Cannabis, as a narcotic, is currently regulated under a myriad of Commonwealth and State laws, including the following:
- Therapeutic Goods Act 1989 (Cth);
- Narcotic Drugs Act 1967 (Cth);
- State and Territory laws, including the Drug Misuse and Trafficking Act 1985 (NSW);
- State and Territory laws which deal with poisons and therapeutic goods, such as Poisons and Therapeutic Goods Act 1966 (NSW); and
- Access to Medicinal Cannabis Act 2016 (Vic).
Cannabis is currently a drug listed in Schedule 9 (Prohibited Substances) of the Poisons Standard, except:
- when separately specified in the Schedules; or
- processed hemp fibre containing 0.1 per cent or less of tetrahydrocannabinol and products manufactured from such fibre.17
Prohibited Substances are substances which may be abused or misused, the manufacture, possession, sale or use of which should be prohibited by law except when required for medical or scientific research, or for analytical, teaching or training purposes with approval of Commonwealth and/or State or Territory Health Authorities.18
There are currently limited legal ways of accessing medical canabis including:
- with Commonwealth and/or State approval and therefore registration in the Australia Register of Therapeutic Goods (ARTG) (which Sativex has obtained, currently for limited treatment of spacicty); and
- for clinical trials under the existing TGA exemption for experimental uses and approval under State/Territory Drug Misuse and Trafficking legislation If approval is given, it is subject to strict conditions as to handling, storage, labelling, packing and record of receipt of disposition.
Whilst under the Therapeutic Goods Act 1989 (Cth) there are mechanisms in place to access medicinal cannabis products, due to cultivation and processing restrictions, trial products are ordinarily sourced from international suppliers.
The Commonwealth Government has passed the Narcotic Drugs Amendment Act 2016, which, upon full commencement, will amend the Narcotic Drugs Act 1967 (Cth).
The Narcotic Drugs Amendment Act 2016 (Cth) sets out:
- a licensing and permit scheme which regulates the cultivation of cannabis plants and the production of cannabis and cannabis resin. Cultivation and production, and related activities, under the scheme are for medicinal purposes or for research relating to medicinal cannabis;
- regulates a cannabis research licence;
- a separate licence and permit scheme which regulates the manufacture of the drug; and
- authorised inspectors have monitoring, inspection and enforcement powers to ensure that the Act is complied with.
Further information is available on the website of the Commonwealth Department of Health, Office of Drug Control at: https://www.odc.gov.au/qa
17 Poisons Standard, July 2016
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