Access to unapproved Schedule 8 cannabis medicines

The 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 Therapeutic Goods Act 1989, which establishes the regulatory framework for all medicines in Australia.

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

  • Authorised Prescriber Scheme (AP)
  • Special Access Scheme (SAS)
  • Clinical trial schemes (CTN/CTX)

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

For further information please visit the TGA website.

The TGA has a responsibility to encourage the use of medicines that are included in the Australian Register of Therapeutic Goods (ARTG), as these products have been evaluated to ensure they meet strict standards of safety, quality and effectiveness.

For this reason, it is expected that medical or nurse practitioners will have considered all clinically appropriate treatment options that are included in the ARTG before applying to access an unapproved cannabis medicine under the SAS. All prescribers must practice within their scope of practice and be competent to assess evidence to use unapproved medicines.

Where products in the ARTG are found to not be clinically suitable, the SAS provides a pathway for prescribers to access unapproved products for individual patients on a case-by-case basis. The TGA does not vouch for the quality, safety and effectiveness of unapproved products accessed through SAS and the prescriber and patient (via informed consent) accept responsibility for any adverse consequences of treatment.

Schedule 8 medicines that are extemporaneously compounded for a particular person for therapeutic application to that person are exempted from registration on the ARTG and from requiring TGA approval. However, there are NSW authority requirements for extemporaneously compounded Schedule 8 medicines.

Current as at: Tuesday 8 November 2022
Contact page owner: Pharmaceutical Services