part 2, item 6AB

650

665

85

Schedule 9, Part 2, item 6ABA

1 955

2 000

86

Schedule 9, Part 2, item 6AC

1 100

1 125

87

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

20 600

21 100

88

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

5 155

5 270

89

Schedule 9, Part 2, item 6A

1 380

1 410

90

Schedule 9, Part 2, item 6B

3 450

3 530

91

Schedule 9, Part 2, item 6C

7 505

7 675

92

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

9 870

10 100

93

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

12 700

13 000

94

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

17 400

17 800

95

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

23 000

23 500

96

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

34 500

35 300

97

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

46 100

47 100

98

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

69 000

70 600

99

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

10 300

10 500

100

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

8 575

8 770

101

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

34 500

35 300

102

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

8 575

8 770

103

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

9 870

10 100

104

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

9 870

10 100

105

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

12 700

13 000

106

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

17 400

17 800

107

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

23 000

23 500

108

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

34 500

35 300

109

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

46 100

47 100

110

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

69 000

70 600

111

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

9 870

10 100

112

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

9 870

10 100

113

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

12 700

13 000

114

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

17 400

17 800

115

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

23 000

23 500

116

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

34 500

35 300

117

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

46 100

47 100

118

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

69 000

70 600

119

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

9 870

10 100

120

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

9 870

10 100

121

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

12 700

13 000

122

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

17 400

17 800

123

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

23 000

23 500

124

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

34 500

35 300

125

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

46 100

47 100

126

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

69 000

70 600

127

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

9 870

10 100

128

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

9 870

10 100

129

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

12 700

13 000

130

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

17 400

17 800

131

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

23 000

23 500

132

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

34 500

35 300

133

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

46 100

47 100

134

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

69 000

70 600

135

Schedule 9, Part 2, item 8

960

980

136

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

630

645

137

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

1 275

1 305

138

Schedule 9, Part 2, item 9AA

630

645

139

Schedule 9, Part 2, item 9AB

850

870

140

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

630

645

141

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

1 235

1 265

142

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

10 600

10 800

143

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

23 700

24 200

144

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

31 900

32 600

145

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

49 700

50 800

146

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

66 200

67 700

147

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

80 700

82 500

148

Schedule 9, Part 2, items 9B and 9C

17 200

17 600

149

Schedule 9, Part 2, item 10

160

165

150

Schedule 9, Part 2, items 14 and 14A, paragraphs (a) and (b)

335

345

151

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

230

235

152

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

280

285

153

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

440

450

154

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

115

120

155

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

200

205

156

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

115

120

157

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

1 130

1 155

158

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

595

610

159

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

850

870

160

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

240

245

161

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

410

420

162

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

290

295

163

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

230

235

164

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

280

285

165

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

440

450

166

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

200

205

167

Schedule 9, Part 2, item 18

2 085

2 130

168

Schedule 9, Part 3, item 1, paragraphs (a) and (b)

1 530

1 565

169

Schedule 9, Part 3, item 1, paragraph (c)

2 450

2 505

170

Schedule 9, Part 3, item 1, paragraph (d)

3 575

3 655

171

Schedule 9, Part 3, item 1, paragraph (e)

5 310

5 430

172

Schedule 9, Part 3, item 1, paragraphs (f) to (h)

1 530

1 565

173

Schedule 9, Part 3, item 1, paragraph (i)

2 450

2 505

174

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

3 780

3 865

175

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

5 360

5 480

176

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

8 270

8 455

177

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

13 700

14 000

178

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

20 300

20 800

179

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

3 780

3 865

180

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

6 330

6 470

181

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

8 270

8 455

182

Schedule 9, Part 3, item 3, paragraphs (d) and (e)

765

780

183

Schedule 9, Part 3, item 3, paragraphs (f) to (h)

1 225

1 255

184

Schedule 9, Part 3, item 4, paragraphs (d) to (f)

4 185

4 280

185

Schedule 9, Part 3, item 5

1 530

1 565

186

Schedule 9, Part 3, item 6, paragraph (a)

5 310

5 430

187

Schedule 9, Part 3, item 6, paragraph (b)

7 860

8 035

188

Schedule 9, Part 3, item 6, paragraph (c)

10 720

11 000

189

Schedule 9A, Part 2, items 1, 2 and 3

1 025

1 050

190

Schedule 9A, Part 2, item 4

68 200

69 700

191

Schedule 9A, Part 2, item 5

136 300

139 400

192

Schedule 9A, Part 2, item 6

221 600

226 600

193

Schedule 9A, Part 2, item 7

22 100

22 600

194

Schedule 9A, Part 2, item 8

1 025

1 050

195

Schedule 9A, Part 2, item 9

6 255

6 395

196

Schedule 9A, Part 2, item 10

16 400

16 800

197

Schedule 9A, Part 2, item 11

32 400

33 100

198

Schedule 9A, Part 2, item 12

20 300

20 800

199

Schedule 9A, Part 2, item 13

15 400

15 700

200

Schedule 9A, Part 2, item 14

630

645

201

Schedule 9A, Part 2, item 16

24 600

25 200

202

Schedule 9A, Part 2, item 17, paragraphs (a) and (b)

320

345

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