Regulatory framework for medicinal cannabis
The medicinal cannabis regulatory framework in Tasmania is shaped by both State and Commonwealth legislation. Australia is a signatory to the United Nations' international convention ‘Single Convention on Narcotic Drugs 1961’. This is an international framework on the control of narcotic drugs.
- Administered by the Office of Drug Control (ODC)
- Provides the Commonwealth government with powers to meet obligations under the Single Convention relating to the regulation of drug manufacture.
- Amendments in 2016 to the Narcotic Drugs Act 1967 provide a framework for cultivation and manufacture of cannabis in Australia for medicinal and related scientific purposes under a national licensing and permit scheme.
- Administered by the Therapeutic Goods Administration (TGA)
- Provides a regulatory framework to ensure therapeutic goods (including medicines) supplied in Australia meet acceptable standards of efficacy, quality and safety.
- Medicines are approved and registered in the Australian Register for Therapeutic Goods (ARTG) to be legally supplied in Australia under this legislation.
- Unregistered medicines can legally be supplied under this legislation if approved via the TGA’s Special Access Scheme or Authorised Prescriber Scheme.
- The TGA have published Therapeutic Goods Order No 93 Standard for Medicinal Cannabis which specifies the minimum quality requirements for all unregistered medicinal cannabis products in Australia.
- Administered by the TGA
- A Commonwealth legislative instrument that classifies different medicines and poisons into ‘Schedules’.
- Tasmania adopts the Poisons Standard by the Tasmanian Poisons (Adoption of Uniform Standard) Order 2012.
- The regulatory measures that apply to different scheduled substances in individual state and territory poisons legislation depends on how the substance is scheduled in the Poisons Standard.
- Changes to scheduling of cannabis came to effect from 1 November 2016, meaning certain cannabis products became Schedule 8 medicines when used for medicinal purposes, in accordance with the Narcotics Drugs Act 1967 and the Therapeutic Goods Act 1989.
- Administered by the Australian Government
- Prohibits the personal importation of unregistered cannabis and cannabis-based products.
- Unregistered cannabis and cannabis-based products can be imported on a patient's behalf by a specified medical practitioner if they are licenced under the Customs Act to do so.
- The Customs Act also has a traveller’s exemption, allowing a person (or their carer) to enter Australia with up to 3 months' supply of a prescribed therapeutic good.
- Administered by the Tasmanian Department of Health.
- Outline the controls on scheduled substances (including scheduled medicines) to minimise harm to individuals and the community.
- Regulates manufacture, possession, prescribing, dispensing, supply, storage, recording and use of scheduled medicines and poisons.
- Regulatory controls vary depending on the schedule of the substance as listed in the Commonwealth Poisons Standard.
- Authorisation under Section 59E of the Tasmanian Poisons Act 1971 is required prior to issuing a prescription for a Schedule 8 medicinal cannabis product to a patient. No authorisation is required to prescribe a Schedule 4 medicinal cannabis product.
- Manufacturers and wholesalers are required to have the necessary licences under Tasmanian poisons legislation.
- Administered by Tasmanian Department of Police, Fire and Emergency Management.
- Prohibits the misuse of drugs and activities associated with the misuse of drugs.
- Offences apply for various activities relating to controlled plants and controlled drugs.
- Cannabis is a controlled plant or drug when the cultivation, manufacture, supply or use is not lawfully authorised.