Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2018 (Cth)

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Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2018

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 07 June 2018

Peter Cosgrove

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 2018.

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.

Sections 1 to 4 and anything in this instrument not elsewhere covered by this table

The day after this instrument is registered.

13 June 2018

2. Schedule 1, Parts 1 and 2

1 July 2018.

1 July 2018

3. Schedule 1, Part 3

1 July 2019.

1 July 2019

Note: This table relates only to the provisions of this instrument as originally made.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Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.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 1Amendment of the Therapeutic Goods (Medical Devices) Regulations 2002 commencing 1 July 2018

Therapeutic Goods (Medical Devices) Regulations 2002

1

Regulation 9.4

Repeal the regulation.

2

Part 1 of Schedule 5 (table item 1.5)

Repeal the item, substitute:

1.5

Application for the following kinds of medical devices to be included in the Register:

Paragraph 41FDB(2)(b) of the Act

(a) a Class AIMD medical device;

1,310

(b) a Class III medical device;

1,310

(c) a Class IIb medical device;

1,020

(d) a Class IIa medical device;

1,020

(e) a Class I medical device that the manufacturer intends to be supplied in a sterile state or that has a measuring function;

1,020

(ea) a Class I medical device to which paragraph (e) does not apply;

530

(f) an IVD medical device, including a Class 4 in‑house IVD medical device but not a Class 2 IVD medical device that was, immediately before the commencement of the Therapeutic Goods (Medical Devices) Amendment (In Vitro Diagnostic Medical Devices) Regulation 2015:

(i) included in the Register; and

(ii) classified as a Class 3 IVD medical device because of subclause 1.3(2) of Schedule 2A (as in force immediately before the commencement of that regulation)

1,020

Note for paragraph (f): There is no fee for an application to include a Class 2 IVD medical device mentioned in paragraph (f) in the Register.

  1. 3

    Part 1 of Schedule 5 (table item 1.8, column headed “Provision of Act or these Regulations”)

Before “Schedule”, insert “Paragraph 63(2)(h) of the Act, and”.

4

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

Schedule 5, Part 1, item 1.1

980

1,000

2

Schedule 5, Part 1, item 1.1A

9,660

9,840

3

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

8,460

8,620

4

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

8,510

8,670

5

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

51,700

52,700

6

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

39,900

40,700

7

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

29,200

29,800

8

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

62,200

63,400

9

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

15,100

15,400

10

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

3,670

3,740

11

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

40,300

41,100

12

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

25,700

26,200

13

Schedule 5, Part 1, item 1.4A

4,400

4,480

14

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

2,410

2,460

15

Schedule 5, Part 1, item 1.4D

71,700

73,100

16

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

51,500

52,500

17

Schedule 5, Part 1, item 1.5A

9,660

9,840

18

Schedule 5, Part 1, items 1.6A and 1.6B, paragraphs (a) and (b)

150

160

19

Schedule 5, Part 1, item 1.7

17,900

18,200

20

Schedule 5, Part 1, item 1.8

350

360

21

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

29,100

29,700

22

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

57,200

58,300

23

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

39,900

40,700

24

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

27,900

28,400

25

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

25,500

26,000

26

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

21,800

22,200

27

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

29,200

29,800

28

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

62,200

63,400

29

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

15,100

15,400

30

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

3,670

3,740

31

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

40,300

41,100

32

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

25,700

26,200

33

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

17,500

17,800

34

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

34,500

35,200

35

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

24,000

24,500

36

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

15,100

15,400

37

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

13,200

13,500

38

Schedule 5, Part 1, item 1.12

410

420

39

Schedule 5, Part 1, item 1.13

3,760

3,830

40

Schedule 5, Part 1, item 1.14

6,900

7,030

41

Schedule 5, Part 1, item 1.14A

6,720

6,850

42

Schedule 5, Part 1, item 1.14B

62,200

63,400

43

Schedule 5, Part 1, item 1.14C

15,100

15,400

44

Schedule 5, Part 1, item 1.15

440

450

45

Schedule 5, Part 1, item 1.17

1,000

1,020

46

Schedule 5, Part 2, paragraph 2.1(b)

410

420

Part 2Amendment of the Therapeutic Goods Regulations 1990 commencing 1 July 2018

Therapeutic Goods Regulations 1990

5

Subregulation 43AAJ(2)

Omit “subregulation 3(2) of the Therapeutic Goods (Charges) Regulations 1990”, substitute “subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018”.

6

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

Omit “and the application is not an application to which item 3A applies”.

  1. 7

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

Omit “subject to paragraph (f),”.

  1. 8

    Clause 3 of Schedule 9 (table items 3A, 3B and 5A)

Repeal the items.

9

Clause 3 of Schedule 9 (table item 6, column 2)

Omit “items 1 to 4”, substitute “items 1 to 3”.

10

Clause 3 of Schedule 9 (table item 6A)

Repeal the item.

  1. 11

    Clause 3 of Schedule 9 (table item 7, column 2)

Omit “items 1 to 4”, substitute “items 1 to 3”.

12

Clause 3 of Schedule 9 (table item 7AA)

Repeal the item.

13

Clause 3 of Schedule 9 (table item 8)

Repeal the item, substitute:

8

(a) Application fee for the purposes of paragraph 37(1)(g) of the Act, for a licence for:

770

(i) the manufacture of therapeutic goods; or

(ii) one or more steps in the manufacture of therapeutic goods; or

(iii) the manufacture of ingredients or components for use in the manufacture of therapeutic goods; or

(iv) the manufacture of herbal or homoeopathic preparations;

unless paragraph (b) applies

(b) Application fee for the purposes of paragraph 37(1)(g) of the Act, for a licence for:

1,020

(i) the manufacture of haematopoietic progenitor cells; or

(ii) the manufacture of human blood and blood components (other than haematopoietic progenitor cells)

8A

Fee for the purposes of paragraph 40B(2)(g) of the Act, for an application for the variation of a licence to which paragraph (a) of item 8 applies

770

14

Clause 3 of Schedule 9 (table item 9)

Repeal the item, substitute:

9

(a) Fee for paragraphs 38(1)(c), 41(1)(f) and 58(3)(b) of the Act for inspection within Australia (except for therapeutic goods mentioned in items 9AA, 9AB, 9AC and 9ACA), per hour, per inspector, for:

970

(i) the manufacture of therapeutic goods; or

(ii) one or more steps in the manufacture of therapeutic goods; or

(iii) the manufacture of ingredients or components for use in the manufacture of therapeutic goods; or

(iv) the manufacture of herbal or homoeopathic preparations

(b) Fee for inspection outside Australia, per hour, per inspector, for inspection of a kind mentioned in paragraph (a)

1,360

  1. 15

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

Omit “or 5”.

16

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 43AAJ(1)(b)

96,100

97,900

2

Paragraph 43AC(2)(a)

3,930

4,000

3

Paragraph 43AC(2)(b)

6,580

6,710

4

Paragraph 43AC(2)(c)

8,590

8,750

5

Paragraph 43ACA(2)(a)

3,960

4,040

6

Paragraph 43ACA(2)(b)

6,190

6,310

7

Paragraph 43ACA(2)(c)

9,160

9,330

8

Paragraph 45(4A)(a)

10,700

10,900

9

Paragraph 45(4A)(b)

8,910

9,080

10

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

8,610

8,770

11

Paragraph 45(4A)(d)

35,900

36,600

12

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

8,610

8,770

13

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

5,360

5,460

14

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

1,960

2,000

15

Schedule 9, clause 3, item 1A

460

470

16

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

1,690

1,720

17

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

21,100

21,500

18

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

17,900

18,200

19

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

2,690

2,740

20

Schedule 9, clause 3, item 1AA

12,300

12,500

21

Schedule 9, clause 3, item 1AB

4,440

4,520

22

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

47,000

47,900

23

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

28,100

28,600

24

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

245,500

250,200

25

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

161,900

165,000

26

Schedule 9, clause 3, item 1AE

28,000

28,500

27

Schedule 9, clause 3, item 1AF

118,100

120,300

28

Schedule 9, clause 3, item 1AG

16,900

17,200

29

Schedule 9, clause 3, item 1B

12,300

12,500

30

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

1,430

1,460

31

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

46,900

47,800

32

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

15,600

15,900

33

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

31,300

31,900

34

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

49,800

50,700

35

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

28,000

28,500

36

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

9,310

9,490

37

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

6,070

6,190

38

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

18,700

19,100

39

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

12,200

12,400

40

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

29,600

30,200

41

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

18,100

18,400

42

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

2,960

3,020

43

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

18,300

18,600

44

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

1,080

1,100

45

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

4,270

4,350

46

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

2,140

2,180

47

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

12,400

12,600

48

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

1,430

1,460

49

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

720

730

50

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

1,650

1,680

51

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

410

420

52

Schedule 9, clause 3, item 2A, paragraphs (d) to (g)

440

450

53

Schedule 9, clause 3, item 2AB

420

430

54

Schedule 9, clause 3, item 2AC

1,080

1,100

55

Schedule 9, clause 3, item 2B

5,360

5,460

56

Schedule 9, clause 3, item 2C

4,280

4,360

57

Schedule 9, clause 3, item 2CA

5,360

5,460

58

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

780

790

59

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

780

790

60

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

440

450

61

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

800

820

62

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

410

420

63

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

188,200

191,800

64

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

62,800

64,000

65

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

125,200

127,600

66

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

199,000

202,800

67

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

111,700

113,800

68

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

37,200

37,900

69

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

24,100

24,600

70

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

37,200

37,900

71

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

24,100

24,600

72

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

74,400

75,800

73

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

48,700

49,600

74

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

4,270

4,350

75

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

118,400

120,600

76

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

71,800

73,200

77

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

11,900

12,100

78

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

72,800

74,200

79

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

4,280

4,360

80

Schedule 9, clause 3, item 5B

17,900

18,200

81

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

31,400

32,000

82

Schedule 9, clause 3, item 6, paragraphs (b) to (ca)

21,400

21,800

83

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

35,900

36,600

84

Schedule 9, clause 3, item 6AA

390

400

85

Schedule 9, clause 3, item 6AB

680

690

86

Schedule 9, clause 3, item 6ABA

2,030

2,070

87

Schedule 9, clause 3, item 6AC

1,140

1,160

88

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

21,400

21,800

89

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

5,360

5,460

90

Schedule 9, clause 3, item 6B

3,590

3,660

91

Schedule 9, clause 3, items 6BA and 6BB, paragraphs (a) and (b)

150

160

92

Schedule 9, clause 3, item 6C

7,800

7,950

93

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

10,300

10,500

94

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

13,200

13,500

95

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

18,100

18,400

96

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

23,900

24,400

97

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

35,900

36,600

98

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

47,900

48,800

99

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

71,800

73,200

100

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

10,700

10,900

101

Schedule 9, clause 3, item 7, paragraphs (b) to (ca)

8,910

9,080

102

Schedule 9, clause 3, item 7, paragraph (d)

35,900

36,600

103

Schedule 9, clause 3, item 7, paragraphs (e) and (f)

8,910

9,080

104

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

10,300

10,500

105

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

10,300

10,500

106

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

13,200

13,500

107

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

18,100

18,400

108

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

23,900

24,400

109

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

35,900

36,600

110

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

47,900

48,800

111

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

71,800

73,200

112

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

10,300

10,500

113

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

10,300

10,500

114

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

13,200

13,500

115

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

18,100

18,400

116

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

23,900

24,400

117

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

35,900

36,600

118

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

47,900

48,800

119

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

71,800

73,200

120

Schedule 9, clause 3, item 7C

1,020

1,040

121

Schedule 9, clause 3, item 9AA

660

670

122

Schedule 9, clause 3, item 9AB

880

900

123

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

660

670

124

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

1,290

1,310

125

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

11,000

11,200

126

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

24,600

25,100

127

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

33,100

33,700

128

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

51,600

52,600

129

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

68,800

70,100

130

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

83,900

85,500

131

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

17,900

18,200

132

Schedule 9, clause 3, item 10

170

180

133

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

350

360

134

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

240

250

135

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

290

300

136

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

460

470

137

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

120

130

138

Schedule 9, clause 3, item 17, paragraph (c)

120

130

139

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

1,170

1,190

140

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

620

630

141

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

880

900

142

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

430

440

143

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

300

310

144

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

240

250

145

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

290

300

146

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

460

470

147

Schedule 9, clause 3, item 18

2,170

2,210

148

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

1,590

1,620

149

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

2,550

2,600

150

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

3,720

3,790

151

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

5,520

5,620

152

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

1,590

1,620

153

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

2,550

2,600

154

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

3,930

4,000

155

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

5,570

5,680

156

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

8,590

8,750

157

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

14,200

14,500

158

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

21,100

21,500

159

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

3,930

4,000

160

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

6,580

6,710

161

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

8,590

8,750

162

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

790

810

163

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

1,280

1,300

164

Schedule 9, clause 4, item 4, paragraphs (d) to (f)

4,350

4,430

165

Schedule 9, clause 4, item 5

1,590

1,620

166

Schedule 9, clause 4, item 6, paragraph (a)

5,520

5,620

167

Schedule 9, clause 4, item 6, paragraph (b)

8,170

8,330

168

Schedule 9, clause 4, item 6, paragraph (c)

11,140

11,400

169

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

1,560

1,590

170

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

7,990

8,140

171

Schedule 9, clause 5, item 1

1,380

1,410

172

Schedule 9, clause 5, item 2

4,690

4,780

173

Schedule 9, clause 5, item 3

6,970

7,100

174

Schedule 9, clause 5, item 4

9,950

10,100

175

Schedule 9, clause 5, item 5

1,380

1,410

176

Schedule 9, clause 5, item 6

730

740

177

Schedule 9, clause 5, item 7

3,960

4,040

178

Schedule 9, clause 5, item 8

780

790

179

Schedule 9, clause 5, item 9

6,190

6,310

180

Schedule 9, clause 5, item 10

790

810

181

Schedule 9, clause 5, item 11

9,160

9,330

182

Schedule 9, clause 5, item 12

530

540

183

Schedule 9, clause 5, item 13

3,060

3,120

184

Schedule 9, clause 5, item 14

1,910

1,950

185

Schedule 9, clause 5, item 15

20,500

20,900

186

Schedule 9, clause 5, item 16

1,910

1,950

187

Schedule 9, clause 5, item 17

20,500

20,900

188

Schedule 9, clause 5, item 18

2,530

2,580

189

Schedule 9, clause 5, item 19

27,800

28,300

190

Schedule 9, clause 5, item 20

2,770

2,820

191

Schedule 9, clause 5, item 21

35,500

36,200

192

Schedule 9, clause 5, item 22

430

440

193

Schedule 9, clause 5, item 23

1,640

1,670

194

Schedule 9, clause 5, item 24

1,760

1,790

195

Schedule 9, clause 5, item 25

13,400

13,700

196

Schedule 9, clause 5, item 26

1,760

1,790

197

Schedule 9, clause 5, item 27

13,400

13,700

198

Schedule 9, clause 5, item 28

1,050

1,070

199

Schedule 9, clause 5, item 29

14,000

14,300

200

Schedule 9, clause 5, item 30

1,050

1,070

201

Schedule 9, clause 5, item 31

14,000

14,300

202

Schedule 9, clause 5, item 32

2,770

2,820

203

Schedule 9, clause 5, item 33

22,900

23,300

204

Schedule 9, clause 5, item 34

2,770

2,820

205

Schedule 9, clause 5, item 35

22,900

23,300

206

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

1,070

1,090

207

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

410

420

208

Schedule 9A, Part 2, item 4

70,900

72,200

209

Schedule 9A, Part 2, item 5

141,700

144,400

210

Schedule 9A, Part 2, item 6

230,300

234,700

211

Schedule 9A, Part 2, item 7

23,000

23,400

212

Schedule 9A, Part 2, item 8

1,070

1,090

213

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

6,500

6,620

214

Schedule 9A, Part 2, item 10

17,100

17,400

215

Schedule 9A, Part 2, item 11

33,600

34,200

216

Schedule 9A, Part 2, item 12

21,100

21,500

217

Schedule 9A, Part 2, item 13

16,000

16,300

218

Schedule 9A, Part 2, item 14

660

670

219

Schedule 9A, Part 2, item 16

25,600

26,100

220

Schedule 9A, Part 2, items 16A and 16B, paragraphs (a) and (b)

150

160

221

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

350

360

Part 3Amendment of the Therapeutic Goods Regulations 1990 commencing 1 July 2019

Therapeutic Goods Regulations 1990

  1. 17

    Clause 3 of Schedule 9 (table item 6AA, column 3)

Omit “400”, substitute “640”.

  1. 18

    Clause 3 of Schedule 9 (table item 6ABA, column 3)

Omit “2,070”, substitute “2,430”.

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