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For questions concerning the import of hemp oil and hemp seed oil see our page on importing hemp products.
The Office of Drug Control (ODC) is part of the Commonwealth Department of Health and was 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 (the Act) and parts of the Customs (Prohibited Imports) Regulations 1956 and the Customs (Prohibited Exports) Regulations 1958 that relate to drugs.
The Narcotic Drugs Act 1967 (the Act) allows the Commonwealth to meet its obligations under the Convention on Narcotic Drugs, 1961 (the Convention), which includes 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 the Act to permit the Commonwealth to allow for the first time cannabis cultivation for medicinal and related scientific purposes in accordance with the 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.
The Narcotic Drugs Act 1967 has been amended to implement a number of the recommendations made by Professor John McMillan AO in his review of the Act on which he reported in 2019.
The amendments to the Narcotic Drugs Act made by the Amendment Act and relevant transitional provisions will commence on a day to be fixed by proclamation, but they must commence by 24 December 2021 at the latest.
A delay in commencement is required to make the necessary changes to the Narcotic Drugs Regulation 2016 and to prepare administratively for the new framework.
It is not anticipated that the full six months would be required and the Office of Drug Control will work towards effecting the changes as soon as practicable.
Industry and stakeholder information sessions will be held prior to the commencement of the Act changes.
The main change is to adopt a single and perpetual licence. There are also some measures which implement other review recommendations, as well as some minor amendments to ensure that the framework operates efficiently and effectively.
The consolidation of the need to apply for up to three licences into one licence will remove duplication. Additionally, the large majority of these single licenses will be perpetual, thus reducing regulatory burden. For example, there will no longer be a requirement to go through a regular licence renewal application and assessment process for potentially multiple licences relevant to an entity's business operations.
A perpetual licence is a licence granted without a fixed end date. It is anticipated that most licences with be granted on a perpetual basis, although the ability to grant a time limited licence where appropriate will be preserved. Licences that authorise non-commercial research will be time limited.
Licence holders will still be able to surrender a licence when it is no longer required. The Office of Drug Control will be able to suspend or revoke licences for where required or appropriate, such for as non-payment of annual charges or compliance concerns.
The actual carrying out of activities authorised by a licence is controlled by permits, which will continue to be time-limited.
No. Within the single licence structure, each licence will specify the activities which are authorised. This is because some aspects of the licencing process depend on which of these activities are proposed. For example, manufacture may require different security arrangements to cultivation.
This structure gives more flexibility to expand the coverage of the licence depending on the circumstances of each licence holder, rather than requiring a licence holder to apply for separate licences for different parts of the cannabis lifecycle.
Licensees can apply for a variation to add an activity at any time, for example, to add manufacture to a single licence that only authorises cultivation.
Consistent with Australia's obligations under the Single Convention on Narcotic Drugs 1961 (the Convention), 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 Convention, and willing to export to Australia.
The Department of Agriculture, Fisheries and Forestry (DAFF) 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, DAFF 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 DAFF 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 licences and permit requirements is available on the Importers page.
You will be able to undertake research for medicinal cannabis purposes, which would include development.
The Office of Drug Control (ODC) 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. While there are no statutory requirements regarding processing times, the ODC endeavours to process applications within 195 business days. Further information regarding timeframes can be found on the application process page of the website.
No.
A cultivation and production licence and associated permits will allow for propagation as part of the cultivation process. New strain development would need a research licence.
The decision maker for licences may grant a licence when he/she considers it appropriate to do so in all the circumstances. There are particular circumstances where the decision maker must refuse a licence - see sections 8G, 9F, 11J and 11K of the Narcotic Drugs Act 1967 (the Act). 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 suitable. Other instances include if the supply of cannabis produced under a cultivation and production licence is not for supply to a licensed manufacturer.
No.
All medicinal cannabis applications are assessed on their suitability to meet the legislated requirements under the Narcotic Drugs Act 1967, and the Single Convention on Narcotic Drugs 1961.
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. The Office of Drug Control will not be considering the worthiness or likelihood of success of the proposed research.
It is the responsibility of the applicant to determine what type 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 type then the grower would be restricted to growing that type 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 United Nations' International Narcotics Control Board.
No.
The Narcotic Drugs Act 1967 only provides for the cultivation, production and manufacture of medicinal cannabis. 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 - see section 8B of the Narcotic Drugs Act 1967. 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.
The cultivation of cannabis for medicinal purposes is only permitted in Australia under the Commonwealth Narcotic Drugs Act 1967 (the Act). The Act does not support the cultivation of medicinal cannabis for personal use.
Applicants may apply for a new licence on our website Application forms and Guidance
Individuals applying for a cultivation licence must demonstrate that they will be supplying to a licensed producer or manufacturer, as appropriate, and must adhere to regulations and guidelines developed by the Office of Drug Control (ODC).
In line with the Narcotics Drug Act 1967 (the Act) and the Single Convention on Narcotic Drugs 1961 (the Convention), in order to effectively regulate and control the domestic cultivation of cannabis, 'mixed crops' are not permitted. Cannabis grown for medicinal purposes is restricted to that one purpose.
The ODC will undertake regular and random property inspections to assess compliance with regulations. All licensees are required to notify the ODC of material changes that are relevant to ongoing compliance with the Narcotic Drugs Act 1967 (the Act) and the conditions of the licence.
No.
The number of cultivators required is demand driven. Australia is a signatory to Single Convention on Narcotic Drugs 1967 (the 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.
Advertising the location of a facility would affect the security of the cannabis and increase the risk of diversion. Therefore, applicants should not advertise any details about the location of the facility.
This is controlled by the Commonwealth Department of Agriculture, Fisheries and Forestry (DAFF) 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 DAFF before you can import seed.
DAFF 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 DAFF. Import permits can be lodged through BICON.
DAFF 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 DAFF.
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 are assessed for compliance with legislative requirements and either granted or rejected on those grounds. The amount to be grown by individual licensees is based on the capabilities of the cultivator and requirements of the manufacturer. Cultivation locations and organisations have not been pre-determined as all applications are 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 on Narcotic Drugs 1961 (the 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.
The growing environment is not 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.
It depends on what the manufacturer requires to meet patient needs. The limits will then be set out in the permit.
No.
This is not regulated by the Narcotic Drugs Act 1967.
If genetically modified seed (GMO) 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 the relevant states and territories. We are not aware of any countries using GMO cannabis crops.
No.
Licences have been granted while facilities are at the design stage. However, applicants must demonstrate their business approach and understanding of the requirements under the Narcotic Drugs Act 1967 (the Act),that they meets the necessary fit and proper requirements, that have planned processes in place to meet the legislative requirements (including physical security) and would be able to adhere to the regulations and guidelines. A growing facility ready for inspection is required before a permit is granted to ensure the applicant has fulfilled the provisions of the licence.
Hemp is a term defined under State and Territory law which applies to the Cannabis plant. Typically in most jurisdictions hemp may not contain more that 1% tetrahydrocannabinol (THC).
The Office of Drug Control regulates the cultivation and production of cannabis for medicinal purposes. The cultivation and production of industrial hemp is regulated by state and territory government. For further information on requirements, please contact your relevant state or territory government.
Yes, if you also hold a licence and permit under the Narcotic Drugs Act 1967, and dual use of the crop does not contravene your State/Territory hemp licence.
No, you only need a licence and permit under the Narcotic Drugs Act 1967. However, you may not use the crop for fibre or food production (seed only), unless you also hold a State/Territory hemp license.
No, you must comply with State/Territory hemp requirements which generally limit THC content to 1% or less.
For crops up to 1% THC, the Office of Drug control will consider the current arrangements if you already hold a hemp licence. Generally the crop security requirements will be less for the plant material compared to high THC crops. Information on crop security are available on our website.
Applicants may apply for a new licence on our website Application forms and Guidance.
Individuals wishing to apply for a licence to manufacture medicinal cannabis products will need to adhere to regulations and guidelines developed by the Office of Drug Control (ODC)
No.
The number of manufacturers required to fulfil the needs of the patient groups is demand driven. Australia, as a signatory to the Single Convention on Narcotic Drugs 1961 (the 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 (the TG Act), 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 is able to hold a manufacturing licence and a cultivation and production licence and/or a cannabis research 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 on Narcotic Drugs 1961 (the 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.
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.
The ODC does not regulate the manufacturing standards of medicinal cannabis. The Therapeutic Goods Administration (TGA) is responsible for governing and regulating the manufacturing standards of medicinal cannabis products in Australia.
Under the Therapeutic Goods Act 1989, a Good Manufacturing Practice (GMP) licence is required and this will regulate the standards for activities such as; production, processing, assembling, packaging, labelling, storage, sterilisation, testing, release for supply.
More information can be found on the TGA website.
Wholesaling is generally regulated by state and territory governments of Australia. However goods may not be supplied by wholesale unless registered in the Australian Register of Therapeutic Goods (ARTG).
Yes.
We require regular reporting so we know how much is being produced and to satisfy our obligations to report to the United Nations' 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 Goods Act 1989 (the TG Act), companies are not permitted to advertise prescription medicines to the public.
Provided domestic supply of medicinal cannabis is not affected, the following products are eligible for export if granted a licence and permit to export
Note: Cannabis or cannabis resin that has not undergone processing under a GMP licence may not be exported.
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.
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 needs 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. Certain imported products are currently available to individual patients through the Special Access Scheme and clinical trials.
In line with the Single Convention on Narcotic Drugs 1961 (the Convention), the cultivation and importation of cannabis for recreational use remains prohibited.
The change to the ACT legislation has no bearing on the legislation the Office of Drug Control operates under.
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 Therapeutic Goods Administration (TGA) will have a role in approving patient access.
States and territories have general responsibility under existing legislation regulating the supply of drugs.
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