Federal Register of Legislation - Australian Government

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Therapeutic Goods Legislation Amendment (Fees) Regulations 2021

Authoritative Version
  • - F2021L00688
  • In force - Latest Version
Regulations as made
This instrument amends the Therapeutic Goods Regulations 1990 and the Therapeutic Goods (Medical Devices) Regulations 2002 to increase the fees set out in those respective regulations by 1.05 per cent, for the financial year 2021-22.
Administered by: Health
Registered 03 Jun 2021
Tabling HistoryDate
Tabled HR15-Jun-2021
Tabled Senate15-Jun-2021
To be repealed 25 Aug 2021
Repealed by Division 1 of Part 3 of Chapter 3 of the Legislation Act 2003
Table of contents.

Commonwealth Coat of Arms of Australia

 

Therapeutic Goods Legislation Amendment (Fees) Regulations 2021

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 27 May 2021

David Hurley

Governor‑General

By His Excellency’s Command

Greg Hunt

Minister for Health and Aged Care

 

  

  


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) Regulations 2021.

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 2021.

1 July 2021

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  Amendments of listed provisions

 

Amendments relating to fees

Item

Provision

Omit

Substitute

1

Schedule 5, Part 1, item 1.1

1,040

1,050

2

Schedule 5, Part 1, item 1.1A

10,200

10,300

3

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

8,970

9,060

4

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

9,020

9,110

5

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

54,800

55,400

6

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

42,300

42,700

7

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

31,000

31,300

8

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

66,000

66,700

9

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

16,000

16,200

10

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

3,890

3,930

11

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

42,700

43,100

12

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

27,200

27,500

13

Schedule 5, Part 1, item 1.4A

4,660

4,710

14

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

2,560

2,590

15

Schedule 5, Part 1, item 1.4D

76,100

76,900

16

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

54,600

55,200

17

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

1,370

1,380

18

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

1,060

1,070

19

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

550

560

20

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

1,060

1,070

21

Schedule 5, Part 1, item 1.5A

10,200

10,300

22

Schedule 5, Part 1, item 1.7

19,000

19,200

23

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

30,900

31,200

24

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

60,700

61,300

25

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

42,300

42,700

26

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

29,600

29,900

27

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

27,000

27,300

28

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

23,100

23,300

29

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

31,000

31,300

30

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

66,000

66,700

31

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

16,000

16,200

32

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

3,890

3,930

33

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

42,700

43,100

34

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

27,200

27,500

35

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

18,600

18,800

36

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

36,600

37,000

37

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

25,500

25,800

38

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

16,000

16,200

39

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

14,100

14,200

40

Schedule 5, Part 1, item 1.13

3,990

4,030

41

Schedule 5, Part 1, item 1.14

7,310

7,390

42

Schedule 5, Part 1, item 1.14A

7,130

7,200

43

Schedule 5, Part 1, item 1.14B

66,000

66,700

44

Schedule 5, Part 1, item 1.14C

16,000

16,200

45

Schedule 5, Part 1, item 1.15, paragraphs (a) and (b)

490

500

46

Schedule 5, Part 1, item 1.17

1,060

1,070

Therapeutic Goods Regulations 1990

2  Clause 3 of Schedule 9 (after table item 9AD)

Insert:

 

9B

Evaluation fee (if an evaluation is necessary) for assessing, for the purposes of paragraph 26(1)(d) of the Act, whether a disinfectant is not safe for the purposes for which it is to be used

19,200

3  Amendments of listed provisions

 

Amendments relating to fees

Item

Provision

Omit

Substitute

1

Paragraph 43AAJ(1)(b)

101,800

102,900

2

Paragraph 43AC(2)(a)

4,160

4,200

3

Paragraph 43AC(2)(b)

6,980

7,050

4

Paragraph 43AC(2)(c)

9,100

9,200

5

Paragraph 43ACA(2)(aa)

1,090

1,100

6

Paragraph 43ACA(2)(ab)

7,920

8,000

7

Paragraph 43ACA(2)(a)

4,200

4,240

8

Paragraph 43ACA(2)(b)

6,570

6,640

9

Paragraph 43ACA(2)(c)

9,710

9,810

10

Paragraph 45(6)(a)

1,140

1,150

11

Paragraph 45(6)(b)

4,540

4,590

12

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

490

500

13

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

1,790

1,810

14

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

22,300

22,500

15

Schedule 9, clause 3, item 1AA

13,000

13,100

16

Schedule 9, clause 3, item 1AB

4,700

4,750

17

Schedule 9, clause 3, item 1ABA

8,570

8,660

18

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

49,900

50,400

19

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

29,800

30,100

20

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

260,300

263,000

21

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

171,700

173,500

22

Schedule 9, clause 3, item 1AE

29,700

30,000

23

Schedule 9, clause 3, item 1AF

125,200

126,500

24

Schedule 9, clause 3, item 1AG

17,900

18,100

25

Schedule 9, clause 3, item 1B

13,000

13,100

26

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

49,800

50,300

27

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

16,500

16,700

28

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

33,200

33,500

29

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

52,700

53,300

30

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

29,700

30,000

31

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

9,870

9,970

32

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

6,440

6,510

33

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

19,900

20,100

34

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

12,900

13,000

35

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

31,400

31,700

36

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

19,200

19,400

37

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

3,140

3,170

38

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

19,400

19,600

39

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

1,140

1,150

40

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

4,530

4,580

41

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

2,260

2,280

42

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

13,200

13,300

43

Schedule 9, clause 3, item 2A, paragraph (a)

1,740

1,760

44

Schedule 9, clause 3, item 2AC

1,140

1,150

45

Schedule 9, clause 3, item 2B

5,680

5,740

46

Schedule 9, clause 3, item 2C

4,540

4,590

47

Schedule 9, clause 3, item 2CA

5,680

5,740

48

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

830

840

49

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

830

840

50

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

860

870

51

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

199,500

201,600

52

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

66,600

67,300

53

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

132,700

134,100

54

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

211,000

213,200

55

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

118,400

119,600

56

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

39,500

39,900

57

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

25,600

25,900

58

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

39,500

39,900

59

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

25,600

25,900

60

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

78,900

79,700

61

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

51,600

52,100

62

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

4,540

4,590

63

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

125,500

126,800

64

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

76,200

77,000

65

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

12,500

12,600

66

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

77,200

78,000

67

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

4,540

4,590

68

Schedule 9, clause 3, item 6AA

660

670

69

Schedule 9, clause 3, item 6AB

710

720

70

Schedule 9, clause 3, item 6ABA

2,530

2,560

71

Schedule 9, clause 3, item 6AC

1,200

1,210

72

Schedule 9, clause 3, item 6B

3,810

3,850

73

Schedule 9, clause 3, item 6C

8,270

8,360

74

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

10,900

11,000

75

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

14,100

14,200

76

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

19,200

19,400

77

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

25,400

25,700

78

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

38,100

38,500

79

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

50,800

51,300

80

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

76,200

77,000

81

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

10,900

11,000

82

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

10,900

11,000

83

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

14,100

14,200

84

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

19,200

19,400

85

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

25,400

25,700

86

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

38,100

38,500

87

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

50,800

51,300

88

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

76,200

77,000

89

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

10,900

11,000

90

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

10,900

11,000

91

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

14,100

14,200

92

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

19,200

19,400

93

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

25,400

25,700

94

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

38,100

38,500

95

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

50,800

51,300

96

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

76,200

77,000

97

Schedule 9, clause 3, item 7C

1,080

1,090

98

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

810

820

99

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

1,060

1,070

100

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

810

820

101

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

1,010

1,020

102

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

1,420

1,430

103

Schedule 9, clause 3, item 9AA

690

700

104

Schedule 9, clause 3, item 9AB

940

950

105

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

690

700

106

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

1,370

1,380

107

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

11,600

11,700

108

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

26,100

26,400

109

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

35,100

35,500

110

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

54,700

55,300

111

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

72,900

73,700

112

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

89,000

89,900

113

Schedule 9, clause 3, item 18

2,300

2,320

114

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

1,680

1,700

115

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

2,700

2,730

116

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

3,950

3,990

117

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

5,850

5,910

118

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

1,680

1,700

119

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

2,700

2,730

120

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

4,160

4,200

121

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

5,910

5,970

122

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

9,100

9,200

123

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

15,100

15,300

124

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

22,300

22,500

125

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

4,160

4,200

126

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

6,980

7,050

127

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

9,100

9,200

128

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

850

860

129

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

1,360

1,370

130

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

4,610

4,660

131

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

1,680

1,700

132

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

5,850

5,910

133

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

8,670

8,760

134

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

11,800

11,900

135

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

1,650

1,670

136

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

8,470

8,560

137

Schedule 9, clause 5, item 1A

2,030

2,050

138

Schedule 9, clause 5, item 1B

8,860

8,950

139

Schedule 9, clause 5, item 1C

810

820

140

Schedule 9, clause 5, items 1D and 1E

940

950

141

Schedule 9, clause 5, item 1F

810

820

142

Schedule 9, clause 5, item 1G

1,090

1,100

143

Schedule 9, clause 5, item 1H

7,920

8,000

144

Schedule 9, clause 5, item 1

1,470

1,490

145

Schedule 9, clause 5, item 2

4,980

5,030

146

Schedule 9, clause 5, item 3

7,390

7,470

147

Schedule 9, clause 5, item 4

10,500

10,600

148

Schedule 9, clause 5, item 5

1,470

1,490

149

Schedule 9, clause 5, item 6

770

780

150

Schedule 9, clause 5, item 7

4,200

4,240

151

Schedule 9, clause 5, item 8

830

840

152

Schedule 9, clause 5, item 9

6,570

6,640

153

Schedule 9, clause 5, item 10

850

860

154

Schedule 9, clause 5, item 11

9,710

9,810

155

Schedule 9, clause 5, item 12

560

570

156

Schedule 9, clause 5, item 13

3,240

3,270

157

Schedule 9, clause 5, item 14

2,030

2,050

158

Schedule 9, clause 5, item 15

21,700

21,900

159

Schedule 9, clause 5, item 16

2,030

2,050

160

Schedule 9, clause 5, item 17

21,700

21,900

161

Schedule 9, clause 5, item 18

2,680

2,710

162

Schedule 9, clause 5, item 19

29,500

29,800

163

Schedule 9, clause 5, item 20

2,940

2,970

164

Schedule 9, clause 5, item 21

37,600

38,000

165

Schedule 9, clause 5, item 23

1,730

1,750

166

Schedule 9, clause 5, item 24

1,870

1,890

167

Schedule 9, clause 5, item 25

14,300

14,500

168

Schedule 9, clause 5, item 26

1,870

1,890

169

Schedule 9, clause 5, item 27

14,300

14,500

170

Schedule 9, clause 5, item 28

1,110

1,120

171

Schedule 9, clause 5, item 29

14,900

15,100

172

Schedule 9, clause 5, item 30

1,110

1,120

173

Schedule 9, clause 5, item 31

14,900

15,100

174

Schedule 9, clause 5, item 32

2,940

2,970

175

Schedule 9, clause 5, item 33

24,300

24,600

176

Schedule 9, clause 5, item 34

2,940

2,970

177

Schedule 9, clause 5, item 35

24,300

24,600

178

Schedule 9A, Part 2, items 1, 2 and 3

1,130

1,140

179

Schedule 9A, Part 2, item 4

75,100

75,900

180

Schedule 9A, Part 2, item 5

150,300

151,900

181

Schedule 9A, Part 2, item 6

244,200

246,800

182

Schedule 9A, Part 2, item 7

24,400

24,700

183

Schedule 9A, Part 2, item 8

1,130

1,140

184

Schedule 9A, Part 2, items 8A and 9

6,890

6,960

185

Schedule 9A, Part 2, item 10

18,100

18,300

186

Schedule 9A, Part 2, item 11

35,600

36,000

187

Schedule 9A, Part 2, item 11A, paragraphs (a) and (b)

490

500

188

Schedule 9A, Part 2, item 12

22,300

22,500

189

Schedule 9A, Part 2, item 13

16,900

17,100

190

Schedule 9A, Part 2, item 14

690

700

191

Schedule 9A, Part 2, item 16

27,100

27,400