Cultivators (also commonly referred to as Producers or Growers) – Cultivators are responsible for growing cannabis. Mature plants are harvested and transferred to a Processor.
Australia Cannabis Cultivation Center Licenses
A cultivator must hold either a medicinal cannabis licence or a cannabis research licence granted by the ODC to cultivate cannabis for medicinal or research-related purposes.
A medicinal cannabis licence authorises either cultivation (the growing of cannabis plants) or production (the separation of cannabis and cannabis resin), or both.
There is no restriction on the number of licences that can be granted; however, under international conventions, the overall quantities produced must not exceed domestic requirements. Therefore, the number of cultivators that will be licensed to grow and supply cannabis to licensed manufacturers will depend on the demand from prescribers and the patient groups they treat.
ODC will not be able to grant a medicinal cannabis licence unless it is satisfied that the cultivation and production of cannabis is for supply either to a person licensed to produce cannabis or a person licensed to manufacture medicinal cannabis products. In practice, this may mean the applicant demonstrating that they are known to the producer/manufacturer and that producer/manufacturer is willing to enter into contracts for the supply of cannabis raw material.
When applying for a permit, a licensee will need to have, and submit to ODC, a contract with the producer/manufacturer that satisfies any requirements set out in the regulations.
Mixed use crops (i.e. separating cannabis from the plant for medicinal/research purposes and using the remainder for industrial purposes) are not permitted under both Australian domestic legislation and international drug conventions. Therefore, cannabis grown for medicinal purposes will need to be grown and used solely for that purpose. A person may hold a medicinal cannabis licence from ODC and an industrial hemp licence from the relevant state/territory, but will have to maintain strict separation between the two crops and comply with the applicable security requirements. Regular site inspections will be undertaken to ensure compliance.
A cannabis research licence authorises the cultivation and/or production of cannabis for research related to the medicinal use of cannabis.
In order to obtain a cannabis research licence, an applicant will need to explain the purpose of the research and how it relates to medicinal cannabis and/or medicinal cannabis products. See the forms and guidance section of the website for further guidance on research activities.
A cultivator may cultivate for both medicinal purposes and related research purposes, but they will need to hold licences and appropriate permits for each.
In all cases the licensee will need to hold a permit(s) issued under the ND Act before any cultivation or production commences.
What kind of tracking system do I need to operate a Cultivation Facility?
Most regulatiory frameworks require an extensive seed-to-sale cannabis tracking system to monitor cultivation efforts and inventory. Our cultivation seed-to-sale-tracking solution provides comprehensive data tracking with an emphasis on compliance. Customized to meet the unique regulatory frameworks in each country, BioTrack also features an all-in-one business tool to help you operate every aspect of the cultivation business by itself, or as part of the vertically-integrated cannabis business.
Manufacturers can produce medical cannabis byproducts using the cannabis plant.
Australia Manufacturer Licences
A person may apply for a licence to manufacture narcotic drugs involving cannabis under the Narcotic Drugs Act 1967 (ND Act).
You must hold both a ND Act licence and a permit before manufacture can occur.
There are several factors to consider when making an application.
- Can I apply for a licence to manufacture medicinal cannabis now?Applications to manufacture medicinal cannabis products are now being accepted. The relevant forms and guidance materials are available on the here.
- Medicinal cannabis products must be manufactured to Good Manufacturing Practice (GMP).The Therapeutic Goods Administration (TGA) is responsible for licensing GMP. Refer to the TGA good manufacturing practice overview.While it is not a prerequisite to hold a GMP licence before applying for a Commonwealth manufacturing licence, you must provide evidence that you hold a GMP licence when applying for a permit to manufacture.
- Supply is controlled.Supply of medicinal cannabis products is limited to clinical trials, Special Access Scheme and Authorised Prescribers (AP). State and territory governments may also have additional requirements for supply, such as patient cohorts or specific indications.Manufacturing licences will be refused if the applicant cannot demonstrate that supply will be in accordance with all pre-requisites.
- State/Territory Licences.It is not a prerequisite to hold a state/territory licence authorising activities related to Schedule 8 (Controlled Drugs) before applying for a Commonwealth Manufacturing Licence. However you must provide evidence that you hold the necessary licences/approvals (if required by the State or Territory where the manufacturing site is located) when applying for a manufacturing permit.
- Export of medicinal cannabis is limited.The export of medicinal cannabis (plant material, extracts and preparations) is not permitted unless the product is registered on the Australian Register of Therapeutic Goods (ARTG) and the exporter holds a licence and permit to export drugs from the Office of Drug Control.An Export Only Listing under the Therapeutic Goods Act 1989 is not sufficient under the ND Act to allow for exportation.
- Import of cannabis material is permitted for manufacture of medicinal cannabis products.A person holding a Commonwealth licence to manufacture narcotic drugs involving cannabis and a Commonwealth licence and permit to import drugs, may import cannabis material, including extracts, for use in manufacture.However, the importer must:
- hold a state/territory licence allowing possession of cannabis material before import approval may be granted.
- only import from countries where cannabis for medicinal use is approved at the federal level.
General information
Persons licensed under the ND Act to manufacture medicinal cannabis products will be able to enter into contractual arrangements with cannabis cultivators/producers to produce cannabis.
Cultivation of cannabis may not commence until both parties (cultivator and manufacturer) hold permits.
A permit may not be issued if the manufacturer does not hold the appropriate state/territory licences/authorisations or if the manufacturer does not hold a GMP licence from the TGA.
Applicants will be subject to a fit and proper test. This may be in addition to any test undertaken by a state/territory Government.
A licence issued under the ND Act does not compel a state or territory to issue any applicable licences required (i.e. licence to manufacture, wholesale, supply) under their respective legislation.
Information will be updated here as it becomes available.
Australia is yet to release a final list of qualifying conditions for patients to access medical cannabis.
Caregivers grow and process cannabis on behalf of patients. They cannot charge for cannabis, only recoup the costs of goods.
Current Estimated Patient Counts: TBD
State and territory governments, in conjunction with the Therapeutic Goods Administration (TGA), will determine which patient groups will receive access to medicinal cannabis products and what medicinal cannabis products can be manufactured.
