Therapeutic Goods Regulations (Amendment) (Cth)

Statutory Rules 1994

No. 222 1

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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 30 June 1994.

 BILL HAYDEN

 Governor-General

By His Excellency’s Command,

ROSEMARY CROWLEY

Minister for Family Services

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1.   Commencement

1.1   These Regulations commence on 1 July 1994.

2.   Amendment

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

3.   New regulation 43A

3.1   After regulation 43, insert:

When is no application fee payable?

“43A.

A fee is not payable in accordance with item 2 or 3 of Schedule 9 for an application for the registration or listing of a therapeutic device if:

• (a)

  the device was included in the Register under regulation 14 immediately before the application is made; and

• (b)

  the application is made because the effect of an amendment of these Regulations is that:

  • (i)

    the device ceases to be required to be listed and becomes required to be registered; or

  • (ii)

    the device ceases to be required to be registered and becomes required to be listed.”.

4.   Regulation 45 (Waiver or reduction of fees)

4.1   Add at the end:

“(5)

Subregulations (6) and (7) apply if:

• (a)

  more than one application for the evaluation of therapeutic goods by the Drug Evaluation Branch of the Department is made at the same time; and

• (b)

  each application is made by the same sponsor; and

• (c)

  the goods in each application:

  • (i)

    are referred to in Schedule 10 to these Regulations; and

  • (ii)

    contain the same therapeutically active ingredient; and

• (d)

  the information provided in support of each application is sufficiently similar in respect of the goods to enable an evaluation of all of the goods to be made simultaneously; and

• (e)

  the total number of pages in all of the applications is at least 1,000; and

• (f)

  the sponsor:

  • (i)

    pays the highest fee set out in item 4 of Schedule 9 for any of the applications (in this regulation called ‘the principal application’); and

  • (ii)

    if there are more than 3 applications for evaluation in addition to the principal application—offers, in writing, to pay in full the total amount of the fees calculated under subregulation (7) before the evaluation is made.

“(6)

If there are 1, 2 or 3 applications for evaluation in addition to the principal application, the evaluation fee set out in item 4 of Schedule 9 for each application other than the principal application is reduced to zero.

“(7)

If there are more than 3 applications for evaluation in addition to the principal application, the evaluation fee set out in item 4 of Schedule 9 for each application other than the principal application is reduced to:

• (a)

  if there are 4 applications for evaluation in addition to the principal application—$500; or

• (b)

  if there are 5 applications for evaluation in addition to the principal application—$700; or

• (c)

  if there are 6 applications for evaluation in addition to the principal application—$750; or

• (d)

  if there are 7 or more applications for evaluation in addition to the principal application:

  • (i)

    for 6 of the applications—$750 each; and

  • (ii)

    for each additional application—$500.”.

5.   Schedule 9 (Fees)

5.1   Item 2:

After “registration of therapeutic goods”, insert “(if regulation 43A does not apply)”.

5.2   Item 3:

Omit the item, substitute:

“3 application fee for the purposes of paragraph 23 (2) (a) of the Act for the listing of therapeutic goods (if regulation 43A does not apply) 110”.

5.3   Subparagraph 4 (c) (iv):

Omit the subparagraph, substitute:

“(iv) more than 100 pages but not more than 1,000 pages (v) more than 1,000 pages but not more than 3,000 pages (vi) more than 3,000 pages

11,200 16,000 22,000”.

5.4   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); and (ii) each additional period of 2 hours, or a part of 2 hours;	1,400 450
(b) in relation to the manufacture of a single sterile or non-sterile drug: (i) initial period of inspection (up to 4 hours); and (ii) each additional period of 2 hours, or a part of 2 hours;	1,400 450

(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); and

• (ii)

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

2,700

800

(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); and

• (ii)

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

2,700

800

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

• (i)

  initial period of inspection (up to 4 hours); and

• (ii)

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

1,400

450

(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); and

• (ii)

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

1,400

450

(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); and

• (ii)

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

1,400

450

(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); and

• (ii)

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

1,400

450

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

• (i)

  initial period of inspection (up to 4 hours); and

• (ii)

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

1,400

450”.

5.5   Further amendments:

Column 1 Provision amended	Column 2 Omit	Column 3 Substitute
Paragraph 2 (a)	320	340
Paragraph 2 (b)	390	420
Paragraph 2 (c)	1,100	1,200
Paragraph 2 (d)	530	560
Paragraph 2 (e)	200	210
Paragraph 2 (f)	160	170
Paragraph 2A (a)	320	340
Paragraph 2A (b)	90	110
Paragraph 2A (c)	90	110
Subparagraph 4 (a) (i)	3,200	3,400

Column 1 Provision amended	Column 2 Omit	Column 3 Substitute
Subparagraph 4 (a) (ii)	10,200	10,800
Subparagraph 4 (a) (iii)	22,900	24,200
Subparagraph 4 (a) (iv)	44,500	47,000
Subparagraph 4 (a) (v)	54,600	57,900
Subparagraph 4 (b) (i)	6,400	6,800
Subparagraph 4 (b) (ii)	22,900	24,200
Subparagraph 4 (b) (iii)	35,300	37,500
Subparagraph 4 (c) (i)	390	420
Subparagraph 4 (c) (ii)	3,700	3,900
Subparagraph 4 (c) (iii)	8,200	8,600
Paragraph 5 (a)	1,800	2,000
Paragraph 5 (b)	390	420
Item 5A	1,800	2,000
Paragraph 6 (a)	7,500	7,900
Paragraph 6 (b)	4,300	4,500
Paragraph 6 (c)	4,300	4,500
Paragraph 6 (d)	8,500	9,000
Item 6A	390	420
Paragraph 7 (a)	2,500	2,600
Paragraph 7 (b)	1,400	1,500

Column 1 Provision amended	Column 2 Omit	Column 3 Substitute
Paragraph 7 (c)	2,200	2,300
Paragraph 7 (d)	8,500	9,000
Item 8	320	340
Item 9A	2,000	2,500
Paragraph 14 (a)	90	110
Paragraph 14 (b)	180	220
Item 14A	90	110
Item 15	390	420

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NOTES

1. Notified in the Commonwealth of Australia Gazette on 30 June 1994.

2. Statutory Rules 1990 No. 394 as amended by 1990 No. 395; 1991 Nos. 84 and 485; 1992 Nos. 19, 89, 109, 323, 370 and 430; 1993 No. 141; 1994 No. 150.