Contents
REVIEW OF ARRANGEMENTS FOR
SCHEDULING SUBSTANCES
PART 6-3 OF THE THERAPEUTIC
GOODS ACT 1989
Information for stakeholders
Part B – Background to the scheduling
arrangements
Contents
Background to scheduling arrangements ................................................................................... 2
1
Review of legislation governing drugs, poisons & controlled substances ......................... 2
1.1
Scheduling arrangements ............................................................................................ 6
1.1.1
Scheduling Policy Framework ............................................................................. 6
1.1.2
National Coordinating Committee on Therapeutic Goods .................................. 7
1.1.3
The Poisons Standard ........................................................................................... 7
1.2
Scheduling principles .................................................................................................. 8
1.2.1
National Drugs and Poisons Schedule Committee (NDPSC) .............................. 9
1.2.2
Advisory Committees ........................................................................................ 10
1.3
Change in the scheduling regime .............................................................................. 10
1.3.1
Legislative changes ............................................................................................ 10
1.3.2
Procedural changes ............................................................................................ 11
1.4
General comparison between the two scheduling arrangements .............................. 12
1.4.1
Transition arrangements..................................................................................... 14
1.4.2
Review of decisions ........................................................................................... 14
APPENDICES ..................................................................................................................... 18
Appendix 1 – Current arrangements for scheduling flowcharts .......................................... 18
i
Background to scheduling arrangements
1 Review of legislation governing drugs, poisons & controlled
substances
The Final Report of the National Competition Policy Review of Drugs, Poisons and
Controlled Substances Legislation (the ‘Galbally Report’) was presented to the Australian
Health Ministers’ Conference (AHMC) in January 2001. This report was prepared following
a review conducted under an independent chair, Ms Rhonda Galbally, then Managing
Director, Australian International Health Institute. Ms Galbally was assisted by a Steering
Committee comprising representatives of the Australian Government and state and territory
governments.
This was one of a number of reviews undertaken under the National Competition Agreement
to which all of the states and territories and the Australian Government are parties.1 The
Council of Australian Governments (COAG) asked for a review to examine state and
territory legislation that imposed controls on supply and use of drugs, poisons and controlled
substances in Australia.
Recommendation 7 of the final report recommended that ‘all Commonwealth, State and
Territory governments agree that:
a)
The Therapeutic Goods Act 1989 and relevant sections of State and Territory
legislation be amended to:


change the title of the Standard for the Uniform Scheduling of Drugs and Poisons
to the Standard for the Uniform Scheduling of Medicines and Poisons;2 and
disband the National Drugs and Poisons Schedule Committee (NDPSC) and
replace it with two separate committees – the Medicines Scheduling Committee,
responsible for scheduling human medicines; and the Poisons Scheduling
Committee, responsible for scheduling agricultural, veterinary and household
chemicals – and that:
− membership of the Committees include a mix of jurisdictional
representatives, appropriate experts and representatives of relevant
government and community sectors;
1
It also follows a number of reviews specifically on substances scheduling arrangements: John Bissett Associates
International 1992, Review of Certain Arrangements at Commonwealth Level for the National Registration of Agricultural
and Veterinary Chemicals and the Poisons Scheduling of Therapeutic Goods; KPMG 1994, Report of the Review of the
Operation of the National Drugs and Poisons Schedule Committee; Industry Commission 1996, The Pharmaceutical
Industry, Report No 51; Brian Wall 1996, Review of the Poisons Scheduling Process in Australia. The more recent
Productivity Commission 2008, Chemicals and Plastics Regulation were also considered in this context.
2
Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) is the ‘common name’ of the Poisons Standard,
which is a Legislative Instrument for the purposes of the Legislative Instruments Act 2003.
2
− decisions of both the Medicines Scheduling Committee and the Poisons
Scheduling Committee be decided by a majority vote of the members
provided that majority also includes a majority of the jurisdictions; and
− the decisions of both Committees be included in the Standard for the
Uniform Scheduling of Medicines and Poisons.
b)
The Therapeutic Goods Act 1989 and the Agricultural and Veterinary Chemicals
Code Act 1994 and related subordinate legislation be amended, as necessary, to enable
the Therapeutic Goods Administration, in the case of human medicines, and the
National Registration Authority for Agricultural and Veterinary Products, in the case
of agricultural and veterinary products, acting on the advice of the Commonwealth
health portfolio in relation to public health matters to:



c)
make decisions about the labelling and packaging of medicines and agvet
products during evaluation of those products;
recommend the schedule in which a new substance should be included; and
recommend changes to the schedule of a substance where, in evaluating new
formulations, new presentations and new uses of substances currently included in
the Standard for the Uniform Scheduling of Medicines and Poisons, a significant
change in the risk profile of the substance is identified.
The Therapeutic Goods Act 1989 be amended to enable the costs of operating the
Medicines Scheduling Committee and the Poisons Scheduling Committee to be fully
recovered by implementing a charge for re-scheduling applications by industry.’
The Australian Health Ministers’ Advisory Council (AHMAC) established a working party in
February 2001 to assist in the preparation of a response to the final report and its
recommendations.3
In preparing its response, the AHMAC working party took into account the comments of the
Primary Industries Ministerial Council, as some of the final report’s recommendations had
implications for the regulation of veterinary medicines and agricultural and veterinary
chemicals. The AHMAC working party also took into account the proposal to establish the
Australia New Zealand Therapeutic Products Authority (ANZTPA) (referred to at that time
as the Trans-Tasman Agency), and recommended that the final report’s recommendations be
implemented in a trans-Tasman context.
In the last quarter of 2003, AHMC unanimously endorsed the AHMAC working party’s
response to the final report out-of-session and agreed that the response and the final report
should be forwarded to COAG for consideration. COAG endorsement of the final report and
the AHMAC Working Party response was completed out-of-session on 28 June 2005.
In 2006 the Council of Australian Governments (COAG) identified chemicals and plastics as
a ‘regulatory hotspot’, and a Ministerial Taskforce was established to develop a streamlined
3
http://www.tga.gov.au/pdf/archive/review-galbally-050628-ahmac.pdf
3
and harmonised national system of chemicals and plastics regulation. COAG also agreed that
the Productivity Commission would undertake a study to assist the work of the Taskforce.
Chemicals and Plastics Regulation Productivity Commission Research Report July 2008 (the
PC report)4 is the culmination of the Commission’s study.
The Productivity Commission proposed building a governance framework that enhances
national uniformity by addressing failures at four levels.

Level 1 — policy development and regime oversight. A national function through
ministerial councils supported by intergovernmental agreements:
– Chemicals policy coordination should be supported by an officer-level, crosscouncil standing committee on chemicals.
 Level 2 — assessment of chemical hazards and risks. An Australian Government
science-based function undertaken under statutory independence:
– the industrial chemicals agency should undertake assessments, not set risk
management standards.
 Level 3 — risk management standards setting. A national function by expertmember agencies operating within the policy frameworks of the ministerial
councils:
− poisons scheduling should be separated from drugs
− maximum residue levels for domestically produced foods that are set by
APVMA should be automatically included in the food standards code,
with right of change by FSANZ and the Australia and NZ Food Regulation
Ministerial Council
− while replacement of the workplace safety agency (ASCC)5 by an
independent agency is supported, it should not be a tripartite representative
body
− the effectiveness of new model regulations for transport needs to be
monitored
− an environmental risk management standards body should be established
− risk management of chemicals of security concern (including ammonium
nitrate) should adopt the Commission’s governance framework.
 Level 4 — administration and enforcement. Generally jurisdiction specific:
− all standards should be adopted in a uniform or nationally consistent
manner by administering agencies
− control of use of agvet chemicals should be consolidated under the
APVMA but delivered through service level agreements by the states and
territories.6
On 7 December 2009 as part of its response to Recommendation 3.1 of the Productivity
Commission’s Report, COAG signed a Memorandum of Understanding on chemicals and
4
http://www.pc.gov.au/__data/assets/pdf_file/0017/82331/chemicals-plastics-regulation.pdf
5
Australian Safety and Compensation Council
6
pxxiv
4
plastics, which established a new national governance framework to help achieve a
streamlined and harmonised national regulatory system and ultimately reduce the regulatory
burden on business. The Standing Committee on Chemicals (SCOC) is part of the new
governance framework. SCOC is responsible to COAG and has reported through the
Business Regulation and Competition Working Group (BRCWG) until the BRCWG ceased
on 31 December 2012, after which the SCOC commenced reporting directly to COAG.
SCOC's role is to:






co-ordinate the implementation of the new governance framework for the
regulation of chemicals and plastics
monitor the timeliness, effectiveness and consistency of reforms of chemicals and
plastics regulation
provide advice and make recommendations as appropriate to BRCWG, COAG
and relevant ministerial councils on how chemicals and plastics policy initiatives
that have cross-portfolio or cross-jurisdictional implications might be best
progressed
provide an ongoing forum for assessing the consistency of chemicals-specific
policy settings across the relevant policy areas, including: public health;
workplace health and safety; transport safety; environment protection; and
national security
oversee a coordinated national approach to regulatory reform of chemicals and
plastics and the consistent application of chemical hazard and risk-assessment
methodologies and international standards such as the Globally Harmonised
System of Classification and Labelling of Chemicals
support the coordinated development of regulatory proposals that have crossportfolio implications, including the conduct of regulatory impact assessments.7
Chapter 5.1 of the PC report dealt directly with poisons scheduling and regulation. The
recommendations made in relation to this were:
Recommendation 5.1 - That the Australian Health Ministers’ Conference should:


7
proceed as soon as feasible with implementing its proposed reforms to separate
poisons and medicines scheduling processes, including that poisons scheduling
decisions be made by the Secretary of the Department of Health and Ageing,
upon advice from a Chemicals Scheduling Committee
undertake a review of the Australian Health Ministers’ Advisory Council model
for poisons two years after commencement, including:
− an analysis of the consistency between the recommendations of the
Chemicals Scheduling Committee and the decisions of the Secretary of the
Department of Health and Ageing
See http://www.innovation.gov.au/INDUSTRY/CHEMICALSANDPLASTICS/SCOC/Pages/default.aspx
5
− an analysis of the impact of the model on national uniformity of poisons
regulations.
Recommendation 5.2 - State and territory governments should:



adopt poisons scheduling decisions made by the Department of Health and
Ageing directly by reference, as published in the Standard for the Uniform
Scheduling of Medicines and Poisons (SUSMP)
uniformly adopt regulatory controls for poisons through either a template or
model approach, as published in the SUSMP
continue to report any variations to nationally-agreed poisons scheduling or
regulatory decisions at the state and territory level to the Australian Health
Ministers’ Conference, and include a statement of reasons for the variations.
Recommendation 5.3 - Where a poison is adequately covered under workplace substances
regulations and there is demonstrated compliance with those regulations, state and territory
governments should exempt workplace users from poisons controls.8
1.1 Scheduling arrangements
The scheduling of substances occurs within a complex framework consisting of:




the Scheduling Policy Framework (SPF)
the National Coordinating Committee on Therapeutic Goods (NCCTG)
the Poisons Standard
principles established within the Act.
These are described below.
1.1.1 Scheduling Policy Framework
The SPF sets out the national system for applying access restrictions on all poisons,
medicines for human therapeutic use and veterinary, agricultural, domestic and industrial
chemicals where there is a potential risk to public health and safety. The SPF has been
developed by the NCCTG, a subcommittee of AHMAC that oversees the development of a
national approach to regulatory policy and administrative protocols relating to scheduling in
Australia. Provisions for scheduling are set out in the Act and the Regulations. The key
aspects to the agreed model under the SPF include:




8
a single point of reference for scheduling policy through the NCCTG
the Secretary of the Department of Health and Ageing being the decision maker
on the scheduling of medicines and chemicals and other changes to the Poisons
Standard
two separate committees: the ACMS and ACCS to advise the decision maker(s)
a single Poisons Standard as the Commonwealth legislative instrument
ppxliii-xliv
6

a single scheduling secretariat to ensure ongoing consistency and cohesiveness of
the process.
1.1.2 National Coordinating Committee on Therapeutic Goods
The NCCTG was established by Order of the Federal Executive Council on 17 March 1971.
The 1971 Order was revoked in October 1986 to facilitate the establishment of NCCTG as a
committee of the AHMAC.
The terms of reference of the NCCTG are to:
a. develop, implement and maintain a uniform national approach to the
regulations and controls over therapeutic goods and chemicals used by the
public
b. contribute to projects relevant to the development of uniform regulations and
controls over therapeutic goods and chemicals
c. share knowledge on matters relevant to the regulation of therapeutic goods and
chemicals
d. provide policy guidance on amending the Poisons Standard to decision-makers
and advisory committees (the Advisory Committee on Medicines Scheduling
and the Advisory Committee on Chemicals Scheduling)
e. consider and report to the Clinical, Technical and Ethical Principal Committee
(CTEPC) on any matter referred to the NCCTG by CTEPC
f. report and make recommendations to the Australian Health Ministers'
Advisory Council (through CTEPC) on agreed principles and desired
outcomes of the regulation of therapeutic goods and chemicals, including the
specific health issues related to people of Aboriginal and Torres Strait Islander
origin.9
In response to a review of committees initiated by AHMAC, it has been proposed that the
NCCTG be replaced by short-term ad hoc working group(s), rather than continue as a
standing committee. This proposal is still under consideration by the two principal
committees that would be most impacted by such an AHMAC decision: the Hospitals
Principal Committee and the Community Care and Population Health Principal Committee.
1.1.3 The Poisons Standard
The Poisons Standard10 contains the decisions made under section 52D of the Therapeutic
Goods Act 1989 and serves two purposes:
1. It contains the classification of medicines and poisons into schedules which sets
the levels of control on the availability of these substances and are
recommendations to states and territories to adopt in their own legislation
9
http://www.tga.gov.au/about/committees-ncctg.htm
10
The current Poisons Standard is the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP), and
supersedes previous versions, which included the Uniform Scheduling of Drugs and Poisons (SUSDP) and the Uniform
Poisons Standard (UPDS).
7
2. It contains model provisions for labelling, containers, storage and possession of
poisons in general which are intended to be adopted for use in state and territories.
It is envisaged that states and territories will adopt the scheduling recommendations in the
Poisons Standard and give effect to them through their relevant drugs and poisons legislation.
States and Territories adopt the Poisons Standard in a variety of ways i.e. by reference or
specifically stipulated in legislation. Each jurisdiction reserves the right to implement a
different scheduling decision to that included in the Poisons Standard to accommodate local
circumstances.
Certain advertising, labelling and packaging requirements may also be a consequence of
scheduling, but are the subject of other Commonwealth registration schemes. These include
the registration of all pharmaceuticals under the Therapeutic Goods Act 1989, the registration
of agricultural and veterinary chemicals under the Agricultural and Veterinary Chemicals Act
1994 and the regulation of industrial chemicals under the Industrial Chemicals (Notification
and Assessment) Act 1989.
The Poisons Standard is a legislative instrument for the purposes of the Legislative
Instruments Act 2003. In order to ensure certainty in the continuing application of state and
territory laws, the Poisons Standard is not a disallowable instrument. Scheduling decisions
are legislative, the lawfulness of the Secretary’s decision is not reviewable under the
Therapeutic Goods Act 1989, in the AAT or in Federal Court.
A consolidated Poisons Standard is published each year. Scheduling decisions that occur
throughout the year are included in any one of the amendments to the Poisons Standard
which are published three times a year. These amendments must be read in conjunction with
the current consolidated Poisons Standard.
The Poisons Standard is available on the ComLaw website11 or may be purchased from
National Mail and Marketing, as the SUSMP, for $85.50.12
1.2 Scheduling principles
The Secretary, when making a decision to amend the Poisons Standard must take into
account the matters stipulated under subsection 52E (1) of the Act. This includes the
a)
b)
c)
d)
e)
f)
11
the risks and benefits
the purpose for which the substance is to be used
the toxicity
the dosage, formulation, labelling, packaging and presentation
the potential for abuse
any other matters the Secretary considers necessary to protect public health.
http://www.comlaw.gov.au/Details/F2012L01200
12
Australia only. Charges vary for international orders. see http://www.tga.gov.au/industry/scheduling-poisons-standard.htm
for the order form.
8
Under subsection 52E (2)(b) of the Act, the Secretary must comply with any guidelines of the
AHMAC and its subcommittee, the NCCTG, and must have regard to any recommendations
or advice of the ACMS or the ACCS.
The NCCTG has given effect to subsection 52E (2)(b) by issuing the SPF. Chapter 3 of the
SPF covers the basics of scheduling and the principles applied to the classification of
medicines and chemicals.
Having considered the above matters, the Secretary can then determine which of the nine
schedules in Poisons Standard is most appropriate.
1.2.1 National Drugs and Poisons Schedule Committee (NDPSC)
Prior to 30 June 2010, scheduling decisions were made by the NDPSC. The NDPSC was a
statutory committee established under the Therapeutic Good Act 1989 and Therapeutic
Goods Regulations 1990 to classify drugs and poisons (substances) for inclusion in the
Poisons Standard. The NDPSC met three times a year - in February, June and October.
Under the NDPSC, submissions to amend the Poisons Standard came from a variety of
avenues. These include via:







Australian Pesticides and Veterinary Medicines Authority (APVMA) including
its product registration and review processes
TGA including its registration process and TGA committees e.g. Adverse Drug
Evaluation Committee
NICNAS
NZ Medicines Classification Committee
states and territories
submissions from stakeholders i.e. professional bodies, companies etc
general public.
Committee members could also raise a submission.
All submissions were considered at the NDPSC meetings. The NDPSC also considered and
noted other areas of interest including the harmonisation of NZ schedules with Australia.
Submissions from stakeholders and the general public (applicants) where encouraged to be
submitted on an approved template. Applicants were requested to supply data to support their
submission.
Submissions and their supporting data were often subject to an external evaluation, if deemed
appropriate by the NDPSC Secretariat. The NDPSC Secretariat could also evaluate certain
aspects of submissions. This was to support the NDPSC by providing sufficient data for it to
consider at its meetings.
When considering complex issues, the NDPSC would form working groups to conduct
further investigations. Working groups included the Drafting Advisory Panel, the Fluorides
9
Working Group, the Atropine Working Group, the Codeine Working Group, the Essential
Oils Working Group and the Schedule 5/6 Storage Requirements Working Group.
The NDPSC was also mindful of the need to avoid undermining any current registration
processes when receiving applications from stakeholders or the general public.
1.2.2 Advisory Committees
The ACMS and ACCS were established as expert advisory committees under sections 52B
and 52C respectively of the Act. The membership and procedural arrangements for the
committees are set out in Divisions 3A and 3B of the Regulations and SPF.
The committees have the following functions:





make recommendations to the Secretary in relation to the classification and
scheduling of substances
make recommendations to the Secretary in relation to other changes in the current
Poisons Standard
reconsider a recommendation at the request of the Secretary
provide other advice to the Secretary in relation to restrictions (accessibility and
availability) on particular substances or any other matter referred to the
committee by the Secretary
any other functions that are prescribed in the Regulations.
1.3 Change in the scheduling regime
1.3.1 Legislative changes
The Therapeutic Goods Amendment (2009 Measures No. 2) Act 2009 (the amendments)
provided for revised scheduling arrangements that commenced on 1 July 2010. This included
the conferral of the power to make amendments to the Poisons Standard from the NDPSC to
the Secretary of the Department of Health and Ageing (the department). The Secretary may
amend the Poisons Standard following an application or of the Secretary’s own initiative.
The amendments also replaced the NDPSC with two expert advisory committees: the ACMS
and the ACCS. The ACMS and ACCS provide recommendations to the Secretary, in relation
to the scheduling of medicines and chemicals, respectively. The ACMS and ACCS also
provide advice to the Secretary in relation to restrictions to be imposed in respect of
particular substances and to any other matter referred to them by the Secretary. It is at the
Secretary’s discretion to seek advice from the advisory committees. The SPF stipulates
certain applications where the Secretary must refer the matter to an advisory committee.
The Therapeutic Goods Regulations 1990 (the Regulations) were also changed to reflect the
amendments. Key components of these changes include:

New Zealand was removed as a representative member of the committees. New
Zealand has observer status on both ACCS and ACMS. This is by convention
only; it is not part of the Regulations.
10







APVMA was removed as a representative member. APVMA has observer status
on the ACCS. This is also by convention only.
NICNAS also has observer status on the ACCS by convention.
Appointed members no longer include individuals to ‘represent’ practicing
pharmacists or consumers, rather these are now areas of expertise a committee
member should possess (as outlined in sub-regulation 42ZCC(2)). Note: this subregulation includes seven fields that are intended to be represented by no more
than six appointed members. The overall membership of the committees must ‘to
the extent reasonably practicable, represent the widest possible range of the fields
mentioned in subregulation (2).’
The Chairs of the committees are no longer required to be Commonwealth
officers.
State and territory representatives are now referred to as nominated members
(previously jurisdictional members).
A decision no longer has to pass by a majority of both the members present and
the majority of jurisdictional members – only members present.
Notices no longer need to be published in the Commonwealth of Australia
Gazette – Government Notices,13 but instead must be published ‘in a manner the
Secretary considers appropriate’. In practice notices inviting public submissions
on the Secretary’s proposed amendments to the Poisons Standards that are
referred to either the ACCS or the ACMS now appear on the TGA website.14
Reasons for scheduling decisions continue to be published on the TGA website,15
as they were previously.
1.3.2 Procedural changes
The Secretary has delegated her role as the decision maker in the following ways:


six medicines delegates (5 of which are for new medicines only) and
one chemicals delegate.
Applications received by the Scheduling Secretariat are to be reviewed by the appropriate
delegate. The delegate considers each application and can either make a decision, refer the
application to an advisory committee for advice and/or seek advice from any appropriate
committee or person.
The delegate uses the SPF to assist their decision on whether to make a delegate-only
decision, or refer the matter to an advisory committee. Again, the delegates must be mindful
of the need to avoid undermining any current registration processes when considering
applications from stakeholders or the general public.
13
http://gazettes.ag.gov.au/portal/govgazonline.nsf/(custom-govnot-pub-view)?OpenView
14
http://www.tga.gov.au/newsroom/consult-scheduling-acmcs.htm
15
http://www.tga.gov.au/industry/scheduling-decisions-final.htm
11
Applications to amend the Poisons Standard are still received in a similar way to the NDPSC.
However, changes to the internal procedures within TGA have resulted in no more referrals
from TGA Committees as they too are now advisory in nature. New medicines are sent from
the appropriate area within TGA for consideration by the appropriate delegate.
Applicants are encouraged to use the approved template and supply sufficient data to support
their application.
The delegate can seek an external evaluation of an application if desired. This differs from
the NDPSC, whose secretariat automatically sent applications for evaluation prior to
consideration by the committee.
Where a substance is both a medicine and a chemical, it may be necessary for two delegates
to make a decision together. In this case, the delegate may seek advice from both advisory
committees.
When the delegate chooses to amend the Poisons Standard of his or her own initiative, he or
she must adhere to the SPF.
The delegate may make urgent scheduling decisions outside the three scheduled amendment
dates each year.
1.4 General comparison between the two scheduling arrangements
One of the key changes to the Act was the replacement of the NDPSC with the Secretary of
DoHA as the decision maker. With this followed a significant change in the processes
involved in amending the Poisons Standard.
Table 3 highlights the key changes to the scheduling regime.
Table 3 – Key changes to the scheduling regime
Scheduling
decisions
Committee(s)
Pre-amendments scheduling
arrangements
Scheduling decisions were made
by the NDPSC
NDPSC and NDPSC work groups
(established to tackle complicated
issues e.g. Fluorides working
group, Atropine working group,
Codeine working group and
Schedule 5/6 Storage requirements
working group).
A Drafting Advisory Panel was
also established to draft wording
for the Poisons Standard.
12
Post-amendments scheduling
arrangements
Secretary of DoHA (s52D)
Two expert advisory committees,
the ACMS and the ACCS, provide
recommendations/advice to the
Secretary .
The Secretary may also seek
advice from any person.
Application
process
including matters
to be taken into
account
Proposed amendments to the
Poisons Standard were considered
by the NDPSC. A gazette notice
was published on the AttorneyGeneral’s Department (AGD)
Gazette website, listing all
considerations and calling for
public submissions.
Application
The NDPSC considered all
process
proposals in relation to s52E of the
including matters Act.
to be taken into
After consideration the NDPSC
account (cont.)
published a Gazette notice on the
AGD Gazette website informing of
their decisions and calling for
public comment.
If public comment was received
the matter was referred to the next
NDPSC meeting to be addressed.
The NDPSC either confirmed or
varied their decision. (If they
varied their decision it was
gazetted for the next NDPSC
meeting).
If no public comment was received
the decision stood.
Public
consultation
A gazette notice was provided
twice in the meeting cycle. A premeeting notice to advise of the
applications to be considered by
the NDPSC and a post-meeting
notice to advise of the outcomes.
The public was invited to comment
in response to be the pre- and postmeeting gazette.
Public submissions on the postmeeting gazette could only be
provided by people who made
submissions relating to the premeeting gazette.
13
When a proposed amendment to
the Poisons Standard is referred
(by the Secretary) to an advisory
committee a public notice must be
published requesting public
submissions. This is done on the
TGA website.
Committees must consider all
public submissions and all matters
referred to in s52E of the Act.
After consideration the committee
must provide advice/
recommendations to the Secretary.
The Secretary, taking into account
matters in 52E of the Act must
make an interim decision
(published thorough a public
notice) or a final decision (if no
public submissions were received).
The interim decision may also
invite further public comments to
be reviewed by the Secretary. The
Secretary can further request
advice from the committee or any
other person to make a final
decision. Final decisions are
published including the decision,
reason and date of effect of
decision including making an
amendment to the Poisons
Standard.
A public notice is provided a
minimum of three times during a
meeting cycle. A pre-meeting
public notice to advise of the
applications to be considered by
the advisory committees; an
interim decision notice and a final
decision notice. The pre-meeting
and interim decision notices call
for public comment.
Public submissions on the interim
decision notice can only be
provided by people who provided
submissions on the pre-meeting
notice.
SPF
A draft scheduling policy frame
work was developed to provide
NDPSC members guidance in
decision making.
Cost recovery16
It cannot be confirmed if a cost
recovery model was ever
considered during the life of the
NDPSC.
The final decision notice also
includes Secretary-only decisions
and does not call for public
comment.
The SPF provides guidance to the
Secretary as well as the advisory
committee members on
decision/recommendation making.
It provides guidance to the
Secretary on which matters will be
referred to an advisory committee.
AHMC agreed that 100% cost
recovery is required for scheduling.
In 2010 the TGA commenced
scoping the introduction of cost
recovery for scheduling of
medicines and chemicals.
1.4.1 Transition arrangements
For the transition from the NDPSC to the new scheduling arrangements, provisions were set
out in Schedule 1, Item 13 of the Therapeutic Goods Amendment (2009 Measures No. 2) Act
2009. In summary, these provisions included:




Any valid amendment to the Poisons Standard made by the NDPSC prior to 1
July 2010 remains valid after this time.
The Secretary must consider any decisions made by the NDPSC between 1
January and 30 June 2010, which have not yet been finalised and incorporated
into an amendment to the current Poisons Standard.
Any application for scheduling of a new substance lodged on or after 1 January
2010, where the application has not been actioned by the NDPSC, will be treated
as if it is an application under the revised scheduling arrangements and the
decision will be made by the Secretary. If it is a rescheduling application, the
Secretary will refer it to the relevant scheduling advisory committee prior to
making the decision.
Applicants will be advised of both the meeting dates (if any) at which an advisory
committee(s) will consider their application, and the decision maker for their
application17.
1.4.2 Review of decisions
As noted in section 3, there are not currently avenues for reviews of final decisions of the
Secretary (other than to progress a new application for amendment to the Poisons Standard).
16
Cost recovery will not be addressed as part of this review.
17
http://www.tga.gov.au/archive/committees-ndpsc.htm
14
This section outlines a decision of the Federal Court of Australia that impacted on
consideration of decisions regarding review and how this matter was considered by
stakeholders and the Australian Government at the time of the amendments.
In Roche Products Pty Limited v National Drugs and Poisons Schedule Committee [2007]
(FCA 1362), the Hon. Justice Branson of the Federal Court of Australia considered an
application to challenge a decision of the NDPSC in relation to the removal of a drug from
Schedule H, the effect of which was to ban its advertising to consumers. The matter at law
was whether a decision of the NDPSC was subject to judicial review, which is only possible
if those decisions are administrative, rather than legislative, in character. The court found that
the decisions of the NDPSC are legislative in character and are therefore not subject to the
jurisdiction of the court under the Administrative Decisions (Judicial Review) Act 1997
(Cth).
At the time of the amendments, questions were raised by Accord during the Senate
Community Affairs Legislation Committee hearings on the bill regarding the continuation of
the existing arrangements that decisions to amend the Poisons Standard not be subject to
Parliamentary disallowance. In its submissions responding to the questions, the department
noted that:
'As a legislative instrument the Poisons Standard is subject to certain requirements of the
Legislative Instruments Act 2003. However, it is not subject to Parliamentary
disallowance as it is utilised by the States and Territories for regulatory enforcement
purposes. ...
As a general principle, decisions to make or amend legislative instruments are not subject
to merits review. ...
Making decisions to include a substance in the [Poisons] Standard merits-reviewable
would pose some legal challenges.
It would significantly delay adoption of amendments to the Standard by States and
Territories - they would be unwilling to adopt changes to the Standard until appeal rights
had been exhausted, thus delaying access to market for new substances, contrary to the
intention of the Galbally Review recommendation.
It should be noted that if merits review was extended to scheduling decisions, any party
whose interests were affected by a decision could apply for merits review. This is likely
to include any party that made a submission to a scheduling advisory committee,
including public interest advocacy groups, as well as the original applicant.
Making scheduling decisions merits reviewable may also impact on the high level of
scheduling uniformity across Australia18.
18
Department of Health and Ageing response to questions and additional information dated 30 July 2009 pp1-2
http://www.aph.gov.au/Parliamentary_Business/Committees/Senate_Committees?url=clac_ctte/completed_inquiries/200810/therapeutic_goods_09/submissions/sublist.htm
15
Thus at the time of the amendments Parliament decided to maintain arrangements that existed
at the time of Roche Products Pty Limited v National Drugs and Poisons Schedule Committee
in relation to the exclusion of a merits review of decisions to amend the Poisons Standard.
16
ACRONYMS
ACCS - Advisory Committee on Chemicals Scheduling
ACMS - Advisory Committee on Medicines Scheduling
AGD - Attorney-General’s Department
AHMAC - Australian Health Ministers’ Advisory Council
AHMC - Australian Health Ministers’ Conference
ANZTPA - Australia New Zealand Therapeutic Products Authority
APVMA - Australian Pesticides and Veterinary Medicines Authority
ASCC – Australian Safety and Compensation Council
BRCWG – Business Regulation and Competition Working Group
COAG - Council of Australian Governments
CTEPC – Clinical, technical and Ethical Principal Committee
DoHA - Department of Health and Ageing
FSANZ – Food Standards Australia New Zealand
NCCTG - National Co-ordinating Committee on Therapeutic Goods
NDPSC – National Drugs and Poisons Schedule Committee
NICNAS – National Industrial Chemicals Notification and Assessment Scheme
SCOC – Standing Committee on Chemicals
SPF – Scheduling Policy Framework
SUSMP – Standard for Uniform Scheduling of Medicines and Poisons
TGA – Therapeutic Goods Administration
17
APPENDICES
Appendix 1 – Current arrangements for scheduling flowcharts
The four flowcharts in Appendix 2 outline the current arrangements for scheduling. These
are:

Flow Chart 1 – the Summary of the scheduling process

Flow Chart 2 – New Chemical Entity for inclusion in Schedule 4, 8 or 9 submitted
under Schedule 10 of the Therapeutic Goods Regulations

Flow Chart 3 – Reconsideration of current Poisons Standard entry for a therapeutic
good.

Flow chart 4 – Application for a Listed product / new unscheduled (Listable)
substance
18
Flowchart 1: Summary of the scheduling process
This flowchart is a basic representation of the process that is expected to apply to scheduling applications made under s52EAA of the
Therapeutic Goods Act 1989, including scheduling reconsiderations and new chemical entities not regulated by the Therapeutic Goods
Administration (TGA). Please refer to the Scheduling Policy Framework for more detailed guidance, accessible at
www.tga.gov.au/pdf/scheduling-policy-framework.pdf
Matters provided to the Delegate for consideration:

Matters resulting from the TGA and APVMA assessment process, for further details:

Medicine – see www.tga.gov.au/regualtion/scheduling-medicines.htm
 Agricultural or veterinary – see www.apvma.gov.au/morag_ag/index.php
 Applications submitted using the ‘Application to Amend the Poisons Standard’ template
www.tga.gov.au/regualtion/scheduling-template.htm. Applications may be referred to NICNAS for technical
advice as required.
 Matters may also be referred by jurisdictions, government regulatory agencies, hospitals, police etc
(e.g. NICNAS, APVMA, FSANZ may refer reports with a scheduling recommendation). Any
stakeholder consultation regarding a decision to refer a matter for scheduling will rely on
New chemical entities for human therapeutic
It is anticipated that the following will be
medicines
assessment by the TGA
policies/practices
ofarethe originating organisation.
referred to the relevant advisory committee:
considered delegate initiated considerations.
These will not be routinely referred to the
ACMS. This process is outlined in Flowchart 2.

Scheduling delegate
decides if they can make a
decision or if the matter
needs to be referred to an
advisory committee
Delegate makes
interim decision
Delegate’s interim decisions
is inconsistent with the
applicant’s request
Delegate’s interim
decisions is consistent
with the applicant’s
request
Applicant* is informed of the
Delegate’s interim decision and
the reasons and asked to comment
Delegate considers proposal in
light of any comments from the
applicant*
*For matters referred as the
result of a separate regulatory
process, it is expected that the
scheduling secretariat will
confirm the applicant(s) contact
details through the referring
organisation. This is the case for
NICNAS and APVMA
Reconsideration of
current scheduling
 Proposals for
Schedule 7 entries
 New chemical
proposals that are
Delegate
refers a proposal
for
considered
straight
scheduling to the
forward and
have not
ACCCS/ACMS
for advice
been subject to the
APVMA registration
Scheduling proposal published
process
and
public comment invited
ACCS/ACMS considers
Delegate’s proposal, public
comment and other relevant
information. Provides advice
to the delegate.
Delegate’s interim decision
and reasons, ACCS/ACMS
recommendation and public
comment published on the
website. Further comment
invited.
Delegate makes final decision
Delegate’s
proposal is
final
Delegate considers the interim
decision in light of any further
comment, may confirm, vary
or set aside the interim
decision.
Scheduling decision is made public on the
website, together with reasons. Poisons Standard
is updated.
19
Flowchart 2 : NCE for inclusion in Schedule 4, 8 or 9, submitted under Schedule 10 of the
Therapeutic Goods Regulations
Product contains a NCE which meets the
criteria for inclusion in Schedule 4, 8 or 9
THIS FLOWCHART IS A BASIC
REPRESENTATION OF THE
SCHEDULING PROCESS THAT IS
EXPECTED TO APPLY MOST OF
THE TIME. IT MAY CHANGE OVER
TIME AS PROCESSES ARE
REFINED IN LINE WITH
APPLICANT OR REGULATOR
NEED. Please refer to the SPF for more
detailed guidance.
Initial review
indicates that
scheduling will
be required
No
No further action
required
Yes
Evaluation undertaken
Delegate
considers
scheduling
Is an appendix entry
required?
No
Yes
Refer to flowchart 1
for process involved
in referral to the
ACMS
Consideration of appendix
inclusion is referred to the
ACMS. Schedule entry is
finalised.
Sponsor is notified of final scheduling decision.
Final decision and reasons are published on the
website. Poisons Standard is updated
accordingly.
20
Delegate’s
decision is final
Flowchart 3: reconsideration of current Poisons Standard entry for a therapeutic good
Application seeking downscheduling from Schedule
4//8/9 to Schedule
3/2/unscheduled
Application seeking up or
down-scheduling from
Schedule 3/2/unscheduled to
Schedule 3/2/unscheduled
Application seeking up or
down-scheduling from
Schedule 4/8/9 to Schedule
4/8/9
Application submitted to the
Medicines and Poisons
Scheduling Secretariat
Application submitted to the
TGA OR Medicines and
Poisons Scheduling
Secretariat
Application submitted to the
TGA OR Medicines and
Poisons Scheduling
Secretariat
Evaluation undertaken
Scheduling proposal referred to ACMS is
published on website and public comment
is invited (including from applicant)
No
Delegate considers
if current
scheduling is
appropriate
THIS FLOWCHART IS A
BASIC REPRESNTATION OF
THE SCEHDULING PROCESS
THAT IS EXPECTED TO
APPLY MOST OF THE TIME
AS PROCESSES ARE REFINED
IN LINE WITH APPLICANT OR
REGULATOR NEED. Please
refer to the SPF for more detailed
guidance.
ACMS considers re-scheduling proposal,
all public comment and background
papers
Delegate makes an interim decision taking
into consideration public submissions and
ACMS recommendations
Interim decision, ACMS recommendation
and public submissions published on
website. Submissions on interim decision
invited.
Delegate considers any further comment
received
Public
submissions
are received
Yes
No
Yes
Delegate makes final
decision
21 scheduling decision. Final
Applicant is notified of final
decision and reasons are published on the website. Poisons
Standard is updated accordingly. ACMS is notified of
decision.
NB: ANY
RESHEDULING
PROPOSAL
MUST BE
CONSIDERED
BY THE ACMS
Flowchart 4: Application for a Listed product/new unscheduled (Listable) substance
4A
4B
Application for a
Listed medicine
Application for a new
Listable substance
All ingredients must
meet the criteria for
inclusion in Listed
medicines
Permitted
Ingredients
List
Evaluation
undertaken
Consideration of
Application for Listed
medicine
Substance meets
the criteria for
inclusion in the
Poisons Standard
No
Consideration
for inclusion in
the Permitted
Ingredients List
Most new Listable
substances should flow
straight through for
consideration on the
Permitted Ingredients List
Yes
Determine any applicable
general exemption or
concentration cut-off, below
which the criteria for inclusion
in a Schedule or Appendix C
of the Poisons Standard would
not apply
Delegate makes an interim
scheduling decision
NOTE: An ingredient is only eligible to be
considered for inclusion in Listed medicines where
it is not subject to the Poisons Standard. Further
criteria may apply to whether an ingredient may be
included in the Permitted Ingredients List
Applicant notified of interim
decision and reasons for
decision. Written submission
is invited.
Delegate considers any further
comment received.
Applicant notified of final scheduling decision
and outcome for Permitted Ingredients List.
Final decision and reasons are published on the
website. Poisons Standard updated accordingly.
New ingredients that may
meet the criteria for inclusion
in Schedule 4 or 8 are not
eligible for Listing and must
be referred to the area
considering prescription
medicines in the first instance.
22
Delegate makes final decision,
confirming, varying or setting
aside interim decision.
Scheduled ingredients are not
eligible for listing. However,
evaluation may include
consideration of potential
scheduling cut-offs.