Pathways to a scheduling decision

15 April 2011

The basic process for reaching a scheduling decision is summarised in Flowchart 1: Summary of the scheduling process.

Depending on the nature of the substance being considered, the pathway to a scheduling decision may be slightly different. The different types of scheduling considerations that may occur and the relevant pathway for a scheduling decision are summarised below. If your substance or application does not fit within any of the below examples, please contact the Medicines and Poisons Scheduling Secretariat for further information.

Application pathways exist for:

TGA sponsors and APVMA applicants should note that any product application submitted to the TGA / APVMA may be referred by the regulator to the scheduling delegate for a scheduling reconsideration at the delegate's discretion. If this does occur, the sponsor/applicant will be notified and given the opportunity to respond to any proposed change to scheduling.

Parties submitting data to the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) should similarly note that in certain circumstances the NICNAS will also refer a matter to the scheduling delegate for a scheduling reconsideration at the delegate's discretion. For scheduling matters that result from a NICNAS assessment of a new chemical it is anticipated that the NICNAS notifier will be given the opportunity to respond to any proposed change to scheduling. In cases of a scheduling consideration arising following NICNAS initiated reviews of existing chemicals, these will be treated as a delegate initiated review for scheduling purposes and an applicant will not be identified.

Substances for agricultural or veterinary (agvet) use regulated by the APVMA

A party seeking to register a new chemical or product with the Australian Pesticides and Veterinary Medicines Authority (APVMA) can include a scheduling request as part of the submission of an APVMA application, in accordance with the Manual of Requirements and Guidelines (MORAG).

In addition, as mentioned above, even if an APVMA application does not make a scheduling request, the APVMA may receive advice that a matter may need to be referred to the scheduling delegate for consideration. For example, during the course of a product evaluation the current scheduling of a substance may be determined to no longer be suitable. Similarly consideration of a substance under the APVMA's Chemical Review Program may result in a matter being referred to the scheduling delegate for consideration.

Process

The following is a brief summary of the agvet specific process as described in full in the Scheduling Policy Framework (SPF).

Following agreement to accept an APVMA matter for scheduling consideration, the delegate may choose to refer this agvet issue to an expert advisory committee (usually this will be the Advisory Committee on Chemicals Scheduling (ACCS), but occasionally consideration will occur jointly with the Advisory Committee on Medicines Scheduling (ACMS) if the substance also has human therapeutic uses). In referring the issue the delegate decides on a 'Scheduling Proposal'. This 'proposal' is not the delegate's decision on the scheduling request, instead this forms the basis of the initial public consultation and is usually worded to facilitate the relevance of submissions through this consultation to the issue under consideration.

As set out in the SPF, it is expected (but not mandated) that all agvet rescheduling proposals (i.e. where the substance has previously been scheduled) will be referred to the ACCS or ACCS-ACMS for advice.

New agvet chemical scheduling proposals to include a new substance in Schedule 7 will be referred to the ACCS given the broad level of interest in such applications. Other new agvet chemical scheduling proposals (such as inclusion in Schedule 5 or Schedule 6) are also likely to be referred to the ACCS unless the proposal is straight forward and the chemical has been subject to the APVMA registration process. For example, many straight forward new veterinary chemical requests for inclusion in Schedule 4 are likely to be considered delegate only decisions.

Agvet scheduling proposals relating to Appendices A, C, G and J must be referred to the ACCS or joint ACCS-ACMS for advice.

The subsequent general process, including the consultation, interim and final decision making process, is summarised in the 'FAQ about the scheduling arrangements' and Flowchart 1.

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Other chemicals (including substances referred by NICNAS) or other proposed changes on matters not regulated by the APVMA or the TGA

Under s52EAA of the Therapeutic Goods Act, any person may submit an application to amend the Poisons Standard regarding the use of a chemical not regulated by the APVMA. Such applications may be submitted directly to the Medicines and Poisons Scheduling Secretariat using the Application to Amend the Poison Standard.

In addition to directly submitted applications, it is also possible that during the course of work by any government regulator or agency it is concluded that the current scheduling of a substance is not considered suitable. If this is the case, such an organisation may request that the delegate consider initiating a reconsideration of scheduling. In particular, NICNAS will continue to refer matters for scheduling consideration as required.

Process

The following is a brief summary of the specific process for use patterns not regulated by the APVMA or TGA, as described in full in the Scheduling Policy Framework (SPF).

Following receipt of a NICNAS assessment outcome (or other agency referred matter) matter for scheduling consideration, the delegate may choose to refer this issue to an expert advisory committee (usually this will be the Advisory Committee on Chemicals Scheduling (ACCS), but occasionally consideration will occur jointly with the Advisory Committee on Medicines Scheduling (ACMS) if the substance also has human therapeutic uses). In referring the issue the delegate decides on a "Scheduling Proposal". This "proposal" is not the delegate's decision on the scheduling request, instead this forms the basis of the initial public consultation and is usually worded to facilitate the relevance of submissions through this consultation to the issue under consideration.

As set out in the SPF, it is expected (but not mandated) that all rescheduling proposals (i.e. where the substance has previously been scheduled) of this type will be referred to the ACCS or ACCS-ACMS for advice.

New chemical scheduling proposals to include a new substance in Schedule 7 will be referred to the ACCS given the broad level of interest in such applications. Other new chemical scheduling proposals (such as inclusion in Schedule 5 or Schedule 6) are also likely to be referred to the ACCS.

Chemical scheduling proposals relating to Appendices A, C, G, I, J must be referred to the ACCS or joint ACCS-ACMS for advice. New or amended entries in Appendices E and F may be made following a specific application in relation to these Appendices, and will require consultation with ACCS. The delegate may also make an entry in Appendices E and F as part of the scheduling decision for a new substance, which may not require referral to the ACCS.

The subsequent general process, including the consultation, interim and final decision making process, is summarised in the 'FAQ about the scheduling arrangements' and Flowchart 1.

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Medicines and human therapeutics regulated by the TGA

Substance Scheduling consideration How should the application be made Process
New Chemical Entity (prescription or non-prescription medicine) Substance not specifically scheduled Product Application submitted directly to the TGA (scheduling consideration is assumed under schedule 10 of the Therapeutic Goods Regulations) Delegate will make a scheduling decision, usually without referral to the Advisory Committee(s)
Application for rescheduling prescription medicine to non-prescription medicine Sponsor seeking to amend current scheduling of substance Application to amend the Poisons Standard submitted directly to the Scheduling Secretariat independent of the product application Expected that the matter will be referred to the Advisory Committee(s)

Application for rescheduling within Prescription medicines or OTC medicines

For example: Schedule 8 to Schedule 4

or

Schedule 3 to Schedule 2

Sponsor seeking to amend current scheduling of substance in conjunction with product application Product application together with application to amend the Poisons Standard submitted to the TGA* Expected that the matter will be referred to the Advisory Committee(s)
New Product for Registration Sponsor has not identified a scheduling issue, however the delegate identifies a need to amend current scheduling Product application to the TGA Scheduling reconsideration delegate initiated

Expected that the matter will be referred to the Advisory Committee(s).

Sponsor will be notified and given an opportunity to respond.

*Sponsors may choose to submit an Application to Amend the Poisons Standard to the Scheduling Secretariat and finalising scheduling consideration prior to submitting a product application.

Nearly all applications (except new chemical entities) to the TGA for product registration do not involve a consideration of scheduling matters and remain unaffected by these changes.

Applications that are likely to require scheduling consideration, i.e. those which may result in a decision to amend (including the addition of new entries) to the Poisons Standard include:

  1. a new chemical entity (NCE); or
  2. an application for rescheduling of the substance; or
  3. a request to add/change an appendix of the Poisons Standard

New chemical entity (NCE)

The process for scheduling of NCEs is outlined in:

  1. Applications for a NCE that is eligible for inclusion in Schedule 4, 8 or 9 of the Poison Standard are made under schedule 10 of the Therapeutic Goods Regulations. Decisions relating to the scheduling of these substances are considered as delegate initiated and will not routinely involve the ACMS. Considerations for inclusion of these substances in an appendix of the Poisons Standard will be referred to the ACMS, as outlined in the SPF. Sponsors will be notified if such consideration is required and given the opportunity to comment.
  2. Where the application relates to a NCE that is eligible for inclusion in Schedule 2 or 3 of the Poison Schedule, either:
    1. Submit the following completed forms to the TGA Application Entry & Support - 'Justification for a particular route of evaluation' and the 'Application to Amend the Poison Standard'. On successful consideration by the delegate of the "Justification for a particular route of evaluation", staff within the TGA Application Entry & Support section will provide specific direction and allow the sponsor to submit a product application via the Over-the-counter Product Application Lodgment system (OPAL)
    2. OR
    3. Submit a scheduling application directly to the Medicines and Poisons Scheduling Secretariat using the Application to Amend the Poison Standard to determine the ingredients scheduling status. Following determination as a Schedule 2 or Schedule 3 medicine, the sponsor can submit a product application to the TGA via the Over-The-Counter (OTC) Products Application Lodgement (OPAL) system.
    (Note: The OPAL ingredient system tables are maintained in accordance with ingredient classifications according to the Poison Standard, which generally prevents submissions of applications for goods with ingredients from higher scheduling being submitted/created).

Medicines rescheduling

The process for rescheduling is outlined in Flowchart 3: Rescheduling process.

In accordance with the SPF, applications for rescheduling are expected to involve the delegate seeking advice from the Advisory Committee on Medicines Scheduling before making their scheduling determination.

Medicines applications for rescheduling

  1. Reconsideration of scheduling of substances within Schedule 4, 8 or 9, for example down-scheduling from Schedule 8 to Schedule 4 or up-scheduling from Schedule 4 to Schedule 8.
    • The Office of Medicines Authorisation (OMA) will provide advice to the delegate prior to referral of the consideration to the ACMS.
    • Sponsors should submit an Application to Amend the Poisons Standard together with their product application to the TGA.
    • Alternatively, sponsors can submit the Application to Amend the Poisons Standard, independent of a product application, directly to the Medicines and Poisons Scheduling Secretariat, and once the scheduling has been resolved submit a product application to the TGA.
  2. Reconsideration of a Schedule 4, 8 or 9 ingredient to be eligible for inclusion in a product supplied as Schedule 2 or 3.
    • Submit an application to the Medicines and Poisons Scheduling Secretariat for rescheduling using the Application to Amend the Poisons Standard. Once the scheduling status has been determined, submit a product application to the TGA via OPAL.
  3. Down scheduling of a Schedule 3 medicine to that of an ingredient/medicine eligible for inclusion in Poison Schedule 2 or unscheduled (generally a listed product)
    • Submit to the TGA both a product application via the Over-the-Counter Medicines Electronic Lodgment System (OPAL) and an Application to Amend the Poison Standard when lodging a Submission for a Medicine to the TGA; or
    • Submit an Application to Amend the Poisons Standard to the Medicines and Poisons Scheduling Secretariat. Once the scheduling status has been determined, submit a product application to the TGA via OPAL/ Electronic Lodgment Facility (ELF) as relevant.
  4. A request to add/change an entry in an appendix of the Poison Schedule, for example consideration of inclusion in Appendix H (Schedule Poisons Permitted to be advertised) or Appendix K Drugs required to be labelled with a sedation warning).
    • Sponsors should submit an Application to Amend the Poisons Standard directly to the Medicines and Poisons Scheduling Secretariat.

Where applications for rescheduling are submitted using the Application to Amend the Poisons Standard, these applications are made under Section 52EAA of the Therapeutic Goods Act 1989. Consequently, these applications result in separate decisions for the scheduling of the substance and the product approval. Sponsors may comment on the scheduling decision but, unlike the registration decisions, this decision is not appealable under the Act (please see section 1.1.1 in the FAQs about the scheduling arrangements).

As the 'scheduling applicant' you will have certain rights. The decision-maker will be required to notify you of any interim scheduling decision (unless it is consistent with your original request), the reasons for the decision and provide you with an opportunity to provide input on the decision. The decision-maker must consider any further comment received before confirming, varying or setting aside their interim decision.

Listable substances

Scheduled ingredients are not eligible for inclusion as Listed medicines. However, to cover situations where a scheduling consideration may form part of an evaluation of a new Listable substance, the process is outlined in:

Scheduled ingredients are not eligible for inclusion as Listed medicines. However, to cover situations where a scheduling consideration may form part of an evaluation of a new Listable substance, the process is outlined in Flowchart 4: Application for a Listed product/new unscheduled (Listable) substance.

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Flowchart 1: Summary of the scheduling process

This flow chart is a basic representation of the process that is expected to apply to scheduling applications made under s52EAA of the Therapeutic Goods Act, including scheduling reconsiderations and new chemical entities not regulated by the TGA. Please refer to the Scheduling Policy Framework for more detailed guidance.

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Text version of Flowchart 1

This text representation of this flow chart is provided as a list with numbered steps.

Matters provided to Delegate for consideration:

New chemical entities for human therapeutic medicines assessment by the TGA are considered delegate initiated considerations. These will not be routinely referred to the ACMS. This process is outlined in Flowchart 2.

It is anticipated that that the following will be referred to the relevant advisory committee:

  • Reconsideration of current scheduling
  • Proposals for Schedule 7 entries.
  • New chemical proposals that are not considered straight forward and have not been subject to the APVMA registration process.
  1. Scheduling delegate decides if they can make a decision or if the matter needs to be referred to an advisory committee - Go to Step 2 or Step 3
  2. Delegate makes interim decision
    1. Delegate's interim decision is consistent with the applicant's request
      1. Delegate's proposal is final
      2. Scheduling decision is made public on the website, together with reasons. Poisons Standard is updated.
      3. End flowchart
    2. Delegate's interim decision is inconsistent with the applicant's request
      1. Applicant* is informed of the Delegate's interim decision and the reasons and asked to comment.
      2. Delegate considers proposal in light of any comments from the applicant*
      3. Delegate makes final decision
      4. Scheduling decision is made public on the website, together with reasons. Poisons Standard is updated.
      5. End flowchart
  3. Delegate refers a proposal for scheduling to the ACCS/ACMS for advice
    1. Scheduling proposal published and public comment invited
    2. ACCS/ACMS considers Delegate's proposal, public comment and other relevant information. Provides advice to the delegate.
    3. Delegate's interim decision and reasons, ACCS/ACMS recommendations and public comment published on the website. Further comment invited.
    4. Delegate considers the interim decision in light of any further comment, may confirm, vary or set aside the interim decision.
    5. Scheduling decision is made public on the website, together with reasons. Poisons Standard is updated.
    6. End flowchart

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Flowchart 2: NCE for inclusion in Schedule 4, 8 or 9, submitted under Schedule 10 of the Therapeutic Goods Regulations

This flow chart 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 wiht applicant or regulator need. Please refer to the Scheduling Policy Framework (SPF) for more detailed guidance.

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Text version of Flowchart 2

This text representation of this flow chart is provided as a list with numbered steps.

  1. Product contains a NCE which meets the criteria for inclusion in Schedule 4, 8 or 9
  2. Initial review indicates that scheduling will be required
    1. No - Nothing further required - End flowchart
    2. Yes
      1. Evaluation undertaken
      2. Delegate considers scheduling
      3. Is an appendix entry required?
        1. No - Delegate's decision is final - Go to Step 3
        2. Yes - Consideration of appendix inclusion is referred to the ACMS. Schedule entry is finalised. - Go to Step 3
  3. Sponsor is notified of final scheduling decision.
    Final decision and reasons are published on the website.
    Poisons Standard is updated accordingly.
  4. End flowchart

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Flowchart 3: Reconsideration of current Poisons Standard entry for a therapeutic good

This flow chart 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 Scheduling Policy Framework (SPF) for more detailed guidance.

NB: ANY RESCHEDULING PROPOSAL MUST BE CONSIDERED BY THE ACMS

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Text version of Flowchart 3

This flowchart has three different starting points, presented here as separate lists with numbered steps.

Application seeking down-scheduling from Schedule 4/8/9 to Schedule 3/2/unscheduled

  1. Application submitted to the Medicines and Poisons Scheduling Secretariat
  2. Evaluation undertaken
  3. Delegate considers if current scheduling is appropriate
    1. Yes - Go to Step 4
    2. No
      1. Scheduling proposal referred to ACMS is published on website and public comment is invited (including from applicant)
      2. ACMS considers re-scheduling proposal, all public comment and background papers
        1. Public submissions are received
          • Yes - Delegate makes an interim decision taking into consideration public submissions and ACMS recommendations. Go to Step 3biiB
          • No - Go to Step 3biiB
        2. Interim decision, ACMS recommendation and public submissions published on website. Submissions on interim decision invited.
        3. Delegate considers any further comment received
        4. Delegate makes final decision - Go to Step 4
  4. Applicant is notified of final scheduling decision.
    Final decision and reasons are published on the website.
    Poisons Standard is updated accordingly.
    ACMS is notified of decision.
  5. End flowchart

Application seeking up or down-scheduling from Schedule 3/2/unscheduled to Schedule 3/2/unscheduled

  1. Application submitted to the TGA OR Medicines and Poisons Scheduling Secretariat
  2. Evaluation undertaken
  3. Delegate considers if current scheduling is appropriate
    1. Yes - Go to Step 4
    2. No
      1. Scheduling proposal referred to ACMS is published on website and public comment is invited (including from applicant)
      2. ACMS considers re-scheduling proposal, all public comment and background papers
        1. Public submissions are received
          • Yes - Delegate makes an interim decision taking into consideration public submissions and ACMS recommendations. Go to Step 3biiB
          • No - Go to Step 3biiB
        2. Interim decision, ACMS recommendation and public submissions published on website. Submissions on interim decision invited.
        3. Delegate considers any further comment received
        4. Delegate makes final decision - Go to Step 4
  4. Applicant is notified of final scheduling decision.
    Final decision and reasons are published on the website.
    Poisons Standard is updated accordingly.
    ACMS is notified of decision.
  5. End flowchart

Application seeking up or down-scheduling from Schedule 4/8/9 to Schedule 4/8/9

  1. Application submitted to the TGA OR Medicines and Poisons Scheduling Secretariat
  2. Evaluation undertaken
  3. Delegate considers if current scheduling is appropriate
    1. Yes - Go to Step 4
    2. No
      1. Scheduling proposal referred to ACMS is published on website and public comment is invited (including from applicant)
      2. ACMS considers re-scheduling proposal, all public comment and background papers
        1. Public submissions are received
          • Yes - Delegate makes an interim decision taking into consideration public submissions and ACMS recommendations. Go to Step 3biiB
          • No - Go to Step 3biiB
        2. Interim decision, ACMS recommendation and public submissions published on website. Submissions on interim decision invited.
        3. Delegate considers any further comment received
        4. Delegate makes final decision - Go to Step 4
  4. Applicant is notified of final scheduling decision.
    Final decision and reasons are published on the website.
    Poisons Standard is updated accordingly.
    ACMS is notified of decision.
  5. End flowchart

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Flowchart 4: Application for a Listed product/new unscheduled (Listable) substance

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Text version of Flowchart 4

This flowchart has two different starting points, presented here as separate lists with numbered steps.

New ingredients that may meet the criteria for inclusion in Schedules 4 or 8 are not eligible for Listing and must be referred to the area considering prescription medicines in the first instance.

Scheduled ingredients are not eligible for listing. However, evaluation may include consideration of potential scheduling cut-offs.

Most new listable substances should flow straight through for consideration on the Permitted Ingredients List

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.

4A: Application for a Listed medicine

  1. Application for a Listed medicine
  2. All ingredients must meet the criteria for inclusion in Listed medicines
  3. Consideration of Application for Listed medicine
  4. End flowchart

4B: Application for a new listable substance

  1. Application for a new listable substance
  2. Evaluation undertaken
  3. Substance meets the criteria for inclusion in the Poisons Standard.
    1. No
      1. Consideration for inclusion in the Permitted ingredients list
      2. Permitted Ingredients List
      3. All ingredients must meet the criteria for inclusion in Listed medicines
      4. Consideration of Application for Listed medicine
      5. End flowchart
    2. Yes
      1. 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 - Go to Step 4 or Step 5
  4. Consideration for inclusion in the Permitted ingredients list
    1. Permitted Ingredients List
    2. All ingredients must meet the criteria for inclusion in Listed medicines
    3. Consideration of Application for Listed medicine
    4. End flowchart
  5. Delegate makes an interim scheduling decision
  6. Applicant notified of interim decision and reasons for decision. Written submission is invited.
  7. Delegate considers any further comment received
  8. Delegate makes final decision, confirming, varying or setting aside interim decision
  9. Applicant notified of final scheduling decision and outcome for Permitted Ingredients List.
    Final decision and reasons are published on the website.
    Poisons Standard is updated accordingly
  10. End flowchart

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