Scheduling committees meeting dates and decisions timeframes

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

27 April 2017

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. As a result of consolidation of the Chemicals and Medicines scheduling functions into a single business unit, thus delivering a more efficient scheduling process, the lodgement deadlines for 2017 meetings are slightly earlier than in previous years. This timetable also reflects public consultation timeframes as required by legislation.

2016 2017 2018

2016 meetings

ACMS and ACCS 2016 meeting dates and decisions timeframes
March 2016 July 2016 November 2016
General scheduling applications[1]
Lodgement deadline[2] for scheduling applications 14 October 2015 2 March 2016 29 June 2016
Public Notice[3] pre-meeting submissions.
Inviting public comment on proposals referred to the Committees by the scheduling delegate
12 November 2015 7 April 2016 4 August 2016
Public comment due 2 December 2015 5 May 2016 1 September 2016
Agvet and delegate-initiated scheduling applications[4]
Lodgement deadline[5] for agvet scheduling applications 2 December 2015 20 April 2016 17 August 2016
Public Notice[6] pre-meeting submissions.
Inviting public comment on proposals referred to the Committees by the scheduling delegate
21 January 2016 26 May 2016 22 September 2016
Public comment due 18 February 2016 23 June 2016 20 October 2016
2016 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. 15-17 March 2016 19-21 July 2016 15-17 November 2016
Anticipated timetable for delegate's decision-making following ACMS/ACCS consideration
Public Notice of delegate's interim decision[7]
Inviting further public comment
12 May 2016 15 September 2016 2 February 2017
Public comment due 26 May 2016 29 September 2016 16 February 2017
Public Notice of delegate's final decision 23 June 2016 27 October 2016 23 March 2017
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 effective date 1 October 2016 1 February 2017 1 June 2017

Footnotes

  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.

2017 meetings

ACMS and ACCS 2017 meeting dates and decisions timeframes
March 2017 July 2017 November 2017
Scheduling Applications[1]
Lodgement deadline[2] for scheduling applications. 17 November 2016 6 April 2017 3 August 2017
Public notice[3] of proposed changes to scheduling and invitation to comment. 22 December 2016 17 May 2017 6 September 2017
Public submission deadline. 10 February 2017 15 June 2017 6 October 2017
2017 ACCS, ACMS and joint ACCS/ACMS meeting dates
Dates 21-23 March 2017 25-27 July 2017 21-23 November 2017
Anticipated timetable for delegate's decision-making
Public notice of interim decisions[4] and invitation to comment. 17 May 2017 15 September 2017 5 February 2018
Public submission deadline. 31 May 2017 3 October 2017 19 February 2018
Public notice of final decisions. 29 June 2017 31 October 2017 20 March 2018
Effective date for SUSMP amendments
SUSMP effective date. 1 October 2017 1 February 2018 1 June 2018

Footnotes

  1. Scheduling Applications
    Scheduling applications must be submitted using the Application to amend the Poisons Standard form approved by the Secretary. To be considered, applications must have sufficient information to support the proposal, and must meet the requirements outlined under section 52EAA of the Therapeutic Goods Act 1989.
  2. Lodgement Deadline
    To be considered within a scheduling cycle, an application must be submitted on or before the associated lodgement deadline. Any applications submitted after the lodgement deadline will be considered in the next scheduling cycle.
  3. Public Notice - Pre-meeting Submissions on Scheduling Proposals
    This public notice provides an opportunity for the public to comment on scheduling proposals that have been referred to an expert advisory committee. To submit a comment on a proposed scheduling amendment, use the Comment on a scheduling proposal coversheet.
  4. Public Notice - Interim decisions
    Only those that have provided a pre-meeting public comment are invited to submit a comment on an interim decision, by using the Comment on an interim decision coversheet.

2018 meetings

ACMS and ACCS 2018 meeting dates and decisions timeframes
March 2018 July 2018 November 2018
Scheduling Applications[1]
Lodgement deadline[2] for scheduling applications. 10 November 2017 2 March 2018 19 July 2018
Public notice[3] of proposed changes to scheduling and invitation to comment. 21 December 2017 12 April 2018 30 August 2018
Public comment due. 2 February 2018 10 May 2018 26 September 2018
2018 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. 13-15 March 2018 26-28 June 2018 6-8 November 2018
Anticipated timetable for delegate's decision-making
Public notice of interim decisions[4] and invitation to comment. 7 June 2018 13 September 2018 7 February 2019
Public comment due. 21 June 2018 26 September 2018 21 February 2019
Public notice of final decisions. 2 August 2018 8 November 2018 4 April 2019
Effective date for Poison Standard SUSMP amendments
Poison Standard SUSMP effective date. 1 October 2018 1 February 2019 1 June 2019[5]

Footnotes

  1. Scheduling Applications
    Scheduling applications must be submitted using the Application to amend the Poisons Standard form approved by the Secretary. To be considered, applications must have sufficient information to support the proposal, and must meet the requirements outlined under section 52EAA of the Therapeutic Goods Act 1989.
  2. Lodgement Deadline
    To be considered within a scheduling cycle, an application must be submitted on or before the associated lodgement deadline. Any applications submitted after the lodgement deadline will be considered in the next scheduling cycle.
  3. Public Notice - Pre-meeting Submissions on Scheduling Proposals
    This public notice provides an opportunity for the public to comment on scheduling proposals that have been referred to an expert advisory committee. To submit a comment on a proposed scheduling amendment, use the Comment on a scheduling proposal coversheet.
  4. Public Notice - Interim decisions
    Only those that have provided a pre-meeting public comment are invited to submit a comment on an interim decision, by using the Comment on an interim decision coversheet.
  5. Implementation date falls on a Saturday