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Therapeutic Goods Regulations (Amendment)

Authoritative Version
  • - F1998B00228
  • No longer in force
SR 1998 No. 247 Regulations as made
These Regulations amend the Therapeutic Goods Regulations.
Administered by: Health
General Comments: This instrument was backcaptured in accordance with Section 36 of the Legislative Instruments Act 2003
Registered 01 Jan 2005
Tabling HistoryDate
Tabled HR10-Nov-1998
Tabled Senate10-Nov-1998
Gazetted 31 Jul 1998
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014

Statutory Rules 1998    No. 2471

__________________

Therapeutic Goods Regulations2 (Amendment)

I, WILLIAM PATRICK DEANE, 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 30 July 1998.

                                                                                 WILLIAM DEANE
                                                                                 Governor-General

By His Excellency’s Command,

trish worth

Parliamentary Secretary
to the Minister for Health and Family Services

for the Minister for Health and Family Services

____________

1.   Commencement

1.1   These regulations commence on 1 August 1998.

2.   Amendment

2.1   The Therapeutic Goods Regulations are amended as set out in these regulations.


3.   Regulation 45 (Waiver or reduction of fees)

3.1   Subregulation 45 (4A) is amended as set out in the following table:

Paragraph

Omit

Substitute

45 (4A) (a)

$3,200

$4,800

45 (4A) (b)

$1,865

$2,795

45 (4A) (c)

$2,790

$4,190

45 (4A) (d)

$11,200

$16,800

45 (4A) (e)

$3,760

$5,640

3.2   Subregulations 45 (5), (6) and (7):

Omit the subregulations.

3.3   Subregulation 45 (9) is amended as set out in the following table:

Paragraph

Omit

Substitute

45 (9) (a)

$3,200

$4,800

45 (9) (b)

$1,865

$2,795

45 (9) (c)

$2,790

$4,190

45 (9) (d)

$3,760

$5,640

3.4   Subregulation 45 (11) is amended as set out in the following table:

Paragraph

Omit

Substitute

45 (11) (a)

$1,070

$1,610

45 (11) (b)

$640

$960

45 (11) (c)

$930

$1,390

45 (11) (d)

$3,760

$5,640

4.   Schedule 9 (Fees)

4.1   Item 2, paragraphs (b) and (e):

Omit the paragraphs.

4.2   Schedule 9 is amended as set out in the following table:

Item

Paragraph

Omit

Substitute

(a)

900

1,100

(b)

11,310

13,500

1

(c)

7,840

9,800

(d)

900

1,125

(a)

430

540

2

(c)

1,460

1,825

(d)

710

890

2

(f)

220

275

(g)

430

540

2

(h)

200

300

4.3   Item 2AA:

Omit “430”, substitute “540”.

4.4   Item 2A:

Omit the item, substitute:

“2A

fee for varying an entry in the Register (not including evaluation of data) under subsections 32 (3), (4) or (5) of the Act, if the variation is for:

 

 

(a)   a registered drug that is mentioned in Part 1 of Schedule 10

500

 

(b)   a registered drug that is mentioned in Part 2 or Part 3 of Schedule 10

540

 

(c)   a listed drug

100

 

(d)   a registered therapeutic device that is mentioned in Part 2 of Schedule 3

300

 

(e)   a registered therapeutic device, other than a device mentioned in paragraph (d)

540

 

(f)   a listed therapeutic device

300”.

4.5   Item 3:

Omit the item, substitute:

“3

application fee for paragraph 23 (2) (a) of the Act for the listing of therapeutic goods (other than for an application to which regulation 43A, or item 3AA applies) if the goods are:

(a)   listed devices

(b)   listed drugs

 

 

 

 

 

 

300

270”.

4.6   Item 3AA:

Omit “220”, substitute “270”.

4.7   Item 3A:

Omit the item.

4.8   Item 4:

Omit the item, substitute:

“4

evaluation fee, for subsection 24 (1) of the Act, for therapeutic goods evaluated by the Drug Safety and Evaluation Branch of the Department, for the evaluation of a document:

(a)   setting out human clinical information, if the document is:

 

 

(i)     not over 25 pages

5,200

 

(ii)    over 25 pages, but not over 300 pages

16,000

 

(iii)   over 300 pages, but not over 2,000 pages

38,000

 

(iv)   over 2,000 pages, but not over 7,000 pages

70,000

 

(v)    over 7,000 pages, but not over 20,000 pages

80,000

 

(vi)   over 20,000 pages, but not over 40,000 pages

85,000

 

(vii)  over 40,000 pages

90,000

 

(b)  setting out animal toxicological information, if the document is:

 

 

(i)     not over 25 pages

3,000

 

(ii)    over 25 pages, but not over 200 pages

10,250

 

(iii)   over 200 pages, but not over 2,000 pages

37,000

 

(iv)   over 2,000 pages, but not over 7,000 pages

55,000

 

(v)    over 7,000 pages, but not over 20,000 pages

60,000

 

(vi)   over 20,000 pages

65,000

 

(c)  setting out chemistry, quality control and manufacturing information, if the document is:

 

 

 

(i)     not over 10 pages

700

 

(ii)    over 10 pages, but not over 50 pages

6,000

 

(iii)   over 50 pages, but not over 100 pages

13,250

 

(iv)   over 100 pages, but not over 1,000 pages

18,000

 

(v)    over 1,000 pages, but not over 3,000 pages

28,000

 

(vi)   over 3,000 pages, but not over 4,000 pages

37,000

 

(vii)  over 4,000 pages

45,000”.

4.9   After item 4, insert:

“4A

application fee, for subsection 24 (1) of the Act, for a drug to which item 4 applies

the lesser of 5,000 and 10% of the relevant fee under item 4”.

4.10   Schedule 9 is amended as set out in the following table:

Item

Omit

Substitute

5A

2,460

3,690

6AA

130

165

6AB

130

165

6A

560

840

8

430

540

 

4.11   Schedule 9 is amended as set out in the following table:

Item

Paragraph

Omit

Substitute

5

(a)

  2,460

3,075

 

5

(b)

     560

700

 

6

(a)

  9,860

14,790

 

6

(b)

  5,600

8,400

 

6

(c)

  5,600

8,400

 

6

(ca)

  5,600

8,400

 

6

(d)

11,200

16,800

 

6AC

(a)

  2,465.00

4,560

 

6AC

(b)

  1,070.00

1,610

 

7

(a)

  3,250

4,880

 

7

(b)

  1,900

2,850

 

7

(c)

  2,800

4,200

 

7

(ca)

  2,800

4,200

 

7

(d)

11,200

16,800

 

7

(e)

  3,760

5,640

 

4.12   Item 9:

Omit the item, substitute:

“9

(a)    fee for paragraphs 38 (1) (c), 41 (1) (f) and 58 (3) (b) of the Act for inspection within Australia, per hour, per inspector, for:

 

 

355

 

(i)     the manufacture of therapeutic goods; or

 

 

(ii)    a step in the manufacture of therapeutic goods; or

 

 

(iii)   the manufacture of ingredients or components for use in the manufacture of therapeutic goods; or

 

 

(iv)   the manufacture of herbal or homoeopathic preparations; or

 

 

(v)    the manufacture of diagnostic goods for in vitro use;

 

 

(b)  fee for paragraphs 38 (1) (c), 41 (1) (f) and 58 (3) (b) of the Act for inspection outside Australia, per hour, per inspector, for inspection of a kind mentioned in paragraph (a):

 

 

 

 

745”.

4.13   Item 9A:

Omit “4,480”, substitute “5,625”.

4.14   Item 10:

Omit “50”, substitute “70”.

4.15   Item 14:

Omit the item, substitute:

“14

fee for notification of intention to sponsor a clinical trial using a specified drug

200”.

 

4.16   Item 14A:

Omit “drug”, substitute “device”.

4.17   Item 14A:

Omit “200”, substitute “250”.

_____________________________________________________

NOTES

1.   Notified in the Commonwealth of Australia Gazette on 31 July 1998.

2.   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 No. 227.