Regulations


Regulation of cannabis medicines in Australia 

Cannabis medicines in Australia 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 therapeutic goods available for supply in Australia are safe and fit for their intended purpose. The TGA administers the Therapeutics Good Act 1989 (the Act), which establishes the regulatory framework for all medicines in Australia.

The Act provides a number of mechanisms to enable access to unapproved therapeutic goods. For medicinal cannabis products these include access through:

While there are additional legal requirements that must be met before cannabis products or medicines can be imported and supplied through these schemes, they do provide a pathway for access to these medicines to appropriate patients.

For more information on Australian Government regulations, visit the TGA’s access to medicinal cannabis products page.

Regulation of cannabis medicines in NSW

In NSW, there are a number of regulations that affect the operation of access to cannabis medicines. These include:

  • Poisons and Therapeutic Goods Act 1966 No 31
  • Drug Misuse and Trafficking Act 1985 No 226
  • Children and Young Persons (Care and Protection) Act 1998 No 157 – Section 175
  • Guardianship Act 1987 No 257
  • Poisons and Therapeutic Goods Amendment (Cannabis Medicines) Regulation 2019

For more information on cannabis medicine regulations outside the state of NSW, please contact your relevant State or Territory government department.