Federal Register of Legislation - Australian Government

Primary content

Therapeutic Goods Regulations (Amendment)

Authoritative Version
  • - F1996B00421
  • No longer in force
SR 1995 No. 192 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 HR22-Aug-1995
Tabled Senate22-Aug-1995
Gazetted 30 Jun 1995
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014

Statutory Rules 1995   No. 1921

__________________

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 1995.

 

                                                                                    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 1995.

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   After subregulation (4), insert:

        “(4A)   If the Secretary reduces the amount of the evaluation fee payable on an application to register a therapeutic device included in Part 1 of Schedule 3, the amount of the reduced fee payable:

             (a)   for an application involving the evaluation of:

                          (i)   design; or

                         (ii)   materials information; or

                       (iii)   testing;

                     is $2,700;

             (b)   for an application involving the evaluation of:

                          (i)   manufacture; or

                         (ii)   quality control; or

                       (iii)   sterile manufacture; or

                        (iv)   testing information;

                     is $1,600;

             (c)   for an application involving the evaluation of:

                          (i)   biocompatibility; or

                         (ii)   pre-clinical information;

                     is $2,400;

             (d)   for an application involving the evaluation of human clinical information—is $9,500;

             (e)   for an application involving the evaluation of a confirmatory review of clinical information—is $3,200.

3.2   Paragraph 45 (7) (a):

Omit “$2,000;”, substitute “$2,100;”.

3.3   Paragraph 45 (7) (b):

Omit “$3,500;”, substitute “$3,700;”.

3.4   Paragraph 45 (7) (c):

Omit “$4,500;”, substitute “$4,800;”.

3.5   Paragraph 45 (7) (d):

Omit “$5,000;”, substitute “$5,300;”.

3.6   Subparagraph 45 (7) (e) (i):

Omit “$5,000;”, substitute “$5,300;”.

3.7   Subparagraph 45 (7) (e) (ii):

Omit “$500”, substitute “$530”.

3.8   Add at the end:

           “(8)   Subregulation (9) applies if:

             (a)   more than 1 application to register a therapeutic device is made at the same time; and

             (b)   each application is made by the same sponsor; and

             (c)   the device to which each application relates is included in Part 1 of Schedule 3; and

             (d)   the information provided in support of each application is sufficiently similar to enable evaluation of each device to be undertaken simultaneously; and

             (e)   the sponsor pays the total amount of the fee payable under item 6 in Schedule 9 for the principal application.

           “(9)   The fee for each application to register a therapeutic device (other than the principal application) to which subregulation (8) applies:

             (a)   in the case of an application involving the evaluation of any or all of the following:

                          (i)   design;

                         (ii)   materials information;

                       (iii)   testing;

                     is reduced to $2,700; and

             (b)   in the case of an application involving the evaluation of any or all of the following:

                          (i)   manufacture;

                         (ii)   quality control;

                       (iii)   sterile manufacture;

                        (iv)   testing information;

                     is reduced to $1,600; and

             (c)   in the case of an application involving the evaluation of either or both of the following:

                          (i)   biocompatibility;

                         (ii)   pre-clinical information;

                     is reduced to $2,400; and

             (d)   in the case of an application involving the evaluation of human clinical information—is reduced to $3,200.

         “(10)   Subregulation (11) applies if:

             (a)   more than 1 application to vary written information in the Register about a therapeutic device is made at the same time; and

             (b)   each application is made by the same sponsor; and

             (c)   the device to which each application relates is included in Part 1 of Schedule 3; and

             (d)   the information provided in support of each application is sufficiently similar to enable evaluation of each device to be undertaken simultaneously; and

             (e)   the sponsor pays the total amount of the fee payable under item 7 in Schedule 9 for the principal application.

         “(11)   The fee for each application to vary written information (other than the principal application) to which subregulation (10) applies:

             (a)   in the case of an application involving review of any or all of the following:

                          (i)   design;

                         (ii)   materials information;

                       (iii)   testing;

                     is reduced to $900; and

             (b)   in the case of an application involving review of any or all of the following:

                          (i)   manufacture;

                         (ii)   quality control;

                       (iii)   sterile manufacture;

                        (iv)   testing information;

                     is reduced to $550; and

             (c)   in the case of an application involving review of either or both of the following:

                          (i)   biocompatibility;

                         (ii)   pre-clinical information;

                     is reduced to $800; and

             (d)   in the case of an application involving review of human clinical information—is reduced to $3,200.”.

4.   New regulation 45AA

4.1   After regulation 45, insert in Part 7:

Payment of fees in instalments

     “45AA.   (1)    Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 6 or 7 in Schedule 9 to be paid in instalments, if:

             (a)   the applicant has applied in writing to pay the amount in instalments; and

             (b)   the amount payable exceeds $10,000; and

             (c)   the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and

             (d)   any information or material to which subregulation (3) applies has been provided to the Secretary.

           “(2)   An application under subregulation (1) must:

             (a)   state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and

             (b)   have with it documents or other material in support of the statement.

           “(3)   If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2 (b), the Secretary may require the applicant to provide the information or material to the Secretary.

           “(4)   If the Secretary approves an application under subregulation (1):

             (a)   50% of the fee is due for payment before the commencement of the evaluation of the application; and

             (b)   25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and

             (c)   the remaining 25% is due for payment:

                          (i)   if the application for evaluation is withdrawn—at the time of withdrawal; or

                         (ii)   if the Secretary decides not to register the therapeutic device—when the applicant is notified under subsection 25 (3) of the Act; or

                       (iii)   if the evaluation is completed—before the therapeutic device is registered.

           “(5)   If:

             (a)   the Secretary approves an application under subregulation (1); and

             (b)   any amount of the fee payable by the applicant is not paid when it becomes due for payment;

the balance of the fee becomes due for payment.

           “(6)   If the Secretary receives an application under subregulation (1), he or she must:

             (a)   give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and

             (b)   if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.

           “(7)   This regulation does not apply if another evaluation fee payable by the applicant under Schedule 9 has not been paid.”.

5.   Regulation 48 (Review of decisions)

5.1   Subregulation 48 (1) (definition of “initial decision”):

Omit “or regulation 45;”, substitute “, regulation 45 or 45AA;”.

6.   Schedule 9 (Fees)

6.1   Item 2:

Add at the end:

           “(g)   if:

                          (i)   a person submits at the same time more than 1 application relating to item 7; and

                         (ii)   the information in support of the applications is sufficiently common in respect of the therapeutic devices to which they relate to enable simultaneous evaluation of the devices;

                     for each additional application

 

360”.

6.2   After item 3, insert:

“3A

fee for a toxicology evaluation by the Drug Safety and Evaluation Branch of the Therapeutic Goods Administration within the Department for the purposes of an application under section 23 of the Act that is referred to the Branch by the Compliance Branch of that Administration

 

 

500”.

6.3   Item 6, paragraph (a):

Omit the paragraph, substitute:

           “(a)   design or materials information or testing

 

8,300”.

 


6.4   Item 7, paragraph (a):

Omit the paragraph, substitute:

           “(a)   design or materials information or testing

 

2,700”.

 

6.5   Item 7:

Add at the end:

           “(e)   confirmatory review of clinical information

 

 

3,200”.

 

6.6   Item 15:

Omit the item.

6.7   Further amendments:

 

Column 1

Provision amended

Column 2

Omit

Column 3

Substitute

Paragraph 2 (a)

340

360

Paragraph 2 (b)

420

460

Paragraph 2 (d)

560

600

Paragraph 2 (e)

210

230

Paragraph 2 (f)

170

180

Paragraph 2A (a)

340

360

Paragraph 2A (b)

110

150

Paragraph 2A (c)

110

150

Item 3

110

150

Subparagraph 4 (a) (i)

3,400

3,600

Subparagraph 4 (a) (ii)

10,800

11,400


 

Column 1

Provision amended

Column 2

Omit

Column 3

Substitute

Subparagraph 4 (a) (iii)

24,200

25,600

Subparagraph 4 (a) (iv)

47,000

49,700

Subparagraph 4 (a) (v)

57,900

61,400

Subparagraph 4 (b) (i)

6,800

7,100

Subparagraph 4 (b) (ii)

24,200

25,600

Subparagraph 4 (b) (iii)

37,500

39,800

Subparagraph 4 (c) (i)

420

460

Subparagraph 4 (c) (ii)

3,900

4,200

Subparagraph 4 (c) (iii)

8,600

9,100

Subparagraph 4 (c) (iv)

11,200

12,500

Subparagraph 4 (c) (v)

16,000

20,100

Subparagraph 4 (c) (vi)

22,000

27,800

Paragraph 5 (a)

2,000

2,100

Paragraph 5 (b)

420

460

Item 5A

2,000

2,100

Paragraph 6 (b)

4,500

4,800

Paragraph 6 (c)

4,500

4,800

Paragraph 6 (d)

9,000

9,500

Item 6A

420

460

Paragraph 7 (b)

1,500

1,600


 

Column 1

Provision amended

Column 2

Omit

Column 3

Substitute

Paragraph 7 (c)

2,300

2,400

Paragraph 7 (d)

9,000

9,500

Item 8

340

360

Item 9A

2,500

3,200

Paragraph 14 (a)

110

150

Paragraph 14 (b)

220

300

Item 14A

110

150

 

 

 

____________________________________________________________

NOTES

1.   Notified in the Commonwealth of Australia Gazette on 30 June 1995.

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 and 111.