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
1 Name of Regulations 2
2 Commencement 2
3 Amendment of Therapeutic Goods Regulations 1990 2
Schedule 1 Amendments commencing day after registration 3
Schedule 2 Amendment commencing 1 March 2012 9
1 Name of Regulations
These Regulations are the Therapeutic Goods Amendment Regulations 2011 (No. 3).
2 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.
3 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
(12) 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
38C Establishment
The Advisory Committee on the Safety of Medical Devices is established.
38D Functions
(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.
38E Membership
(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
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.
