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Advisory committees on medicines & chemicals scheduling (ACMS & ACCS)

Advisory Committee on Medicines Scheduling (ACMS) & Advisory Committee on Chemicals Scheduling (ACCS)

18 November 2013

Role of the ACMS and the ACCS

Scheduling is a classification system that controls how medicines and chemicals are accessible to consumers. Medicines and chemicals are grouped into Schedules according to the appropriate level of regulatory control over their availability (e.g. Schedule 4 - medicines available only by prescription; Schedule 2 - medicines available over the counter in pharmacies).

Under revised scheduling arrangements, which took effect on 1 July 2010, the Secretary to the Department of Health (Health) (or the Secretary's delegate) superseded the National Drugs and Poisons Schedule Committee (NDPSC) as the decision maker for the scheduling of medicines and chemicals. The revised arrangements also established two expert advisory committees, the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS), as statutory committees under the Therapeutic Goods Act 1989 (the Act) to advise and make recommendations to the Secretary of the Department of Health (or delegate) on the level of access required for medicines and chemicals.

Committee membership

Under the Therapeutic Goods Regulations 1990 (the Regulations), each Committee comprises of nine nominated members and no more than six appointed members.

Under the Act, the Commonwealth, each State, the Australian Capital Territory and the Northern Territory are entitled to nominate a member on each of these Committees. These Committee members are referred to as 'nominated' members.

Under the Regulations, the Minister must appoint no more than six additional members, selected through an open invitation process.

These Committee members are referred to as 'appointed' members. In accordance with the Regulations, all Committee members are required to have expertise in at least one of the following fields:

ACMS

  • the regulation of scheduled medicines in Australia
  • toxicology or pharmacology
  • clinical pharmacology
  • pharmacy medicine
  • medical practice
  • consumer health issues relating to the regulation of therapeutic goods
  • industry issues relating to the regulation of therapeutic goods

ACCS

  • the regulation of scheduled chemicals in Australia
  • veterinary medicines or veterinary pathology
  • toxicology
  • industrial or domestic chemicals
  • agricultural or veterinary chemicals
  • clinical aspects of human poisoning
  • occupational health issues, particularly as a medical practitioner
  • consumer health issues relating to the regulation of chemicals
  • industry issues relating to the regulation of chemicals

Committee members

Advisory Committee on Medicines Scheduling (ACMS) members

Chair

  • Mr John Jackson, BPharm, GDHP, MPH, FSHP

Appointed members

  • Professor Andrew H Dawson
  • Mrs Mary Emanuel, BPharm, MPS
  • A/Professor John Gullotta, AM
  • Mr John Daye, OAM
  • Mr David Newgreen

Nominated members

  • Dr Anthony Hobbs
    Commonwealth
  • Mr Peter Gilfedder
    New South Wales
  • Ms Megan Smith
    Victoria
  • Dr Susan Ballantyne
    Queensland
  • Ms Jane Carpenter
    Western Australia
  • Ms Elizabeth Hender
    South Australia
  • Mr Peter Boyles
    Tasmania
  • Ms Gay Lavery
    Northern Territory
  • Mr Michael Fitzsimons
    Australian Capital Territory

Advisory Committee on Chemicals Scheduling (ACCS) members

Chair

  • Dr Peter Di Marco, BSc, PhD, FATS

Appointed members

  • Ms Bronwyn Capanna
  • Professor Andrew H Dawson
  • Dr Simon Robinson, BSc, BVetMed, MBA, MRCVS
  • Em Professor Alan A Seawright
  • A/Professor John Edwards

Nominated members

  • Mr Paul Harvey
    Commonwealth
  • Mr Peter Gilfedder
    New South Wales
  • Ms Megan Smith
    Victoria
  • Ms Uma Rajappa
    Queensland
  • Ms Jane Carpenter
    Western Australia
  • Dr David Simon
    South Australia
  • Mr Peter Boyles
    Tasmania
  • Ms Gay Lavery
    Northern Territory
  • Mr Michael Fitzsimons
    Australian Capital Territory

ACMS and ACCS meeting dates & decisions timeframes

Stakeholders should note that the following timetable outlines the anticipated administrative timeframes associated with matters referred by the delegates to an expert advisory committee meeting. This timetable also reflects public consultation timeframes as required by legislation.

March 2013 July 2013 November 2013 March 2014 July 2014 November 2014
General scheduling applications1
Lodgement deadline2 for scheduling applications 23 Oct 2012 19 Mar 2013 23 Jul 2013 16 Oct 2013 26 Feb 2014 9 Jul 2014
Public Notice3 pre-meeting submissions.
Inviting public comment on proposals referred to the Committees by the scheduling delegate
29 Nov 2012 24 Apr 2013 29 Aug 2013 21 Nov 2013 3 Apr 2014 7Aug 2014
Public comment due 17 Jan 2013 23 May 2013 26 Sep 2013 19 Dec 2013 8 May 2014 4 Sep 2014
Agvet and delegate-initiated scheduling applications4
Lodgement deadline5 for agvet scheduling applications 14 Dec 2012 9 May 2013 12 Sep 2013 11 Dec 2013 23 Apr 2014 27 Aug 2014
Public Notice6 pre-meeting submissions.
Inviting public comment on proposals referred to the Committees by the scheduling delegate
7 Feb 2013 13 Jun 2013 17 Oct 2013 30 Jan 2014 29 May 2014 25 Sep 2014
Public comment due 7 Mar 2013 11 Jul 2013 14 Nov 2013 20 Feb 2014 26 Jun 2014 23 Oct 2014
2013-2014 ACCS, ACMS and joint ACCS/ACMS meeting dates
The sequence of meetings is subject to the length of specific agenda(s) and may occur on any or all of the dates listed. 19-21 Mar 2013 23-25 Jul 2013 26-28 Nov 2013 18-20 March 2014 22-24 Jul 2014 18-20 Nov 2014
Anticipated timetable for delegate's decision-making following ACMS/ACCS consideration
Public Notice of delegate's interim decision7
Inviting further public comment
23 May 2013 26 Sep 2013 20 Feb 2014 29 May 2014 18 Sep 2014 5 Feb 2015
Public comment due 6 Jun 2013 14 Oct 2013 6 Mar 2014 12 Jun 2014 2 Oct 2014 19 Feb 2015
Public Notice of delegate's final decision 27 Jun 2013 31 Oct 2013 27 Mar 2014 3 Jul 2014 23 Oct 2014 12 Mar 2015
Anticipated that the delegate's final decisions following ACMS/ACCS consideration could be included in the following SUSMP Amendments, unless otherwise decided by the delegate (likely to occur frequently)
SUSMP Amendment and effective date SUSMP No.4
Amendment No.1
1 Sep 2013
SUSMP No.4
Amendment No.2
1 Feb 2014
SUSMP No.4
Amendment No.3
1 Jun 2014
SUSMP No.4
Amendment No.1
1 Oct 2014
SUSMP No.4
Amendment No.2
1 Feb 2015
SUSMP No.4
Amendment No.3
1 Jun 2015
  1. General scheduling applications
    General scheduling applications are those applications proposing to amend the Poisons Standard and must be supported by sufficient information and be in a form approved by the Secretary.
  2. Lodgement deadline
    Each applicant is required to lodge an application for consideration by a scheduling delegate by the lodgement deadline. Not all applications are referred to a committee meeting; in some instances the delegate may make a delegate-only decision.
  3. Public Notice - pre-meeting submissions
    The Public Notice provides the opportunity for public comment on the scheduling proposals that have been referred to the advisory committees for advice. The Public Notice is open for consultation on the TGA website for a period of 20 business days.
  4. Agvet and delegate-initiated scheduling applications
    Applications related to agricultural and veterinary chemicals (agvet) must be referred by the Australian Pesticides and Veterinary Medicines Authority (APVMA) in partnership with the Office of Chemical Safety (OCS). Applications for industrial chemicals may be referred by the National Industrial Chemicals Notification and Assessment Scheme (NICNAS). Delegate-initiated applications are those that the delegate themselves have referred to the advisory committees for advice.
    Delegate-initiated applications are those that the delegate themselves have referred to the advisory committees for advice.
  5. Lodgement deadline
    Agvet and NICNAS applications are required to be lodged for consideration by a Scheduling Delegate by the lodgement deadline. Not all applications are referred to a committee meeting; in some instances the delegate may make a delegate-only decision.
  6. Public Notice - pre-meeting submissions
    The Public Notice provides the opportunity for public comment on the scheduling proposals that have been referred to the advisory committees for advice. The Public Notice is open for consultation on the TGA website for a period of 20 business days.
  7. Public Notice - delegate's interim decision
    Persons who provide comment at the Public Notice-pre-meeting submission stages3,6 are then also invited to comment on the delegate’s interim decision and have 10 business days to respond.

Scheduling secretariat

Secretariat services are provided by the Department of Health Office of Chemical Safety. The contact details for the Secretariat are:

Email smp@health.gov.au
Phone +61 2 6289 2659
Fax +61 2 6289 2650
Postal address The Secretary
Medicines and Poisons Scheduling Secretariat
Office of Chemical Safety (MDP 88)
Department of Health
GPO Box 9848
Canberra ACT 2600
Australia
Street address
(for deliveries)
Department of Health
Loading Dock/Basement, Sirius House
Atlantic Street
Woden ACT 2606
Australia

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Content last updated: Monday, 18 November 2013

Content last reviewed: Monday, 18 November 2013

Web page last updated: Monday, 18 November 2013

URL: http://www.tga.gov.au/about/committees-acmcs.htm