The Therapeutic Goods Administration (TGA) has recognised that there are circumstances where patients may require access to medicines, medical devices and/or biologicals that have not been approved by the TGA. This includes medicinal cannabis.
The TGA’s Authorised Prescriber Access Scheme provides a mechanism by which a medical practitioner may be granted authority to become an Authorised Prescriber of a specified unapproved therapeutic good or class of unapproved therapeutic goods to specific patients or classes of recipients who have a particular medical condition (https://www.tga.gov.au/form/authorised-prescribers). Medical practitioners seeking to become Authorised Prescribers need to have their application approved by a HREC or endorsed by a specialist college.
Information about Medicinal Cannabis access schemes can be found on the TGA website available at: https://www.tga.gov.au/access-medicinal-cannabis-products-steps-using-access-schemes
The ANZCCP HREC is now accepting applications by medical practitioners seeking to become Authorised Prescribers.
State and Territory Regulations
The TGA advise that: ‘The medical practitioner should check for any relevant state/territory approvals to prescribe a particular medicinal cannabis product for the particular patient, noting that these may vary depending on the scheduling and between jurisdictions’ (https://www.tga.gov.au/access-medicinal-cannabis-products-steps-using-access-schemes). Applicants are advised to check their state and territory regulations prior to submitting their application to the ANZCCP HREC.
Policy and Procedures
ANZCCP has a policy and procedures that set out the principles and processes for applications by medical practitioners for Authorised Prescriber status under the TGA’s Authorised Prescriber Scheme.
Terms of Reference
The aim of these terms is to set out the principles by which the ANZCCP Human Research Ethics Committee (HREC) will receive and where appropriate approve applications from medical practitioners to access and prescribe unapproved therapeutic goods under the Therapeutic Goods Administration’s (TGA’s) Authorised Prescriber Scheme.
Click here to read the TOR: Terms of Reference
The aim of these procedures is to set out the processes for applications to the ANZCCP Human Research Ethics Committee (HREC) under the Therapeutic Goods Administration’s (TGA’s) Authorised Prescriber Scheme.
Click here for the Procedures: Procedures
Application Due Dates and HREC Meeting Dates
The HREC meets on a regular basis at least every 3 months. The HREC holds at least 4 scheduled meetings in each year for the purpose of reviewing new applications.
HREC Submission cut-off dates for 2023 are:
HREC Meeting Dates for 2023 are: