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Scheduling handbook: Guidance for amending the Poisons Standard

Version 1.1, July 2019

30 July 2019

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Advisory committees

The Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS) are established under sections 52B and 52C of the Therapeutic Goods Act 1989 (CTH), respectively. The membership, functions and procedures for the expert advisory committees are set out in the Therapeutic Goods Regulations 1990 and this handbook [section 52E(2), Therapeutic Goods Act 1989 (CTH)].

Functions of ACMS and ACCS

Each advisory committee will:

  • make recommendations to the Secretary regarding the classification and scheduling of substances
  • make recommendations to the Secretary in relation to other changes to the current Poisons Standard
  • reconsider a recommendation at the request of the Secretary
  • provide advice to the Secretary in relation to restrictions (including restrictions as to accessibility and availability) to be imposed in respect of particular substances
  • provide advice to the Secretary in relation to any other matter referred by the Secretary
  • perform any other functions prescribed by the Therapeutic Goods Regulations 1990

Subcommittees

The advisory committees may, with the agreement of the Secretary of the Department of Health, form subcommittees to undertake discrete bodies of work as provided for in Divisions3A.3 and 3B.3 of Part 6 of the Therapeutic Goods Regulations 1990.

Advisory committee procedures

The advisory committees are required to conduct and hold meetings in accordance with subdivision 3A.3 and 3B.3 of Part 6 of the Therapeutic Goods Regulations 1990.

If an evaluation of a proposal has been undertaken or commissioned by the TGA, the evaluator may be invited to attend, and participate, in the meeting.

Publication of recommendations

Recommendations of the expert advisory committees and a summary of reasons for the recommendations are published on the TGA website in the context of the scheduling delegate's interim decision.

Secretariat

The Scheduling Secretariat is located within the Department of Health.

Committee membership

The scheduling advisory committees are filled in accordance with subdivisions 3A.2 and 3B.3 of Part 6 of the Therapeutic Goods Regulations 1990.

There are two kinds of members on the expert advisory committees, nominated and appointed members.

Nominated members

To reflect the cooperative nature of the scheduling process and to encourage scheduling uniformity across Australia, the Australian Government and each state and territory may nominate a member for each advisory committee (ACMS and ACCS). These members are nominated on the basis of their knowledge and experience in regulation of scheduled medicines and poisons and not as a representative of a government. Nominated members independently assess the merit of a proposal based on their expertise and consideration of the submissions about the proposal.

Appointed members

Appointed members are selected from employees of a broad range of government agencies, academic institutions, healthcare, consumer and industry groups, and the general public.

The Minister appoints in writing whomever the Minister believes to be appropriately qualified, upon recommendations from the Department. Members and acting members are appointed on the basis of expertise rather than to represent a particular jurisdiction or interest group.

Confidentiality and Conflict of Interest

All members are required to make an undertaking in relation to confidential information and conflicts of interest.

Costs

Participation at advisory committee meetings by members employed by the Commonwealth or states and territories, as well as implementation of recommendations decisions, will be borne by the respective government employers.

Appointed members who are not government appointees and are permitted by their employer to be remunerated, are remunerated in accordance with the principles and rates set by the Remuneration Tribunal.

How items are allocated to ACMS and ACCS

The Secretary may refer an application or proposal to amend the Poisons Standard to either or both of the advisory committee(s), as provided for by Subdivision 3D.2 of Part 6 of the Therapeutic Goods Regulations 1990. The tables below summarise the types of proposals for which each committee will provide advice.

Joint meetings

Given the potential overlap of membership and interests, meetings of the ACMS and the ACCS may be run consecutively.

Where matters of interest to both advisory committees are identified, sufficient time is to be allowed for both advisory committees to discuss these matters jointly, including any matters relating to the Scheduling handbook. Details outlining the procedures for joint meetings are in Division 3C of Part 6 of the Therapeutic Goods Regulations 1990.

A recommendation arising from a joint meeting is a recommendation to the Secretary from each advisory committee.

Proposals to go to the ACMS

Proposals to go to ACMS:

  • Proposal to amend a substance in Parts 1 to 3 that affects only therapeutic goods
  • Rescheduling of substance included in a therapeutic good (human medicine)
  • Proposal to amend or include an entry in appendices A, G or Schedule 10 for human therapeutic use
  • Proposal to amend or include entry in:
    • Appendix D for human therapeutic use
    • Appendices H, K, L or M
    • Appendices E, F or J for human therapeutic use
  • Scheduling of a substance that may meet the criteria for inclusion in Schedule 9

Proposals to go to ACCS

Proposals to go to ACCS:

  • Proposal to amend a substance in Parts 1 to 3 that affects only agricultural, domestic, industrial or veterinary chemicals
  • Rescheduling of industrial, domestic or personal use chemical
  • Rescheduling of agricultural chemical, pesticide or veterinary medicine
  • Proposal to amend or include an entry in:
    • Appendices A, G or Schedule 10 for some other use excluding human therapeutic use
    • Appendix D for some other use excluding human therapeutic use
    • Appendices E, F, J for some other use excluding human therapeutic use
  • Scheduling of a new substance (agricultural, veterinary or industrial) that may meet the criteria for inclusion in Schedule 7

Proposals to go to joint meetings

Where any of the proposals above relate to substances that may have a human therapeutic use (including as an excipient) as well as a non-human therapeutic use, the proposal may be referred to a joint meeting to the ACMS and ACCS.

Any proposal to amend a substance in Parts 1 to 3 that is not listed above may also be referred to a joint meeting.

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