Therapeutic Goods Regulations (Amendment) (Cth)
Statutory Rules 1995 No. 192 1
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.
95R196, 21/8/95, 10:21 AM 95059155
2 Therapeutic Goods 1995 No. 192 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.
Therapeutic Goods 1995 No. 192 3
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
4 Therapeutic Goods 1995 No.
(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;
Therapeutic Goods 1995 No. 5
(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
6 Therapeutic Goods 1995 No.
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.".
Therapeutic Goods 1995 No. 7
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: 360".
(i) a person submits at the same time more than 1 application relating to item 7; and
(ii) the information in support of the applicat ions is sufficiently common in respect of the therapeutic devices to which they relate to enable simultaneous evaluation of the devices;
for each additional application
6.2 After item 3, insert:
"3A fee for a toxicology evaluation by the Drug 500". 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
6.3 Item 6, paragraph (a):
Omit the paragraph, substitute:
"(a) design or materials information or testing 8,300".
8 Therapeutic Goods 1995 No.
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:
confirmatory review of clinical
"(e) 3,200".
information
6.6 Item 15:
Omit the item.
6.7 Further amendments:
Column 1 Column 2 Column 3 Provision amended Omit 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
Therapeutic Goods 1995 No. 9
Column 1 Column 2 Column 3 Provision amended Omit 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
10 Therapeutic Goods 1995 No. Column 1
Column 2 Column 3 Provision amended
Omit Substitute
Paragraph 7 (c) 2,300 2,400 Paragraph 7 (d) 9,000 9,500
Item 8 340 360
Item 9 A 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. S ta tu tory Rules 1990 No. 89 as amended by 1991 No. 85; 1992 No. 88; 1993 No. 140; 1994 Nos. 149 and 223.
Statutory Rules 1990 No. 394 as amended by 1991 Nos. 84 and 485; 1992 Nos. 19,82, 109, 332, 370, 430; 1993 No. 141, 1994 Nos. 150, 222 and 364; 1995 Nos. 33 and 111.
0
0
0