Source: https://www.tga.gov.au/final-decision-scheduling-cannabis-and-tetrahydrocannabinols-frequently-asked-questions
Timestamp: 2019-07-19 21:40:27
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Final decision on scheduling of cannabis and tetrahydrocannabinols: Frequently asked questions | Therapeutic Goods Administration (TGA)
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Scheduling delegate's final decisions: Cannabis and tetrahydrocannabinols, August 2016
Scheduling changes for cannabis and tetrahydrocannabinols
On 31 August 2016, the Medicines Scheduling Delegate gave notice of the delegates' final decision for amending the scheduling of cannabis and tetrahydrocannabinols in the Poisons Standard (commonly referred to as the Standard for the Uniform Scheduling of Medicines and Poisons - SUSMP) under subsections 42ZCZS and 42ZCZX of the Therapeutic Goods Regulations 1990 (the Regulations). This decision was made following a scheduling proposal for cannabis and tetrahydrocannabinols that was initially referred to the March 2016 meeting of the Advisory Committee on Medicines Scheduling (ACMS).
For further information about scheduling, refer to the TGA website.
For further information about changes to scheduling for cannabis and tetrahydrocannabinols, see Contact details.
email: medicines.scheduling@tga.gov.au
phone: 1800 020 653 (freecall within Australia)
On this page: Cannabis and tetrahydrocannabinols | Scheduling decision | Definitions | Access and related issues | Scheduling process
In the Poisons Standard, cannabis describes all plants of the Cannabis genus. Cannabis includes the seeds, extracts, resins, and the plant as well as any part of the plant. The Cannabis plant produces a resin containing compounds called cannabinoids.
Cannabinoids have been associated with claims relating to use for pain relief and as a muscle relaxant. Cannabis contains about 60 cannabinoids, of which the two main components reported to have medicinal properties are delta-9-tetrahydrocannabinol and cannabidiol.
What are tetrahydrocannabinols?
Tetrahydrocannabinols are a class of cannabinoids (as compared to a single component) extracted from Cannabis. Some cannabinoids in the tetrahydrocannabinols class include delta-9-tetrahydrocannabinol, tetrahydrocannabivarol, and their acids. Delta-9-tetrahydrocannabinol is the main component of the Cannabis plant reputed to have psychoactive properties. For more information on class entries refer to the TGA website.
What is the legal basis for the decision?
Links to scheduling legislation are available on the TGA website.
Part 6-3 of Therapeutic Goods Act 1989 (the TG Act) provides the basis for a uniform system of access controls for goods containing scheduled substances. The scheduling of substances allows restrictions to be placed on their public access and supply, in the interests of public health and safety. Substance scheduling aims to minimise the health risks associated with poisoning from, misuse or abuse of, scheduled substances.
The Poisons Standard (known as the Standard for Uniform Scheduling of Drugs and Poisons) consists of decisions of the Secretary of the Department of Health, under Subsection 52D(2), Part 6-3 of the TG Act, regarding the classification of substances into the different Schedules, signifying the degree of control recommended to be exercised over the substance's availability to the public.
Often, the delegate will seek advice from the Advisory Committee on Medicines Scheduling (the ACMS), in accordance with the Subdivision 3D.2 of Part 6 of the Therapeutic Goods Regulations 1990 before amending the Poisons Standard.
The ACMS is made up of experts, including state and territory representatives, who make recommendations regarding how medicines will be made available to the public. More information on the ACMS is available on the TGA website.
The Poisons Standard aims to deliver a consistent approach that all state and territory governments can adopt to allow the supply of substances. However, it is up to the individual state and territory governments as to how they adopt and implement the Poisons Standard. This will depend on the respective state and territory legislation. For information on how each state and territory controls access to substances, refer to the state and territory drugs and poisons units.
What is the Scheduling decision for Medicinal Cannabis?
The purpose of the scheduling decision was to enable appropriate, timely access to medicinal cannabis products for human therapeutic use.
The Medicines Scheduling delegate's final decision on the scheduling of cannabis and tetrahydrocannabinols is available on the TGA website.
The final decision was to amend the current Schedule 9 entries and create new Schedule 8 entries for cannabis and tetrahydrocannabinols. In relation to the new Schedule 8 entries, the final decision also includes Appendix D (1) and Appendix K entries for cannabis and tetrahydrocannabinols.
The Appendix K entries for cannabis and tetrahydrocannabinols require products containing these substances to be labelled with a warning statement regarding the potential for sedation.
The Appendix D (1) entries for cannabis and tetrahydrocannabinols places an additional control such that these substances will only be 'available from or on the prescription or order of an authorised medical practitioner' and where the medical practitioner has been authorised by the 'appropriate authority' as defined in Part 1, Interpretation, Paragraph 1(1) of the Poisons Standard (these are generally senior health executives of the states and territories), see below.
The amended Schedule 9 and new Schedule 8 entries (which are subject to implementation by the state and territory governments) place limits on the cultivation, preparation, production, extraction, manufacture, packaging and use of cannabis and tetrahydrocannabinols for human therapeutic use.
The amended Schedule 9 and new Schedule 8 entries complement recent amendments to the Narcotic Drugs Act 1967 made by the Narcotic Drugs Amendment Act 2016 and aim to make available for the first time in Australia medicinal cannabis products for patients who qualify, while retaining appropriate controls to prevent such products from being diverted to illicit uses.
There are exceptions to the new Schedule 8 listings for cannabis and tetrahydrocannabinols. One of exceptions refers to products containing cannabis or tetrahydrocannabinols to which items 4, 8, 10, 11 or 12 of Schedule 5A to the Therapeutic Goods Regulations 1990 apply. In these circumstances, when brought into Australia, such products would remain in Schedule 9.
This means that products containing cannabis and tetrahydrocannabinols remain in Schedule 9 under items 4, 8, 10, 11 and 12 of Schedule 5A to the Therapeutic Goods Regulations 1990, when imported by a member of a group of persons. These groups of persons include: those participating in sporting events; military forces; medical practitioners or members of medical teams (under professional supervision of a medical practitioner); senior foreign country Government officials and Heads of State on official business; and therapeutic goods that are part of medical supplies on maritime vessels and aircraft to treat a passenger or crew member.
How is this scheduling decision implemented across Australia?
Each state and territory has its own laws that determine where consumers can access a particular drug or poison, and how it is to be packaged and labelled. It remains with the state and territory governments as to how they give effect to any decision to down-schedule in their own jurisdiction. Information relating to medicinal cannabis access is available through state and territory Health department websites as follows:
Medicines and poisons - Synthetic Cannabinoids (Synthetic Cannabis)
Output 1.3 - Public Health Services
Medical Cannabis - Controlled Access Scheme (pdf,119kb)
Tasmania takes action on Medical Cannabis
How are tetrahydrocannabinols scheduled?
Tetrahydrocannabinols, as a class of substances, are included in a number of schedules in the Poisons standard, depending on the concentration and the purpose of use.
Tetrahydrocannabinols are captured by Schedule 9 when not for human therapeutic use. Synthetic tetrahydrocannabinols are covered by the Schedule 9 entry unless otherwise specified in the Schedules.
The Schedule 8 entry for tetrahydrocannabinols allows for human therapeutic use under certain circumstances that are tightly defined and controlled. This includes that it must be extracted from Cannabis.
Tetrahydrocannabinols found in hemp seed oil in concentrations less than 50 mg/kg, when labelled with a warning statement 'Not for internal use' or 'Not to be taken', are not scheduled.
Tetrahydrocannabinols found in non-therapeutic products in concentrations less than 50 mg/kg for purposes other than internal human use are not scheduled.
When will the scheduling changes take effect?
The scheduling changes take effect in November 2016, when the new Poisons Standard (a legislative instrument) is published and include the amended and new entries for cannabis and tetrahydrocannabinols. The changes in the Poisons standard are then adopted through state and territory government legislation.
What do the scheduling changes mean?
The change to the Poisons Standard will amend the existing Schedule 9 entries, and create Schedule 8 entries for cannabis and tetrahydrocannabinols for human therapeutic use. This means that for purposes other than human therapeutic use, cannabis and tetrahydrocannabinols remain in Schedule 9.
The new Schedule 8 entries are specific for human therapeutic use and products are required to be prescribed by a medical doctor that is an authorised medical practitioner. The authorised prescriber, and whether products containing these substances may be prescribed, may differ between states and territories in Australia.
Prescribed products containing cannabis and tetrahydrocannabinols require sedation warnings.
What is an 'Appropriate authority' and an 'Authorised prescriber' and how are travellers affected?
Inclusion of Appendix D (1) for cannabis and tetrahydrocannabinols restricts the availability of cannabis and tetrahydrocannabinols that are listed in Schedule 8 of the current Poisons Standard. Schedule 8 cannabis and tetrahydrocannabinols can only be made available on authorised prescription, or by order of an authorised medical practitioner. The authority can only be issued by an Australian, State, Territory Health department or agency. Thus, not all registered medical practitioners can prescribe products containing these substances.
An 'Appropriate authority' under the Poisons Standard in relation to the Schedule 8 entries for cannabis and tetrahydrocannabinols means:
in the Australian Capital Territory, ACT Government Health Directorate;
in New South Wales, the Secretary of Health;
in the Northern Territory, the Chief Health Officer of the Department of Health;
in Queensland, the Chief Executive of Queensland Health;
in South Australia, the Chief Executive of the Department for Health and Ageing;
in Tasmania, the Secretary of the Department of Health and Human Services;
in Victoria, the Secretary to the Department of Health;
in Western Australia, the Chief Executive Officer of the Department of Health.
An 'Authorised prescriber' in relation to the Schedule 8 entries for cannabis and tetrahydrocannabinols means a registered medical practitioner authorised by the appropriate authority or such other person authorised by the appropriate authority.
This means that the medical practitioners that can prescribe or order cannabis and tetrahydrocannabinols will be limited to those specifically authorised by those Commonwealth, state and territory agencies described as the 'appropriate authority' for that jurisdiction.
How are the terms 'substance' and 'derivatives' applied in relation to the decision?
Under Part 1, Interpretation, Paragraph (2)(b) of the Poisons Standard, the term 'substance' covers a plant and any part of that plant when packed and prepared for therapeutic use, other than a plant included in Schedules 8 or 9. In the decision, the references to cannabis in the Schedules 8 and 9 are to be interpreted as including the substance when packed and prepared for human therapeutic use.
The term 'derivatives' does not appear in the Poisons Standard Schedules 8 and 9 entries for cannabis or tetrahydrocannabinols because according to Part 1, Interpretation, Paragraph 1(2) of the Poisons Standard, a Schedule entry includes preparations containing the poison in any concentration and all salts and derivatives of the poison unless the entry specifically states otherwise.
How are 'cultivated', 'produced' and 'manufactured' defined in the new schedule entries?
'Cultivation', 'production' and 'manufacture' take their meaning from the Narcotic Drugs Act 1967, where they are defined as follows:
Cultivation of a Cannabis plant includes the following:
to sow a seed of a Cannabis plant;
to plant, grow, tend, nurture or harvest a Cannabis plant;
to graft, divide or transplant a Cannabis plant; but does not include the separation of cannabis or cannabis resin from a cannabis plant
Production means the separation of cannabis and cannabis resin from the plants from which they are obtained. The production of cannabis involves the separation of cannabis flowering or fruiting tops of the Cannabis plant (excluding the seeds and leaves when not accompanied by the tops) where the resin has not been extracted.
Manufacture of cannabis involves all processes, other than production (as defined above), by which drugs may be obtained and includes refining as well as the transformation of drugs into other drugs.
No. Hemp seed oil is as defined in Part 1 Interpretation, Paragraph (1) of the Poisons Standard as the oil obtained by cold expression from the ripened fruits (seeds) of Cannabis sativa.
Hemp oil, on the other hand, includes extracts from the flowering tops or leaves or any other part of the Cannabis plant other than the ripened fruit (seeds).
Access and related issues
How do patients access medicinal cannabis?
The aim of the decision is to provide genuine patients access to a safe, legal and sustainable supply of locally produced products for the management of painful and chronic conditions.
Questions regarding eligibility and availability of medicinal cannabis products start with a registered medical practitioner. They may need to refer patients to an appropriate authorised medical specialist. For information about when medicinal cannabis will be available, refer to the Office of Drug Control website.
Also refer above to the question on How is this scheduling decision implemented across Australia?
For further information on how to access medicinal cannabis please refer to the Access to Medicinal cannabis products area of our website.
What is the role of the Therapeutic Goods Act 1989 in governing a consistent approach to supply of medicinal cannabis products?
The role of the TG Act relates to the regulation of the supply of therapeutic goods and works in tandem with state and territory legislation on the access to scheduled particular substances. For medicinal cannabis, the down-scheduling aims to simplify access for those qualified to do so (generally specialist medical practitioners or researchers).
Medical practitioners/researchers are still required to adhere to state and territory Poisons Standard legislation regarding the possession, storage, prescribing and dispensing/supply of therapeutic goods when accessing medicinal cannabis.
How are other cannabinoids affected by the changes to the scheduling of cannabis and tetrahydrocannabinols?
Nabilone, dronabinol (synthetic delta-9-tetrahydrocannabinol), and nabiximols listed in Schedule 8 or and cannabidiol listed in Schedule 4, for therapeutic use for specific medical conditions remain in the same Schedules of the Poisons Standard.
Are Cannabis ('hemp') fibre products affected by the decision?
No. Processed hemp fibre containing 0.1 per cent or less of tetrahydrocannabinols and hemp fibre products manufactured from such fibre are not scheduled. The exclusion of hemp fibre is consistent with Article 28 of the Single Convention on Narcotic Drugs, 1961, to which Australia is a signatory.
Are food products affected by the decision?
No. The change in scheduling for cannabis and tetrahydrocannabinols to schedule 8 was only for human therapeutic use. The scheduling change does not change the legal status of cannabis and tetrahydrocannabinols in food. The schedule 9 entries in the Poisons Standard mean that cannabis and tetrahydrocannabinols are prohibited from being added to food or sold as food in Australia. All cannabis species are also prohibited from being sold as food or ingredients in food in the Australia New Zealand Food Standards Code, which is administered by Food Standards Australia New Zealand.
In July 2016, FSANZ published request for public submissions on a proposal to permit the addition to food of products from the seeds of low tetrahydrocannabinols varieties of Cannabis sativa. For further information on foods containing cannabis refer to Food Standards Australia New Zealand (FSANZ).
Are products for use in animals affected by the decision?
No. The new Schedule 8 entries for cannabis and tetrahydrocannabinols are only for human therapeutic use. Products for non-human therapeutic use are captured by the Schedule 9 cannabis and tetrahydrocannabinols entries and Schedule 4 (cannabidiol) entry of the Poisons Standard.
What does the Schedule 4 entry for cannabidiol mean in relation to the allowed amount of cannabinoids?
Cannabidiol is included in Schedule 4 of the Poisons Standard in preparations for therapeutic use containing 2 per cent or less of other cannabinoids found in cannabis. The TGA website includes a link to the final scheduling decision for cannabidiol. The Delegate's reasons for the Schedule 4 entry mean that a 2% limit for total other cannabinoids in the Schedule 4 entry for cannabidiol apply to both human therapeutic and veterinary use. Outside of this Schedule 4 listing, cannabidiol is captured by the schedule entry for Cannabis in Schedule 9.
Who can import, cultivate, produce or manufacture products that contain cannabis and tetrahydrocannabinols?
In February 2016 the Narcotic Drugs Amendment Act 2016, took effect. This legislation allows the controlled cultivation of cannabis for medicinal and scientific purposes in Australia. Information relating to requirements for importation, cultivation, production and manufacture of medicinal cannabis products is available through the Office of Drug Control website.
Where is there more information on the scheduling process?
More information on the Scheduling process is available on the TGA website.
What does a 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.
Tags:questions & answers, cannabis
URL:https://www.tga.gov.au/node/730633