Federal Register of Legislation - Australian Government

Primary content

Regulations as made
This instrument principally updates fees relating to therapeutic goods, and licences to manufacture therapeutic goods, by 2.6 per cent for the 2022-23 financial year, to support cost recovery.
Administered by: Health and Aged Care
Registered 13 Apr 2022
Tabling HistoryDate
Tabled HR26-Jul-2022
Tabled Senate26-Jul-2022
Date of repeal 26 Oct 2022
Repealed by Division 1 of Part 3 of Chapter 3 of the Legislation Act 2003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 and Other Measures) Regulations 2022

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 10 April 2022

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 and Other Measures) Regulations 2022.

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 2022.

1 July 2022

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  Subregulation 4A.6(2)

Omit all the words after “Schedule 3AA”.

2  Part 1 of Schedule 5 (after table item 1.7)

Insert:

 

1.7A

Request to vary a medical device, or kind of medical device, specified in an approval to use that device or kind of device solely for experimental purposes in humans, or to vary the conditions of such an approval

Paragraph 41HB(8)(e) of the Act

5,376

3  Paragraph 2.1(b) of Part 2 of Schedule 5

Omit “$440”, substitute “$451”.

4  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

1,050

1,077

2

Item 1.1A

10,300

10,568

3

Item 1.2, paragraph (a)

9,060

9,296

4

Item 1.2, paragraph (b)

9,110

9,347

5

Item 1.3, paragraph (a)

55,400

56,840

6

Item 1.3, paragraph (b)

42,700

43,810

7

Item 1.3A, paragraph (a)

31,300

32,114

8

Item 1.3A, paragraph (b)

66,700

68,434

9

Item 1.3A, paragraph (c)

16,200

16,621

10

Item 1.3A, paragraph (d)

3,930

4,032

11

Item 1.3A, paragraph (e)

43,100

44,221

12

Item 1.3A, paragraph (f)

27,500

28,215

13

Item 1.4A

4,710

4,832

14

Items 1.4B and 1.4C

2,590

2,657

15

Item 1.4D

76,900

78,899

16

Items 1.4E and 1.4F

55,200

56,635

17

Item 1.5, paragraph (b)

1,380

1,416

18

Item 1.5, paragraphs (c) to (e)

1,070

1,098

19

Item 1.5, paragraph (f)

90

92

20

Item 1.5, paragraph (g)

560

575

21

Item 1.5, paragraph (h)

1,070

1,098

22

Item 1.5, paragraph (i)

90

92

23

Item 1.5A

10,300

10,568

24

Item 1.6A, paragraphs (a) and (b)

160

164

25

Item 1.6A, paragraph (b)

50

51

26

Item 1.6B, paragraphs (a) and (b)

160

164

27

Item 1.6B, paragraph (b)

50

51

28

Item 1.7

19,200

19,699

29

Item 1.8

380

390

30

Item 1.9, paragraph (a)

31,200

32,011

31

Item 1.9, paragraph (b)

61,300

62,894

32

Item 1.9, paragraph (c)

42,700

43,810

33

Item 1.9, paragraph (d)

29,900

30,677

34

Item 1.9, paragraph (e)

27,300

28,010

35

Item 1.9, paragraph (f)

23,300

23,906

36

Item 1.9A, paragraph (a)

31,300

32,114

37

Item 1.9A, paragraph (b)

66,700

68,434

38

Item 1.9A, paragraph (c)

16,200

16,621

39

Item 1.9A, paragraph (d)

3,930

4,032

40

Item 1.9A, paragraph (e)

43,100

44,221

41

Item 1.9A, paragraph (f)

27,500

28,215

42

Item 1.10, paragraph (a)

18,800

19,289

43

Item 1.10, paragraph (b)

37,000

37,962

44

Item 1.10, paragraph (c)

25,800

26,471

45

Item 1.10, paragraph (d)

16,200

16,621

46

Item 1.10, paragraph (e)

14,200

14,569

47

Item 1.12

440

451

48

Item 1.13

4,030

4,135

49

Item 1.14

7,390

7,582

50

Item 1.14A

7,200

7,387

51

Item 1.14B

66,700

68,434

52

Item 1.14C

16,200

16,621

53

Item 1.15, paragraphs (a) and (b)

500

513

54

Item 1.15, paragraph (b)

100

103

55

Item 1.17

1,070

1,098

Therapeutic Goods Regulations 1990

5  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)

102,900

105,575

2

Paragraph 43AC(2)(a)

4,200

4,309

3

Paragraph 43AC(2)(b)

7,050

7,233

4

Paragraph 43AC(2)(c)

9,200

9,439

5

Paragraph 43ACA(2)(aa)

1,100

1,129

6

Paragraph 43ACA(2)(ab)

8,000

8,208

7

Paragraph 43ACA(2)(a)

4,240

4,350

8

Paragraph 43ACA(2)(b)

6,640

6,813

9

Paragraph 43ACA(2)(c)

9,810

10,065

10

Paragraph 45(6)(a)

1,150

1,180

11

Paragraph 45(6)(b)

4,590

4,709

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

Insert:

 

1AAA

Fee for the purposes of paragraph 19(4B)(e) of the Act, for a request under subsection 19(4B) to vary the therapeutic goods specified in an approval to use those goods solely for experimental purposes in humans, or to vary the conditions of such an approval:

 

 

(a) if the request relates to:

(i) goods that are medicines; and

(ii) paragraph (a) of item 1 applied to the evaluation of the application for approval

510

 

(b) if the request relates to:

(i) goods that are medicines; and

(ii) paragraph (b) of item 1 applied to the evaluation of the application for approval

6,300

7  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 1A, paragraphs (a) and (b)

500

513

2

Item 1A, paragraph (b)

100

103

3

Item 1, paragraph (a)

1,810

1,857

4

Item 1, paragraph (b)

22,500

23,085

5

Item 1AA

13,100

13,441

6

Item 1AB

4,750

4,874

7

Item 1ABA

8,660

8,885

8

Item 1AC, paragraph (a)

50,400

51,710

9

Item 1AC, paragraph (b)

30,100

30,883

10

Item 1AD, paragraph (a)

263,000

269,838

11

Item 1AD, paragraph (b)

173,500

178,011

12

Item 1AE

30,000

30,780

13

Item 1AF

126,500

129,789

14

Item 1AG

18,100

18,571

15

Item 1B

13,100

13,441

16

Item 2, paragraph (ba)

50,300

51,608

17

Item 2, paragraph (bb)

16,700

17,134

18

Item 2, paragraph (bc)

33,500

34,371

19

Item 2, paragraph (bca)

53,300

54,686

20

Item 2, paragraph (bd)

30,000

30,780

21

Item 2, subparagraph (be)(i)

9,970

10,229

22

Item 2, subparagraph (be)(ii)

6,510

6,679

23

Item 2, subparagraph (bf)(i)

20,100

20,623

24

Item 2, subparagraph (bf)(ii)

13,000

13,338

25

Item 2, paragraph (bfa)

31,700

32,524

26

Item 2, paragraph (bg)

19,400

19,904

27

Item 2, paragraph (bh)

3,170

3,252

28

Item 2, paragraph (bi)

19,600

20,110

29

Item 2, paragraphs (bj) and (bk)

1,150

1,180

30

Item 2, paragraph (c)

4,580

4,699

31

Item 2, paragraph (d)

2,280

2,339

32

Item 2, paragraph (d)

13,300

13,646

33

Item 2A, paragraph (a)

1,760

1,806

34

Item 2A, paragraph (b)

440

451

35

Item 2A, paragraphs (ba) and (c)

470

482

36

Item 2AB

450

462

37

Item 2AC

1,150

1,180

38

Item 2B

5,740

5,889

39

Item 2C

4,590

4,709

40

Item 2CA

5,740

5,889

41

Items 2CB to 2CE (wherever occurring)

840

862

42

Item 3, paragraph (a)

470

482

43

Item 3, paragraph (b)

870

893

44

Item 3AB, paragraphs (a) and (b)

440

451

45

Item 3AB, paragraph (b)

50

51

46

Item 4, paragraph (a)

201,600

206,842

47

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

67,300

69,050

48

Item 4, subparagraph (aa)(iii)

134,100

137,587

49

Item 4, paragraph (ab)

213,200

218,743

50

Item 4, paragraph (b)

119,600

122,710

51

Item 4, subparagraph (bb)(i)

39,900

40,937

52

Item 4, subparagraph (bb)(i)

25,900

26,573

53

Item 4, subparagraph (bb)(ii)

39,900

40,937

54

Item 4, subparagraph (bb)(ii)

25,900

26,573

55

Item 4, subparagraph (bb)(iii)

79,700

81,772

56

Item 4, subparagraph (bb)(iii)

52,100

53,455

57

Item 4, paragraph (bc)

4,590

4,709

58

Item 4, paragraph (bd)

126,800

130,097

59

Item 4, paragraph (c)

77,000

79,002

60

Item 4, paragraph (d)

12,600

12,928

61

Item 4, paragraph (g)

78,000

80,028

62

Item 4, paragraph (h)

4,590

4,709

63

Item 6AA

670

687

64

Item 6AB

720

739

65

Item 6ABA

2,560

2,627

66

Item 6AC

1,210

1,241

67

Item 6B

3,850

3,950

68

Item 6BA, paragraphs (a) and (b)

160

164

69

Item 6BA, paragraph (b)

50

51

70

Item 6BB, paragraphs (a) and (b)

160

164

71

Item 6BB, paragraph (b)

50

51

72

Item 6C

8,360

8,577

73

Item 6D, paragraph (a)

11,000

11,286

74

Item 6D, paragraph (b)

14,200

14,569

75

Item 6D, paragraph (c)

19,400

19,904

76

Item 6D, paragraph (d)

25,700

26,368

77

Item 6D, paragraph (e)

38,500

39,501

78

Item 6D, paragraph (f)

51,300

52,634

79

Item 6D, paragraph (g)

77,000

79,002

80

Item 7A, paragraph (a)

11,000

11,286

81

Item 7A, subparagraph (b)(i)

11,000

11,286

82

Item 7A, subparagraph (b)(ii)

14,200

14,569

83

Item 7A, subparagraph (b)(iii)

19,400

19,904

84

Item 7A, subparagraph (b)(iv)

25,700

26,368

85

Item 7A, subparagraph (b)(v)

38,500

39,501

86

Item 7A, subparagraph (b)(vi)

51,300

52,634

87

Item 7A, subparagraph (b)(vii)

77,000

79,002

88

Item 7B, paragraph (a)

11,000

11,286

89

Item 7B, subparagraph (b)(i)

11,000

11,286

90

Item 7B, subparagraph (b)(ii)

14,200

14,569

91

Item 7B, subparagraph (b)(iii)

19,400

19,904

92

Item 7B, subparagraph (b)(iv)

25,700

26,368

93

Item 7B, subparagraph (b)(v)

38,500

39,501

94

Item 7B, subparagraph (b)(vi)

51,300

52,634

95

Item 7B, subparagraph (b)(vii)

77,000

79,002

96

Item 7C

1,090

1,118

97

Item 8, paragraph (a)

820

841

98

Item 8, paragraph (b)

1,070

1,098

99

Items 8A to 8C

820

841

100

Item 9, paragraph (a)

1,020

1,047

101

Item 9, paragraph (b)

1,430

1,467

102

Item 9AA

700

718

103

Item 9AB

950

975

104

Items 9AC and 9ACA

700

718

105

Item 9AD, paragraph (a)

1,380

1,416

106

Item 9AD, paragraph (b)

11,700

12,004

107

Item 9AD, paragraph (c)

26,400

27,086

108

Item 9AD, paragraph (d)

35,500

36,423

109

Item 9AD, paragraph (e)

55,300

56,738

110

Item 9AD, paragraph (f)

73,700

75,616

111

Item 9AD, paragraph (g)

89,900

92,237

112

Item 9B

19,200

19,699

113

Item 10

180

185

114

Item 14, paragraphs (a) and (b)

380

390

115

Item 18

2,320

2,380

8  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)

1,700

1,744

2

Item 1, paragraph (c)

2,730

2,801

3

Item 1, paragraph (d)

3,990

4,094

4

Item 1, paragraph (e)

5,910

6,064

5

Item 1, paragraphs (f) to (h)

1,700

1,744

6

Item 1, paragraph (i)

2,730

2,801

7

Item 2, paragraph (a)

4,200

4,309

8

Item 2, paragraph (b)

5,970

6,125

9

Item 2, paragraph (c)

9,200

9,439

10

Item 2, paragraph (d)

15,300

15,698

11

Item 2, paragraph (e)

22,500

23,085

12

Item 2, paragraph (f)

4,200

4,309

13

Item 2, paragraph (g)

7,050

7,233

14

Item 2, paragraph (h)

9,200

9,439

15

Item 3, paragraphs (d) and (e)

860

882

16

Item 3, paragraphs (f) to (h)

1,370

1,406

17

Item 4, paragraphs (d) to (f)

4,660

4,781

18

Item 5, paragraph (a)

1,700

1,744

19

Item 5, paragraph (b)

5,910

6,064

20

Item 5, paragraph (c)

8,760

8,988

21

Item 5, paragraph (d)

11,900

12,209

22

Item 7, paragraph (a)

1,670

1,713

23

Item 7, paragraph (b)

8,560

8,783

9  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

2,050

2,103

2

Item 1B

8,950

9,183

3

Item 1C

820

841

4

Items 1D and 1E

950

975

5

Item 1F

820

841

6

Item 1G

1,100

1,129

7

Item 1H

8,000

8,208

8

Item 1

1,490

1,529

9

Item 2

5,030

5,161

10

Item 3

7,470

7,664

11

Item 4

10,600

10,876

12

Item 5

1,490

1,529

13

Item 6

780

800

14

Item 7

4,240

4,350

15

Item 8

840

862

16

Item 9

6,640

6,813

17

Item 10

860

882

18

Item 11

9,810

10,065

19

Item 12

570

585

20

Item 13

3,270

3,355

21

Item 14

2,050

2,103

22

Item 15

21,900

22,469

23

Item 16

2,050

2,103

24

Item 17

21,900

22,469

25

Item 18

2,710

2,780

26

Item 19

29,800

30,575

27

Item 20

2,970

3,047

28

Item 21

38,000

38,988

29

Item 22

460

472

30

Item 23

1,750

1,796

31

Item 24

1,890

1,939

32

Item 25

14,500

14,877

33

Item 26

1,890

1,939

34

Item 27

14,500

14,877

35

Item 28

1,120

1,149

36

Item 29

15,100

15,493

37

Item 30

1,120

1,149

38

Item 31

15,100

15,493

39

Item 32

2,970

3,047

40

Item 33

24,600

25,240

41

Item 34

2,970

3,047

42

Item 35

24,600

25,240

10  Part 2 of Schedule 9A (after table item 16)

Insert:

 

16AA

Fee for the purposes of paragraph 32CK(9A)(e) of the Act, for a request under subsection 32CK(9A) of the Act to vary the biological specified in an approval to use the biological solely for experimental purposes in humans, or to vary the conditions of such an approval

$7,670

11  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 3

1,140

1,170

2

Item 3A, paragraphs (a) and (b)

440

451

3

Item 3A, paragraph (b)

50

51

4

Item 4

75,900

77,873

5

Item 5

151,900

155,849

6

Item 6

246,800

253,217

7

Item 7

24,700

25,342

8

Item 8

1,140

1,170

9

Items 8A and 9

6,960

7,141

10

Item 10

18,300

18,776

11

Item 11

36,000

36,936

12

Item 11A, paragraphs (a) and (b)

500

513

13

Item 11A, paragraph (b)

100

103

14

Item 12

22,500

23,085

15

Item 13

17,100

17,545

16

Item 14

700

718

17

Item 16

27,400

28,112

18

Item 16A, paragraphs (a) and (b)

160

164

19

Item 16A, paragraph (b)

50

51

20

Item 16B, paragraphs (a) and (b)

160

164

21

Item 16B, paragraph (b)

50

51

22

Item 17, paragraphs (a) and (b)

380

390