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.

Commonwealth legislation

The Narcotic Drugs Act 1967

• 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.

The Therapeutic Goods Act 1989

• 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.

The Poisons Standard (SUSMP)

• 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.

The Customs Act 1901

• 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.

Tasmanian legislation

Poisons Act 1971

Poisons Regulations 2018

• 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.

Misuse of Drugs Act 2001

• 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.