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Therapeutic Goods Amendment Regulations 2011 (No. 2)

Authoritative Version
  • - F2011L01100
  • No longer in force
SLI 2011 No. 102 Regulations as made
These Regulations amend the Therapeutic Goods Regulations 1990 to increase certain fees by 3.4 per cent, to make changes to the collection of application and evaluation fees for prescription medicines and to make other amendments that are mainly of minor and machinery nature.
Administered by: Health
Registered 21 Jun 2011
Tabling HistoryDate
Tabled HR22-Jun-2011
Tabled Senate22-Jun-2011
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014

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


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.