Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2020 (Cth)

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Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2020

I, General the Honourable David Hurley AC DSC (Retd), Governor‑General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following regulations.

Dated 11 June 2020

David Hurley

Governor‑General

By His Excellency’s Command

Greg Hunt

Minister for Health

Contents

1Name

This instrument is the Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2020.

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 2020.

1 July 2020

Note: This table relates only to the provisions of this instrument as originally made.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Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.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 1—Amendments

Part 1Fees

Therapeutic Goods (Medical Devices) Regulations 2002

1

Amendments of listed provisions

Amendments relating to fees

Item

Provision

Omit

Substitute

1

Schedule 5, Part 1, item 1.1

1,020

1,040

2

Schedule 5, Part 1, item 1.1A

10,000

10,200

3

Schedule 5, Part 1, item 1.2, paragraph (a)

8,800

8,970

4

Schedule 5, Part 1, item 1.2, paragraph (b)

8,850

9,020

5

Schedule 5, Part 1, item 1.3, paragraph (a)

53,800

54,800

6

Schedule 5, Part 1, item 1.3, paragraph (b)

41,500

42,300

7

Schedule 5, Part 1, item 1.3A, paragraph (a)

30,400

31,000

8

Schedule 5, Part 1, item 1.3A, paragraph (b)

64,700

66,000

9

Schedule 5, Part 1, item 1.3A, paragraph (c)

15,700

16,000

10

Schedule 5, Part 1, item 1.3A, paragraph (d)

3,820

3,890

11

Schedule 5, Part 1, item 1.3A, paragraph (e)

41,900

42,700

12

Schedule 5, Part 1, item 1.3A, paragraph (f)

26,700

27,200

13

Schedule 5, Part 1, item 1.4A

4,570

4,660

14

Schedule 5, Part 1, items 1.4B and 1.4C

2,510

2,560

15

Schedule 5, Part 1, item 1.4D

74,600

76,100

16

Schedule 5, Part 1, items 1.4E and 1.4F

53,600

54,600

17

Schedule 5, Part 1, item 1.5, paragraphs (a) and (b)

1,340

1,370

18

Schedule 5, Part 1, item 1.5, paragraphs (c), (d) and (e)

1,040

1,060

19

Schedule 5, Part 1, item 1.5, paragraph (g)

540

550

20

Schedule 5, Part 1, item 1.5, paragraph (h)

1,040

1,060

21

Schedule 5, Part 1, item 1.5A

10,000

10,200

22

Schedule 5, Part 1, item 1.7

18,600

19,000

23

Schedule 5, Part 1, item 1.8

370

380

24

Schedule 5, Part 1, item 1.9, paragraph (a)

30,300

30,900

25

Schedule 5, Part 1, item 1.9, paragraph (b)

59,500

60,700

26

Schedule 5, Part 1, item 1.9, paragraph (c)

41,500

42,300

27

Schedule 5, Part 1, item 1.9, paragraph (d)

29,000

29,600

28

Schedule 5, Part 1, item 1.9, paragraph (e)

26,500

27,000

29

Schedule 5, Part 1, item 1.9, paragraph (f)

22,700

23,100

30

Schedule 5, Part 1, item 1.9A, paragraph (a)

30,400

31,000

31

Schedule 5, Part 1, item 1.9A, paragraph (b)

64,700

66,000

32

Schedule 5, Part 1, item 1.9A, paragraph (c)

15,700

16,000

33

Schedule 5, Part 1, item 1.9A, paragraph (d)

3,820

3,890

34

Schedule 5, Part 1, item 1.9A, paragraph (e)

41,900

42,700

35

Schedule 5, Part 1, item 1.9A, paragraph (f)

26,700

27,200

36

Schedule 5, Part 1, item 1.10, paragraph (a)

18,200

18,600

37

Schedule 5, Part 1, item 1.10, paragraph (b)

35,900

36,600

38

Schedule 5, Part 1, item 1.10, paragraph (c)

25,000

25,500

39

Schedule 5, Part 1, item 1.10, paragraph (d)

15,700

16,000

40

Schedule 5, Part 1, item 1.10, paragraph (e)

13,800

14,100

41

Schedule 5, Part 1, item 1.12

430

440

42

Schedule 5, Part 1, item 1.13

3,910

3,990

43

Schedule 5, Part 1, item 1.14

7,170

7,310

44

Schedule 5, Part 1, item 1.14A

6,990

7,130

45

Schedule 5, Part 1, item 1.14B

64,700

66,000

46

Schedule 5, Part 1, item 1.14C

15,700

16,000

47

Schedule 5, Part 1, item 1.17

1,040

1,060

48

Schedule 5, Part 2, paragraph 2.1(b)

430

440

Therapeutic Goods Regulations 1990

2

Amendments of listed provisions

Amendments relating to fees

Item

Provision

Omit

Substitute

1

Paragraph 43AAJ(1)(b)

99,900

101,800

2

Paragraph 43AC(2)(a)

4,080

4,160

3

Paragraph 43AC(2)(b)

6,850

6,980

4

Paragraph 43AC(2)(c)

8,930

9,100

5

Paragraph 43ACA(2)(aa)

1,070

1,090

6

Paragraph 43ACA(2)(ab)

7,770

7,920

7

Paragraph 43ACA(2)(a)

4,120

4,200

8

Paragraph 43ACA(2)(b)

6,440

6,570

9

Paragraph 43ACA(2)(c)

9,520

9,710

10

Paragraph 45(6)(a)

1,120

1,140

11

Paragraph 45(6)(b)

4,450

4,540

12

Schedule 9, clause 3, item 1, paragraph (a)

1,760

1,790

13

Schedule 9, clause 3, item 1, paragraph (b)

21,900

22,300

14

Schedule 9, clause 3, item 1AA

12,800

13,000

15

Schedule 9, clause 3, item 1AB

4,610

4,700

16

Schedule 9, clause 3, item 1AC, paragraph (a)

48,900

49,900

17

Schedule 9, clause 3, item 1AC, paragraph (b)

29,200

29,800

18

Schedule 9, clause 3, item 1AD, paragraph (a)

255,300

260,300

19

Schedule 9, clause 3, item 1AD, paragraph (b)

168,400

171,700

20

Schedule 9, clause 3, item 1AE

29,100

29,700

21

Schedule 9, clause 3, item 1AF

122,800

125,200

22

Schedule 9, clause 3, item 1AG

17,600

17,900

23

Schedule 9, clause 3, item 1B

12,800

13,000

24

Schedule 9, clause 3, item 2, paragraph (ba)

48,800

49,800

25

Schedule 9, clause 3, item 2, paragraph (bb)

16,200

16,500

26

Schedule 9, clause 3, item 2, paragraph (bc)

32,600

33,200

27

Schedule 9, clause 3, item 2, paragraph (bca)

51,700

52,700

28

Schedule 9, clause 3, item 2, paragraph (bd)

29,100

29,700

29

Schedule 9, clause 3, item 2, subparagraph (be)(i)

9,680

9,870

30

Schedule 9, clause 3, item 2, subparagraph (be)(ii)

6,320

6,440

31

Schedule 9, clause 3, item 2, subparagraph (bf)(i)

19,500

19,900

32

Schedule 9, clause 3, item 2, subparagraph (bf)(ii)

12,700

12,900

33

Schedule 9, clause 3, item 2, paragraph (bfa)

30,800

31,400

34

Schedule 9, clause 3, item 2, paragraph (bg)

18,800

19,200

35

Schedule 9, clause 3, item 2, paragraph (bh)

3,080

3,140

36

Schedule 9, clause 3, item 2, paragraph (bi)

19,000

19,400

37

Schedule 9, clause 3, item 2, paragraphs (bj) and (bk)

1,120

1,140

38

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

4,440

4,530

39

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

2,220

2,260

40

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

12,900

13,200

41

Schedule 9, clause 3, item 2AB

440

450

42

Schedule 9, clause 3, item 2AC

1,120

1,140

43

Schedule 9, clause 3, item 2B

5,570

5,680

44

Schedule 9, clause 3, item 2C

4,450

4,540

45

Schedule 9, clause 3, item 2CA

5,570

5,680

46

Schedule 9, clause 3, items 2CB, 2CC and 2CD

810

830

47

Schedule 9, clause 3, item 2CE, paragraphs (a) and (b)

810

830

48

Schedule 9, clause 3, item 3, paragraph (a)

460

470

49

Schedule 9, clause 3, item 3, paragraph (b)

840

860

50

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

430

440

51

Schedule 9, clause 3, item 4, paragraph (a)

195,700

199,500

52

Schedule 9, clause 3, item 4, subparagraphs (aa)(i) and (ii)

65,300

66,600

53

Schedule 9, clause 3, item 4, subparagraph (aa)(iii)

130,200

132,700

54

Schedule 9, clause 3, item 4, paragraph (ab)

207,000

211,000

55

Schedule 9, clause 3, item 4, paragraph (b)

116,100

118,400

56

Schedule 9, clause 3, item 4, subparagraph (bb)(i)

38,700

39,500

57

Schedule 9, clause 3, item 4, subparagraph (bb)(i)

25,100

25,600

58

Schedule 9, clause 3, item 4, subparagraph (bb)(ii)

38,700

39,500

59

Schedule 9, clause 3, item 4, subparagraph (bb)(ii)

25,100

25,600

60

Schedule 9, clause 3, item 4, subparagraph (bb)(iii)

77,400

78,900

61

Schedule 9, clause 3, item 4, subparagraph (bb)(iii)

50,600

51,600

62

Schedule 9, clause 3, item 4, paragraph (bc)

4,450

4,540

63

Schedule 9, clause 3, item 4, paragraph (bd)

123,100

125,500

64

Schedule 9, clause 3, item 4, paragraph (c)

74,700

76,200

65

Schedule 9, clause 3, item 4, paragraph (d)

12,300

12,500

66

Schedule 9, clause 3, item 4, paragraph (g)

75,700

77,200

67

Schedule 9, clause 3, item 4, paragraph (h)

4,450

4,540

68

Schedule 9, clause 3, item 6AA

650

660

69

Schedule 9, clause 3, item 6AB

700

710

70

Schedule 9, clause 3, item 6ABA

2,480

2,530

71

Schedule 9, clause 3, item 6AC

1,180

1,200

72

Schedule 9, clause 3, item 6B

3,740

3,810

73

Schedule 9, clause 3, item 6C

8,110

8,270

74

Schedule 9, clause 3, item 6D, paragraph (a)

10,700

10,900

75

Schedule 9, clause 3, item 6D, paragraph (b)

13,800

14,100

76

Schedule 9, clause 3, item 6D, paragraph (c)

18,800

19,200

77

Schedule 9, clause 3, item 6D, paragraph (d)

24,900

25,400

78

Schedule 9, clause 3, item 6D, paragraph (e)

37,400

38,100

79

Schedule 9, clause 3, item 6D, paragraph (f)

49,800

50,800

80

Schedule 9, clause 3, item 6D, paragraph (g)

74,700

76,200

81

Schedule 9, clause 3, item 7A, paragraph (a)

10,700

10,900

82

Schedule 9, clause 3, item 7A, subparagraph (b)(i)

10,700

10,900

83

Schedule 9, clause 3, item 7A, subparagraph (b)(ii)

13,800

14,100

84

Schedule 9, clause 3, item 7A, subparagraph (b)(iii)

18,800

19,200

85

Schedule 9, clause 3, item 7A, subparagraph (b)(iv)

24,900

25,400

86

Schedule 9, clause 3, item 7A, subparagraph (b)(v)

37,400

38,100

87

Schedule 9, clause 3, item 7A, subparagraph (b)(vi)

49,800

50,800

88

Schedule 9, clause 3, item 7A, subparagraph (b)(vii)

74,700

76,200

89

Schedule 9, clause 3, item 7B, paragraph (a)

10,700

10,900

90

Schedule 9, clause 3, item 7B, subparagraph (b)(i)

10,700

10,900

91

Schedule 9, clause 3, item 7B, subparagraph (b)(ii)

13,800

14,100

92

Schedule 9, clause 3, item 7B, subparagraph (b)(iii)

18,800

19,200

93

Schedule 9, clause 3, item 7B, subparagraph (b)(iv)

24,900

25,400

94

Schedule 9, clause 3, item 7B, subparagraph (b)(v)

37,400

38,100

95

Schedule 9, clause 3, item 7B, subparagraph (b)(vi)

49,800

50,800

96

Schedule 9, clause 3, item 7B, subparagraph (b)(vii)

74,700

76,200

97

Schedule 9, clause 3, item 7C

1,060

1,080

98

Schedule 9, clause 3, item 8, paragraph (a)

790

810

99

Schedule 9, clause 3, item 8, paragraph (b)

1,040

1,060

100

Schedule 9, clause 3, items 8A, 8B and 8C

790

810

101

Schedule 9, clause 3, item 9, paragraph (a)

990

1,010

102

Schedule 9, clause 3, item 9, paragraph (b)

1,390

1,420

103

Schedule 9, clause 3, item 9AA

680

690

104

Schedule 9, clause 3, item 9AB

920

940

105

Schedule 9, clause 3, items 9AC and 9ACA

680

690

106

Schedule 9, clause 3, item 9AD, paragraph (a)

1,340

1,370

107

Schedule 9, clause 3, item 9AD, paragraph (b)

11,400

11,600

108

Schedule 9, clause 3, item 9AD, paragraph (c)

25,600

26,100

109

Schedule 9, clause 3, item 9AD, paragraph (d)

34,400

35,100

110

Schedule 9, clause 3, item 9AD, paragraph (e)

53,700

54,700

111

Schedule 9, clause 3, item 9AD, paragraph (f)

71,500

72,900

112

Schedule 9, clause 3, item 9AD, paragraph (g)

87,300

89,000

113

Schedule 9, clause 3, item 14, paragraphs (a) and (b)

370

380

114

Schedule 9, clause 3, item 17, subparagraph (a)(i)

260

270

115

Schedule 9, clause 3, item 17, subparagraph (a)(ii)

310

320

116

Schedule 9, clause 3, item 17, subparagraph (a)(iii)

480

490

117

Schedule 9, clause 3, item 17A, subparagraph (a)(i)

1,210

1,230

118

Schedule 9, clause 3, item 17A, subparagraph (a)(ii)

640

650

119

Schedule 9, clause 3, item 17A, sub‑subparagraph (a)(iii)(A)

920

940

120

Schedule 9, clause 3, item 17A, sub‑subparagraph (a)(iii)(B)

260

270

121

Schedule 9, clause 3, item 17A, subparagraph (a)(iv)

450

460

122

Schedule 9, clause 3, item 17A, subparagraph (a)(v)

320

330

123

Schedule 9, clause 3, item 17A, sub‑subparagraph (a)(vi)(A)

260

270

124

Schedule 9, clause 3, item 17A, sub‑subparagraph (a)(vi)(B)

310

320

125

Schedule 9, clause 3, item 17A, sub‑subparagraph (a)(vi)(C)

480

490

126

Schedule 9, clause 3, item 18

2,260

2,300

127

Schedule 9, clause 4, item 1, paragraphs (a) and (b)

1,650

1,680

128

Schedule 9, clause 4, item 1, paragraph (c)

2,650

2,700

129

Schedule 9, clause 4, item 1, paragraph (d)

3,870

3,950

130

Schedule 9, clause 4, item 1, paragraph (e)

5,740

5,850

131

Schedule 9, clause 4, item 1, paragraphs (f), (g) and (h)

1,650

1,680

132

Schedule 9, clause 4, item 1, paragraph (i)

2,650

2,700

133

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

4,080

4,160

134

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

5,800

5,910

135

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

8,930

9,100

136

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

14,800

15,100

137

Schedule 9, clause 4, item 2, paragraph (e)

21,900

22,300

138

Schedule 9, clause 4, item 2, paragraph (f)

4,080

4,160

139

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

6,850

6,980

140

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

8,930

9,100

141

Schedule 9, clause 4, item 3, paragraphs (d) and (e)

830

850

142

Schedule 9, clause 4, item 3, paragraphs (f), (g) and (h)

1,330

1,360

143

Schedule 9, clause 4, item 4, paragraphs (d), (e) and (f)

4520

4,610

144

Schedule 9, clause 4, item 5, paragraph (a)

1,650

1,680

145

Schedule 9, clause 4, item 5, paragraph (b)

5,740

5,850

146

Schedule 9, clause 4, item 5, paragraph (c)

8,500

8,670

147

Schedule 9, clause 4, item 5, paragraph (d)

11,600

11,800

148

Schedule 9, clause 4, item 7, paragraph (a)

1,620

1,650

149

Schedule 9, clause 4, item 7, paragraph (b)

8,310

8,470

150

Schedule 9, clause 5, item 1A

1,990

2,030

151

Schedule 9, clause 5, item 1B

8,690

8,860

152

Schedule 9, clause 5, item 1C

790

810

153

Schedule 9, clause 5, items 1D and 1E

920

940

154

Schedule 9, clause 5, item 1F

790

810

155

Schedule 9, clause 5, item 1G

1,070

1,090

156

Schedule 9, clause 5, item 1H

7,770

7,920

157

Schedule 9, clause 5, item 1

1,440

1,470

158

Schedule 9, clause 5, item 2

4,880

4,980

159

Schedule 9, clause 5, item 3

7,250

7,390

160

Schedule 9, clause 5, item 4

10,300

10,500

161

Schedule 9, clause 5, item 5

1,440

1,470

162

Schedule 9, clause 5, item 6

760

770

163

Schedule 9, clause 5, item 7

4,120

4,200

164

Schedule 9, clause 5, item 8

810

830

165

Schedule 9, clause 5, item 9

6,440

6,570

166

Schedule 9, clause 5, item 10

830

850

167

Schedule 9, clause 5, item 11

9,520

9,710

168

Schedule 9, clause 5, item 12

550

560

169

Schedule 9, clause 5, item 13

3,180

3,240

170

Schedule 9, clause 5, item 14

1,990

2,030

171

Schedule 9, clause 5, item 15

21,300

21,700

172

Schedule 9, clause 5, item 16

1,990

2,030

173

Schedule 9, clause 5, item 17

21,300

21,700

174

Schedule 9, clause 5, item 18

2,630

2,680

175

Schedule 9, clause 5, item 19

28,900

29,500

176

Schedule 9, clause 5, item 20

2,880

2,940

177

Schedule 9, clause 5, item 21

36,900

37,600

178

Schedule 9, clause 5, item 22

450

460

179

Schedule 9, clause 5, item 23

1,700

1,730

180

Schedule 9, clause 5, item 24

1,830

1,870

181

Schedule 9, clause 5, item 25

14,000

14,300

182

Schedule 9, clause 5, item 26

1,830

1,870

183

Schedule 9, clause 5, item 27

14,000

14,300

184

Schedule 9, clause 5, item 28

1,090

1,110

185

Schedule 9, clause 5, item 29

14,600

14,900

186

Schedule 9, clause 5, item 30

1,090

1,110

187

Schedule 9, clause 5, item 31

14,600

14,900

188

Schedule 9, clause 5, item 32

2,880

2,940

189

Schedule 9, clause 5, item 33

23,800

24,300

190

Schedule 9, clause 5, item 34

2,880

2,940

191

Schedule 9, clause 5, item 35

23,800

24,300

192

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

1,110

1,130

193

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

430

440

194

Schedule 9A, Part 2, item 4

73,700

75,100

195

Schedule 9A, Part 2, item 5

147,400

150,300

196

Schedule 9A, Part 2, item 6

239,500

244,200

197

Schedule 9A, Part 2, item 7

23,900

24,400

198

Schedule 9A, Part 2, item 8

1,110

1,130

199

Schedule 9A, Part 2, items 8A and 9

6,760

6,890

200

Schedule 9A, Part 2, item 10

17,800

18,100

201

Schedule 9A, Part 2, item 11

34,900

35,600

202

Schedule 9A, Part 2, item 12

21,900

22,300

203

Schedule 9A, Part 2, item 13

16,600

16,900

204

Schedule 9A, Part 2, item 14

680

690

205

Schedule 9A, Part 2, item 16

26,600

27,100

206

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

370

380

Part 2Other measures

Therapeutic Goods (Medical Devices) Regulations 2002

3

Part 1 of Schedule 5 (table item 1.15)

Repeal the item, substitute:

1.15

Application for consent of Secretary to importation into Australia, supply for use in Australia, or exportation from Australia of a medical device, including an IVD medical device:

Sections 41MA and 41MAA and paragraph 63(2)(h) of the Act

(a) for an application relating to a medical device to which a single entry in the Register relates; or

490 (for all the devices to which the application relates)

(b) for an application relating to medical devices to which both of the following apply:

(i) there are separate entries in the Register in relation to the devices;

(ii) the way in which the devices do not comply with essential principles is the same for all the devices

490 for the first entry plus 100 for each additional entry

Therapeutic Goods Regulations 1990

4

Regulation 2

Insert:

medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).

5

Subregulation 45AA(1)

Omit “item 6 or 7 in Part 2 of Schedule 9 or”.

6

Subparagraph 45AA(4)(c)(ii)

Omit “decides not to register the therapeutic device or”.

7

Subparagraph 45AA(4)(c)(ii)

Omit “subsection 25(3) or”.

8

Subparagraph 45AA(4)(c)(iii)

Omit “the therapeutic device is registered or”.

  1. 9

    Schedule 5A (table item 1A, column 3, subparagraph (a)(ii))

Omit “—supply”, substitute “, give”.

10

Schedule 5A (after table item 1A)

Insert:

2

Therapeutic goods that are medicinal cannabis products manufactured in Australia under a licence granted under Part 3-3 of the Act and are held under the direct control of the sponsor, until the goods are:

(a) the subject of a notification under item 3; or

(b) approved for supply in Australia under subsection 19(1) or section 19A of the Act; or

(c) authorised for supply under subsection 19(5) of the Act; or

(d) authorised for supply under rules made under subsection 19(7A) of the Act

(a) the supply of the goods must be in accordance with the relevant notification, approval or authorisation; and

(b) the goods must be kept in a warehouse or a properly secured area under the control of the sponsor; and

(c) the sponsor must:

(i) keep records relating to the source and supply of the goods; and

(ii) if requested by the Secretary, give the records to the Secretary

2A

Therapeutic goods that are medicinal cannabis products manufactured in Australia under a licence granted under Part 3-3 of the Act and are held under the direct control of the sponsor, until a decision is made under section 25 or 26 of the Act about the goods

the sponsor must:

(a) keep records about the source of the goods; and

(b) if requested by the Secretary, give the records to the Secretary; and

(c) have lodged an application under section 23 of the Act for the goods before their manufacture

  1. 11

    Schedule 5A (table item 3, column 3, paragraph (b))

Omit “or 14A”.

12

Clause 3 of Schedule 9 (table item 1A)

Repeal the item, substitute:

1A

Application fee for processing an application for consent under section 14 or 14A of the Act:

(a) for an application relating to goods to which a single entry in the Register relates

490 (for all the goods to which the application relates)

(b) for an application relating to goods to which both of the following apply:

(i) there are separate entries in the Register in relation to the goods;

(ii) the way in which the goods do not conform with a standard applicable to the goods is the same for all the goods

490 for the first entry plus 100 for each additional entry

  1. 13

    Clause 3 of Schedule 9 (table item 1, column 2, paragraph (c))

Repeal the paragraph.

  1. 14

    Clause 3 of Schedule 9 (table item 1, column 3, fee relating to paragraph (c))

Omit “18,600”.

  1. 15

    Clause 3 of Schedule 9 (table item 1, column 2, paragraph (d))

Repeal the paragraph.

  1. 16

    Clause 3 of Schedule 9 (table item 1, column 3, fee relating to paragraph (d))

Omit “2,800”.

  1. 17

    Clause 3 of Schedule 9 (table item 2, column 2, subparagraph (d)(i))

Omit “or are therapeutic devices”.

  1. 18

    Clause 3 of Schedule 9 (table item 2, column 2, paragraph (g))

Repeal the paragraph.

  1. 19

    Clause 3 of Schedule 9 (table item 2, column 3, fee relating to paragraph (g))

Omit “1,490”.

20

Clause 3 of Schedule 9 (table item 2A)

Repeal the item, substitute:

2A

Fee for varying an entry in the Register (not including evaluation of data) under section 9D (other than subsection 9D(2C)) of the Act, if the variation is for:

(a) a registered medicine that is mentioned in Part 1 of Schedule 10—for each submission

1,740

(b) a listed medicine

440

(c) a medical device

470

  1. 21

    Clause 3 of Schedule 9 (table item 4, column 2, paragraphs (aa) and (bb))

Omit “or a therapeutic device”.

  1. 22

    Clause 3 of Schedule 9 (table items 6, 6AD, 7, 9B and 9C)

Repeal the items.

23

Clause 3 of Schedule 9 (table item 9D)

Repeal the item, substitute:

9D

Fee for evaluation, under subsection 9D(1), (2) or (3), subsection 24(1A) or paragraph 26(1)(d) of the Act, of data relating to the device component, to which Chapter 4 of the Act applies, of a medicine (in addition to the fee prescribed in item 4, or in Part 3 of this Schedule, for evaluating the medicine)

The fee applicable, under item 1.9, 1.10, 1.12 or 1.16 (and, if applicable, clause 2.2) of Schedule 5 to the Therapeutic Goods (Medical Devices) Regulations 2002, to the kind of work to be undertaken

  1. 24

    Clause 3 of Schedule 9 (table item 12, column 3)

Omit “, 5, 6 or 7”, substitute “or 5”.

  1. 25

    Clause 3 of Schedule 9 (table item 13, column 3)

Omit “, 5, 6 or 7”, substitute “or 5”.

26

Clause 3 of Schedule 9 (table item 14A)

Repeal the item.

27

Part 2 of Schedule 9A (after table item 11)

Insert:

11A

Application fee for processing an application for consent under section 14 or 14A of the Act:

(a) for an application relating to goods that are biologicals to which a single entry in the Register relates

490 (for all the goods to which the application relates)

(b) for an application relating to goods that are biologicals to which both of the following apply:

(i) there are separate entries in the Register in relation to the goods;

(ii) the way in which the goods do not conform with a standard applicable to the goods is the same for all the goods

490 for the first entry plus 100 for each additional entry

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