Become a natural heathcare prescriber

Natural heathcare in the Australian market is largely unapproved and treatment follows two commonly used pathways:

  1. SAS Category B, and
  2. Authorised Prescriber

The process for becoming a prescriber of natural healthcare may seem complex and unclear. Now, the TGA’s online portal provides a singular tool for applying to become registered for the TGA and State Health (if required) simultaneously.

There are many factors for prescribers to consider before applying to become registered prescribers of natural healthcare products, including but not limited to:

  • Dosing

  • Monitoring

  • Reporting

  • Drug-to-Drug interactions

  • Support

  • Education

  • Patient History

* This is not an exhaustive list, this list exists to inform potential prescribers of the many various factors to consider before applying to become a prescriber of natural healthcare.

SAS Category B

Generally, accessing this pathway should be used if the below pathways cannot be achieved;

This pathway is available to prescribing healthcare practitioners including Medical Practitioners and Nurse Practitioners. Under the SAS Category B, practitioners must provide clinical justification that includes:

  • Seriousness of the patient’s condition
  • Consideration for the use of medicines that are included in the ARTG
  • Potential risks and benefits of using the proposed unapproved medicine

SAS Category B Pathway
Key Features

  • Medical practitioners can apply

  • Other health practitioners can apply

  • Specified list of medicines

  • Requires approval from a HREC

  • Requires submission from the TGA for every patient

  • Requires six monthly patient reports

Authorised Prescriber

There are two types of accepted Authorised Prescriber pathways;

Established History of Use Lists

If the medicine you want to access is on the lists, you can apply to become an authorized prescriber. All listed criteria must be met in order to be an authorized prescriber of products on the established history of use lists. More information.

Authorised Prescriber
Key Features

  • Medical practitioners can apply

  • Other health practitioners can apply

  • Specified list of medicines

  • Requires approval from a HREC

  • Requires submission from the TGA for every patient

  • Requires six monthly patient reports

Standard Pathway

If the natural healthcare product is not on the established history of use list, you will need either:

  • HREC approval OR;
  • Endorsement from a specialist college

Where to find a HREC or Specialist College

The National Health and Medical Research Council maintains a list of HREC’s.

If you can’t access a HREC, you can seek endorsement from a specialist college. The college must have the relevant expertise relevant to the condition you want to treat. The list is maintained here.

To learn more about the standard pathway and Authorised Prescriber Scheme, click this link.

Want to know more?

Speak to a representative