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Scheduling FAQs

1 June 2011

FAQs on revised scheduling arrangements from 1 July 2010

What are the key differences between the previous and the revised scheduling arrangements?

• Until 30 June 2010, scheduling decisions were made by the National Drugs and Poisons Schedule Committee (NDPSC), an independent expert committee established under now repealed provisions of the Therapeutic Goods Act 1989 (the Act).
• New provisions of the Act authorise the Secretary to the Department of Health and Ageing, or a delegate, to make scheduling decisions.
• The new arrangements under the Act provide for the establishment of two expert advisory committees. The Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS) provide recommendations to the delegate in relation to the scheduling of medicines and chemicals, respectively. The ACMS and ACCS also provide advice to the delegate in relation to restrictions to be imposed in respect of particular substances and on any other matters referred by the delegate.
• The delegate's decisions are then incorporated into the Poisons Standard (known as the Standard for the Uniform Scheduling of Medicines and Poisons – SUSMP) for adoption or incorporation into relevant State and Territory legislation. As under the previous arrangements, the inclusion of a substance in a particular schedule in the Poisons Standard determines the lawfulness of conduct associated with that substance under the Act, such as in relation to advertising.

Why have these changes been made to the framework for scheduling?

• The revised arrangements aim to improve the way that substances are scheduled, supporting safe access and availability.
• The improvements reflect recommendations from the Galbally Review which were supported in the recommendations from the Productivity Commission's report on Chemicals and Plastics Regulation released in 2008 and accepted by the Council of Australian Governments. They were informed by consultation across Commonwealth and state/territory jurisdictions and with the pharmaceutical and chemical industries and other interested parties.

What is the legal basis for the revised scheduling arrangements?

• The revised arrangements were implemented by the Therapeutic Goods Amendment (2009 Measures No. 2) Act 2009 (the amending Act) which amended the Therapeutic Goods Act 1989 (the Act) to improve and strengthen the regulation of therapeutic goods in Australia.
• Regulations in relation to the new scheduling arrangements authorised by the amending Act were implemented by the Therapeutic Goods Amendment Regulations 2010 (No. 2).

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Why was the authority to schedule transferred to the Secretary or Secretary's delegate?

• The Australian Health Ministers' Conference advanced the Galbally Review recommendations and agreed that the Secretary to the Department of Health and Ageing, or the Secretary's delegate, should be the final decision maker for scheduling.
• This was done to increase efficiency by more closely aligning the scheduling and product registration processes where a Commonwealth registration scheme for those products exists, thus increasing speed to market.
• The delegate is empowered by the Act to make a decision amending the Poisons Standard following consideration of an application submitted under section 52EAA or on the delegate's own initiative. In making a scheduling decision, the delegate may decide to refer the proposed amendment to the ACMS or the ACCS for its recommendation or advice.

What will be the financial impact of these changes on industry?

• Provision has been made to charge an application fee for scheduling applications.
• The Commonwealth Government is currently examining cost recovery arrangements.

Is a review of the revised scheduling arrangements planned?

• A review of the revised scheduling arrangements is required under section 52EC of the Act.
• This review must commence no later than 1 July 2013 and must be completed within six months.

General scheduling FAQs

What is a scheduled/unscheduled substance?

• Substances are scheduled if they are included in the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP), also known as the Poisons Standard (apart from an Appendix B listing).
• A substance may be captured by a class entry for a group of substances with similar qualities.
• A substance may also be captured as a salt, derivative or active principle of another substance which is listed in the SUSMP.
• or through a class entry.
• If a substance is not listed in the SUSMP or captured as a derivative or by a class entry then it is considered to be unscheduled. It is important to note that if a substance is unscheduled it does not indicate that it is "safe". Many substances are not scheduled because they have not been referred for consideration.
• Many schedule entries also contain scheduling exemptions, e.g. for low concentrations of a substance. Preparations qualifying for such exemptions are then also unscheduled.
• Appendix A lists general exemptions from scheduling for all substances with a particular use pattern.
• There are also general scheduling exemptions for substances which have been actively determined to not require controls through scheduling (Appendix B).
• If a substance is unscheduled, access may still be controlled by other legislation separate from scheduling or by certain regulatory agencies (i.e. the Therapeutic Goods Administration).

What is the Poisons Standard?

• The Poisons Standard consists of decisions of the delegate made according to subsection 52D(2) of the Act. It classifies substances into nine different Schedules which signify the degree of risk and the degree of control recommended to be exercised over their availability to the public.
• The Poisons Standard is a legislative instrument within the meaning of the Legislative Instruments Act 2003 and is required to be registered in the Federal Register of Legislative Instruments for it, or any amendment to it, to be enforceable.
• The Poisons Standard consists of the Standard for the Uniform Scheduling of Medicines and Poisons (the SUSMP) and its amendments. Further information on the current Poisons Standard is available at: The Poisons Standard.

How are scheduling controls implemented?

• A legislative instrument known as the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) (also known as the Poisons Standard) lists scheduling controls for specific substances or classes of substances.
• These restrictions are given legal effect through relevant State and Territory legislation. Hence, implementation of these restrictions may differ depending on the State/Territory.
• Specific jurisdictions may also impose additional restrictions on access to a substance and/or product labelling and packaging.
• Licenses and applications for access to scheduled substances are administered through the jurisdictions and other regulatory agencies (i.e. the Therapeutic Goods Administration or the Australian Pesticides and Veterinary Medicines Authority).
• More information on State and Territory implementation (including contact details) is available at: State/Territory scheduling information.

How can I make an application to change the current Poisons Standard?

An application to amend the current Poisons Standard may be made under section 52EAA of the Act. The process for making an application depends on several factors as outlined below:

Human medicines

• In most cases the decision to schedule a medicinal substance will be made in conjunction with a product application to the Therapeutic Goods Administration's (TGA). Sponsors should continue to submit product applications as with the previous arrangements. Medicines sponsors who wish to change the current Poisons Standard under section 52EAA of the TG Act at the same time as lodging a submission for a medicine with the TGA must provide the electronically completed scheduling application form available on the TGA website, together with their completed submission, on CD to the TGA. The TGA will acknowledge receipt of the electronically-submitted application form to the email address provided by the applicant. Additional information is available at: Scheduling of medicinal substances.
• Where a scheduling application relates to human therapeutic use and does not form part of an associated application to the TGA to register or list a new medicine, a scheduling application may be made using the template available on the TGA website. Please note: In addition to electronic submission via email to the Scheduling Secretariat, applicants must also submit two hardcopy and two CD electronic copy versions to the Scheduling Secretariat. The template requires provision of specific information for consideration and should be read in conjunction with the Scheduling Policy Framework available on the TGA website.

Agricultural and veterinary chemicals

• Applications for the scheduling of new agricultural and veterinary chemicals, or the rescheduling of an existing agricultural and veterinary chemical, are made directly to the Australian Pesticides and Veterinary Medicines Authority (APVMA).
• Application and information requirements are contained in the Manual of Requirements and Guidelines published by the APVMA.

All other uses e.g. domestic and industrial chemicals

• All scheduling applications for a use not regulated by the TGA or APVMA must be made on the prescribed form available on the TGA website. The template requires provision of specific information for consideration and should be read in conjunction with the Scheduling Policy Framework available on the TGA website.

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What is the process that occurs after an application is submitted?

• Receipt of scheduling applications will be acknowledged. The applicant will be notified via a public notice on the TGA website if the application is referred to either the ACMS or ACCS for advice. This notification will include details of the meeting(s) at which the application will be considered. Applicants are strongly encouraged to subscribe to the scheduling notification service.
• The information provided in scheduling applications will be assessed and this assessment:
  • provided to the decision-maker for an interim decision; or
  • forwarded to the ACMS or ACCS by the decision-maker for advice prior to the decision-maker making an interim decision.
• Once an interim decision is made, the applicant will be advised of the reasons for this decision and invited to comment. This interim decision may be published and the public also invited to submit comment (principally for rescheduling decisions).
• Where public submissions are received, the interim decision may be revised in light of those public submissions.
• When the decision is finalised, the applicant will be advised of this final decision and the reasons for that decision.
• Diagrams broadly describing the processes for scheduling of substances included in prescription, non-prescription and complementary (listed) medicines are available at: Scheduling of medicinal substances on the TGA website.
• A process map broadly describing the processes for scheduling of other substances is available at: Medicines and Poisons scheduling from 1 July 2010.

Will applicants see, and be allowed to respond to, an evaluation of a scheduling application made directly to the secretariat?

• A scheduling application made directly to the secretariat can, where warranted, be referred for an independent evaluation (scheduling matters arising from separate applications to a regulator will, as always, be evaluated by the regulator).
• This evaluation report can be distributed to the applicant for comment prior to consideration by the delegate or expert advisory committee. Personal information, such as the evaluator's name, and confidential information not belonging to the applicant, will be deleted. Distribution will, where possible, be by email.
• The applicant will have a maximum of 10 working days to comment, with comments to be sent by email to the scheduling mailbox smp@health.gov.au. Comments are to be limited to 6 single sided A4 pages and in a font no smaller than 12 point.
• The response may only address issues raised in the evaluation report and must not contain any new or additional data. Inclusion of new or additional data is likely to be grounds for consideration of the application to be deferred to allow assessment of this information. Evaluation reports are confidential and are released to the applicant on the understanding that they are not to be released to third parties without permission.

What does the delegate consider when making a scheduling decision?

• Scheduling decisions take into account relevant matters of public health as set out under section 52E of the Act. These matters include the risks and benefits of the use of a substance, the purposes for which a substance is to be used, the substance's toxicity, dosage, formulation, labelling, packaging, presentation and any potential for abuse.
• The delegate must also comply with the Scheduling Policy Framework.
• Where the delegate seeks advice from the ACMS or the ACCS the delegate must have regard to any recommendations or advice of the committee.

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Will applicants be consulted before a decision is made?

• The delegate has the discretion to choose whether or not to refer a matter to an advisory committee. The Scheduling Policy Framework provides details as to when this is likely to occur.
• If the delegate chooses to consider a matter without referral to an advisory committee and the delegate decides to amend the current Poisons Standard, and this amendment:
  • is consistent with the request in the application then this decision may be finalised without making an interim decision and without further consultation with the application; or
  • differs from the request in the application then this decision is an interim decision. The applicant will be invited to provide further comment and the delegate will need to consider such comment before a final decision can be reached.
• If the delegate decides to refer a matter to an advisory committee, the delegate's proposal must be published in a public notice. This notice must also invite the public, including the applicant, to comment on the proposal before consideration by the advisory committee.
• Proposals referred to an expert committee require that an interim decision be made. The applicant will be notified of an interim decision and invited to comment if the interim decision differs from their proposed amendment to the Poisons Standard as set out in their application.

Who else will be consulted and when?

• Certain circumstances, as detailed in Chapter 2 of the Scheduling Policy Framework, may require that a proposed amendment to the Poisons Standard be published and the public invited to comment. Where the delegate seeks advice from either advisory committee the public will be invited to comment before consideration by either advisory committee.
• Further public consultation may occur after the delegate makes an interim decision on an application, as detailed in Chapter 5 of the Scheduling Policy Framework.
• Applications not referred to an advisory committee would not normally require an invitation for public submissions. However, if the interim decision differs from the requested amendment, the applicant will be invited to comment.

Will submissions be publicly released?

• Matters for consideration by either the ACMS or ACCS will be published on the Scheduling website inviting public submissions. The public submissions will be published on the website, together with the interim decision of the delegate. This would include any submissions from the applicant, however the application itself will not be published.
• If advice was sought from either ACMS or ACCS, the delegate's interim decision will also be published on the scheduling website with an invitation for further public submissions. Further submissions would be limited to the applicant or those parties who made an initial public submission. These further public submissions will also be published on the website when the final decision and reasons for the final decision are published.
• Commercial-in-confidence and personal details will be removed prior to publication of public submissions and will need to be identified by the party making the submission.

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Can I appeal if I am unhappy with the final decision?

• Subsection 52D(4A) of the Act provides that an instrument made under paragraph 52D(2)(a) or (2)(b) is a legislative instrument but that section 42(disallowance) of the Legislative Instruments Act 2003 (the LIA) does not apply to the instrument.
• Subsection 5(1) of the LIA provides that a legislative instrument is an instrument in writing, that is of a legislative character and that is or was made in the exercise of a power delegated by the Parliament.
• Scheduling decisions under subsection 52D(2) are legislative in character as they determine the future lawfulness of conduct as provided for under the Act and the Regulations, such as in relation to advertising, as well as State and Territory legislation. Changes to the Poisons Standard alter the content of the law, and have the indirect effect of imposing or varying obligations or rights. The Federal Court in Roche Products v National Drugs and Poisons Schedule Committee [2007] FCA 1352 held that a decision by the NDPSC to amend the Poisons Standard was legislative in nature and the Court gave several reasons to support that decision which remain applicable to the new scheduling arrangement.
• As scheduling decisions are legislative in character, they cannot be the subject of an appeal under the Administrative Decisions (Judicial Review) Act 1977 in the Federal Court.
• Scheduling decisions under subsection 52D(2) are not "initial decisions" which are open for reconsideration under section 60 of the Act. Therefore they are not reviewable by the AAT.

More information

• The Scheduling Secretariat for general matters on scheduling, the ACMS and ACCS.
• The TGA for details of scheduling applications regarding a substance for human therapeutic use.
• The APVMA regarding details of scheduling applications regarding a substance for agricultural or veterinary use.

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