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

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

5 September 2014

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which took effect on 1 July 2010, the Secretary to the Department of Health (Health) (or the Secretary's delegate) superseded the National Drugs and Poisons Schedule Committee (NDPSC) as the decision maker for the scheduling of medicines and chemicals.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 2014 July 2014 November 2014 March 2015 July 2015 November 2015
General scheduling applications1
Lodgement deadline2 for scheduling applications 16 October 2013 26 February 2014 9 July 2014 15 October 2014 25 February 2015 8 July 2015
Public Notice3 pre-meeting submissions.
Inviting public comment on proposals referred to the Committees by the scheduling delegate
14 November 2013 3 April 2014 7 August 2014 13 November 2014 2 April 2015 6 August 2015
Public comment due 12 December 2013 8 May 2014 4 September 2014 11 December 2014 7 May 2015 3 September 2015
Agvet and delegate-initiated scheduling applications4
Lodgement deadline5 for agvet scheduling applications 11 December 2013 23 April 2014 27 August 2014 10 December 2014 22 April 2015 26 August 2015
Public Notice6 pre-meeting submissions.
Inviting public comment on proposals referred to the Committees by the scheduling delegate
30 January 2014 29 May 2014

25 September 2014

29 January 2015 28 May 2015 24 September 2015
Public comment due 20 February 2014 26 June 2014 23 October 2014 19 February 2015 25 June 2015 22 October 2015
2014-2015 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. 18-20 March 2014 22-24 July 2014 18-20 November 2014 17-19 March 2015 21-23 July 2015 17-19 November 2015
Anticipated timetable for delegate's decision-making following ACMS/ACCS consideration
Public Notice of delegate's interim decision7
Inviting further public comment
29 May 2014 18 September 2014 5 February 2015 4 June 2015 1 October 2015 4 February 2016
Public comment due 12 June 2014 2 October 2014 19 February 2015 18 June 2015 15 October 2015 18 February 2016
Public Notice of delegate's final decision 3 July 2014 23 October 2014 21 March 2015 23 July 2015 19 November 2015 17 March 2016
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.5
Amendment No.1
1 October 2014
SUSMP No.5
Amendment No.2
1 February 2015
SUSMP No.5
Amendment No.3
1 June 2015
SUSMP No.6
Amendment No.1
1 October 2015
SUSMP No.6
Amendment No.2
1 February 2016
SUSMP No.6
Amendment No.3
1 June 2016
  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 to the Advisory Committee on Chemicals Scheduling (ACCS) are provided by Chemicals Scheduling Secretariat, located in the Department of Health Office of Chemical Safety.

Secretariat services to the Advisory Committee on Medicines Scheduling (ACMS) are provided by Medicines Scheduling Secretariat, located with the Therapeutic Goods Administration.

The contact details for each Secretariat are:

Medicines Scheduling Secretariat

Email medicines.scheduling@tga.gov.au
Phone 1800 020 653
Fax +61 2 6289 8145
Postal address Medicines Scheduling Secretariat
Office of Medicines Authorisation (MDP 122)
PO Box 100
Woden ACT 2606
Australia
Street address
(for deliveries)
Medicines Scheduling Secretariat
Therapeutic Goods Administration
136 Narrabundah Lane
Symonston ACT 2606
Australia

Chemicals Scheduling Secretariat

Email chemicals.scheduling@health.gov.au
Phone +61 2 6289 2659
Fax +61 2 6289 2650
Postal address Chemicals Scheduling Secretariat
Office of Chemical Safety (MDP 88)
GPO Box 9848
Canberra ACT 2601
Australia
Street address
(for deliveries)
Chemicals Scheduling Secretariat
Loading Dock/Basement
Sirius Building
Atlantic Street, Woden ACT 2606
Australia

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Content last updated: Friday, 5 September 2014

Content last reviewed: Friday, 5 September 2014

Web page last updated: Friday, 5 September 2014

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