Therapeutic Goods Amendment Regulations 2003 (No. 2) (Cth)

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Therapeutic Goods Amendment Regulations 2003 (No. 2)1

Statutory Rules 2003 No. 1512

I, GUY STEPHEN MONTAGUE GREEN, Administrator of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following Regulations under the Therapeutic Goods Act 1989.

Dated 25 June 2003

G. S. M. GREEN

Administrator

By His Excellency’s Command

TRISH WORTH

Parliamentary Secretary to the Minister for Health and Ageing

1Name of Regulations

These Regulations are the Therapeutic Goods Amendment Regulations 2003 (No. 2).

2Commencement

These Regulations commence on 1 July 2003.

3Amendment of Therapeutic Goods Regulations 1990

Schedule 1 amends the Therapeutic Goods Regulations 1990.

Schedule 1Amendments

(regulation 3)

  

[1]Regulation 2, after definition of generic information

insert

generic medicine means a medicine that, in comparison to a registered medicine:

  1. (a)

    has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the registered medicine; and

  2. (b)

    has the same pharmaceutical form; and

  3. (c)

    is bioequivalent; and

  4. (d)

    has the same safety and efficacy properties.

[2]Regulation 2, after definition of sterilant

insert

submission has the meaning given by subclause 1 (2) in Part 1 of Schedule 9.

[3]Regulation 2, after definition of Therapeutic Goods Advertising Code

insert

trade name, for therapeutic goods of a particular kind, means the commercial name:

  1. (a)

    given to goods of that kind by the manufacturer; and

  2. (b)

    under which the goods are supplied.

[4]After regulation 16

insert in Part 3

16AADocuments and other information that may be required (Act subs 31 (2))

For paragraph 31 (2) (h) of the Act, the following matters are prescribed:

  1. (a)

    the quality of the goods;

  2. (b)

    the efficacy of the goods for the purposes for which the goods are to be used.

[5]Paragraph 16D (1) (b)

omit

subsection 32 (5)

insert

subsection 9D (3)

[6]Regulation 16F, heading

substitute

16FApplications under subsection 9D (3) of the Act — periods within which certain decisions must be made

[7]Regulation 16GA, heading

substitute

16GAEvaluation other than evaluation under subsection 9D (1), (2) or (3) or 24 (1) of the Act

[8]Subregulation 16GA (2)

omit

section 23 or subsection 32 (3), (4) or (5)

insert

subsection 9D (1), (2) or (3) or section 23

[9]Subregulation 43 (1)

substitute

  1. (1)

    Subject to the other provisions of this Part, the fee specified in column 3 of an item in Part 2 of Schedule 9 is prescribed for the matter that, in relation to that fee, is specified in column 2 of the item.

[10]Subregulation 43 (3)

omit

[11]Subregulation 45 (2)

substitute

  1. (2)

    The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:

    1. (a)

      the goods to which each application relates:

      1. (i)

        contain the same active ingredient; or

      2. (ii)

        are therapeutic devices;

    2. (b)

      the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.

[12]Subregulation 45 (4)

substitute

  1. (4)

    The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):

    1. (a)

      to register goods; or

    2. (b)

      in relation to registered goods that are a medicine — to vary the information entered in the Register;

if the Secretary has information relating to the goods that enables the evaluation procedure to be abridged.

  1. (4AA)

    The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:

    1. (a)

      supply of the goods in Australia is necessary because of a public health emergency; and

    2. (b)

      the waiver or reduction is necessary to enable the goods to be supplied in Australia; and

    3. (c)

      the Secretary has information relating to the goods that allows the evaluation procedure to be abridged.

[13]Regulation 45A, heading

substitute

45ACharges reduced if annual turnover is not more than $62 985

[14]Subregulation 45A (1)

omit

$61 000

insert

$62 985

[15]Subregulation 45A (1)

omit

Therapeutic Goods (Charges) Regulations

insert

Therapeutic Goods (Charges) Regulations 1990

[16]Schedule 9, before the table

insert

Part 1Interpretation of table

1Definitions

  1. (1)

    In this table:

major variation, for therapeutic goods of a particular kind, means a change to:

  1. (a)

    the strength, as recorded in the entry in the Register; or

  2. (b)

    the dosage, the recommended dose regimen or the maximum daily dose; or

  3. (c)

    the dosage form; or

  4. (d)

    the route of administration; or

  5. (e)

    the intended patient group.

minor variation, for therapeutic goods of a particular kind, means a change (other than a change that is a major variation) to:

  1. (a)

    the formulation, composition or design specification; or

  2. (b)

    the container for the goods; or

  3. (c)

    any other attribute of the goods that results in the goods being separate and distinct.

new chemical entity means:

  1. (a)

    a chemical, biological or radiopharmaceutical substance that has not previously been included in the Register; or

  2. (b)

    an isomer, mixture of isomers, complex of, derivative of or salt of, a registered chemical substance that, having previously been included in the Register, differs from the registered substance in having different safety or efficacy properties; or

  3. (c)

    a biological substance that, having previously been included in the Register, differs from the registered substance:

    1. (i)

      in having a different molecular structure; or

    2. (ii)

      in deriving from source material of a different nature or from a different manufacturing process; or

  4. (d)

    a radiopharmaceutical substance that:

    1. (i)

      is a radionucleide or ligand that has not previously been included in the Register; or

    2. (ii)

      has a coupling mechanism, linking the molecule and radionucleide, that has not previously been included in the Register; or

  5. (e)

    a fixed combination of active substances that have not previously been included in the Register as that fixed combination.

page means:

  1. (a)

    a legible photocopy of 1 side of 1 leaf of a published work, diagram or chart; or

  2. (b)

    in respect of any other work — 1 side of 1 leaf (or a copy of 1 side of 1 leaf):

    1. (i)

      that has a maximum length of 297 millimetres and a maximum width of 210 millimetres; and

    2. (ii)

      that has a left-hand margin that is at least 25 millimetres in width; and

    3. (iii)

      the information on which is typed or printed in legible characters at least 8 points in size; and

    4. (iv)

      that, if it is part of a document exceeding 1 page in length — is paginated.

  1. (2)

    For item 4 in Part 2, an application for registration, or variation of the registration, of therapeutic goods of a kind mentioned in Part 1 of Schedule 10 that requires evaluation is taken to be a submission.

  2. (3)

    A person making more than 1 application of a kind mentioned in subclause (2), simultaneously, is taken to be making a submission that includes all of those applications if the goods concerned contain the same active ingredient.

Part 2Table of fees

[17]Schedule 9, item 1, column 2, sub-subparagraph (a) (ii) (D)

omit

committee

insert

committee;

[18]Schedule 9, item 1, column 2, after sub-subparagraph (a) (ii) (D)

insert

— for each medicine

[19]Schedule 9, item 1, paragraph (a), column 3

omit

for each drug — 1 240

insert

1 240

[20]Schedule 9, item 2, paragraph (ba), columns 2 and 3

substitute

  1. (ba)

    for an application relating to a medicine to which item 4 applies, if:

    1. (i)

      the Secretary considers that the application cannot be determined because of insufficiency of information delivered (Act, paragraph 23 (2) (b)); or

    2. (ii)

      the application is withdrawn before notification of acceptance is sent under subregulation 16B (1)

5 670; or

20% of the relevant fee under item 4;

whichever is the less

[21]Schedule 9, item 2A, paragraph (a), columns 2 and 3

substitute

  1. (a)

    a registered medicine that is mentioned in Part 1 of Schedule 10 — for each submission

1 310

[22]Schedule 9, after item 2A

insert

2B

fee for an application to which regulation 16F or 16G applies, for evaluation of the chemistry, quality control or manufacturing process of the medicine

4 300

2C

fee for an application under subsection 9D (1), (2) or (3) of the Act (other than an application to which item 4 applies), for evaluation of clinical, pre-clinical or bioequivalence data, or the chemistry, quality control or manufacturing process, of the goods

4 300

[23]Schedule 9, item 3, paragraph (a), column 2

omit

listed devices

insert

a device

[24]Schedule 9, item 3, paragraph (b), column 2

omit

listed medicines

insert

a medicine

[25]Schedule 9, item 3B, paragraph (b), column 3

omit

paragraph 4 (b)

insert

item 4

[26]Schedule 9, item 3B, paragraph (c), column 3

omit

paragraph 4 (c)

insert

item 4

[27]Schedule 9, item 4

substitute

4

Evaluation fee, for subsection 24 (1) of the Act, under a submission (if paragraph (ba) of item 2 does not apply) for evaluation relating to:

  1. (a)

    a new chemical entity

192 600

  1. (b)

    an extension of indications

114 500

  1. (c)

    a new generic product

65 000

  1. (d)

    an additional trade name

12 100

  1. (e)

    a change to product information

4 400

  1. (f)

    a change to consumer patient information

1 350

  1. (g)

    a major variation (that is not a variation mentioned in any of paragraphs (a) to (f))

74 650

  1. (h)

    a minor variation (that is not a variation mentioned in any of paragraphs (a) to (f))

4 300

[28]Schedule 9, item 5A, column 2

omit

items 2 to 6 of Part 2, Schedule 3 apply

insert

any of items 2 to 5 of Part 2 of Schedule 3 applies

[29]Schedule 9, items 6AA, 6AB and 6AC

substitute

6AA

fee for evaluation of data in relation to goods, a step in the manufacture of which was carried out outside Australia (in addition to any other fee prescribed in this Schedule in relation to the application) to determine whether the manufacturing and quality control procedures used in the manufacture of the goods are acceptable:

  1. (a)

    for the purposes of subsection 9D (1), (2) or (3) of the Act; or

  2. (b)

    for the purposes of paragraph 25 (1) (g), 26 (1) (g), 31 (1) (e) or 31 (2) (d) of the Act

240

6AB

fee for Department obtaining evidence from overseas regulatory authority of the manufacturing and quality control procedures used in the manufacture of goods, a step in the manufacture of which was carried out outside Australia (in addition to fee prescribed in item 6AA)

210

6AC

fee for reinstatement of acceptance status of data relating to the manufacturing and quality control procedures used in the manufacture of goods, a step in the manufacture of which was carried out outside Australia (in addition to fee prescribed in item 6AA)

750

6AD

fee for evaluation, under section 25 of the Act, in relation to a therapeutic device:

  1. (a)

    establishing from overseas reports or data that the manufacture of the device is of an acceptable standard

14 045

  1. (b)

    if a person makes simultaneous applications in relation to more than 1 device and the overseas reports or data in support of the application for each device have sufficient commonality that a simultaneous evaluation of the manufacture of each device may conveniently be made — performing the function mentioned in paragraph (a) in relation to each such additional device

3 515

[30]Schedule 9, item 6A, column 2

omit

items 2 to 6 of Part 2, Schedule 3 apply

insert

any of items 2 to 5 of Part 2 of Schedule 3 applies

[31]Schedule 9, item 6C

substitute

6C

fee for evaluating documents and other information, relating to the safety of a medicine, obtained under paragraph 31 (2) (f) of the Act (other than an evaluation to which item 6D applies)

4 680

6D

fee for evaluating documents and other information, relating to the safety, quality and efficacy of a medicine, obtained under paragraphs 31 (2) (f) and (h) of the Act, if the total number of pages of the evaluation documentation is:

  1. (a)

    not over 50 pages

5 030

  1. (b)

    over 50 pages, but not over 250 pages

6 435

  1. (c)

    over 250 pages, but not over 500 pages

8 790

  1. (d)

    over 500 pages, but not over 1 000 pages

11 700

  1. (e)

    over 1 000 pages, but not over 2 000 pages

17 555

  1. (f)

    over 2 000 pages, but not over 3 000 pages

23 410

  1. (g)

    over 3 000 pages

35 105

[32]Schedule 9, item 7AA, paragraph (b), column 3

omit

paragraphs 4 (b), 4 (c) and 7 (d)

insert

item 4 and paragraph (d) of item 7

[33]Schedule 9, item 7AA, paragraph (c), column 3

omit

paragraphs 4 (b) and 4 (c), and item 7,

insert

items 4 and 7

[34]Schedule 9, after item 9B

insert

9C

fee for evaluating documents and other information, relating to the safety of a listed therapeutic device, obtained under paragraph 31 (2) (f) of the Act

11 700

9D

fee for evaluation, under subsection 9D (1), (2) or (3), subsection 24 (1) or paragraph 26 (1) (d) of the Act, of data relating to the device component of a medicine (in addition to the fee prescribed in item 4 or 5 for evaluating the medicine):

  1. (a)

    for a device component to which Chapter 3 of the Act applies

The fee applicable under item 5A, 6, 7 or 9B for an evaluation of that nature

  1. (b)

    for a device component to which Chapter 4 of the Act applies

The fee applicable, under item 1.9, 1.10, 1.12 or 1.16 (and, if applicable, clause 2.2) of Schedule 5 to the Therapeutic Goods (Medical Devices) Regulations 2002, to the kind of work to be undertaken

[35]Schedule 9, after item 17

insert

18

fee for testing a sample of, and providing advice in relation to, a prescription medicine on request by the Pharmaceutical Benefits Program of the Department before listing the medicine in the Pharmaceutical Benefits Listing Program of the Department

9 990

[36]Schedules 12 and 13, introductory clause, 4th dot point

omit

section 32

insert

section 9D

[37]Further amendments — regulation 45

Provision

omit

insert

Paragraph (4A) (a)

$6 800

$7 025

Paragraphs (4A) (b), (c) and (ca)

$5 670

$5 855

Paragraph (4A) (d)

$22 670

$23 410

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

$5 670

$5 855

Paragraphs (9) (a), (b), (c), (ca), (d) and (e)

$3 400

$3 515

Paragraphs (11) (a), (b), (c), (ca), (d) and (e)

$1 140

$1 285

[38]Further amendments — Schedule 9, column 3

Provision

omit

insert

Item 1A

280

290

Item 1, paragraph (c)

11 330

11 700

Item 1, paragraph (d)

1 700

1 760

Item 2, paragraph (a)

730

755

Item 2, paragraph (b)

900

930

Item 2, paragraph (c)

2 720

2 810

Item 2, paragraph (d)

1 360

1 405

Item 2, paragraph (d)

7 930

8 190

Item 2, paragraph (f)

310

325

Item 2, paragraph (g)

900

930

Item 2, paragraph (h)

460

475

Item 2AA

620

645

Item 2A, paragraph (b)

730

755

Item 2A, paragraph (c)

220

230

Item 2A, paragraph (d)

460

475

Item 2A, paragraph (e)

900

930

Item 2A, paragraph (f)

280

290

Item 2A, paragraph (g)

280

290

Item 3, paragraph (a)

280

290

Item 3, paragraph (b)

460

475

Item 3AA

310

325

Item 5, paragraph (a)

4 870

5 030

Item 5, subparagraph (b) (i)

4 870

5 030

Item 5, subparagraph (b) (ii)

6 230

6 435

Item 5, subparagraph (b) (iii)

8 510

8 790

Item 5, subparagraph (b) (iv)

11 330

11 700

Item 5, subparagraph (b) (v)

17 000

17 555

Item 5, subparagraph (b) (vi)

22 670

23 410

Item 5, subparagraph (b) (vii)

34 000

35 105

Item 5, paragraph (c)

1 750

1 810

Item 5, subparagraph (d) (i)

1 750

1 810

Item 5, subparagraph (d) (ii)

6 230

6 435

Item 5, subparagraph (d) (iii)

8 510

8 790

Item 5, subparagraph (d) (iv)

11 330

11 700

Item 5, subparagraph (d) (v)

17 000

17 555

Item 5, subparagraph (d) (vi)

22 670

23 410

Item 5, subparagraph (d) (vii)

34 000

35 105

Item 5A, paragraphs (a), (b), (c), (d), (e) and (f)

3 400

3 515

Item 5B

11 330

11 700

Item 6, paragraph (a)

19 950

20 600

Item 6, paragraphs (b), (c) and (ca)

13 600

14 045

Item 6, paragraph (d)

22 670

23 410

Item 6A

900

930

Item 6B

2 270

2 345

Item 7, paragraph (a)

6 800

7 025

Item 7, paragraphs (b), (c) and (ca)

5 670

5 855

Item 7, paragraph (d)

22 670

23 410

Item 7, paragraphs (e) and (f)

5 670

5 855

Item 7A, paragraph (a)

4 870

5 030

Item 7A, subparagraph (b) (i)

4 870

5 030

Item 7A, subparagraph (b) (ii)

6 230

6 435

Item 7A, subparagraph (b) (iii)

8 510

8 790

Item 7A, subparagraph (b) (iv)

11 330

11 700

Item 7A, subparagraph (b) (v)

17 000

17 555

Item 7A, subparagraph (b) (vi)

22 670

23 410

Item 7A, subparagraph (b) (vii)

34 000

35 105

Item 7B, paragraph (a)

4 870

5 030

Item 7B, subparagraph (b) (i)

4 870

5 030

Item 7B, subparagraph (b) (ii)

6 230

6 435

Item 7B, subparagraph (b) (iii)

8 510

8 790

Item 7B, subparagraph (b) (iv)

11 330

11 700

Item 7B, subparagraph (b) (v)

17 000

17 555

Item 7B, subparagraph (b) (vi)

22 670

23 410

Item 7B, subparagraph (b) (vii)

34 000

35 105

Item 8

620

645

Item 9, paragraph (a)

400

415

Item 9, paragraph (b)

840

870

Item 9AB

560

580

Item 9AC

400

415

Item 9AD, paragraph (a)

820

850

Item 9AD, paragraph (b)

7 030

7 260

Item 9AD, paragraph (c)

15 590

16 100

Item 9AD, paragraph (d)

20 970

21 655

Item 9AD, paragraph (e)

32 860

33 930

Item 9AD, paragraph (f)

43 630

45 050

Item 9AD, paragraph (g)

53 260

54 995

Item 9B

4 530

11 700

Item 10

150

80

Item 14

220

240

Item 14A

220

240

Item 17, subparagraph (a) (i)

130

135

Item 17, subparagraph (a) (ii)

160

170

Item 17, subparagraph (a) (iii)

290

300

Item 17, subparagraphs (a) (iv) and (v)

60

65

Item 17, paragraph (b)

110

115

Notes

1. These Regulations amend Statutory Rules 1990 No. 394, as amended by 1991 Nos. 84 and 485; 1992 Nos. 19, 89, 109, 332, 370 and 430; 1993 No. 141; 1994 Nos. 150, 222 and 364; 1995 Nos. 33, 111, 192, 208, 253, 320 and 328; 1996 Nos. 9, 25 (disallowed by the House of Representatives on 10 September 1996), 131, 200 and 208; 1997 Nos. 162, 398, 399, 400 and 401 (disallowed by the Senate on 31 March 1998); 1998 Nos. 227, 247 and 369; 1999 Nos. 62, 209 and 324; 2000 Nos. 29, 48, 70, 123, 124, 267 and 358; 2001 Nos. 159, 160, 252 and 343; 2002 Nos. 9, 84, 114, 143, 234, 315 and 345; 2003 No. 111.

2. Notified in the Commonwealth of Australia Gazette

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