Federal Register of Legislation - Australian Government

Primary content

Regulations as made
This instrument amends the Therapeutic Goods Regulations 1990 (the TG Regulations) and the Therapeutic Goods (Medical Devices) Regulations 2002 (the MD Regulations), to increase the fees for the financial year 2017-18.
Administered by: Health
Registered 19 May 2017
Tabling HistoryDate
Tabled HR22-May-2017
Tabled Senate13-Jun-2017
Date of repeal 02 Jul 2017
Repealed by Division 1 of Part 3 of Chapter 3 of the Legislation Act 2003
Table of contents.

 

Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2017

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 regulations.

Dated 18 May 2017

Peter Cosgrove

Governor‑General

By His Excellency’s Command

Greg Hunt

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 instrument is the Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2017.

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 2017.

1 July 2017

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 1Amendments

  

Therapeutic Goods (Medical Devices) Regulations 2002

1  Part 1 of Schedule 5 (after table item 1.6)

Insert:

 

1.6A

Request for the revocation of the cancellation of an entry of a kind of medical device from the Register:

Paragraph 41GLA(1)(c) of the Act

 

 

(a) if the request relates to one entry;

 

150

 

(b) if the request relates to more than one entry

 

150 for the first entry plus 50 for each additional entry

 

2  Amendments of listed provisions

The provisions listed in the following table are amended as set out in the table.

 

Amendments of fees

Item

Provision

Omit

Substitute

1

Paragraph 9.4(2)(b)

3 870

3,930

2

Schedule 5, item 1.1

960

980

3

Schedule 5, item 1.2, paragraph (a)

8 320

8,460

4

Schedule 5, item 1.2, paragraph (b)

8 375

8,510

5

Schedule 5, item 1.3, paragraph (a)

50 900

51,700

6

Schedule 5, item 1.3, paragraph (b)

39 300

39,900

7

Schedule 5, item 1.3A, paragraph (a)

28 700

29,200

8

Schedule 5, item 1.3A, paragraph (b)

61 200

62,200

9

Schedule 5, item 1.3A, paragraph (c)

14 900

15,100

10

Schedule 5, item 1.3A, paragraph (d)

3 615

3,670

11

Schedule 5, item 1.3A, paragraph (e)

39 600

40,300

12

Schedule 5, item 1.3A, paragraph (f)

25 300

25,700

13

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

1 265

1,290

14

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

980

1,000

15

Schedule 5, item 1.7

17 600

17,900

16

Schedule 5, item 1.8

345

350

17

Schedule 5, item 1.9, paragraph (a)

28 600

29,100

18

Schedule 5, item 1.9, paragraph (b)

56 300

57,200

19

Schedule 5, item 1.9, paragraph (c)

39 300

39,900

20

Schedule 5, item 1.9, paragraph (d)

27 400

27,900

21

Schedule 5, item 1.9, paragraph (e)

25 100

25,500

22

Schedule 5, item 1.9, paragraph (f)

21 400

21,800

23

Schedule 5, item 1.9A, paragraph (a)

28 700

29,200

24

Schedule 5, item 1.9A, paragraph (b)

61 200

62,200

25

Schedule 5, item 1.9A, paragraph (c)

14 900

15,100

26

Schedule 5, item 1.9A, paragraph (d)

3 615

3,670

27

Schedule 5, item 1.9A, paragraph (e)

39 600

40,300

28

Schedule 5, item 1.9A, paragraph (f)

25 300

25,700

29

Schedule 5, item 1.10, paragraph (a)

17 200

17,500

30

Schedule 5, item 1.10, paragraph (b)

33 900

34,500

31

Schedule 5, item 1.10, paragraph (c)

23 600

24,000

32

Schedule 5, item 1.10, paragraph (d)

14 900

15,100

33

Schedule 5, item 1.10, paragraph (e)

13 000

13,200

34

Schedule 5, item 1.12

400

410

35

Schedule 5, item 1.13

3 700

3,760

36

Schedule 5, item 1.14

6 790

6,900

37

Schedule 5, item 1.14A

6 610

6,720

38

Schedule 5, item 1.14B

61 200

62,200

39

Schedule 5, item 1.14C

14 900

15,100

40

Schedule 5, item 1.15

430

440

41

Schedule 5, item 1.17

980

1,000

42

Schedule 5, paragraph 2.1(b)

400

410

 

Therapeutic Goods Regulations 1990

3  Part 2 of Schedule 9 (after table item 6B)

Insert:

 

6BA

Application fee for a request, under subsection 30A(1) of the Act, for the revocation of the cancellation of the registration or listing of therapeutic goods from the Register:

 

 

(a) if the request relates to one registration or listing;

150

 

(b) if the request relates to more than one registration or listing

150 for the first registration or listing plus 50 for each additional registration or listing

 

4  Part 2 of Schedule 9A (after table item 16)

Insert:

 

16A

Application fee for a request, under subsection 32GD(1) of the Act, for the revocation of the cancellation of an entry of a biological from the Register:

 

 

(a) if the request relates to one entry;

$150

 

(b) if the request relates to more than one entry

$150 for the first entry plus $50 for each additional entry

 

5  Amendments of listed provisions

The provisions listed in the following table are amended as set out in the table.

 

Amendments of fees etc.

Item

Provision

Omit

Substitute

1

Paragraph 43AAJ(1)(b)

94 500

96,100

2

Paragraph 43AC(2)(a)

3 780

3,930

3

Paragraph 43AC(2)(b)

6 330

6,580

4

Paragraph 43AC(2)(c)

8 270

8,590

5

Paragraph 45(4A)(a)

10 500

10,700

6

Paragraph 45(4A)(b)

8 770

8,910

7

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

8 475

8,610

8

Paragraph 45(4A)(d)

35 300

35,900

9

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

8 475

8,610

10

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

5 270

5,360

11

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

1 925

1,960

12

Schedule 9, Part 2, item 1A

450

460

13

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

1 665

1,690

14

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

20 800

21,100

15

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

17 600

17,900

16

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

2 645

2,690

17

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

1 510

1,530

18

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

1 410

1,430

19

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

46 100

46,900

20

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

15 300

15,600

21

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

30 800

31,300

22

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

27 500

28,000

23

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

9 160

9,310

24

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

5 975

6,070

25

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

18 400

18,700

26

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

12 000

12,200

27

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

17 800

18,100

28

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

2 910

2,960

29

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

18 000

18,300

30

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

1 060

1,080

31

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

4 200

4,270

32

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

2 105

2,140

33

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

12 200

12,400

34

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

665

680

35

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

1 410

1,430

36

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

705

720

37

Schedule 9, Part 2, item 2AA

645

660

38

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

1 625

1,650

39

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

1 510

1,530

40

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

400

410

41

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

430

440

42

Schedule 9, Part 2, item 2AB

410

420

43

Schedule 9, Part 2, item 2AC

1 060

1,080

44

Schedule 9, Part 2, item 2B

5 270

5,360

45

Schedule 9, Part 2, item 2C

4 215

4,280

46

Schedule 9, Part 2, item 2CA

5 270

5,360

47

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

430

440

48

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

790

800

49

Schedule 9, Part 2, item 3AA

645

660

50

Schedule 9, Part 2, item 3AB, paragraphs (a) and (b)

400

410

51

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

185 100

188,200

52

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

61 800

62,800

53

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

123 200

125,200

54

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

109 900

111,700

55

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

36 600

37,200

56

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

23 700

24,100

57

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

36 600

37,200

58

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

23 700

24,100

59

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

73 200

74,400

60

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

47 900

48,700

61

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

4 200

4,270

62

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

70 600

71,800

63

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

11 700

11,900

64

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

71 600

72,800

65

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

4 215

4,280

66

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

10 100

10,300

67

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

10 100

10,300

68

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

13 000

13,200

69

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

17 800

18,100

70

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

23 500

23,900

71

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

35 300

35,900

72

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

47 100

47,900

73

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

70 600

71,800

74

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

3 645

3,710

75

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

3 645

3,710

76

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

13 000

13,200

77

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

17 800

18,100

78

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

23 500

23,900

79

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

35 300

35,900

80

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

47 100

47,900

81

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

70 600

71,800

82

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

5 270

5,360

83

Schedule 9, Part 2, item 5B

17 600

17,900

84

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

30 900

31,400

85

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

21 100

21,400

86

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

35 300

35,900

87

Schedule 9, Part 2, item 6AA

380

390

88

Schedule 9, Part 2, item 6AB

665

680

89

Schedule 9, Part 2, item 6ABA

2 000

2,030

90

Schedule 9, Part 2, item 6AC

1 125

1,140

91

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

21 100

21,400

92

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

5 270

5,360

93

Schedule 9, Part 2, item 6A

1 410

1,430

94

Schedule 9, Part 2, item 6B

3 530

3,590

95

Schedule 9, Part 2, item 6C

7 675

7,800

96

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

10 100

10,300

97

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

13 000

13,200

98

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

17 800

18,100

99

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

23 500

23,900

100

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

35 300

35,900

101

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

47 100

47,900

102

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

70 600

71,800

103

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

10 500

10,700

104

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

8 770

8,910

105

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

35 300

35,900

106

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

8 770

8,910

107

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

10 100

10,300

108

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

10 100

10,300

109

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

13 000

13,200

110

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

17 800

18,100

111

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

23 500

23,900

112

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

35 300

35,900

113

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

47 100

47,900

114

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

70 600

71,800

115

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

10 100

10,300

116

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

10 100

10,300

117

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

13 000

13,200

118

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

17 800

18,100

119

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

23 500

23,900

120

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

35 300

35,900

121

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

47 100

47,900

122

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

70 600

71,800

123

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

10 100

10,300

124

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

10 100

10,300

125

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

13 000

13,200

126

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

17 800

18,100

127

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

23 500

23,900

128

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

35 300

35,900

129

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

47 100

47,900

130

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

70 600

71,800

131

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

10 100

10,300

132

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

10 100

10,300

133

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

13 000

13,200

134

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

17 800

18,100

135

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

23 500

23,900

136

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

35 300

35,900

137

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

47 100

47,900

138

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

70 600

71,800

139

Schedule 9, Part 2, item 8

980

1,000

140

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

645

660

141

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

1 305

1,330

142

Schedule 9, Part 2, item 9AA

645

660

143

Schedule 9, Part 2, item 9AB

870

880

144

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

645

660

145

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

1 265

1,290

146

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

10 800

11,000

147

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

24 200

24,600

148

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

32 600

33,100

149

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

50 800

51,600

150

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

67 700

68,800

151

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

82 500

83,900

152

Schedule 9, Part 2, items 9B and 9C

17 600

17,900

153

Schedule 9, Part 2, item 10

165

170

154

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

345

350

155

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

235

240

156

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

285

290

157

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

450

460

158

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

205

210

159

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

1 155

1,170

160

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

610

620

161

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

870

880

162

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

245

250

163

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

420

430

164

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

295

300

165

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

235

240

166

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

285

290

167

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

450

460

168

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

205

210

169

Schedule 9, Part 2, item 18

2 130

2,170

170

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

1 565

1,590

171

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

2 505

2,550

172

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

3 655

3,720

173

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

5 430

5,520

174

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

1 565

1,590

175

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

2 505

2,550

176

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

3 865

3,930

177

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

5 480

5,570

178

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

8 455

8,590

179

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

14 000

14,200

180

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

20 800

21,100

181

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

3 865

3,930

182

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

6 470

6,580

183

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

8 455

8,590

184

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

780

790

185

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

1 255

1,280

186

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

4 280

4,350

187

Schedule 9, Part 3, item 5

1 565

1,590

188

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

5 430

5,520

189

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

8 035

8,170

190

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

11 000

11,140

191

Schedule 9, Part 3, item 7, paragraph (a)

1 530

1,560

192

Schedule 9, Part 3, item 7, paragraph (b)

7 860

7,990

193

Schedule 9A, Part 2, items 1, 2 and 3

1 050

1,070

194

Schedule 9A, Part 2, item 3A, paragraphs (a) and (b)

400

410

195

Schedule 9A, Part 2, item 4

69 700

70,900

196

Schedule 9A, Part 2, item 5

139 400

141,700

197

Schedule 9A, Part 2, item 6

226 600

230,300

198

Schedule 9A, Part 2, item 7

22 600

23,000

199

Schedule 9A, Part 2, item 8

1 050

1,070

200

Schedule 9A, Part 2, items 8A and 9

6 395

6,500

201

Schedule 9A, Part 2, item 10

16 800

17,100

202

Schedule 9A, Part 2, item 11

33 100

33,600

203

Schedule 9A, Part 2, item 12

20 800

21,100

204

Schedule 9A, Part 2, item 13

15 700

16,000

205

Schedule 9A, Part 2, item 14

645

660

206

Schedule 9A, Part 2, item 16

25 200

25,600

207

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

345

350