Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2024 (Cth)

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Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2024

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 12 June 2024

David Hurley

Governor‑General

By His Excellency’s Command

Mark Butler

Minister for Health and Aged Care

Contents

1Name

This instrument is the Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2024.

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

1 July 2024.

1 July 2024

2.

Schedule 1

1 July 2024.

1 July 2024

3.

Schedule 2

1 January 2025.

1 January 2025

Note: This table relates only to the provisions of this instrument as originally made.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Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.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 1Amendments commencing 1 July 2024

Therapeutic Goods (Medical Devices) Regulations 2002

1

Subsection 9.1AA(1)

Omit “$30”, substitute “$31”.

2

Subsection 9.1AA(2) (method statement, step 2)

Omit “$30”, substitute “$31”.

3

Paragraph 9.7(1)(d)

After “1.14A,”, insert “1.14AA,”.

4

In the appropriate position in Part 11

Insert:

Division 11.21—Application provisions relating to the Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2024

11.77Application provision—application audit assessment fees

Table items 1.14A, 1.14AA and 1.14B of Part 1 of Schedule 5 to these Regulations, as amended or inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2024, apply in relation to an application that is made on or after 1 July 2024 and in relation to which an application audit assessment fee is payable because of subsection 41LA(3) of the Act.

  1. 5

    Part 2 of Schedule 4 (table item 2.3, column headed “Conditions”, paragraph (b))

Before “item 1.8”, insert “paragraph (a) of”.

  1. 6

    Part 2 of Schedule 4 (table item 2.3, column headed “Conditions”, after paragraph (h))

Insert:

(ha) The notification must be accompanied by the notification fee specified in paragraph (b) of item 1.8 of Schedule 5.

  1. 7

    Part 1 of Schedule 5 (table item 1.4, column headed “Amount ($)”)

After “1.14A”, insert “, 1.14AA, 1.14B or 1.14C (as the case may be)”.

8

Part 1 of Schedule 5 (table item 1.8)

Repeal the item, substitute:

1.8

Each of the following:

Paragraph 63(2)(h) of the Act, and Schedule 4, item 2.3, paragraphs (b) and (ha) of these Regulations

(a) notification of intention to sponsor a clinical trial of a medical device, including an IVD medical device, to be used solely for experimental purposes in humans, at a trial site;

429

(b) each notification of an additional trial site or additional trial sites for the clinical trial

429

  1. 9

    Part 1 of Schedule 5 (at the end of paragraph (b) of table item 1.14A)

Add “, other than devices to which item 1.14AA applies”.

  1. 10

    Part 1 of Schedule 5 (subparagraph (c)(ii) of table item 1.14A)

After “item”, insert “1.14AA,”.

11

Part 1 of Schedule 5 (after table item 1.14A)

Insert:

1.14AA

Application audit assessment for Class 3 IVD medical devices or Class 4 IVD medical devices (other than devices to which paragraph (d) of item 1.14A, or item 1.14C, applies), where the devices are not subject to laboratory testing as part of the auditing of the application

Subsections 41LA(3) and (4) of the Act

14,865

  1. 12

    Part 1 of Schedule 5 (table item 1.14B, column headed “Matter”)

After “item”, insert “1.14AA or”.

13

Paragraph 2.1(b) of Schedule 5

Omit “$474”, substitute “$496”.

  1. 14

    Amendments of listed provisions—Part 1 of Schedule 5

The items of the table in Part 1 of Schedule 5 listed in the following table are amended as set out in the table.

Amendments relating to fees

Item

Provision

Omit

Substitute

1

Item 1.1

1,416

1,483

2

Item 1.1A

10,568

11,065

3

Item 1.2, paragraph (a)

9,296

9,733

4

Item 1.2, paragraph (b)

9,347

9,786

5

Item 1.3, paragraph (a)

56,840

59,511

6

Item 1.3, paragraph (b)

43,810

45,869

7

Item 1.3A, paragraph (a)

32,114

33,623

8

Item 1.3A, paragraph (b)

68,434

71,650

9

Item 1.3A, paragraph (c)

16,621

17,402

10

Item 1.3A, paragraph (d)

4,032

4,222

11

Item 1.3A, paragraph (e)

44,221

46,299

12

Item 1.3A, paragraph (f)

28,215

29,541

13

Item 1.4A

5,083

5,322

14

Items 1.4B and 1.4C

2,795

2,926

15

Item 1.4D

83,002

86,903

16

Items 1.4E and 1.4F

59,580

62,380

17

Item 1.5, paragraph (b)

1,416

1,483

18

Item 1.5, paragraphs (c) and (d)

1,098

1,150

19

Item 1.5, paragraph (e)

575

602

20

Item 1.5, paragraph (f)

92

96

21

Item 1.5, paragraph (g)

575

602

22

Item 1.5, paragraph (h)

1,098

1,150

23

Item 1.5, paragraph (i)

92

96

24

Item 1.5A

11,118

11,641

25

Item 1.6A, paragraphs (a) and (b)

173

181

26

Item 1.6A, paragraph (b)

54

57

27

Item 1.6B, paragraphs (a) and (b)

173

181

28

Item 1.6B, paragraph (b)

54

57

29

Item 1.7

20,723

21,697

30

Item 1.7A

5,656

5,922

31

Item 1.9, paragraph (a)

32,011

33,516

32

Item 1.9, paragraph (b)

62,894

65,850

33

Item 1.9, paragraph (c)

43,810

45,869

34

Item 1.9, paragraph (d)

30,677

32,119

35

Item 1.9, paragraph (e)

28,010

29,326

36

Item 1.9, paragraph (f)

23,906

25,030

37

Item 1.9A, paragraph (a)

32,114

33,623

38

Item 1.9A, paragraph (b)

68,434

71,650

39

Item 1.9A, paragraph (c)

16,621

17,402

40

Item 1.9A, paragraph (d)

4,032

4,222

41

Item 1.9A, paragraph (e)

44,221

46,299

42

Item 1.9A, paragraph (f)

28,215

29,541

43

Item 1.10, paragraph (a)

19,289

20,196

44

Item 1.10, paragraph (b)

37,962

39,746

45

Item 1.10, paragraph (c)

26,471

27,715

46

Item 1.10, paragraph (d)

16,621

17,402

47

Item 1.10, paragraph (e)

14,569

15,254

48

Item 1.10A, paragraph (a)

19,268

20,174

49

Item 1.10A, paragraph (b)

41,060

42,990

50

Item 1.10A, paragraph (c)

9,973

10,442

51

Item 1.10A, paragraph (d)

2,419

2,533

52

Item 1.10A, paragraph (e)

26,533

27,780

53

Item 1.10A, paragraph (f)

16,929

17,725

54

Item 1.12

474

496

55

Item 1.13

4,350

4,554

56

Item 1.14, paragraph (a)

16,000

16,752

57

Item 1.14, paragraph (b)

4,000

4,188

58

Item 1.14A, paragraph (a)

7,387

7,734

59

Item 1.14A, paragraphs (b) and (c)

22,387

23,439

60

Item 1.14A, paragraph (d)

16,621

17,402

61

Item 1.14B

22,387

23,439

62

Item 1.14C

16,621

17,402

63

Item 1.15, paragraphs (a) and (b)

540

565

64

Item 1.15, paragraph (b)

108

113

65

Item 1.17

1,155

1,209

Therapeutic Goods Regulations 1990

15

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

565 (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

565 for the first entry plus 113 for each additional entry

(c) for an application relating to goods to which no entry in the Register relates

3,712

  1. 16

    Part 2 of Schedule 9A (table, heading to column headed “Fee”)

Repeal the heading, substitute:

Fee $

17

Amendments of listed provisions

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

Amendments relating to fees

Item

Provision

Omit

Substitute

1

Paragraph 43AAJ(1)(b)

$111,065

$118,064

2

Paragraph 43AC(2)(a)

$4,533

$4,746

3

Paragraph 43AC(2)(b)

$7,609

$7,967

4

Paragraph 43AC(2)(c)

$9,930

$10,397

5

Paragraph 43ACA(2)(aa)

$1,188

$1,244

6

Paragraph 43ACA(2)(ab)

$8,635

$9,041

7

Paragraph 43ACA(2)(a)

$4,576

$4,791

8

Paragraph 43ACA(2)(b)

$7,167

$7,504

9

Paragraph 43ACA(2)(c)

$10,588

$11,086

10

Paragraph 45(6)(a)

$1,241

$1,299

11

Paragraph 45(6)(b)

$4,954

$5,187

  1. 18

    Amendments of listed provisions—clause 3 of Schedule 9

The items of the table in clause 3 of Schedule 9 listed in the following table are amended as set out in the table.

Amendments relating to fees

Item

Provision

Omit

Substitute

1

Item 1, paragraph (a)

1,954

2,046

2

Item 1, paragraph (b)

24,285

25,426

3

Item 1AAA, paragraph (a)

537

562

4

Item 1AAA, paragraph (b)

6,628

6,940

5

Item 1AA

14,140

14,805

6

Item 1AB

5,127

5,368

7

Item 1ABA

9,347

9,786

8

Item 1AC, paragraph (a)

54,399

56,956

9

Item 1AC, paragraph (b)

32,489

34,016

10

Item 1AD, paragraph (a)

283,870

297,212

11

Item 1AD, paragraph (b)

187,268

196,070

12

Item 1AE

32,381

33,903

13

Item 1AF

136,538

142,955

14

Item 1AG

19,537

20,455

15

Item 1B

14,140

14,805

16

Item 2, paragraph (ba)

54,292

56,844

17

Item 2, paragraph (bb)

18,025

18,872

18

Item 2, paragraph (bc)

36,158

37,857

19

Item 2, paragraph (bca)

57,530

60,234

20

Item 2, paragraph (bcb)

1,241

1,299

21

Item 2, paragraph (bd)

32,381

33,903

22

Item 2, subparagraph (be)(i)

10,761

11,267

23

Item 2, subparagraph (be)(ii)

7,026

7,356

24

Item 2, subparagraph (bf)(i)

21,695

22,715

25

Item 2, subparagraph (bf)(ii)

14,032

14,692

26

Item 2, paragraph (bfa)

34,215

35,823

27

Item 2, paragraph (bg)

20,939

21,923

28

Item 2, paragraph (bh)

3,421

3,582

29

Item 2, paragraph (bi)

21,156

22,150

30

Item 2, paragraphs (bj) and (bk)

1,241

1,299

31

Item 2, paragraph (c)

4,943

5,175

32

Item 2, paragraph (d)

2,461

2,577

33

Item 2, paragraph (d)

14,356

15,031

34

Item 2A, paragraph (a)

1,900

1,989

35

Item 2A, paragraph (b)

474

496

36

Item 2A, paragraph (c)

1,400

1,466

37

Item 2A, paragraph (d)

1,750

1,832

38

Item 2A, paragraphs (e) and (f)

1,000

1,047

39

Item 2A, paragraph (g)

190

199

40

Item 2AC

1,241

1,299

41

Item 2B

6,195

6,486

42

Item 2C

4,954

5,187

43

Item 2CA

6,195

6,486

44

Items 2CB to 2CE (wherever occurring)

907

950

45

Item 3, paragraph (a)

2,200

2,303

46

Item 3, paragraph (b)

939

983

47

Item 3AB, paragraphs (a) and (b)

474

496

48

Item 3AB, paragraph (b)

54

57

49

Item 4, paragraph (a)

217,598

227,825

50

Item 4, subparagraphs (aa)(i) and (ii)

72,641

76,055

51

Item 4, subparagraph (aa)(iii)

144,742

151,545

52

Item 4, paragraph (ab)

230,118

240,934

53

Item 4, paragraph (ac)

4,954

5,187

54

Item 4, paragraph (b)

129,091

135,158

55

Item 4, subparagraph (bb)(i)

43,066

45,090

56

Item 4, subparagraph (bb)(i)

27,955

29,269

57

Item 4, subparagraph (bb)(ii)

43,066

45,090

58

Item 4, subparagraph (bb)(ii)

27,955

29,269

59

Item 4, subparagraph (bb)(iii)

86,024

90,067

60

Item 4, subparagraph (bb)(iii)

56,235

58,878

61

Item 4, paragraph (bc)

4,954

5,187

62

Item 4, paragraph (bd)

136,862

143,295

63

Item 4, paragraph (c)

83,110

87,016

64

Item 4, paragraph (d)

13,600

14,239

65

Item 4, paragraph (g)

84,189

88,146

66

Item 4, paragraph (h)

4,954

5,187

67

Item 6AA

723

757

68

Item 6AB

777

814

69

Item 6ABA

2,764

2,894

70

Item 6AC

1,306

1,367

71

Item 6B

4,155

4,350

72

Item 6BA, paragraphs (a) and (b)

173

181

73

Item 6BA, paragraph (b)

54

57

74

Item 6BB, paragraphs (a) and (b)

173

181

75

Item 6BB, paragraph (b)

54

57

76

Item 6C

9,023

9,447

77

Item 6D, paragraph (a)

11,873

12,431

78

Item 6D, paragraph (b)

15,327

16,047

79

Item 6D, paragraph (c)

20,939

21,923

80

Item 6D, paragraph (d)

27,739

29,043

81

Item 6D, paragraph (e)

41,555

43,508

82

Item 6D, paragraph (f)

55,371

57,973

83

Item 6D, paragraph (g)

83,110

87,016

84

Item 7A, paragraph (a)

11,873

12,431

85

Item 7A, subparagraph (b)(i)

11,873

12,431

86

Item 7A, subparagraph (b)(ii)

15,327

16,047

87

Item 7A, subparagraph (b)(iii)

20,939

21,923

88

Item 7A, subparagraph (b)(iv)

27,739

29,043

89

Item 7A, subparagraph (b)(v)

41,555

43,508

90

Item 7A, subparagraph (b)(vi)

55,371

57,973

91

Item 7A, subparagraph (b)(vii)

83,110

87,016

92

Item 7B, paragraph (a)

11,873

12,431

93

Item 7B, subparagraph (b)(i)

11,873

12,431

94

Item 7B, subparagraph (b)(ii)

15,327

16,047

95

Item 7B, subparagraph (b)(iii)

20,939

21,923

96

Item 7B, subparagraph (b)(iv)

27,739

29,043

97

Item 7B, subparagraph (b)(v)

41,555

43,508

98

Item 7B, subparagraph (b)(vi)

55,371

57,973

99

Item 7B, subparagraph (b)(vii)

83,110

87,016

100

Item 7C

1,176

1,231

101

Item 8, paragraph (a)

885

927

102

Item 8, paragraph (b)

1,155

1,209

103

Items 8A to 8C

855

927

104

Item 9, paragraph (a)

1,101

1,153

105

Item 9, paragraph (b)

1,543

1,616

106

Item 9AA

755

790

107

Item 9AB

1,026

1,074

108

Items 9AC and 9ACA

755

790

109

Item 9AD, paragraph (a)

1,490

1,560

110

Item 9AD, paragraph (b)

12,628

13,222

111

Item 9AD, paragraph (c)

28,494

29,833

112

Item 9AD, paragraph (d)

38,317

40,118

113

Item 9AD, paragraph (e)

59,688

62,493

114

Item 9AD, paragraph (f)

79,548

83,287

115

Item 9AD, paragraph (g)

97,033

101,594

116

Item 10

195

204

117

Item 14, paragraphs (a) and (b)

410

429

118

Item 18

2,504

2,622

  1. 19

    Amendments of listed provisions—clause 4 of Schedule 9

The items of the table in clause 4 of Schedule 9 listed in the following table are amended as set out in the table.

Amendments relating to fees

Item

Provision

Omit

Substitute

1

Item 1, paragraphs (a) and (b)

1,835

1,921

2

Item 1, paragraph (c)

2,947

3,086

3

Item 1, paragraph (d)

4,307

4,509

4

Item 1, paragraph (e)

6,379

6,679

5

Item 1, paragraphs (f) to (h)

1,835

1,921

6

Item 1, paragraph (i)

2,947

3,086

7

Item 2, paragraph (a)

4,533

4,746

8

Item 2, paragraph (b)

6,444

6,747

9

Item 2, paragraph (c)

9,930

10,397

10

Item 2, paragraph (d)

16,514

17,290

11

Item 2, paragraph (e)

24,285

25,426

12

Item 2, paragraph (f)

4,533

4,746

13

Item 2, paragraph (g)

7,609

7,967

14

Item 2, paragraph (h)

9,930

10,397

15

Item 3, paragraphs (d) and (e)

928

972

16

Item 3, paragraphs (f) to (h)

1,479

1,549

17

Item 4, paragraphs (d) to (f)

5,030

5,266

18

Item 5, paragraph (a)

1,835

1,921

19

Item 5, paragraph (b)

6,379

6,679

20

Item 5, paragraph (c)

9,455

9,899

21

Item 5, paragraph (d)

12,844

13,448

22

Item 7, paragraph (a)

1,802

1,887

23

Item 7, paragraph (b)

9,240

9,674

  1. 20

    Amendments of listed provisions—clause 5 of Schedule 9

The items of the table in clause 5 of Schedule 9 listed in the following table are amended as set out in the table.

Amendments relating to fees

Item

Provision

Omit

Substitute

1

Item 1A

2,212

2,316

2

Item 1B

9,661

10,115

3

Item 1C

885

927

4

Items 1D and 1E

1,026

1,074

5

Item 1F

885

927

6

Item 1G

1,188

1,244

7

Item 1H

8,635

9,041

8

Item 1

1,609

1,685

9

Item 2

5,429

5,684

10

Item 3

8,063

8,442

11

Item 4

11,442

11,980

12

Item 5

1,609

1,685

13

Item 6

842

882

14

Item 7

4,576

4,791

15

Item 8

907

950

16

Item 9

7,167

7,504

17

Item 10

928

972

18

Item 11

10,588

11,086

19

Item 12

615

644

20

Item 13

3,529

3,695

21

Item 14

2,212

2,316

22

Item 15

23,637

24,748

23

Item 16

2,212

2,316

24

Item 17

23,637

24,748

25

Item 18

2,925

3,062

26

Item 19

32,165

33,677

27

Item 20

3,205

3,356

28

Item 21

41,015

42,943

29

Item 22

497

520

30

Item 23

1,889

1,978

31

Item 24

2,040

2,136

32

Item 25

15,651

16,387

33

Item 26

2,040

2,136

34

Item 27

15,651

16,387

35

Item 28

1,209

1,266

36

Item 29

16,299

17,065

37

Item 30

1,209

1,266

38

Item 31

16,299

17,065

39

Item 32

3,205

3,356

40

Item 33

26,552

27,800

41

Item 34

3,205

3,356

42

Item 35

26,552

27,800

  1. 21

    Amendments of listed provisions—Part 2 of Schedule 9A

The items of the table in Part 2 of Schedule 9A listed in the following table are amended as set out in the table.

Amendments relating to fees

Item

Provision

Omit

Substitute

1

Items 1 to 2AA

$1,231

1,289

2

Item 2A

$14,697

15,388

3

Item 3

$1,231

1,289

4

Item 3A, paragraphs (a) and (b)

$474

496

5

Item 3A, paragraph (b)

$54

57

6

Item 4, paragraph (a)

$85,630

89,655

7

Item 4, paragraph (b)

$81,922

85,772

8

Item 5, paragraph (a)

$171,683

179,752

9

Item 5, paragraph (b)

$163,953

171,659

10

Item 6, paragraph (a)

$277,423

290,462

11

Item 6, paragraph (b)

$266,384

278,904

12

Item 7

$26,660

27,913

13

Item 8

$1,231

1,289

14

Items 8A and 9

$7,512

7,865

15

Item 10

$19,752

20,680

16

Item 11

$38,857

40,683

17

Item 11A, paragraphs (a) and (b)

$540

565

18

Item 11A, paragraph (b)

$108

113

19

Item 12

$24,285

25,426

20

Item 13

$18,457

19,324

21

Item 14

$755

790

22

Item 16

$29,574

30,964

23

Item 16AA

$8,069

$8,448

24

Item 16A, paragraphs (a) and (b)

$173

181

25

Item 16A, paragraph (b)

$54

57

26

Item 16B, paragraphs (a) and (b)

$173

181

27

Item 16B, paragraph (b)

$54

57

28

Item 17, paragraphs (a) and (b)

$410

429

Schedule 2Amendments commencing 1 January 2025

Therapeutic Goods Regulations 1990

1

Clause 3 of Schedule 9 (after table item 1AF)

Insert:

1AFA

Fee for the purposes of subsection 28(3A) of the Act for a request under that subsection:

(a) if the request relates to therapeutic goods that are specified in Part 1 of Schedule 10 to these Regulations

2,879

(b) if the request relates to any other therapeutic goods not covered by paragraph (a) of this item

1,790

2

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

Insert:

2B

Fee for the purposes of subsection 32EE(2) of the Act for a request under that subsection.

2,010

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