Therapeutic Goods Amendment Regulations 2009 (No. 6)1
Select Legislative Instrument 2009 No. 374
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 14 December 2009
QUENTIN BRYCE
Governor-General
By Her Excellency’s Command
MARK BUTLER
Parliamentary Secretary for Health
Contents
1 Name of Regulations 2
2 Commencement 2
3 Amendment of Therapeutic Goods Regulations 1990 2
4 Transitional 2
Schedule 1 Amendments commencing on 1 January 2010 5
Schedule 2 Amendments commencing on 25 January 2010 19
1 Name of Regulations
These Regulations are the Therapeutic Goods Amendment Regulations 2009 (No. 6).
2 Commencement
These Regulations commence as follows:
(a) on 1 January 2010 — regulations 1 to 4 and Schedule 1.
(b) on 25 January 2010 — Schedule 2.
3 Amendment of Therapeutic Goods Regulations 1990
Schedules 1 and 2 amend the Therapeutic Goods Regulations 1990.
4 Transitional
(1) These Regulations apply to a person who is a member or associate member of a committee mentioned in column 2 of the following table (the old committee), as if the person was a member of the corresponding committee mentioned in column 3 of the table (the new committee) until:
(a) the term of that person’s current appointment to the old committee expires; or
(b) the person resigns from the new committee; or
(c) the person is removed from the new committee.
Item
Old Committee
New Committee
1
Australian Drug Evaluation Committee
Advisory Committee on Prescription Medicines
2
Medicines Evaluation Committee
Advisory Committee on Non‑prescription Medicines
3
Complementary Medicines Evaluation Committee
Advisory Committee on Complementary Medicines
4
Medical Devices Evaluation Committee
Advisory Committee on Medical Devices
(2) A request for advice by, or referred by, the Minister or the Secretary to the old committee is taken to be a request for advice to the new committee if:
(a) the request is referred to the old committee before the establishment of the new committee; and
(b) the advice has not been given by the old committee.
(3) In considering a request for advice mentioned in subregulation (2), the new committee must take into account any relevant considerations or recommendations of the old committee.
(4) Recommendations, evaluations or assessments made by the old committee or a subcommittee of the old committee must be taken into account by the new committee if:
(a) the recommendations, evaluations or assessments were made before the establishment of the new committee; and
(b) the recommendations, evaluations or assessments were not formally given to the Minister or the Secretary.
(5) A request for advice on the safety of a medicine to the Adverse Drug Reactions Advisory Committee is taken to be a request for advice to the Advisory Committee on the Safety of Medicines if:
(a) the request is referred to the Adverse Drug Reactions Advisory Committee before the establishment of the Advisory Committee on the Safety of Medicines; and
(b) the advice has not been given by the Adverse Drug Reactions Advisory Committee.
(6) In considering a request for advice mentioned in subregulation (5), the Advisory Committee on the Safety of Medicines must take into account any relevant considerations or recommendations of the Adverse Drug Reactions Advisory Committee.
(7) Recommendations, evaluations or assessments made by the Adverse Drug Reactions Advisory Committee on the safety of a medicine must be taken into account by the Advisory Committee on the Safety of Medicines if they:
(a) were made before the establishment of the Advisory Committee on the Safety of Medicines; and
(b) were not formally given to the Minister or the Secretary.
(8) In this regulation:
Adverse Drug Reactions Advisory Committee means the subcommittee of that name appointed by the Australian Drug Evaluation Committee under subregulation 36 (6) of the Therapeutic Goods Regulations 1990 as in force on 31 December 2009.
Advisory Committee on Complementary Medicines means the committee established under regulation 39 of the Therapeutic Goods Regulations 1990 as in force on 25 January 2010.
Advisory Committee on Medical Devices means the committee established under regulation 38 of the Therapeutic Goods Regulations 1990 as in force on 1 January 2010.
Advisory Committee on Non-prescription Medicines means the committee established under regulation 36 of the Therapeutic Goods Regulations 1990 as in force on 1 January 2010.
Advisory Committee on Prescription Medicines means the committee established under regulation 35 of the Therapeutic Goods Regulations 1990 as in force on 1 January 2010.
Advisory Committee on the Safety of Medicines means the committee established under regulation 37 of the Therapeutic Goods Regulations 1990 as in force on 1 January 2010.
Australian Drug Evaluation Committee means the committee established under subregulation 36 (1) of the Therapeutic Goods Regulations 1990 as in force on 31 December 2009.
Complementary Medicines Evaluation Committee means the committee established under subsection 52G (1) of the Therapeutic Goods Act 1989 as in force on 31 December 2009.
Medical Devices Evaluation Committee means the committee established under subregulation 35 (1) of the Therapeutic Goods Regulations 1990 as in force on 31 December 2009.
Medicines Evaluation Committee means the committee of that name established under subregulation 42ZZB (1) of the Therapeutic Goods Regulations 1990 as in force on 31 December 2009.
Schedule 1 Amendments commencing on 1 January 2010
(regulation 3)
[1] Part 6, Division 1
substitute
Division 1 Therapeutic Goods Committee
34 Establishment
The Therapeutic Goods Committee is established.
34A Functions
(1) The committee’s functions are as follows:
(a) to advise and make recommendations to the Minister about the following:
(i) the adoption of standards for therapeutic goods;
(ii) matters relating to standards for therapeutic goods;
(iii) requirements for labelling and packaging of therapeutic goods;
(iv) standards for manufacture of therapeutic goods;
(v) matters relating to medical device standards;
(vi) matters relating to conformity assessment standards;
(b) to advise and make recommendations to the Minister or Secretary on matters referred to the committee by the Minister or Secretary.
(2) The committee must:
(a) give to the Minister and Secretary the reasons for any advice of the committee; and
(b) for a matter mentioned in paragraph (1) (a) — consider:
(i) the desirability of adopting any default standards or other recognised international standards for therapeutic goods in the interests of international harmonisation of therapeutic goods standards; and
(ii) whether the application of those standards to Australian conditions is appropriate.
(3) The Minister or Secretary may require the committee to give its advice to other persons or bodies.
(4) The committee must publish its recommendations.
34B Membership
(1) The Minister may appoint, in writing, up to 12 persons to the committee in accordance with subregulation (2).
(2) Each member of the committee must be a person who:
(a) is nominated to the Minister in writing by a body that represents, or a combination of bodies that together represent, the interests of 1 of the following:
(i) Australian manufacturers of prescription medicine products;
(ii) Australian manufacturers of non-prescription medicine products;
(iii) Australian manufacturers of complementary medicines;
(iv) Australian manufacturers of medical devices and other therapeutic goods;
(v) consumers of health services; or
(b) has expertise in at least 1 of the following fields:
(i) microbiology and virology;
(ii) biomedical engineering;
(iii) biological safety of biomaterials;
(iv) biotechnology;
(v) pharmaceutical science;
(vi) community or hospital pharmacy practice.
Division 1A Advisory Committee on Prescription Medicines
35 Establishment
The Advisory Committee on Prescription Medicines is established.
35A Functions
(1) The committee’s functions are to advise and make recommendations to the Minister or Secretary about the following matters:
(a) inclusion of a prescription medicine in the Australian Register of Therapeutic Goods (the Register);
(b) variation of an entry for a prescription medicine included in the Register;
(c) removal or continued retention of a prescription medicine in the Register;
(d) any other matter concerning a prescription medicine;
(e) any other matter referred to the committee by the Minister or Secretary (whether or not related to prescription medicines).
(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.
35B Membership
(1) The Minister may appoint, in writing, up to 25 persons to the committee in accordance with subregulations (2) and (3).
(2) Each member of the committee must have expertise in at least 1 of the following fields:
(a) general medical practice in Australia;
(b) consumer issues;
(c) epidemiology or biostatistics;
(d) clinical pharmacology or pharmacokinetics;
(e) paediatrics;
(f) gerontology;
(g) internal medicine, including the following:
(i) haematology;
(ii) oncology;
(iii) infectious diseases;
(iv) cardiology;
(v) gastroenterology or hepatology;
(vi) renal disease;
(vii) endocrinology;
(viii) neurology;
(ix) immunology;
(x) rheumatology;
(xi) respiratory disease;
(h) intensive care;
(i) anaesthetics;
(j) psychiatry;
(k) toxicology;
(l) pharmaceutical chemistry.
(3) Membership of the committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).
Division 1B Advisory Committee on Non‑prescription Medicines
36 Establishment
The Advisory Committee on Non-prescription Medicines is established.
36A Functions
(1) The committee’s functions are to advise and make recommendations to the Minister or Secretary about the following matters:
(a) inclusion of a non-prescription medicine in the Australian Register of Therapeutic Goods (the Register);
(b) variation of an entry for a non-prescription medicine included in the Register;
(c) removal or continued retention of a non-prescription medicine in the Register;
(d) any other matter concerning a non-prescription medicine;
(e) any other matters referred to the committee by the Minister or Secretary (whether or not related to non-prescription medicines).
(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.
36B Membership
(1) The Minister may appoint, in writing, up to 12 persons to the committee in accordance with subregulations (2) and (3).
(2) Each member must have expertise in at least 1 of the following fields:
(a) general medical practice in Australia;
(b) specialist medical practice of a kind relevant to the committee’s functions;
(c) pharmaceutical chemistry;
(d) pharmacology;
(e) toxicology;
(f) microbiology;
(g) community pharmacy;
(h) manufacture of medicines;
(i) 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).
Division 1C Advisory Committee on the Safety of Medicines
37 Establishment
The Advisory Committee on the Safety of Medicines is established.
37A Functions
(1) The committee’s functions are to advise and make recommendations to the Minister or Secretary about the following matters:
(a) safety of medicines;
(b) risk assessment and risk management of medicines;
(c) other matters related to pharmacovigilance;
(d) any other matters referred to the committee by the Minister or Secretary (whether or not related to medicines 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.
37B Membership
(1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (2) and (3).
(2) Each member must have expertise in at least 1 of the following fields:
(a) pharmacoepidemiology;
(b) clinical pharmacology;
(c) clinical pharmacy;
(d) general medical practice in Australia;
(e) general medicine;
(f) complementary medicine;
(g) paediatrics;
(h) clinical immunology;
(i) hepatology;
(j) 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).
Division 1D Advisory Committee on Medical Devices
38 Establishment
The Advisory Committee on Medical Devices is established.
38A Functions
(1) The committee’s functions are to advise and make recommendations to the Minister or Secretary about the following matters:
(a) inclusion of a medical device or other therapeutic goods in the Australian Register of Therapeutic Goods (the Register);
(b) variation of an entry for a medical device or other therapeutic goods in the Register;
(c) removal or continued retention of a medical device or other therapeutic goods in the Register;
(d) any matter concerning a medical device or other therapeutic goods;
(e) any other matter referred to the committee by the Minister or Secretary (whether or not related to medical devices or other therapeutic goods).
(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.
38B Membership
(1) The Minister may appoint, in writing, up to 32 persons to the committee in accordance with subregulation (2).
(2) Each member of the committee must have expertise in 1 of the following fields:
(a) medical or surgical expertise in 1 of the following fields:
(i) gastroenterology;
(ii) vascular;
(iii) orthopaedics;
(iv) neurology;
(v) cardiology;
(vi) plastic and reconstructive surgery;
(vii) respiratory medicine;
(viii) obstetrics or gynaecology;
(ix) pathology;
(x) anaesthetics;
(xi) ophthalmology;
(xii) dentistry;
(xiii) ear nose and throat;
(xiv) renal;
(b) manufacture of medical devices;
(c) consumer issues;
(d) biomedical engineering;
(e) biomaterials;
(f) clinical medicine.
(3) Membership of the committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).
Division 1F General
40 Application of this Division
This Division applies to committees mentioned in Divisions 1, 1A, 1B, 1C and 1D.
41 Appointment of members
(1) A member is appointed to a committee for the term stated in the member’s instrument of appointment.
(2) A term of appointment must not be longer than 3 years.
(3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.
(4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.
41A Appointment of the chair
The Minister must appoint, in writing, a member of a committee to be its chair.
41B Resignation or vacancy
(1) A member or chair may resign by giving written notice to the Minister.
(2) If a chair ceases to be a member of a committee, the position is taken to be vacant.
41C Termination of appointment
(1) The Minister may terminate a member’s appointment on any of the following grounds:
(a) physical or mental incapacity;
(b) misbehaviour;
(c) incompetence;
(d) inefficiency;
(e) bankruptcy;
(f) failing to comply with the disclosure of interest requirements mentioned in regulation 42.
(2) The Minister must terminate a member’s appointment if:
(a) the member is convicted of an offence punishable by imprisonment for at least 1 year; or
(b) if the member is absent without leave of absence from 3 consecutive meetings of the committee.
41D Leave of absence
(1) The Minister may grant leave of absence to the chair.
(2) The chair may grant leave of absence to another committee member.
41E Acting members
(1) The Minister may appoint a person to act as a member of a committee.
(2) A person may act as a member of a committee:
(a) during a vacancy in the office, whether or not an appointment has previously been made to the office; or
(b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.
(3) A person appointed to act in an office must, to the extent reasonably practicable:
(a) if a particular qualification is required for a substantive member — hold that qualification; or
(b) if different qualifications are required for all members of the committee — hold 1 of those qualifications.
(4) A person appointed to act during a vacancy must not continue to act for more than 12 months.
41F Committee procedures
In performing its functions, a committee:
(a) must act in accordance with this Division; and
(b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and
(c) is not bound by the rules of evidence; and
(d) may obtain information about an issue in any way it considers appropriate (subject to subregulation 42 (9)); and
(e) may receive information or submissions orally or in writing; and
(f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).
41G Meetings
(1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.
(2) The procedure of a meeting must be determined by the committee in accordance with this Division.
41H Presiding member
(1) The chair must preside at a committee meeting or nominate a member of the committee to preside at the meeting.
(2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.
(3) A member chosen to preside under subregulation (2) may exercise the powers and functions of the chair.
41I Quorum
A quorum exists at a committee meeting when:
(a) at least half of the members are present; or
(b) at least half of the members who have been directed to hold the meeting under subregulation 41G (1) are present.
41J Voting
(1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.
(2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.
42 Miscellaneous
Sitting fees and travel entitlements
(1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.
When committee may establish subcommittees
(2) A committee, with the approval of the National Manager of the Therapeutic Goods Administration, may establish subcommittees, consisting of members and other persons.
(3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.
Disclosure of interests
(4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.
(5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.
(6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect pecuniary interest in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.
(7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.
Seeking further advice
(8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.
(9) In performing its functions, a committee may seek advice from other persons.
Validity of acts of members
(10) Anything done by a person purporting to be or act as a member (including a chair) is not invalid because:
(a) the person had not yet been appointed; or
(b) there is a defect or irregularity in connection with the person’s appointment; or
(c) the person’s appointment had ceased to have effect.
Records and reports
(11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.
[2] Part 6, Division 5
omit
Schedule 2 Amendments commencing on 25 January 2010
(regulation 3)
[1] Regulation 2, definition of active ingredient
substitute
active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.
[2] Regulation 2, definitions of complementary medicines and traditional use
omit
[3] After regulation 6
insert
6AA Prescribed committees
For paragraph 42DF (4) (b) of the Act, the following committees are prescribed:
(a) Advisory Committee on Non-prescription Medicines;
(b) Advisory Committee on Complementary Medicines.
[4] Part 6, after Division 1D
insert
Division 1E Advisory Committee on Complementary Medicines
39 Establishment
The Advisory Committee on Complementary Medicines is established.
39A Functions
(1) The committee’s functions are to advise and make recommendations to the Minister or Secretary about the following matters:
(a) inclusion of a complementary medicine in the Australian Register of Therapeutic Goods (the Register);
(b) variation of an entry for a complementary medicine in the Register;
(c) removal or continued retention of a complementary medicine in the Register;
(d) any other matter concerning a complementary medicine;
(e) any other matters referred to the committee by the Minister or Secretary (whether or not related to a complementary medicine).
(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.
39B Membership
(1) The minister may appoint, in writing, up to 12 persons to the committee in accordance with subregulations (2), (3) and (4).
(2) Each member of the committee must have expertise in at least 1 of the following fields:
(a) complementary medical practice;
(b) manufacture of medicines;
(c) consumer issues;
(d) general medical practice in Australia;
(e) herbal medicine;
(f) naturopathy;
(g) nutrition and nutritional medicine;
(h) pharmacology;
(i) pharmacognosy;
(j) toxicology;
(k) epidemiology.
(3) At least 4 of the members of the committee must have clinical experience in 1 of the fields mentioned in subregulation (2).
(4) Membership of the committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).
[5] Regulation 40
omit
1C and 1D.
insert
1C, 1D and 1E.
[6] Part 6, Division 4
omit
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.
