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
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
There are currently limited legal ways of accessing medical
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
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
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
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
17Poisons Standard, July
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
To print this article, all you need is to be registered on Mondaq.com.
Click to Login as an existing user or Register so you can print this article.
We discuss this recent decision which considered classification levels.
Some comments from our readers… “The articles are extremely timely and highly applicable” “I often find critical information not available elsewhere” “As in-house counsel, Mondaq’s service is of great value”
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).