2 May 2017

General

The Office of Drug Control (ODC) is part of the Commonwealth Department of Health and has been established to regulate the import, export and manufacture of controlled drugs as well as the domestic cultivation of medicinal cannabis. It administers the Narcotic Drugs Act 1967 and parts of the Customs (Prohibited Imports) Regulations 1956 and the Customs (Prohibited Exports) Regulations 1958 that relate to drugs.

Legislation

The Narcotic Drugs Act 1967 allows the Commonwealth to meet its obligations under the Single Convention on Narcotic Drugs, 1961 (the Single Convention), which include the regulation of narcotic drug manufacture and cannabis cultivation for medicinal and related research purposes.

The Narcotic Drugs Amendment Act 2016 included amendments to the Narcotic Drugs Act 1967 to permit the Commonwealth to allow for the first time cannabis cultivation for medicinal and related scientific purposes in accordance with the Single Convention.

Prior to the amendment all cannabis cultivation for medicinal and related scientific purposes was prohibited.

The Single Convention aims to combat drug abuse by coordinated international action. It seeks to limit the possession, use, trade, distribution, import, export, manufacture and production of drugs exclusively to medical and scientific purposes. It also combats drug trafficking through international cooperation to deter and discourage drug traffickers.

The legislative change provides a legal, domestic source of medicinal cannabis products for use in treating patients with illnesses where a health professional feels there may be some benefit. Domestic cultivation ensures sufficient supply for Australian patients and the production of a high quality product.

The legislation was changed due to a growing awareness of the potential benefits of medicinal cannabis products within the medical community; however, there is a global shortage of appropriate products that can be prescribed. The legislation provides for the cultivation and manufacture of Australian produced medicinal cannabis products, addressing the supply shortage and expanding the tools available to medical practitioners where appropriate.

Acquiring seeds

Consistent with Australia's obligations under the Single Convention on Narcotic Drugs 1961, seeds can only be sourced from lawful cultivation, including Australian growers of industrial hemp and anywhere globally where the industry is regulated, compliant with the Single Convention, and willing to export to Australia.

The Department of Agriculture and Water Resources (DAWR) advises that the hot water treatment required for import of cannabis seeds (50°C for 20 minutes) is a standard quarantine treatment for seeds for horticultural use and is not known to prevent seed germination. Importers are advised to undertake their own trials of imported seeds before importing large quantities. As an alternative to hot water treatment, DAWR has developed import conditions that allow cannabis seed to enter Australia subject to exporting government certification for disease freedom in conjunction with a fungicide treatment.

To import cannabis seed for sowing, all importers require an import permit issued by DAWR prior to import into Australia. Import permits can be lodged through BICON.

Yes. Seeds must be imported from a legal source (for example Canada, where medicinal cannabis is regulated) and can include global industrial hemp exporters. Further consideration regarding accessing seeds is underway. Information on import requirements is available on the Importers, Exporters & Travellers page.

You will be able to undertake research for medicinal cannabis purposes, which would include strain development.

Licences and permits

The Office of Drug Control will assess all applications on their ability to meet the legislated requirements and their clear connection to manufacturer demand. This process may require inquiries to third parties and physical site inspections to satisfy the delegate for the purpose of a decision. As such, there are no statutory requirements regarding processing times.

No. A cultivation licence and associated permits will allow for propagation as part of the cultivation process. New strain development would need a research licence.

This is necessary to ensure there is annual review of compliance with the licence. Any licence holder who has been compliant could generally expect to have a further licence granted. As the system matures, the licence periods may be subsequently increased to 2 or 3 years, but it would depend on the circumstances of the individual licensee.

The only grounds on which a licence can be rejected is if the legislative requirements are not met or one of the specific instances when a licence must not be granted exists. For instance, the Secretary must not grant a licence if not satisfied that the applicant (natural person or body corporate) or a business associate of the applicant is a fit and proper person or that the proposed location is not suitable. Other instances include if the supply of cannabis produced under a cultivation/production licence is not for supply to a licensed manufacturer.

Any applicant for a research licence will need to be able to demonstrate that it is either for research relating to medicinal cannabis or research relating to medicinal cannabis products.

It is the responsibility of the applicant to determine what strain is to be grown. This will be determined by the needs of the patient groups, through medical professionals and manufacturers. If the permit nominates that particular strain then the grower would be restricted to growing that strain under that permit.

The permit can indicate both the weight and number of plants permitted to be grown. Manufacturing permits will designate the weight of product in line with the requirements on Australia to report to the International Narcotics Control Board.

Any consideration of other applications is a matter for Government to consider. At this time, this is only for human therapeutic use.

The legislation requires licensees and their business associates to be 'fit and proper'. The 'fit and proper' requirements are set out in the legislation. Someone who has recently spent time in prison for drug offences would be unlikely to meet this requirement. Licences can be issued to individual persons or body corporates - all directors of a body corporate must be considered fit and proper.

Other matters that are taken into account in determining fit and proper include the applicant's financial background and circumstances, their capacity and capability to operate a medicinal cannabis enterprise and whether they are considered of 'good repute'.

Licensees can only employ suitable staff. It is the responsibility of the licensee to ensure that all employees meet the requirements of a 'suitable person' set out in the legislation and the regulations. Suitable staff must, as a minimum, be over 18 years old and have no conviction for a serious offence in the last 5 years.

Industrial hemp growers who plan to grow a crop for medicinal purposes must do so under the medicinal cannabis scheme. This means that plants grown for medicinal purposes must be kept separate from those grown for other purposes. Under the Single Convention the same rules apply irrespective of the amount of THC or CBD in a plant.

Cultivation

Individuals applying for a cultivation licence will have to demonstrate that they will be supplying to a licensed producer or manufacturer, as appropriate, and must also adhere to regulations and guidelines currently being developed by the Office of Drug Control. Further details on how to apply for a cultivation licence and any requirements that must be met will be released before the commencement date of 30 October 2016.

Applicants will also have to demonstrate that they and any relevant business associates are 'fit and proper persons', which will involve consideration of the applicant's criminal history, financial viability, business history and capacity to comply with licensing requirements.

In line with the Narcotics Drug Act and the Single Convention, in order to effectively regulate and control the domestic cultivation of cannabis, 'mixed crops' will not be permitted. Cannabis grown for medicinal purposes will be restricted to that one purpose.

The ODC will undertake regular and random property inspections to assess compliance with regulations. All licensees will also be required to notify ODC of material changes that are relevant to ongoing compliance with the Narcotic Drugs Act 1967 and the conditions of the licence.

No. The number of cultivators required will be demand driven. Australia is a signatory to the Single Convention and has an obligation to avoid the accumulation of cannabis in excess of domestic requirements.

International experience suggests that only a small number of cultivators will be necessary to meet domestic demand.

For security reasons, the Office of Drug Control will not publicise cultivation locations.

This is controlled by the Commonwealth Department of Agriculture and Water Resources (DAWR) and relevant state and territory departments and agencies. Conditions on the importation of cannabis seeds have been developed to ensure seeds are not carrying pests or diseases with them. You will need to apply for and receive an import permit from DAWR before you can import seed.

DAWR has completed a pest risk analysis for seeds, and has published the import conditions on their import conditions system, BICON. To import cannabis seed for sowing, all importers require an import permit issued by DAWR. Import permits can be lodged through BICON.

DAWR is also working on an import protocol for tissue cultures and other forms of nursery stock. Until import conditions are published, import permit applications for tissue culture and nursery stock will not be accepted by DAWR.

Your buyers will be the manufacturers of medicinal cannabis products or manufacturers licensed to manufacture drugs for the purpose of research relating to medicinal cannabis products. The quantity of cannabis allowed to be cultivated will depend on the supply contract with the manufacturer which in turn will depend on the requirements of the medical professionals and patients.

All applications for cultivation licences will be assessed for compliance with legislative requirements and either granted or rejected on those grounds. The amount to be grown by individual licensees will be based on the capabilities of the cultivator and requirements of the manufacturer. Cultivation locations and organisations have not been pre-determined as all applications will be assessed on a case-by-case basis against the legislated criteria.

It is difficult to assess the predicted tonnage of cannabis required until we know more about patient numbers and likely dosage requirements. Various estimates suggest somewhere between 5 and 10 tonnes is likely to satisfy Australian patients which could be fulfilled with approximately 2 hectares of greenhouses or 10 hectares of broad acre crop. Under the Single Convention stockpiling is not allowed. However, there will be allowances for storage of material to satisfy peaks and troughs in demand, potentially up to 6 months' worth. We will be avoiding stockpiling by linking permits to product quantity required by the patient group.

No; that would not be consistent with the Single Convention.

It is unlikely that the growing environment will be mandated; however, there are a range of security and other conditions (including satisfying your manufacturing partner on quality) that you will have to be able to comply with. In addition, cultivators must prevent spread of their crop or cross-pollination of their crop, either from a legal industrial hemp crop or from illegal crops grown nearby.

This, together with the relatively small amounts required to meet patient needs, is likely to make growing outdoors difficult.

This will be determined by what the manufacturer requires to fulfil patient needs.

It depends on what the manufacturer requires to meet patient needs. The limits will then be set out in the permit.

If GMO seed is to be used, it would have to satisfy all regulatory requirements in Australia, including those of the Office of the Gene Technology Regulator and states and territories. We are not aware of any countries using genetically modified cannabis crops.

All applicants will need to be able to demonstrate they have an interested manufacturer and specific processes in place to meet the legislative requirements (including physical security) and would be able to adhere to the regulations and guidelines. Before providing a permit we would undertake an inspection of the facilities to ensure the applicant has fulfilled the provisions of the licence.

Manufacturers

Individuals wishing to apply for a licence to manufacture medicinal cannabis products will need to adhere to regulations currently being developed by the Commonwealth. Guidance documentation will also be developed to assist.

Applicants will have to demonstrate that they and any relevant business associates are 'fit and proper persons', which will involve consideration of the applicant's criminal history, financial viability, business history and capacity to comply with licensing requirements. They will also need to obtain relevant state and territory licence/approvals to manufacture medicinal cannabis products.

No. The number of manufacturers required to fulfil the needs of the patient groups is demand driven and currently unknown. Australia, as a signatory to the Single Convention, has an obligation to not allow the accumulation of cannabis in excess of domestic requirements.

Manufacturers will need to meet the conditions outlined in their licence to manufacture medicinal cannabis products. The conditions aim to protect patient safety by ensuring the production of high quality products.

Manufacturing of medicinal cannabis products is subject to provisions under the Therapeutic Goods Act 1989, as well as any relevant state or territory legislation. Potential manufacturers must ensure that they comply with all legislative requirements before commencing manufacturing operations.

Yes, a manufacturer will be able to hold both a manufacturing licence and a medicinal cannabis licence and develop a vertically integrated supply chain.

The manufacture of medicinal cannabis products will be determined by reference to patient need, therefore the products authorised to be manufactured will be those supported by clinical evidence. The determining factor will be the products that approved medical prescribers are willing to prescribe, noting that state/territory and TGA approvals will then be required for their supply.

Yes. The definition of 'manufacture' under the Single Convention refers to the carrying out of any process by which a drug may be obtained and includes refining as well as the transformation of one drug into another drug. Extraction is the removal of the cannabinoids from the plant.

Yes, it is possible but the necessary approvals under customs legislation would be required.

Yes, provided both licences are obtained.

The nature of medicinal cannabis products manufactured under a licence will be determined by patient need and what medical practitioners are authorised to prescribe based on supporting clinical evidence. It is up to the manufacturer to deliver those products using the raw materials that licensed cultivators can provide.

Compliance

We will be developing our own in-house inspection process. We will require regular reporting so we know how much is being produced and to satisfy our obligations to report to the International Narcotic Control Board. It will be a condition of your licence that you advise us of any breaches of conditions or of the licence. Records required to be kept will be viewed when inspectors visit.

We expect industry to have systems in place to undertake internal auditing and ensure compliance with the licence conditions and the legislation.

Medicinal cannabis products will be prescription medicines. Under the Therapeutic Good Act, companies are not permitted to advertise prescription medicines to the public.

Cost-recovery

Currently, the cost model is being developed and no final decisions on fees and any charges have been made.

Export

To enable sufficient product to be available to address the needs of Australian patients, export of domestically grown cannabis products will not be permitted at this time.

The scheme is limiting supply to domestic purposes only for an initial period. This is necessary to establish the system of controls and to ensure they are robust, demonstrating to the international community, in particular the International Narcotics Control Board and potential trading partners, that Australia has an appropriate system for managing the risks of diversion. Under the Act it will be possible to provide for exports at some further date.

Import

Yes, there are existing arrangements for the importing of cannabis. There is, currently, not a significant supply of cannabis or medicinal cannabis products available for import, which is why the Government decided to legalise the cultivation for this purpose. Finished products can be imported subject to customs and therapeutic goods legislative requirements as well as any applicable state and territory requirements.

Imports, exports and domestic production are limited internationally through 'consumption estimates' that are controlled by the United Nations' International Narcotic Control Board. These are estimated on likely demand for a given narcotic annually. Estimates are varied if legitimate demand exceeds initial estimates.

Patients

The states and territories in conjunction with the Therapeutic Goods Administration (TGA) are working together to ensure patient access provisions are as uniform as possible. Questions about suitability and availability of medicinal cannabis products should begin with your medical practitioner, who may need to refer you to a suitable specialist. A prescribing practitioner will need to be approved under Commonwealth law and, depending on the nature of the product, also under relevant state and territory law. They will only be authorised to prescribe medicinal cannabis products for conditions where there is satisfactory scientific evidence supporting such use.

Access to medicinal cannabis products cultivated and manufactured within Australia will occur sometime after October 2016. Certain imported products are currently available to individual patients through the Special Access Scheme and clinical trials.

In line with the Single Convention, the cultivation and importation of cannabis for recreational use will remain prohibited.

Currently no specific conditions have been established by the Commonwealth. The states and territories have a key role in this area and a number are setting up advisory committees for that purpose. Several are also coordinating clinical trials of specific medicinal cannabis products. Unique to Australia is our model of availability only under a prescription and dispensing through pharmacists, so medical conditions that may potentially be amenable to treatment with medicinal cannabis remain largely a question for the medical profession. Both the states and territories and the TGA will have a role in approving patient access.

States and territories have general responsibility under existing legislation regulating the supply of drugs.

Hemp products and medicinal cannabis

Hemp oil is an extract of a plant in the genus Cannabis. It may contain various cannabinoids such as cannabidiol (CBD) and tetrahydrocannabinols (THC). Generally hemp oil will contain less than 50mg/kg of tetrahydrocannabinol (THC).

Hemp oil is not to be confused with another product known as hemp seed oil.

Hemp seed oil is the oil obtained by cold pressing the ripened fruits (seeds) of a plant in the genus Cannabis.

Hemp seed oil does not contain cannabinoids, such as CBD, apart from trace levels that may be present from inadequate cleaning of the seeds.

Hemp and cannabis are both terms used to describe a plant in the genus Cannabis.

Colloquially, hemp is a term used to describe any cannabis plant that is cultivated for fibre and seed. It will generally contain very low levels of THC.

For the purpose of the Narcotic Drugs Act 1967 (the Act) an 'extract of cannabis' is any substance that may be obtained by the separation of components from a plant in the genus Cannabis using solvents or other means.

Extraction of a plant in the genus Cannabis is considered to be 'manufacture' under the Act and requires a manufacture licence.

There is no difference; hemp oil is the extract of cannabis. The manufacture of hemp oil requires a manufacture licence under the Act.

The Act implements the manufacturing obligations of the Single Convention on Narcotic Drugs of 1961 (the Single Convention), to which Australia is a signatory.

Under the Single Convention an extract of cannabis is a drug; therefore by definition 'hemp oil' is also a drug and is subject to the manufacturing obligations under the Single Convention.

All cultivation of cannabis is controlled under the Single Convention, and under the Act, except for cannabis cultivated exclusively for fibre and seed.

The Australian Government has not changed the classification of hemp oil. Since the commencement of the Act in 1967, any person manufacturing hemp oil must have a licence to manufacture under the Act.

The Single Convention and Australian law is silent on the levels of THC in cannabis extracts. All extracts of cannabis are drugs, regardless of specific cannabinoid levels.

No. Hemp seed oil is an extract of cannabis seeds and does not contain any extracts from the cannabis plant. Therefore, by definition, hemp seed oil is not a drug under the Act. In addition, hemp seed oil does not contain anything more than trace amounts of cannabinoids.

If a product labelled 'hemp seed oil' contains cannabinoids, such as CBD, it is not hemp seed oil. The product may have been mislabelled, mixed with hemp oil or adulterated with CBD.

Hemp oil is a drug.

Hemp oil that is a medicinal cannabis product may only be accessed by prescription from your doctor who has been granted Special Access Scheme Approval or is an Authorised Prescriber.

Hemp oil may only be imported if the importer holds a licence and permit to import from the Office of Drug Control. Information relating to licences and permits can be found on the import and export page of this site.

No, unless the product is hemp seed oil, then it is not legal to purchase or import without a doctor’s prescription, Special Access Scheme approval, and if from overseas, import permission.

Maybe. Many products are incorrectly labelled as containing 'hemp oil' and actually contain 'hemp seed oil'.

If the product contains more than 50mg/kg of cannabinoids, such as cannabidiol (CBD), it is a drug and therefore requires a doctor’s prescription and Special Access Scheme approval.

No. Hemp oil, being an extract of cannabis, is a drug.

Drugs may not be used in cosmetics unless approved, with a therapeutic claim, by the TGA under the Therapeutic Goods Act 1989.

No

Regulation 5 of the Customs (Prohibited Imports) Regulations 1956 does not permit the import of hemp seed or hemp seed oil unless for medicinal or scientific purposes.

The Department notes the Australia and New Zealand Ministerial Forum on Food Regulation recently supported the draft FSANZ standard to allow low-THC hemp seed to be sold as food and has also supported the establishment of an implementation and monitoring working group.

Any changes to the import regulations concerning the import of hemp seeds as food will be announced in due course.

The Office of Drug Control is part of the Health Products Regulation Group