Therapeutic Goods Amendment Regulations 2004 (No. 3) (Cth)

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Therapeutic Goods Amendment Regulations 2004 (No. 3)1

Statutory Rules 2004 No. 1592

I, PHILIP MICHAEL JEFFERY, Governor-General 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 24 June 2004

P. M. JEFFERY

Governor-General

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 2004 (No. 3).

2Commencement

These Regulations commence on 1 July 2004.

3Amendment of Therapeutic Goods Regulations 1990

Schedule 1 amends the Therapeutic Goods Regulations 1990.

Schedule 1Amendments

(regulation 3)

  

[1]Subparagraph 42ZCAB (1) (a) (i)

substitute

  1. (i)

    subsection 22 (5) or section 42C, 42DL, 42DM or 42DP of the Act; or

[2]Regulation 45 — amendment of fees

Provision

omit

insert

Paragraph 45 (4A) (a)

$7 025;

$7 240;

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

$5 855;

$6 040;

Paragraph 45 (4A) (d)

$23 410;

$24 200;

Paragraph 45 (4A) (e)

$5 855;

$6 040;

Paragraph 45 (4A) (f)

$5 855.

$6 040.

Paragraphs 45 (9) (a), (b), (c), (ca) and (d)

$3 515;

$3 630;

Paragraph 45 (9) (e)

$3 515.

$3 630.

Paragraphs 45 (11) (a), (b), (c), (ca) and (d)

$1 285;

$1 330;

Paragraph 45 (11) (e)

$1 285.

$1 330.

[3]Regulation 45A, heading

substitute

45ACharges reduced if annual turnover is not more than $65 000

[4]Subregulation 45A (1)

omit

$62 985

insert

$65 000

[5]Schedule 9, Part 1, subclause 1 (1), before definition of major variation

insert

broadcast media has the meaning given by section 42B of the Act.

[6]Schedule 9, Part 1, subclause 1 (1), after definition of page

insert

primary site means the principal manufacturing premises in the capital city of each State and Territory where human blood and blood components are manufactured.

regional area means an area in a State or Territory other than the metropolitan area of the capital city of that State or Territory.

regional station means a radio station or television station that delivers radio programs or television programs to persons in a regional area only.

specified media has the meaning given by section 42B of the Act.

[7]Schedule 9, Part 1, subclause 1 (2)

substitute

  1. (2)

    For paragraph (a) of item 2A and items 2B and 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 is taken to be a submission.

[8]Schedule 9, Part 2, item 2B, column 2

omit

medicine

insert

medicine — for each submission

[9]Schedule 9, Part 2, item 4, columns 2 and 3, paragraphs (a) and (b)

substitute

  1. (a)

    a new chemical entity (other than an entity to which paragraph (aa) applies)

189 900

  1. (aa)

    a new chemical entity incorporated as an ancillary medicinal component of a medical device or a therapeutic device if the evaluation of the new chemical entity involves an evaluation of:

  1. (i)

    documentation setting out the chemistry, quality control and manufacturing of the new chemical entity; or

one-third of the fee specified in paragraph (a)

  1. (ii)

    documentation relating to pre-clinical studies; or

one-third of the fee specified in paragraph (a)

  1. (iii)

    documentation mentioned in subparagraphs (i) and (ii)

two-thirds of the fee specified in paragraph (a)

  1. (b)

    an extension of indications (other than an extension of indications to which paragraph (bb) applies)

112 900

  1. (bb)

    an extension of indications or a major variation in respect of a medicine incorporated as an ancillary medicinal component of a medical device or a therapeutic device if the evaluation of the medicine involves an evaluation of:

  1. (i)

    documentation setting out the chemistry, quality control and manufacturing of the medicine; or

one-third of the fee specified in paragraph (b) or (g) for an evaluation of that nature

  1. (ii)

    documentation relating to pre-clinical studies; or

one-third of the fee specified in paragraph (b) or (g) for an evaluation of that nature

  1. (iii)

    documentation mentioned in subparagraphs (i) and (ii)

two-thirds of the fee specified in paragraph (b) or (g) for an evaluation of that nature

[10]Schedule 9, Part 2, item 9, paragraph (a)

omit

items 9AB and 9AC),

insert

items 9AB, 9AC and 9ACA),

[11]Schedule 9, Part 2, item 9AB, column 2

omit

metropolitan site

insert

primary site

[12]Schedule 9, Part 2, item 9AC, column 2

omit

metropolitan site,

insert

primary site,

[13]Schedule 9, Part 2, after item 9AC

insert

9ACA

Fee for inspection (including an inspection for paragraph 58 (3) (b) of the Act) of manufacturing premises or operations for the preparation of human tissues under licence, for each inspector engaged per hour, or part of an hour

430

[14]Schedule 9, Part 2, item 10, column 3

omit

80

insert

90

[15]Schedule 9, Part 2, item 17

substitute

17

Fee for an application, under regulation 5F, for approval of an advertisement intended to be published in specified media (other than broadcast media):

  1. (a)

    if the time needed to process the application is an hour or less — for an advertisement:

  1. (i)

    of not more than 100 words

140

  1. (ii)

    of more than 100 words

180

  1. (iii)

    of more than 300 words (including an advertorial)

310

  1. (iv)

    that is intended for publication in the classified advertisement columns of a newspaper or other publication

70

  1. (b)

    if the time needed to process the application is more than an hour

The fee applicable under paragraph (a) plus $120 for each additional hour or part of an hour

  1. (c)

    if the application is for approval of a minor change to an approved advertisement (other than a change to information of the kind mentioned in paragraph 5C (2) (b), (e) or (f) of these Regulations) and the application is made more than 3 months after the advertisement was approved

70

  1. (d)

    if the application is for approval of an advertisement that is identical to an approved advertisement the approval number of which has expired under subregulation 5J (3)

50% of the fee applicable under paragraph (a) and, if applicable, paragraph (b)

  1. (e)

    if the application is for approval of a variation of an approved advertisement the approval number of which has not expired under subregulation 5J (3)

50% of the fee applicable under paragraph (a) and, if applicable, paragraph (b)

17A

Fee for an application, under regulation 5F, for approval of an advertisement intended to be broadcast in broadcast media:

  1. (a)

    if the time needed to process the application is an hour or less — for an advertisement that is:

  1. (i)

    a television or cinema advertisement of not more than 150 seconds, including up to 3 variations of the advertising concept for the same product

800

  1. (ii)

    a television advertisement for a retail outlet that is intended to be broadcast on 1 regional station only in that station’s regional area

400

  1. (iii)

    a television advertorial of more than 150 seconds:

(A) for the first minute of each script

600

(B) for each additional minute or part of a minute of each script

150

  1. (iv)

    a radio advertisement, including up to 6 variations of the advertising concept for the same product

290

  1. (v)

    a radio advertisement that is intended to be broadcast in a regional area only, including up to 6 variations of the advertising concept for the same product

190

  1. (vi)

    a still cinema media advertisement (including outdoor media):

  1. (A)

    of not more than 100 words

140

  1. (B)

    of not more than 300 words

180

  1. (C)

    of more than 300 words

310

  1. (b)

    if the time needed to process the application is more than an hour

The fee applicable under paragraph (a) plus $120 for each additional hour or part of an hour

  1. (c)

    if the application is for approval of a minor change to an approved advertisement (other than a change to information of the kind mentioned in paragraph 5C (2) (b), (e) or (f) of these Regulations) and the application is made more than 3 months after the advertisement was approved

50% of the fee applicable under paragraph (a) and, if applicable, paragraph (b)

  1. (d)

    if the application is for approval of an advertisement that is identical to an approved advertisement the approval number of which has expired under subregulation 5J (3)

50% of the fee applicable under paragraph (a) and, if applicable, paragraph (b)

  1. (e)

    if the application is for approval of a variation of an approved advertisement the approval number of which has not expired under subregulation 5J (3)

50% of the fee applicable under paragraph (a) and, if applicable, paragraph (b)

[16]Schedule 9, Part 2 — amendment of fees

Provision

omit

insert

Item 1A

290

300

Item 1, paragraph (c)

11 700

12 100

Item 1, paragraph (d)

1 760

1 820

Item 2, paragraph (a)

755

780

Item 2, paragraph (b)

930

960

Item 2, paragraph (ba)

5 670;

5 850;

Item 2, paragraph (c)

2 810

2 900

Item 2, paragraph (d)

1 405

1 450

Item 2, paragraph (d)

$8 190

$8 440

Item 2, paragraph (f)

325

340

Item 2, paragraph (g)

930

960

Item 2, paragraph (h)

475

490

Item 2AA

645

670

Item 2A, paragraph (a)

1 310

1 300

Item 2A, paragraph (b)

755

780

Item 2A, paragraph (c)

230

240

Item 2A, paragraph (d)

475

490

Item 2A, paragraph (e)

930

960

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

290

300

Items 2B and 2C

4 300

4 280

Item 3, paragraph (a)

290

300

Item 3, paragraph (b)

475

490

Item 3AA

325

340

Item 4, paragraph (c)

65 000

67 000

Item 4, paragraph (d)

12 100

11 900

Item 4, paragraph (e)

4 400

4 280

Item 4, paragraph (f)

1 350

1 300

Item 4, paragraph (g)

74 650

73 600

Item 4, paragraph (h)

4 300

4 280

Item 5, paragraph (a) and subparagraph (b) (i)

5 030

5 190

Item 5, subparagraph (b) (ii)

6 435

6 640

Item 5, subparagraph (b) (iii)

8 790

9 060

Item 5, subparagraph (b) (iv)

11 700

12 060

Item 5, subparagraph (b) (v)

17 555

18 100

Item 5, subparagraph (b) (vi)

23 410

24 200

Item 5, subparagraph (b) (vii)

35 105

36 200

Item 5, paragraph (c) and subparagraph (d) (i)

1 810

1 870

Item 5, subparagraph (d) (ii)

6 435

6 640

Item 5, subparagraph (d) (iii)

8 790

9 060

Item 5, subparagraph (d) (iv)

11 700

12 100

Item 5, subparagraph (d) (v)

17 555

18 100

Item 5, subparagraph (d) (vi)

23 410

24 200

Item 5, subparagraph (d) (vii)

35 105

36 200

Item 5A, paragraphs (a) to (f)

3 515

3 630

Item 5B

11 700

12 100

Item 6, paragraph (a)

20 600

21 300

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

14 045

14 500

Item 6, paragraph (d)

23 410

24 200

Item 6AA

240

250

Item 6AB

210

220

Item 6AC

750

780

Item 6AD, paragraph (a)

14 045

14 500

Item 6AD, paragraph (b)

3 515

3 630

Item 6A

930

960

Item 6B

2 345

2 420

Item 6C

4 680

4 830

Item 6D, paragraph (a)

5 030

5 190

Item 6D, paragraph (b)

6 435

6 640

Item 6D, paragraph (c)

8 790

9 060

Item 6D, paragraph (d)

11 700

12 100

Item 6D, paragraph (e)

17 555

18 100

Item 6D, paragraph (f)

23 410

24 200

Item 6D, paragraph (g)

35 105

36 200

Item 7, paragraph (a)

7 025

7 240

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

5 855

6 040

Item 7, paragraph (d)

23 410

24 200

Item 7, paragraphs (e) and (f)

5 855

6 040

Item 7A, paragraph (a) and subparagraph (b) (i)

5 030

5 190

Item 7A, subparagraph (b) (ii)

6 435

6 640

Item 7A, subparagraph (b) (iii)

8 790

9 060

Item 7A, subparagraph (b) (iv)

11 700

12 100

Item 7A, subparagraph (b) (v)

17 555

18 100

Item 7A, subparagraph (b) (vi)

23 410

24 200

Item 7A, subparagraph (b) (vii)

35 105

36 200

Item 7B, paragraph (a) and subparagraph (b) (i)

5 030

5 190

Item 7B, subparagraph (b) (ii)

6 435

6 640

Item 7B, subparagraph (b) (iii)

8 790

9 060

Item 7B, subparagraph (b) (iv)

11 700

12 100

Item 7B, subparagraph (b) (v)

17 555

18 100

Item 7B, subparagraph (b) (vi)

23 410

24 200

Item 7B, subparagraph (b) (vii)

35 105

36 200

Item 8

645

670

Item 9, paragraph (a)

415

430

Item 9, paragraph (b)

870

900

Item 9AB

580

600

Item 9AC

415

430

Item 9AD, paragraph (a)

850

880

Item 9AD, paragraph (b)

7 260

7 490

Item 9AD, paragraph (c)

16 100

16 600

Item 9AD, paragraph (d)

21 655

22 400

Item 9AD, paragraph (e)

33 930

35 000

Item 9AD, paragraph (f)

45 050

46 500

Item 9AD, paragraph (g)

54 995

56 700

Items 9B and 9C

11 700

12 100

Item 18

9 990

10 300

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 Nos. 111, 151, 257, 258, 301 and 361; 2004 Nos. 78 and 127.

2. Notified in the Commonwealth of Australia Gazette

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