AHMAC - Scheduling policy framework for medicines and chemicals

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12 February 2015

Chapter 2: Guidelines for amending the Poisons Standard

The principles and factors in these guidelines should be taken into account by the Secretary and Advisory Committees when considering proposals to amend the Poisons Standard.

Guidelines for amending parts 1-3

Parts 1-3 provide a description of the nature of controls implemented by states and territories on substances scheduled in the Poisons Standard.

The states and territories, through AHMAC (or the relevant Principal Committee), may propose to the Secretary the introduction of a new regulatory provision or vary an existing regulatory provision in Parts 1-3 of the SUSMP. In such cases, the Secretary need not consult the Advisory Committees.

Should the Secretary wish to otherwise make a new regulatory provision or vary an existing regulatory provision in Parts 1-3 of the SUSMP (ie. a proposal is received that is not from AHMAC or the relevant Principal Committee), consultation with states and territories must first take place.

In making a decision to amend Parts 1-3 the Secretary needs to consider:

  • the scope of the proposed provision (whether the provision applies to poisons that are not human medicines or all poisons);
  • the effect of the proposal on existing entries for poisons in the Schedules and Appendices;
  • the regulatory need and justification for the change; and
  • the potential implications of the change for jurisdictions.

The Secretary will refer to the relevant Advisory Committee for advice, an application to amend an existing chemical substance in Parts 1-3 of the SUSMP. 

Minor administrative amendments to Parts 1 -3 may be made by the Secretary without referral to AHMAC (or the relevant Principal Committee) or an Advisory Committee.

Guidelines for amending the schedules - part 4

When considering a new substance application (i.e. a substance for which a scheduling decision has not already been made), the Secretary will consider whether to include the new substance in the Poisons Standard based on the Scheduling factors set out in Chapter 3. If the substance is to be included in any Schedule, the Secretary must determine:

  1. the name or description of the substance to be used;
  2. the scope of the entry and the schedule(s) in which the substance is to be included; and
  3. which other parts of the Poisons Standard may also apply to the substance.

Rescheduling applications may only be made in relation to substances that have an existing entry or entries in the Poisons Standard.

When considering a re-scheduling application the Secretary must determine:

  1. the scope of the entry and the schedule(s) in which the substance is to be included; and
  2. which other parts of the Poisons Standard may also apply to the substance.

Detailed guidance for Advisory Committees and the Secretary in relation to proposals to amend Part 4 of the Poisons Standard are included in Chapter 3.

Guidelines for amending the appendices - part 5

For products covered by the two Commonwealth product registration schemes, entries in certain Appendices in Part 5 can only be made. This potentially includes entries in Appendices A, B, G, H and K for therapeutic goods and Appendices A, B, G and J for agricultural and veterinary chemicals.

Changes to certain Appendices in Part 5, in particular Appendices A and B can only be considered in the context of an application for scheduling or rescheduling of an existing poison.

For amendments to Appendices A and G, where a proposal is clearly and exclusively related to:

  1. human therapeutic use then the ACMS must be consulted; or
  2. some other use excluding human therapeutic use, then the ACCS must be consulted; or
  3. where neither of these situations applies, then a joint meeting must be consulted prior to any decision.

Where the Appendix may have direct implications for the labelling, storage or supply of a product, an application to vary the specific entry must be made either through the relevant product registration authority (TGA/APVMA) or as set out in this document. This includes Appendices D, G, H, K and L for therapeutic goods and F, E, G, J, and L for all other poisons.

Appendix A - General exemptions

Appendix A provides general exemptions from the controls set out in the Poisons Standard for classes of products where the physical nature of the products, or their use, or other legislative controls applicable to the class of product, mitigate to an acceptable level, the public health risk of any substances in that class.

Inclusion of an entry in Appendix A may be made by the Secretary, where classification of representative members from a product or substance class have consistently demonstrated that they do not meet any of the criteria for inclusion in the Schedules. When considering an entry in Appendix A the Secretary must consider whether making or amending an entry will:

  • be generally consistent with the safety profile of members of the proposed class;
  • address a regulatory need for a class exemption; and
  • provide a public benefit through the class exemption.

Appendix B - Substances considered not to require control by scheduling

Appendix B is a positive list of substances that have been considered to be exempt from scheduling requirements on the basis of information available at the time. No direct application can be made for inclusion of a substance in Appendix B and there are no explicit criteria for inclusion in the Appendix.

An entry in Appendix B may be made by the Secretary following consideration of the application for scheduling if the substance does not meet the factors for inclusion in the Schedules of the Poisons Standard. In this instance the Secretary may decide that there is a public benefit gained by adding an entry to Appendix B to record the outcome. 

The Secretary may make an entry in Appendix B for a new substance and should consult with the appropriate Advisory Committee for a rescheduling application.

Appendix C

Schedule 10 supersedes Appendix C. In March 2016, the Secretary will consider the removal of Appendix C . In this case, the Secretary need not consult the Advisory Committees.

Appendix D - Additional controls on possession or supply of poisons included in Schedules 4 or 8

Inclusion of a substance in Appendix D may be considered by the Secretary for any human medicine where the assessment of the proposal identifies:

  • a specific health risk that may be mitigated by restricting availability through specialist medical practitioners; or
  • significant potential for illicit diversion and/or abuse which does not warrant inclusion in Schedule 8 but warrants particular control of possession; or
  • a specific high potential for abuse, particular international treaty restrictions on availability or other matters of national public health policy which when weighed against the need for access the substance, warrants in addition to inclusion of the substance in Schedule 8, further restrictions on access such as authorisation by the Secretary of the Department of Health or some other appropriate authority;
  • taking into account the implications for professional practice by affected healthcare practitioners and regulatory control by the states and territories.

Inclusion of a substance in Appendix D should be made following consultation with the ACMS.

Appendix E - First aid instructions for poisons

Appendix F - Warning statements and general safety directions for poisons

First aid and safety directions for human medicines are assessed as a component of the registration requirements and are included in the TGA publication Required Advisory Statements for Medicines Labels. The same directions for agricultural and veterinary chemicals are included in the Department of Health publication First Aid Instructions and Safety Directions Handbook. Accordingly these two Appendices do not apply to therapeutic goods or agricultural and veterinary chemical products.

Appendices E and F include safety and first aid directions required to be included on the label to promote safe use of products available to the public. These directions supplement the directions for use of the product by identifying specific hazards of the product, precautions to be taken, any personal protective equipment to be worn during use of the product and appropriate first aid measures to be taken following any misadventure involving the product.

Entries are based on the assessment of the scheduling proposal and take into account current best-practice in occupational and emergency medicine.

The Secretary may make an entry in these Appendices as part of the scheduling decision for a new substance. An entry or amended entry may also be made in these appendices following a rescheduling application and consultation with the ACCS. New or amended entries in these appendices may also be made following a specific application in relation to these Appendices, after consultation with ACCS.

Appendix G - Dilute preparations

An entry in Appendix G exempts the substance from all requirements of the Poisons Standard when included in a product at a concentration at or below that specified in the Appendix. 

The Secretary may make an entry in the Appendix;

  • following consultation with one or both Advisory Committees, depending on the scope of the entry; and
  • where the assessment of the substance at the proposed maximum concentration does not meet the criteria for inclusion in any Schedule of the Poisons Standard; and
  • where the assessment of the undiluted substance does not meet the factors for inclusion in Schedule 8, 9 or 10; and
  • there are no other public health concerns in relation to the proposed entry.

Appendix H - Schedule 3 medicines permitted to be advertised

A new or amended entry to Appendix H may be made by the Secretary after taking into account matters set out in the NCCTG Guidelines for brand advertising of substances included in Schedule 3 of the Standard for Uniform Scheduling of Drugs and Poisons (SUSDP) (November 2000).

Appendix I - Uniform paint standard

Part 2 Section 7 supersedes Appendix I. In March 2016, the Secretary will consider the removal of Appendix I. In this case, the Secretary need not consult the Advisory Committees.

Appendix J - Conditions for availability and use of Schedule 7 poisons

A new or amended entry to Appendix J will only be considered in the context of a new substance meeting the criteria for Schedule 7 or a rescheduling application for an existing entry in Schedule 7. The Secretary may make a new entry or vary an existing entry following consultation with the ACCS and will consider the need for any additional state and territory controls over access, training or possession of the substance, to ensure its safe use.

Appendix K - Medicines required to be labelled with a sedation warning

The Secretary can make a new entry or vary an existing entry following consultation with ACMS. In making a decision to vary an entry or make a new entry in Appendix K the Secretary must consider:

  • the potential for sedation in humans exhibited by a medicine in normal use;
  • animal or human data demonstrating any impairment of critical motor reflexes and cognitive skills applicable to driving or the operation of machinery;
  • the need to warn users of any potential danger of the medication when the user is in control of machinery or an automobile; and
  • regulatory implications for the states and territories.

Appendix L - Requirements for dispensing labels for human and veterinary medicines

The Secretary may make a new entry or vary an existing entry following consultation with ACMS for dispensing of human medicines, ACCS for dispensing of veterinary medicines or both if relevant. An amendment to Appendix L may be considered following a proposal for a new or existing medicine where:

  • specific labelling needs to be applied for safe use of a medicine when dispensed;
  • professional practice standards require specific labelling of the medicine when dispensed.

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