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Therapeutic Goods Regulations (Amendment)

Authoritative Version
  • - F1996B00417
  • No longer in force
SR 1994 No. 222 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 HR23-Aug-1994
Tabled Senate23-Aug-1994
Gazetted 30 Jun 1994
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014

Statutory Rules 1994   No. 2221

__________________

Therapeutic Goods Regulations2 (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

____________

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

____________________________________________________________

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.