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AHMAC - Scheduling policy framework for medicines and chemicals
Endorsed by AHMAC December 2017
Considerations for amending the appendices (Part 5 of the Poisons Standard)
Version 1.0, January 2018
Changes to certain Appendices in Part 5 of the Poisons Standard, 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 B, where a proposal is clearly and exclusively related to:
- human therapeutic use, then the ACMS may be consulted; or
- some other use excluding human therapeutic use, then the ACCS may be consulted; or
- where neither of these situations applies, the ACMS and ACCS may be consulted at a joint meeting 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 through the relevant product registration authority or scheme (Therapeutic Goods Administration, Australian Pesticides and Veterinary Medicine Authority or National Industrial Chemicals Notification and Assessment Scheme). This includes Appendices D, K and L for therapeutic goods and F, E, 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 has 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 of the decision not to schedule them.
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. However an application may be made to exclude a substance from scheduling.
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 by adding an entry to Appendix B to record the outcome.
The Secretary may make an entry in Appendix B for a new substance or for clarity and may consult with the appropriate Advisory Committee for a rescheduling application.
Schedule 10 supersedes Appendix C.
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 or veterinary 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 to the substance, warrants, in addition to inclusion of the substance in Schedule 4 or 8, further restrictions on access, such as authorisation by the Secretary of the Department of Health or some other appropriate State/Territory or Commonwealth authority.
Inclusion of a substance in Appendix D may be made following consultation with the appropriate advisory committee or a joint meeting, and must take into account the implications for professional practice by affected healthcare practitioners and regulatory control by the states and territories.
Appendix E - First aid instructions for poisons
Appendix F - Warning statements and general safety directions for poisons
The requirements under Appendices E and F do not apply to workplace chemicals, industrial, manufacturing, laboratory or dispensary use, these chemicals must meet the requirements under the Globally Harmonised System (GHS).
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 APVMA publication First Aid Instructions and Safety Directions Handbook. Accordingly these two Appendices do not apply to agricultural and veterinary chemical products and only apply to therapeutic goods that are exempted from the requirements of the Act such as medicines that are compounded by a pharmacist on a prescription for an individual patient.
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, ACMS or a Joint meeting.
New or amended entries in these appendices may also be made following a specific application in relation to these Appendices, after consultation with ACCS, ACMS or a Joint meeting.
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 Guidelines for advertising of substances included in Schedule 3 of the Poisons Standard (the Guideline).
In principle, schedule 3 substances will be included in Appendix H unless the Secretary determines there are reasons for not permitting the advertising of a particular substance. The Guideline sets out when substances cannot be advertised.
Appendix I - Uniform paint standard
Part 2 Section 7 supersedes Appendix I.
Appendix J - Schedule 7 poisons requiring additional controls on availability and use
A new or amended entry to Appendix J will only be considered if:
- Significant, or potential to cause, severe and possible irreversible injury may occur without the individual being aware of exposure - whether that is a single or repeated exposure or a low or high dose exposure.
- Specialised skills and/or equipment are required to mitigate the risks of using the poison.
- The patterns of use of the poison pose an unacceptable risk resulting from direct or indirect exposure to the public.
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 on his or her own initiative or 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 on his or her own initiative or 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.
Appendix M - Additional requirements for Schedule 3 medicines
The Secretary may, in consultation with ACMS, require additional controls or supply requirements for certain Schedule 3 substances to enable them to be provided by a pharmacist. This Appendix is intended to facilitate down scheduling from Schedule 4 to Schedule 3 where, for example, there is community need for access to a medicine but additional controls and oversight, including by the dispensing pharmacist are needed.
The substance and proposed intervention/additional requirement(s) will be listed in the Appendix.
All proposals for inclusion in Appendix M must be referred to ACMS and undergo public consultation.