Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2019 (Cth)

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Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2019

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 21 March 2019

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 2019.

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.

26 March 2019

2.

Schedule 1, Parts 1 and 2

1 July 2019.

1 July 2019

3.

Schedule 1, Part 3

Immediately after the commencement of Part 3 of Schedule 1 to the Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2018.

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Note: This table relates only to the provisions of this instrument as originally made.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Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.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 commencing 1 July 2019

Part 1Fees

Therapeutic Goods (Medical Devices) Regulations 2002

  1. 1

    Part 1 of Schedule 5 (table item 1.5, column headed “Matter”, paragraph (h))

Omit “but not”, substitute “, but not a device that is intended by the manufacturer to be for export only or”.

  1. 2

    Part 1 of Schedule 5 (at the end of table item 1.5)

Add:

(i) an IVD medical device that is intended by the manufacturer to be for export only

90

3

Amendments of listed provisions

Amendments relating to fees

Item

Provision

Omit

Substitute

1

Schedule 5, Part 1, item 1.1

1,000

1,020

2

Schedule 5, Part 1, item 1.1A

9,840

10,000

3

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

8,620

8,800

4

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

8,670

8,850

5

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

52,700

53,800

6

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

40,700

41,500

7

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

29,800

30,400

8

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

63,400

64,700

9

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

15,400

15,700

10

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

3,740

3,820

11

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

41,100

41,900

12

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

26,200

26,700

13

Schedule 5, Part 1, item 1.4A

4,480

4,570

14

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

2,460

2,510

15

Schedule 5, Part 1, item 1.4D

73,100

74,600

16

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

52,500

53,600

17

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

1,310

1,340

18

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

1,020

1,040

19

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

530

540

20

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

1,020

1,040

21

Schedule 5, Part 1, item 1.5A

9,840

10,000

22

Schedule 5, Part 1, item 1.7

18,200

18,600

23

Schedule 5, Part 1, item 1.8

360

370

24

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

29,700

30,300

25

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

58,300

59,500

26

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

40,700

41,500

27

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

28,400

29,000

28

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

26,000

26,500

29

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

22,200

22,700

30

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

29,800

30,400

31

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

63,400

64,700

32

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

15,400

15,700

33

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

3,740

3,820

34

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

41,100

41,900

35

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

26,200

26,700

36

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

17,800

18,200

37

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

35,200

35,900

38

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

24,500

25,000

39

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

15,400

15,700

40

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

13,500

13,800

41

Schedule 5, Part 1, item 1.12

420

430

42

Schedule 5, Part 1, item 1.13

3,830

3,910

43

Schedule 5, Part 1, item 1.14

7,030

7,170

44

Schedule 5, Part 1, item 1.14A

6,850

6,990

45

Schedule 5, Part 1, item 1.14B

63,400

64,700

46

Schedule 5, Part 1, item 1.14C

15,400

15,700

47

Schedule 5, Part 1, item 1.15

450

460

48

Schedule 5, Part 1, item 1.17

1,020

1,040

49

Schedule 5, Part 2, paragraph 2.1(b)

420

430

Therapeutic Goods Regulations 1990

4

Regulation 2

Insert:

L(A)C1 (section 9D) request means a request under subsection 9D(1), (2) or (3) of the Act for a variation that:

  1. (a)

    is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and

  2. (b)

    is of a kind specified in the changes table as an L(A)C1 (section 9D)level change.

L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:

  1. (a)

    the new medicine is a changed form of a medicine (the existing medicine) listed under section 26AE of the Act; and

  2. (b)

    the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and

  3. (c)

    the change is of a kind specified in the changes table as an L(A)C1 (section 23) level change.

L(A)C2 (section 9D) request means a request under subsection 9D(1), (2) or (3) of the Act for a variation that:

  1. (a)

    is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and

  2. (b)

    is of a kind specified in the changes table as an L(A)C2 (section 9D)level change.

L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:

  1. (a)

    the new medicine is a changed form of a medicine (the existing medicine) listed under section 26AE of the Act; and

  2. (b)

    the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and

  3. (c)

    the change is of a kind specified in the changes table as an L(A)C2 (section 23) level change.

L(A)CN (section 9D) request means a request under subsection 9D(1), (2) or (3) of the Act for a variation that:

  1. (a)

    is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and

  2. (b)

    is of a kind specified in the changes table as an L(A)CN (section 9D)level change.

L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:

  1. (a)

    the new medicine is a changed form of a medicine (the existing medicine) listed under section 26AE of the Act; and

  2. (b)

    the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and

  3. (c)

    the change is of a kind specified in the changes table as an L(A)CN (section 23) level change.

  1. 5

    Regulation 2 (paragraphs (a), (b) and (c) of the definition of RCMC1 (section 23) application)

Repeal the paragraphs, substitute:

  1. (a)

    the new medicine is a changed form of a registered complementary medicine (the existing medicine); and

  2. (b)

    the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and

  3. (c)

    the change is of a kind specified in the changes table as an RCMC1 (section 23) level change.

  1. 6

    Regulation 2 (paragraphs (a), (b) and (c) of the definition of RCMC2 (section 23) application)

Repeal the paragraphs, substitute:

  1. (a)

    the new medicine is a changed form of a registered complementary medicine (the existing medicine); and

  2. (b)

    the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and

  3. (c)

    the change is of a kind specified in the changes table as an RCMC2 (section 23) level change.

  1. 7

    Regulation 2 (paragraphs (a), (b) and (c) of the definition of RCMC3 (section 23) application)

Repeal the paragraphs, substitute:

  1. (a)

    the new medicine is a changed form of a registered complementary medicine (the existing medicine); and

  2. (b)

    the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and

  3. (c)

    the change is of a kind specified in the changes table as an RCMC3 (section 23) level change.

  1. 8

    Regulation 2 (paragraphs (a), (b) and (c) of the definition of RCMC4 (section 23) application)

Repeal the paragraphs, substitute:

  1. (a)

    the new medicine is a changed form of a registered complementary medicine (the existing medicine); and

  2. (b)

    the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and

  3. (c)

    the change is of a kind specified in the changes table as an RCMC4 (section 23) level change.

9

After paragraph 10AA(1)(d)

Insert:

  1. (da)

    the definition of L(A)C1 (section 9D) request;

  2. (db)

    the definition of L(A)C2 (section 9D) request;

  3. (dc)

    the definition of L(A)CN (section 9D) request;

10

Subregulation 16GG(2) (before table item 1)

Insert:

1A

L(A)C1 (section 9D) request

Within 40 working days after the Secretary receives the request

Within 30 working days after the Secretary notifies the applicant that the request has been accepted

1B

L(A)C2 (section 9D) request

Within 40 working days after the Secretary receives the request

Within 120 working days after the Secretary notifies the applicant that the request has been accepted

11

Subregulation 16GH(1) (after table item 3)

Insert:

3A

L(A)C1 (section 23) application

Within 40 working days after the Secretary receives the application

Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment

3B

L(A)C2 (section 23) application

Within 40 working days after the Secretary receives the application

Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment

12

Regulation 43ACA (heading)

Omit “registered complementary”, substitute “certain registered and listed”.

13

Paragraph 43ACA(1)(a)

Omit “an application of a kind mentioned in item”, substitute “a request of a kind mentioned in item 1A, 1B,”.

14

Paragraphs 43ACA(1)(b) and (c)

Omit “of the application”, substitute “of the request”.

15

Before paragraph 43ACA(2)(a)

Insert:

  1. (aa)

    for an L(A)C1 (section 9D) request—$1,070;

  2. (ab)

    for an L(A)C2 (section 9D) request—$7,770;

16

Regulation 43AF (heading)

Omit “registered complementary”, substitute “certain registered and listed”.

17

Before subparagraph 43AF(b)(i)

Insert:

  1. (ia)

    an L(A)C1 (section 9D) request; or

  2. (ib)

    an L(A)C2 (section 9D) request; or

  1. 18

    Clause 2 of Schedule 9 (at the end of the heading)

Add “or 4”.

19

At the end of clause 2 of Schedule 9

Add “or 4”.

20

Clause 5 of Schedule 9 (before table item 1)

Insert:

1A

Application fee under paragraph 9D(7)(f) of the Act for an L(A)C1 (section 9D) request

1,990

1B

Application fee under paragraph 9D(7)(f) of the Act for an L(A)C2 (section 9D) request

8,690

1C

Application fee under paragraph 9D(7)(f) of the Act for an L(A)CN (section 9D) request

790

1D

Application fee under paragraph 23B(2)(b) of the Act for an L(A)C1 (section 23) application

920

1E

Application fee under paragraph 23B(2)(b) of the Act for an L(A)C2 (section 23) application

920

1F

Application fee under paragraph 23B(2)(b) of the Act for an L(A)CN (section 23) application

790

1G

Evaluation fee under subsection 26AC(2) of the Act for an L(A)C1 (section 23) application

1,070

1H

Evaluation fee under subsection 26AC(2) of the Act for an L(A)C2 (section 23) application

7,770

21

Amendments of listed provisions

Amendments relating to fees

Item

Provision

Omit

Substitute

1

Paragraph 43AAJ(1)(b)

97,900

99,900

2

Paragraph 43AC(2)(a)

4,000

4,080

3

Paragraph 43AC(2)(b)

6,710

6,850

4

Paragraph 43AC(2)(c)

8,750

8,930

5

Paragraph 43ACA(2)(a)

4,040

4,120

6

Paragraph 43ACA(2)(b)

6,310

6,440

7

Paragraph 43ACA(2)(c)

9,330

9,520

8

Paragraph 45(6)(a)

1,100

1,120

9

Paragraph 45(6)(b)

4,360

4,450

10

Schedule 9, clause 3, item 1A

470

480

11

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

1,720

1,760

12

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

21,500

21,900

13

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

18,200

18,600

14

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

2,740

2,800

15

Schedule 9, clause 3, item 1AA

12,500

12,800

16

Schedule 9, clause 3, item 1AB

4,520

4,610

17

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

47,900

48,900

18

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

28,600

29,200

19

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

250,200

255,300

20

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

165,000

168,400

21

Schedule 9, clause 3, item 1AE

28,500

29,100

22

Schedule 9, clause 3, item 1AF

120,300

122,800

23

Schedule 9, clause 3, item 1AG

17,200

17,600

24

Schedule 9, clause 3, item 1B

12,500

12,800

25

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

47,800

48,800

26

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

15,900

16,200

27

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

31,900

32,600

28

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

50,700

51,700

29

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

28,500

29,100

30

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

9,490

9,680

31

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

6,190

6,320

32

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

19,100

19,500

33

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

12,400

12,700

34

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

30,200

30,800

35

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

18,400

18,800

36

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

3,020

3,080

37

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

18,600

19,000

38

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

1,100

1,120

39

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

4,350

4,440

40

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

2,180

2,220

41

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

12,600

12,900

42

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

1,460

1,490

43

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

1,680

1,710

44

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

420

430

45

Schedule 9, clause 3, item 2A, paragraphs (e), (f) and (g)

450

460

46

Schedule 9, clause 3, item 2AB

430

440

47

Schedule 9, clause 3, item 2AC

1,100

1,120

48

Schedule 9, clause 3, item 2B

5,460

5,570

49

Schedule 9, clause 3, item 2C

4,360

4,450

50

Schedule 9, clause 3, item 2CA

5,460

5,570

51

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

790

810

52

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

790

810

53

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

450

460

54

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

820

840

55

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

420

430

56

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

191,800

195,700

57

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

64,000

65,300

58

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

127,600

130,200

59

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

202,800

207,000

60

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

113,800

116,100

61

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

37,900

38,700

62

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

24,600

25,100

63

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

37,900

38,700

64

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

24,600

25,100

65

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

75,800

77,400

66

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

49,600

50,600

67

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

4,350

4,450

68

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

120,600

123,100

69

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

73,200

74,700

70

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

12,100

12,300

71

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

74,200

75,700

72

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

4,360

4,450

73

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

32,000

32,700

74

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

21,800

22,200

75

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

36,600

37,400

76

Schedule 9, clause 3, item 6AB

690

700

77

Schedule 9, clause 3, item 6AC

1,160

1,180

78

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

21,800

22,200

79

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

5,460

5,570

80

Schedule 9, clause 3, item 6B

3,660

3,740

81

Schedule 9, clause 3, item 6C

7,950

8,110

82

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

10,500

10,700

83

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

13,500

13,800

84

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

18,400

18,800

85

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

24,400

24,900

86

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

36,600

37,400

87

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

48,800

49,800

88

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

73,200

74,700

89

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

10,900

11,100

90

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

9,080

9,270

91

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

36,600

37,400

92

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

9,080

9,270

93

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

10,500

10,700

94

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

10,500

10,700

95

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

13,500

13,800

96

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

18,400

18,800

97

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

24,400

24,900

98

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

36,600

37,400

99

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

48,800

49,800

100

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

73,200

74,700

101

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

10,500

10,700

102

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

10,500

10,700

103

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

13,500

13,800

104

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

18,400

18,800

105

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

24,400

24,900

106

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

36,600

37,400

107

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

48,800

49,800

108

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

73,200

74,700

109

Schedule 9, clause 3, item 7C

1,040

1,060

110

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

770

790

111

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

1,020

1,040

112

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

770

790

113

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

970

990

114

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

1,360

1,390

115

Schedule 9, clause 3, item 9AA

670

680

116

Schedule 9, clause 3, item 9AB

900

920

117

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

670

680

118

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

1,310

1,340

119

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

11,200

11,400

120

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

25,100

25,600

121

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

33,700

34,400

122

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

52,600

53,700

123

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

70,100

71,500

124

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

85,500

87,300

125

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

18,200

18,600

126

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

360

370

127

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

250

260

128

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

300

310

129

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

470

480

130

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

1,190

1,210

131

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

630

640

132

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

900

920

133

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

250

260

134

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

440

450

135

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

310

320

136

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

250

260

137

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

300

310

138

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

470

480

139

Schedule 9, clause 3, item 18

2,210

2,260

140

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

1,620

1,650

141

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

2,600

2,650

142

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

3,790

3,870

143

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

5,620

5,740

144

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

1,620

1,650

145

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

2,600

2,650

146

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

4,000

4,080

147

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

5,680

5,800

148

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

8,750

8,930

149

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

14,500

14,800

150

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

21,500

21,900

151

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

4,000

4,080

152

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

6,710

6,850

153

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

8,750

8,930

154

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

810

830

155

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

1,300

1,330

156

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

4,430

4520

157

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

1,620

1,650

158

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

5,620

5,740

159

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

8,330

8,500

160

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

11,400

11,600

161

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

1,590

1,620

162

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

8,140

8,310

163

Schedule 9, clause 5, item 1

1,410

1,440

164

Schedule 9, clause 5, item 2

4,780

4,880

165

Schedule 9, clause 5, item 3

7,100

7,250

166

Schedule 9, clause 5, item 4

10,100

10,300

167

Schedule 9, clause 5, item 5

1,410

1,440

168

Schedule 9, clause 5, item 6

740

760

169

Schedule 9, clause 5, item 7

4,040

4,120

170

Schedule 9, clause 5, item 8

790

810

171

Schedule 9, clause 5, item 9

6,310

6,440

172

Schedule 9, clause 5, item 10

810

830

173

Schedule 9, clause 5, item 11

9,330

9,520

174

Schedule 9, clause 5, item 12

540

550

175

Schedule 9, clause 5, item 13

3,120

3,180

176

Schedule 9, clause 5, item 14

1,950

1,990

177

Schedule 9, clause 5, item 15

20,900

21,300

178

Schedule 9, clause 5, item 16

1,950

1,990

179

Schedule 9, clause 5, item 17

20,900

21,300

180

Schedule 9, clause 5, item 18

2,580

2,630

181

Schedule 9, clause 5, item 19

28,300

28,900

182

Schedule 9, clause 5, item 20

2,820

2,880

183

Schedule 9, clause 5, item 21

36,200

36,900

184

Schedule 9, clause 5, item 22

440

450

185

Schedule 9, clause 5, item 23

1,670

1,700

186

Schedule 9, clause 5, item 24

1,790

1,830

187

Schedule 9, clause 5, item 25

13,700

14,000

188

Schedule 9, clause 5, item 26

1,790

1,830

189

Schedule 9, clause 5, item 27

13,700

14,000

190

Schedule 9, clause 5, item 28

1,070

1,090

191

Schedule 9, clause 5, item 29

14,300

14,600

192

Schedule 9, clause 5, item 30

1,070

1,090

193

Schedule 9, clause 5, item 31

14,300

14,600

194

Schedule 9, clause 5, item 32

2,820

2,880

195

Schedule 9, clause 5, item 33

23,300

23,800

196

Schedule 9, clause 5, item 34

2,820

2,880

197

Schedule 9, clause 5, item 35

23,300

23,800

198

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

1,090

1,110

199

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

420

430

200

Schedule 9A, Part 2, item 4

72,200

73,700

201

Schedule 9A, Part 2, item 5

144,400

147,400

202

Schedule 9A, Part 2, item 6

234,700

239,500

203

Schedule 9A, Part 2, item 7

23,400

23,900

204

Schedule 9A, Part 2, item 8

1,090

1,110

205

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

6,620

6,760

206

Schedule 9A, Part 2, item 10

17,400

17,800

207

Schedule 9A, Part 2, item 11

34,200

34,900

208

Schedule 9A, Part 2, item 12

21,500

21,900

209

Schedule 9A, Part 2, item 13

16,300

16,600

210

Schedule 9A, Part 2, item 14

670

680

211

Schedule 9A, Part 2, item 16

26,100

26,600

212

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

360

370

Part 2Other measures

Therapeutic Goods Regulations 1990

  1. 22

    Schedule 4 (table item 3, column headed “Therapeutic goods”, paragraph (c))

Repeal the paragraph, substitute:

(c) the ingredients in the medicine are not of a kind required to be sterile; and

(ca) the medicine does not contain a substance included in a Schedule to the Poisons Standard; and

  1. 23

    Schedule 4 (table item 4A, column headed “Therapeutic goods”, paragraph (e))

Repeal the paragraph, substitute:

(e) the preparation does not contain a substance (other than one that is more than a 1,000‑fold dilution of mother tincture) included in a Schedule to the Poisons Standard; and

  1. 24

    Schedule 4 (table item 8, column headed “Therapeutic goods”, paragraph (c))

Repeal the paragraph, substitute:

(c) the ingredients in the medicine are not of a kind required to be sterile; and

(ca) the medicine does not contain a substance included in a Schedule to the Poisons Standard; and

Part 3Amendments commencing after Part 3 of Schedule 1 to the Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2018

Therapeutic Goods Regulations 1990

  1. 25

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

Omit “640”, substitute “650”.

  1. 26

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

Omit “2,430”, substitute “2,480”.

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