Therapeutic Goods Amendment Regulations 2011 (No. 3) (Cth)

Therapeutic Goods Amendment Regulations 2011 (No. 3)¹

Select Legislative Instrument 2011 No. 281

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 7 December 2011

QUENTIN BRYCE

Governor-General

By Her Excellency’s Command

CATHERINE KING

Parliamentary Secretary for Health and Ageing

Contents

1Name of Regulations                                            2

2Commencement                                                 2

3Amendment of Therapeutic Goods Regulations 1990      2

Schedule 1Amendments commencing day after registration 3

Schedule 2Amendment commencing 1 March 2012 9

Name of Regulations

These Regulations are the Therapeutic Goods Amendment Regulations 2011 (No. 3).

Commencement

These Regulations commence as follows:

(a)on the day after they are registered — regulations 1 to 3 and Schedule 1;

(b)on 1 March 2012 — Schedule 2.

Amendment of Therapeutic Goods Regulations 1990

Schedules 1 and 2 amend the Therapeutic Goods Regulations 1990.

Schedule 1 Amendments commencing day after registration

(regulation 3)

[1] Subregulation 3 (2)

omit

[2] Paragraphs 3 (3) (b)

substitute

(b)the Poisons and Therapeutic Goods Regulation 2008 (NSW);

(ba)the Therapeutic Goods (Victoria) Act 2010 (Vic);

[3] Subregulation 5Q (2)

omit

to approve or refuse to approve advertisements

[4] Subregulation 5Q (3)

omit

to approve or refuse to approve

insert

in relation to

[5] Subregulations 5Q (4) and (5)

substitute

(4)The Secretary may delegate to the ASMI the Secretary’s power under regulation 5G in relation to:

(a)an advertisement about designated therapeutic goods that are complementary medicines if the advertisement is to be broadcast in broadcast media; and

(b)an advertisement about designated therapeutic goods that are not complementary medicines if the advertisement is to be published or broadcast in specified media.

(5)The Secretary may delegate the Secretary’s power under regulation 5K or 5L in relation to a class of advertisements to a person if the Secretary has delegated to the person the Secretary’s power under regulation 5G for the same class of advertisements.

[6] After subregulation 10H (11)

insert

An offence against subregulation (11) is an offence of strict liability.

Note For strict liability, see section 6.1 of the Criminal Code.

[7] Paragraph 16A (2) (a)

substitute

(a)the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:

(i)at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or

(ii)if subsection 31 (1B) or (1C) of the Act applies:

(A)at the end of the last day in the period specified in the notice given by the Secretary under subsection 31 (1) of the Act; or

(B)if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub-subparagraph — that day.

[8] Subregulation 16GB (3)

omit

40

insert

30 working

[9] Subregulations 16GC (2) and 16GD (2)

omit

365

insert

255 working

[10] Subregulation 38B (1)

omit

subregulation (2).

insert

subregulations (2) and (3).

[11] After regulation 38B

insert

Division 1DA Advisory Committee on the Safety of Medical Devices

38CEstablishment

The Advisory Committee on the Safety of Medical Devices is established.

38DFunctions

(1)The committee’s functions are to advise and make recommendations to the Minister or Secretary about the following matters:

(a)safety of medical devices;

(b)risk assessment and risk management of medical devices;

(c)other matters related to performance of medical devices;

(d)any other matters referred to the committee by the Minister or Secretary (whether or not related to medical device safety).

(2)The Minister or Secretary may require the committee to give its advice to other persons or bodies.

(3)The committee must publish its recommendations.

38EMembership

(1)The Minister may appoint, in writing, up to 15 persons to the committee in accordance with subregulations (2) and (3).

(2)Each member of the committee must have expertise in at least one of the following fields:

(a)gastrointestinal surgery;

(b)anaesthetics;

(c)biomaterial science;

(d)nursing;

(e)cardiology;

(f)cardio-thoracic surgery;

(g)orthopaedic surgery;

(h)epidemiology;

(i)biomedical engineering;

(j)neurosurgery;

(k)human factors analysis;

(l)oro-maxillofacial surgery;

(m)consumer issues.

(3)Membership of the committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).

[12] Regulation 40

after

1D,

insert

1DA,

[13] Regulation 43AAA

omit

month immediately following

insert

second month after

[14] Schedule 4, Part 1, item 3, subparagraph (a) (i)

after

Poisons

insert

Standard or Appendix C of the Poisons

[15] Schedule 4, Part 1, item 4A, subparagraph (a) (iii)

omit

subject to a Schedule to

insert

included in a Schedule to the Poisons Standard or Appendix C of

[16] Schedule 4, Part 1, item 8, paragraph (a)

after

Poisons

insert

Standard or Appendix C of the Poisons

[17] Schedule 4, Part 1, item 10, paragraph (c)

after

Poisons

insert

Standard or Appendix C of the Poisons

[18] Schedule 4, Part 1, item 10A, paragraph (c)

after

Poisons

insert

Standard or Appendix C of the Poisons

[19] Schedule 9, subclause 1 (2)

omit

2C

insert

2C, 2CA

[20] Schedule 9, Part 2, items 2B and 2C

substitute

2B	Evaluation fee in relation to an application under subsection 9D (3) of the Act to which regulation 16F applies, for the evaluation of data — for each submission	4 540
2C	Evaluation fee in relation to an application under subsection 9D (3) of the Act to which regulation 16D applies, for the evaluation of data — for each submission	3 630
2CA	Evaluation fee in relation to an application under subsection 9D (2) of the Act, for the evaluation of data — for each submission	4 540

Schedule 2 Amendment commencing 1 March 2012

(regulation 3)

[1] After paragraph 3 (3) (ba)

insert

(bb)the Controlled Substances Act 1984 (SA);

(bc)the Controlled Substances (Poisons) Regulations 2011 (SA);

Note

All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. See