Regulation of cannabis medicines in Australia
In Australia, like all medicines, cannabis medicines are regulated at both the Australian Government and State / Territory level.
At a national level, the Australian Government’s Therapeutic Goods Administration (TGA) is responsible for ensuring that the therapeutic goods available in Australia are safe and fit for their intended purpose. The TGA administers the Therapeutics Good Act 1989 (Cth) (the Act), which establishes the regulatory framework for all medicines in Australia.
Under the Act, there are several pathways for accessing unapproved therapeutic goods. For cannabis medicines, these include access through:
- The Authorised Prescriber Scheme (AP)
- The Special Access Scheme (SAS)
- Clinical trials
These pathways enable patients to access unregistered cannabis medicines provided certain legal requirements are met.
For more information on how the Australian Government regulates cannabis medicines, visit the TGA’s website.
Regulation of cannabis medicines in NSW
In NSW, legislation governing access to cannabis medicines includes the:
- Poisons and Therapeutic Goods Act 1966 (NSW)
- Drug Misuse and Trafficking Act 1985 (NSW)
- Children and Young Persons (Care and Protection) Act 1998 (NSW)
- Guardianship Act 1987 (NSW)
- Poisons and Therapeutic Goods Regulation
For information about the regulatory framework for cannabis medicines in other states and territories, please contact the relevant health department. Contact details for the health departments in each Australian state and territory can be found on the TGA's website.