Skip to Content
Skip to Main Navigation
Skip to Local Navigation
Skip to Search

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

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

16 January 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took effect on 1 July 2010, the Secretary to the Department of Health and Ageing (DoHA) (or the Secretary's delegate) superseded the National Drugs and Poisons Schedule Committee (NDPSC) as the decision maker for the scheduling of medicines and chemicals.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 DoHA (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:

Committee members

ACMS and ACCS meeting dates & decisions timeframes

It is anticipated that the ACMS and ACCS will hold three face to face meetings annually. However, this will ultimately be determined by the individual and/or joint meeting agendas of proposals referred to the Committees by the delegate.

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.

	February 2012	June 2012	October 2012	March 2013	July 2013	November 2013
General scheduling applications1
Lodgement deadline2 for scheduling applications	4 Oct 2011	14 Feb 2012	5 Jun 2012	23 Oct 2012	19 Mar 2013	23 Jul 2013
Public Notice3 pre-meeting submissions. Inviting public comment on proposals referred to the Committees by the scheduling delegate	14 Dec 2011	26 Apr 2012	14 Aug 2012	29 Nov 2012	24 Apr 2013	29 Aug 2013
Public comment due	19 Jan 2012	25 May 2012	12 Sep 2012	17 Jan 2013	23 May 2013	26 Sep 2013
Agvet and delegate-initiated scheduling applications4
Lodgement deadline5 for agvet scheduling applications	n/a	n/a	n/a	14 Dec 2012	9 May 2013	12 Sep 2013
Public Notice6 pre-meeting submissions. Inviting public comment on proposals referred to the Committees by the scheduling delegate	n/a	n/a	n/a	7 Feb 2013	13 Jun 2013	17 Oct 2013
Public comment due	n/a	n/a	n/a	7 Mar 2013	11 Jul 2013	14 Nov2013
2012-2013 ACCS and ACMS meeting dates
ACCS meeting	21 Feb 2012	27 Jun 2012	24 Oct 2012	19 Mar 2013	23 Jul 2013	26 Nov 2013
ACMS-ACCS joint meeting	nil	27 Jun 2012	24 Oct 2012	20 Mar 2013 (if applicable)	24 Jul 2013 (if applicable)	27 Nov 2013 (if applicable)
ACMS meeting	22 Feb 2012	27 Jun 2012	24 & 25 Oct 2012	20 or 21 Mar 2013	24 or 25 Jul 2013	27 or 28 Nov 2013
Anticipated timetable for delegate's decision-making following ACMS/ACCS consideration
Public Notice of delegate's interim decision7 Inviting further public comment	26 Apr 2012	5 Sep 2012	19 Dec 2012	23 May 2013	26 Sep2013	20 Feb 2014
Public comment due	10 May 2012	19 Sep 2012	11 Jan 2013	6 June 2013	14 Oct 2013	6 Mar 2014
Public Notice of delegate's final decision	30 May 2012	10 Oct 2012	6 Feb 2013	27 June 2013	31 Oct 2013	27 Mar 2014
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.3 Amendments No. 1&2 1 Sep 2012	SUSMP No.3 Amendment No. 3 1 Jan 2013	SUSMP No.3 Amendment No.4 1 May 2013	SUSMP No.4 Amendment No.1 1 Sep 2013	SUSMP No.4 Amendment No.2 1 Jan 2014	SUSMP No.4 Amendment No.3 1 May 2014

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 18 weeks before an advisory committee meeting. 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).
   Delegate-initiated applications are those that the delegate themselves have referred to the advisory committees for advice.
5. Lodgement deadline
   Agvet applications are required to be lodged for consideration by a Scheduling Delegate 7 weeks before an advisory committee meeting. Not all applications are referred to a committee meeting; in some instances the delegate may make a delegate-only decision.
   There is no lodgement deadline for delegate-initiated applications.
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 stages^3,6 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 DoHA Office of Chemical Safety and Environmental Health. 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 and Ageing GPO Box 9848 Canberra ACT 2600 Australia
Street address (for deliveries)	Department of Health and Ageing Level 5, Scarborough House Atlantic Street Woden ACT 2606 Australia

Top of page