Therapeutic Goods Amendment Regulations 2011 (No. 2)1
Select Legislative Instrument 2011 No. 102
I, QUENTIN BRYCE, 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 16 June 2011
QUENTIN BRYCE
Governor-General
By Her Excellency’s Command
CATHERINE KING
Parliamentary Secretary for Health and Ageing
1              Name of Regulations
                These Regulations are the Therapeutic Goods Amendment Regulations 2011 (No. 2).
2              Commencement
                These Regulations commence on 1 July 2011.
3              Amendment of Therapeutic Goods Regulations 1990
                Schedule 1 amends the Therapeutic Goods Regulations 1990.
Schedule 1        Amendments
(regulation 3)
 
[1]           Regulation 2, definition of Complementary Medicines Evaluation Committee
substitute
complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.
designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.
[2]           Regulation 2, definition of Therapeutic Goods Advertising Code
substitute
Therapeutic Goods Advertising Code means the code made under section 42BAA of the Act.
[3]           Regulation 2, after definition of trade name
insert
traditional use, for a designated active ingredient, means use of the designated active ingredient that:
                (a)    is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and
               (b)    accords with well-established procedures of preparation, application and dosage.
[4]           Regulation 2, note
omit
medicine and poison
insert
medicine, poison and product information
[5]           Paragraph 3 (3) (e)
omit
(ACT).
insert
(ACT);
[6]           After paragraph 3 (3) (e)
insert
                (f)    Medicines, Poisons and Therapeutic Goods Regulation 2008 (ACT).
[7]           After regulation 3
insert
3AA        Unacceptable presentation of therapeutic goods — prescribed class of medicine
                For paragraph 3 (5) (ca) of the Act, a prescribed class of medicine is medicine for supply in Australia that is not:
                (a)    a product of a kind mentioned in Part 1 of Schedule 10; or
               (b)    a medicine that satisfies the following requirements:
                          (i)    the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3 (5A) of the Act for the medicine;
                         (ii)    the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);
                        (iii)    the medicine complies with the terms of the Secretary’s consent mentioned in subparagraph (ii).
[8]           Subregulation 9B (4), definition of product information
omit
[9]           Subregulation 15 (1)
omit
paragraph 20 (2) (a)
insert
paragraphs 19D (3) (c) and (4) (c)
[10]         Subregulation 15A (1)
omit
Of Registered Medicines Regulated By Office of Prescription Medicines
[11]         Subregulation 35B (1)
omit
25
insert
32
[12]         Subregulation 36B (2)
after
member
insert
of the committee
[13]         Subregulation 37B (1)
omit
12
insert
15
[14]         Subregulation 37B (2)
after
member
insert
of the committee
[15]         Subregulation 38B (2)
after
expertise in
insert
at least
[16]         Subregulation 39B (3)
after
experience in
insert
at least
[17]         Paragraphs 41C (1) (d), (e) and (f)
substitute
               (d)    bankruptcy;
                (e)    failing to comply with the disclosure of interest requirements mentioned in regulation 42.
[18]         Subregulation 42 (6)
omit
pecuniary interest
insert
material personal interest (whether pecuniary or not)
[19]         Subparagraph 42C (1) (a) (v)
substitute
                         (v)    the Medical Technology Association of Australia;
[20]         Subparagraph 42C (1) (b) (ii)
substitute
                         (ii)    the Communications Council;
[21]         Paragraph 42C (1) (f)
omit
Australian Publishers Bureau
insert
Publishers’ Advertising Advisory Bureau
[22]         Subregulations 42N (1) and (3)
omit
pecuniary interest
insert
material personal interest (whether pecuniary or not)
[23]         Subregulation 42T (1)
omit
8 members
insert
9 members
[24]         Paragraph 42T (1) (b)
omit
2 members
insert
3 members
[25]         After subparagraph 42T (1) (b) (ii)
insert
                        (iii)    the Medical Technology Association of Australia;
[26]         Subregulation 42T (1A)
omit
must
insert
may
[27]         Subregulation 42T (1A)
omit
medical device or other therapeutic goods
insert
therapeutic device
[28]         Subregulation 42T (2)
omit
4 members
insert
5 members
[29]         Subregulation 42Y (1)
omit
subregulations (2) and (3),
insert
subregulation (3),
[30]         Subregulation 42Y (2)
omit
[31]         Subregulations 42ZB (1) and (3)
omit
pecuniary interest
insert
material personal interest (whether pecuniary or not)
[32]         After paragraph 42ZCAI (4) (a)
insert
              (ab)    suspend the registration or listing of goods under subsection 29D (1) of the Act;
[33]         Paragraph 42ZCAI (4) (b)
omit
paragraph 30 (2) (e)
insert
section 30
[34]         Regulation 43AAJ, heading
substitute
43AAJ    Licensing charge — reduction in certain circumstances
[35]         After subregulation 43A (2)
insert
         (3)   An application fee is taken not to have been payable for an application for the registration of a therapeutic good made in accordance with section 23 of the Act if:
                (a)    the application was made during the period:
                          (i)    beginning on 1 August 1998 and ending on 23 March 2000; or
                         (ii)    beginning on 1 July 2003 and ending on the commencement of this subregulation; and
               (b)    the following provisions applied to the application:
                          (i)    paragraph (c) or (d) of item 2 of Part 2 of Schedule 9;
                         (ii)    item 4 of Part 2 of Schedule 9; and
                (c)    the fee prescribed in paragraph (c) or (d) of item 2 of Part 2 of Schedule 9 for making the application was not paid; and
               (d)    the therapeutic good was included in the Register because of the application.
[36]         Regulation 43AA
substitute
43AA      Fee for evaluation — refund in certain circumstances
                If:
                (a)    an applicant has paid the whole of the evaluation fee payable under Schedule 9 for an evaluation of an application under subsection 9D (3) of the Act to which regulation 16D applies; and    
               (b)    the Secretary has notified the applicant of the decision; and
                (c)    the notification did not occur within the period specified for the application in subregulation 16D (3);
                then 25% of the evaluation fee must be refunded to the applicant.
[37]         Subregulation 46 (3)
omit
[38]         Schedule 9, Part 1, subclause 1 (2)
omit
2B
insert
2B, 2C
[39]         Schedule 9, Part 2, item 2, paragraph (ba), columns 2 and 3
substitute
 
(ba)   for an application relating to a medicine in relation to which an evaluation fee is payable under paragraph (a) of item 4
39 800

 
(bb)   for an application relating to a medicine in relation to which an evaluation fee is payable under subparagraph (aa) (i) or (ii) of item 4
13 300

 
(bc)   for an application relating to a medicine in relation to which an evaluation fee is payable under subparagraph (aa) (iii) of item 4
26 500

 
(bd)   for an application relating to a medicine in relation to which an evaluation fee is payable under paragraph (b) of item 4
23 700

 
(be)   for an application relating to a medicine in relation to which an evaluation fee is payable under subparagraph (bb) (i) or (ii) of item 4 for an evaluation of:
 

 
         (i)   an extension of indications
        (ii)   a major variation
7 890
5 140

 
(bf)   for an application relating to a medicine in relation to which an evaluation fee is payable under subparagraph (bb) (iii) of item 4 for an evaluation of:
 

 
         (i)   an extension of indications
        (ii)   a major variation
15 800
10 300

 
(bg)   for an application relating to a medicine in relation to which an evaluation fee is payable under paragraph (c) of item 4
15 200

 
(bh)   for an application relating to a medicine in relation to which an evaluation fee is payable under paragraph (d) of item 4
2 500

 
(bi)    for an application relating to a medicine in relation to which an evaluation fee is payable under paragraph (g) of item 4
15 400

 
(bj)    for an application relating to a medicine in relation to which an evaluation fee is payable under paragraph (h) of item 4
910

[40]         Schedule 9, Part 2, item 2A
omit
subsection 9D (1), (2) or (3)
insert
section 9D
[41]         Schedule 9, Part 2, after item 2AB
insert
2AC
Application fee for an application under subsection 9D (3) of the Act to which regulation 16D applies
910
[42]         Schedule 9, Part 2, item 2C
omit
goods
insert
goods — for each submission
[43]         Schedule 9, Part 2, item 4
omit
(if paragraph (ba) of item 2 does not apply)
[44]         Schedule 9, Part 2, item 4, paragraph (a)
omit
192 400
insert
159 200
[45]         Schedule 9, Part 2, item 4, subparagraphs (aa) (i) and (ii)
omit
one-third of the fee specified in paragraph (a)
insert
53 100
[46]         Schedule 9, Part 2, item 4, subparagraph (aa) (iii)
omit
two-thirds of the fee specified in paragraph (a)
insert
106 100
[47]         Schedule 9, Part 2, item 4, paragraph (b)
omit
114 400
insert
94 600
[48]         Schedule 9, Part 2, item 4, subparagraphs (bb) (i) and (ii)
omit
one-third of the fee specified in paragraph (b) or (g) for an evaluation of that nature
insert
for an evaluation relating to:
     (a)  an extension of indications — 31 500
     (b)  a major variation — 20 500
[49]         Schedule 9, Part 2, item 4, subparagraph (bb) (iii)
omit
two-thirds of the fee specified in paragraph (b) or (g) for an evaluation of that nature
insert
for an evaluation relating to:
     (a)  an extension of indications — 63 100
     (b)  a major variation — 41 100
[50]         Schedule 9, Part 2, item 4, paragraph (c)
omit
73 400
insert
60 700
[51]         Schedule 9, Part 2, item 4, paragraph (d)
omit
12 100
insert
10 000
[52]         Schedule 9, Part 2, item 4, paragraphs (e) and (f)
omit
[53]         Schedule 9, Part 2, item 4, paragraph (g)
omit
74 500
insert
61 600
[54]         Schedule 9, Part 2, item 4, paragraph (h)
omit
4 390
insert
3 630
[55]         Schedule 9, Part 2, item 9AC, column 2
omit
other than the primary site,
insert
(other than a site to which item 9AB applies),
[56]         Schedule 9, Part 2, item 12
after
Act
insert
that is not covered by another item in this Part
[57]         Schedule 10, Part 1, heading
substitute
Part 1          Evaluation by Office of Medicines Authorisation of prescription and other medicines
[58]         Schedule 10, Part 1, item 14
substitute
14
therapeutic goods referred to the Office of Medicines Authorisation of the Therapeutic Goods Administration within the Department for the purpose of evaluation as a prescription medicine
[59]         Schedule 10, Part 3, heading
substitute
Part 3          Evaluation by Office of Medicines Authorisation of non-prescription and other medicines
[60]         Schedule 10, Part 3, item 5
substitute
5
therapeutic goods referred to the Office of Medicines Authorisation of the Therapeutic Goods Administration within the Department for the purpose of evaluation as a non-prescription medicine
[61]         Schedules 12 and 13
omit
(within the meaning of section 9D of the Act)
[62]         Schedule 14, heading
substitute
Schedule 14      Designated active ingredients
(regulation 2)
  
[63]         Further amendments
Provision
omit each mention of
insert

Paragraph 43AAJ (1) (b)
$78 600
$81 300

Paragragh 45 (4A) (a)
$8 770
$9 070

Paragraph 45 (4A) (b)
$7 300
$7 550

Paragraph 45 (4A) (d)
$29 400
$30 400

Subregulation 45 (9)
$4 390
$4 540

Subregulation 45 (11)
$1 610
$1 660

Schedule 9, Part 2, item 1A
380
390

Schedule 9, Part 2, item 1
1 390
1 440

Schedule 9, Part 2, item 1
17 300
17 900

Schedule 9, Part 2, item 1
14 600
15 100

Schedule 9, Part 2, item 1
2 200
2 270

Schedule 9, Part 2, item 2
1 260
1 300

Schedule 9, Part 2, item 2
1 170
1 210

Schedule 9, Part 2, item 2
3 500
3 620

Schedule 9, Part 2, item 2
1 750
1 810

Schedule 9, Part 2, item 2
10 200
10 500

Schedule 9, Part 2, item 2
550
570

Schedule 9, Part 2, item 2
590
610

Schedule 9, Part 2, item 2AA
530
550

Schedule 9, Part 2, item 2A
1 350
1 400

Schedule 9, Part 2, item 2A
1 260
1 300

Schedule 9, Part 2, item 2A
330
340

Schedule 9, Part 2, item 2A
360
370

Schedule 9, Part 2, item 2AB
340
350

Schedule 9, Part 2, items 2B and 2C
4 390
4 540

Schedule 9, Part 2, item 3
360
370

Schedule 9, Part 2, item 3
660
680

Schedule 9, Part 2, item 3AA
530
550

Schedule 9, Part 2, item 5
8 390
8 680

Schedule 9, Part 2, item 5
10 800
11 200

Schedule 9, Part 2, item 5
14 700
15 200

Schedule 9, Part 2, item 5
19 600
20 300

Schedule 9, Part 2, item 5
29 400
30 400

Schedule 9, Part 2, item 5
39 200
40 500

Schedule 9, Part 2, item 5
58 700
60 700

Schedule 9, Part 2, item 5
3 030
3 130

Schedule 9, Part 2, item 5A
4 390
4 540

Schedule 9, Part 2, item 5B
14 600
15 100

Schedule 9, Part 2, item 6
25 700
26 600

Schedule 9, Part 2, item 6
17 500
18 100

Schedule 9, Part 2, item 6
29 400
30 400

Schedule 9, Part 2, item 6AA
310
320

Schedule 9, Part 2, item 6AB
550
570

Schedule 9, Part 2, item 6ABA
1 660
1 720

Schedule 9, Part 2, item 6AC
940
970

Schedule 9, Part 2, item 6AD
17 500
18 100

Schedule 9, Part 2, item 6AD
4 390
4 540

Schedule 9, Part 2, item 6A
1 170
1 210

Schedule 9, Part 2, item 6B
2 940
3 040

Schedule 9, Part 2, item 6C
6 390
6 610

Schedule 9, Part 2, item 6D
8 390
8 680

Schedule 9, Part 2, item 6D
10 800
11 200

Schedule 9, Part 2, item 6D
14 700
15 200

Schedule 9, Part 2, item 6D
19 600
20 300

Schedule 9, Part 2, item 6D
29 400
30 400

Schedule 9, Part 2, item 6D
39 200
40 500

Schedule 9, Part 2, item 6D
58 700
60 700

Schedule 9, Part 2, item 7
8 770
9 070

Schedule 9, Part 2, item 7
7 300
7 550

Schedule 9, Part 2, item 7
29 400
30 400

Schedule 9, Part 2, item 7A
8 390
8 680

Schedule 9, Part 2, item 7A
10 800
11 200

Schedule 9, Part 2, item 7A
14 700
15 200

Schedule 9, Part 2, item 7A
19 600
20 300

Schedule 9, Part 2, item 7A
29 400
30 400

Schedule 9, Part 2, item 7A
39 200
40 500

Schedule 9, Part 2, item 7A
58 700
60 700

Schedule 9, Part 2, item 7B
8 390
8 680

Schedule 9, Part 2, item 7B
10 800
11 200

Schedule 9, Part 2, item 7B
14 700
15 200

Schedule 9, Part 2, item 7B
19 600
20 300

Schedule 9, Part 2, item 7B
29 400
30 400

Schedule 9, Part 2, item 7B
39 200
40 500

Schedule 9, Part 2, item 7B
58 700
60 700

Schedule 9, Part 2, item 8
810
840

Schedule 9, Part 2, item 9
530
550

Schedule 9, Part 2, item 9
1 090
1 130

Schedule 9, Part 2, item 9AA
530
550

Schedule 9, Part 2, item 9AB
730
750

Schedule 9, Part 2, items 9AC and 9ACA
530
550

Schedule 9, Part 2, item 9AD
1 050
1 090

Schedule 9, Part 2, item 9AD
9 080
9 390

Schedule 9, Part 2, item 9AD
20 200
20 900

Schedule 9, Part 2, item 9AD
27 100
28 000

Schedule 9, Part 2, item 9AD
42 400
43 800

Schedule 9, Part 2, item 9AD
56 300
58 200

Schedule 9, Part 2, item 9AD
68 600
70 900

Schedule 9, Part 2, items 9B and 9C
14 600
15 100

Schedule 9, Part 2, items 14 and 14A
280
290

Schedule 9, Part 2, item 17
190
200

Schedule 9, Part 2, item 17
240
250

Schedule 9, Part 2, item 17
380
390

Schedule 9, Part 2, item 17A
960
990

Schedule 9, Part 2, item 17A
500
520

Schedule 9, Part 2, item 17A
730
750

Schedule 9, part 2, item 17A
200
210

Schedule 9, Part 2, item 17A
350
360

Schedule 9, Part 2, item 17A
250
260

Schedule 9, Part 2, item 17A
190
200

Schedule 9, Part 2, item 17A
240
250

Schedule 9, Part 2, item 17A
380
390

Schedule 9, Part 2, item 18
1 770
1 830

Note
1.       All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. See http://www.frli.gov.au.