Therapeutic Goods Regulations (Amendment) (Cth)

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Statutory Rules 1996

No. 131 1

__________________

Therapeutic Goods Regulations 2(Amendment)

I, The 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 28 June 1996.

 WILLIAM DEANE

 Governor-General

By His Excellency’s Command,

R. L. WOODS

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 July 1996.

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   Paragraph 45 (4A) (a):

Omit “$2,700”; substitute “$2,860”.

3.2   Paragraph 45 (4A) (b):

Omit “$1,600”, substitute “$1,665”.

3.3   Paragraph 45 (4A) (c):

Omit “$2,400”, substitute “$2,495”.

3.4   Paragraph 45 (4A) (d):

Omit “$9,500”, substitute “$10,000”.

3.5   Paragraph 45 (4A) (e):

Omit “$3,200”, substitute “$3,360”.

3.6   Paragraph 45 (9) (a):

Omit “$2,700”, substitute “$2,860”.

3.7   Paragraph 45 (9) (b):

Omit “$1,600”, substitute “$1,665”.

3.8   Paragraph 45 (9) (c):

Omit “$2,400”, substitute “$2,495”.

3.9   Paragraph 45 (9) (d):

Omit “$3,200”, substitute “$3,360”.

3.10   Paragraph 45 (11) (a):

Omit “$900”, substitute “$955”.

3.11   Paragraph 45 (11) (b):

Omit “$550”, substitute “$570”.

3.12   Paragraph 45 (11) (c):

Omit “$800”, substitute “$830”.

3.13   Paragraph 45 (11) (d):

Omit “$3,200”, substitute “$3,360”.

4.   Schedule 9 (Fees)

4.1   Item 2:

Omit “if regulation 43A does not apply”, substitute “if regulation 43A does not apply and the application is not an application to which item 2AA applies”.

4.2   After item 2, insert:

“2AA

Application fee for the purposes of paragraph 23 (2) (a) of the Act for the registration of therapeutic goods if the previous registration was cancelled solely because of failure to pay the annual registration charge and the application is made within

 30 days of the cancellation

380”.

4.3   Item 3:

Omit “if regulation 43A does not apply”, substitute “if regulation 43A does not apply and the application is not an application to which item 3AA applies”.

4.4   After item 3, insert:

“3AA

Application fee for the purposes of paragraph 23 (2) (a) of the Act for the listing of therapeutic goods if the previous listing was cancelled solely because of failure to pay the annual listing charge and the application is made within 30 days of the cancellation

200”.

4.5   After item 6, insert:

“6AA

fee for evaluation of data to determine whether the manufacturing and quality control procedures used in the manufacture of goods, a step in the manufacture of which was carried out outside Australia, are acceptable for the purposes of paragraph 25 (1) (g), 26 (1) (g), or 31 (1) (e) of the Act (in addition to any other fee payable under this Schedule in relation to an evaluation or assessment of an application to include therapeutic goods in the Register)

120

“6AB

fee for evaluation of data for the purposes of subsection 32 (3), (4) or (5) of the Act in relation to goods if a step in the manufacture of the goods has been carried out outside Australia

120”.

4.6   Item 9:

Omit the item, substitute:

“9

inspection fee for the purposes of paragraphs 38 (1) (c), 41 (1) (f) and 58 (3) (b) of the Act

 is as follows:

  • (a)

    in relation to the manufacture of a single sterile or non-sterile type of therapeutic device:

    • (i)

      initial period of inspection (up to 4 hours):

  • (A)

    for inspection within Australia; or

1,400

  • (B)

    for inspection outside Australia;

     and

1,800

  • (ii)

    each additional period of 2 hours, or in part of 2 hours:

  • (A)

    for inspection within Australia; or

450

  • (B)

    for inspection outside Australia;

600

  • (b)

    in relation to the manufacture of a single sterile or non-sterile drug:

  • (i)

    initial period of inspection (up to 4 hours):

  • (A)

    for inspection within Australia; or

1,400

  • (B)

    for inspection outside Australia;

     and

1,800

  • (ii)

    each additional period of 2 hours, or a part of 2 hours:

  • (A)

    for inspection within Australia; or

450

  • (B)

    for inspection outside Australia;

600

  • (c)

    in relation to the manufacture of therapeutic goods, to which paragraph (a) or (b) does not apply, that are or are represented to be sterile:

  • (i)

    initial period of inspection (up to 4 hours):

  • (A)

    for inspection within Australia; or

2,700

  • (B)

    for inspection outside Australia; and

3,400

  • (ii)

    each additional period of 2 hours, or a part of 2 hours:

  • (A)

    for inspection within Australia; or

800

  • (B)

    for inspection outside Australia;

1,100

  • (d)

    in relation to the manufacture of therapeutic goods to which paragraph (a) or (b) does not apply that are not sterile:

    • (i)

      initial period of inspection (up to 4 hours):

  • (A)

    for inspection within Australia; or

2,700

  • (B)

    for inspection outside Australia; and

3,400

  • (ii)

    each additional period of 2 hours, or a part of 2 hours:

  • (A)

    for inspection within Australia; or

800

  • (B)

    for inspection outside Australia;

1,100

  • (e)

    in relation to a single step in the manufacture of therapeutic goods:

    • (i)

      initial period of inspection (up to 4 hours):

  • (A)

    for inspection within Australia; or

1,400

  • (B)

    for inspection outside Australia; and

1,800

  • (ii)

    each additional period of 2 hours, or a part of 2 hours:

  • (A)

    for inspection within Australia; or

450

  • (B)

    for inspection outside Australia;

600

  • (f)

    in relation to the manufacture of ingredients or components for use in the manufacture of therapeutic goods, and paragraph (e) does not apply:

    • (i)

      initial period of inspection (up to 4 hours):

  • (A)

    for inspection within Australia; or

1,400

  • (B)

    for inspection outside Australia; and

1,800

  • (ii)

    each additional period of 2 hours, or a part of 2 hours:

  • (A)

    for inspection within Australia; or

450

  • (B)

    for inspection outside Australia;

600

  • (g)

    in relation to the manufacture of herbal or homoeopathic preparations that are not included in a Schedule of the Poisons Standard:

    • (i)

      initial period of inspection (up to 4 hours):

  • (A)

    for inspection within Australia; or

1,400

  • (B)

    for inspection outside Australia; and

1,800

  • (ii)

    each additional period of 2 hours, or a part of 2 hours:

  • (A)

    for inspection within Australia; or

450

  • (B)

    for inspection outside Australia;

600

  • (h)

    in relation to the manufacture of herbal or homoeopathic preparations that are included in Schedule 5 or 6 of the Poisons Standard:

    • (i)

      initial period of inspection (up to 4 hours):

  • (A)

    for inspection within Australia; or

1,400

  • (B)

    for inspection outside Australia; and

1,800

  • (ii)

    each additional period of 2 hours, or a part of 2 hours:

  • (A)

    for inspection within Australia; or

450

  • (B)

    for inspection outside Australia;

600

  • (j)

    in relation to the manufacture of diagnostic goods for in vitro use:

    • (i)

      initial period of inspection (up to 4 hours):

  • (A)

    for inspection within Australia; or

1,400

  • (B)

    for inspection outside Australia; and

1,800

  • (ii)

    each additional period of 2 hours, or a part of 2 hours:

  • (A)

    for inspection within Australia; or

450

  • (B)

    for inspection outside Australia

600”.

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

Column 1

Item, paragraph or subparagraph

Column 2

Omit

Column 3

Substitute

2 (a)

360

380

2 (b)

460

500

2 (c)

1,200

1,300

2 (d)

600

630

2 (e)

230

250

2 (f)

180

200

2 (g)

360

380

2A (a)

360

380

2A (b)

150

200

2A (c)

150

200

3

150

200

4 (a) (i)

3,600

3,800

4 (a) (ii)

11,400

12,000

4 (a) (iii)

25,600

27,000

4 (a) (iv)

49,700

52,500

4 (a) (v)

61,400

65,000

4 (b) (i)

7,100

7,500

Column 1

Item, paragraph or subparagraph

Column 2

Omit

Column 3

Substitute

4 (b) (ii)

25,600

27,000

4 (b) (iii)

39,800

42,000

4 (c) (i)

460

500

4 (c) (ii)

4,200

4,400

4 (c) (iii)

9,100

9,600

4 (c) (iv)

12,500

13,120

4 (c) (v)

20,100

21,100

4 (c) (vi)

27,800

29,200

5 (a)

2,100

2,200

5 (b)

460

500

5A

2,100

2,200

6 (a)

8,300

8,800

6 (b)

4,800

5,000

6 (c)

4,800

5,000

6 (d)

9,500

10,000

6A

460

500

7 (a)

2,700

2,900

7 (b)

1,600

1,700

7 (c)

2,400

2,500

7 (d)

9,500

10,000

7 (e)

3,200

3,360

8

360

380

9A

3,200

4,000

14 (a)

150

175

14A

150

175

____________________________________________________________

NOTES

1. Notified in the Commonwealth of Australia Gazette on 28 June 1996.

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 and 25.

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