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During October 2016, Australia’s federal legislation went into effect. The government now allows patients and doctors reliable and legal access to cannabis. The legislation allows cultivation, production, and manufacturing of medicinal cannabis products in Australia. The Therapeutic Goods Act (TGA) establishes the regulatory framework for all medicines in Australia, but doesn’t currently specify which illnesses are eligible for special access to medical cannabis.
In order to get a legal and steady supply of medical cannabis, doctor’s can become “authorized prescribers” of medicinal cannabis to patients with particular medical conditions. Patients can also go to pharmacies supplied by wholesalers, such as Health House International, to fill a prescription.
By May 2017, Australia received its first shipment of 60ml bottles of medical grade oil from Canada. The oil is available in three different strengths to suit different illnesses.
So far, Australia has issued 30 permits to allow the import of cannabis products from Canada, Switzerland, and Netherlands. The country is currently working to streamline an easier access path for patients to acquire medical cannabis.
Individual consumers cannot apply to obtain approval to import and access unapproved medicinal cannabis products. Such access can only be arranged through an Australian registered medical practitioner (a doctor) with appropriate qualifications and/or expertise for the medical condition requiring treatment. This doctor should first apply and obtain approval under the applicable state or territory laws to prescribe a medicinal cannabis product to a particular patient. Please note the rules relating to medicinal cannabis products may vary between states and territories and could affect whether or not you can be prescribed those medicines in that jurisdiction.
Subsequently, the doctor can apply on the patient's behalf for approval to import and supply these products through the Special Access Scheme (SAS). Alternatively, the doctor can apply to become an Authorized Prescriber. Approval or authorization is granted on a case-by-case basis.
Additionally, if both state and TGA approval requirements are satisfied, the doctor (or pharmacist/hospital on the doctor's behalf) wishing to import the product will then need to obtain import permits from the Office of Drug Control (ODC). The office administers the following schemes that allow eligible medical practitioners to apply for the importation and supply of medicinal cannabis products that are not registered on the Australian Register of Therapeutic Goods (ARTG):
- Authorized Prescriber Scheme
- Special Access Scheme
While there are additional legal requirements that must be met before medicinal cannabis products can be imported and supplied through these schemes, they do provide a pathway for access to these medicines to appropriate patients.
Australia also allows access for the purposes of clinical trials, which may be conducted to develop an evidence base to support safety and efficacy of medicines.
Cannabis remains a highly regulated drug in Australia and the use and supply of cannabis for non-medicinal purposes (for example, recreational use) is illegal in Australia, in accordance with applicable Commonwealth, state, and territory laws.
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