TGA Authorised Prescriber Scheme Applications: including Medicinal Cannabis

On this page:

  • Overview
  • Policy and Procedures
  • Application Process
  • Application Form
  • Application Due Dates and HREC Meeting Dates
  • Application Fee
  • Appeals Against the Outcome of an Application

Overview

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 NIIM 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 NIIM HREC.

 

Policy and Procedures

NIIM 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.

Policy

The aim of this policy is to set out the principles by which the NIIM 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 Policy: NIIM HREC: TGA Authorised Prescriber Scheme Application Approval Policy

Procedures

The aim of these procedures is to set out the processes for applications to the NIIM Human Research Ethics Committee (HREC) under the Therapeutic Goods Administration’s (TGA’s) Authorised Prescriber Scheme.

Click here for the Procedures: NIIM HREC: TGA Authorised Prescriber Scheme Application Approval Procedures

 

Application Process

Applications are assessed at the NIIM HREC meetings in accordance with the NIIM HREC: TGA Authorised Prescriber Scheme Application Approval Policy and its related Procedures.

 

Application Form

The application form is included in the Appendix of the Procedures.

Click here for an Application Form.

 

Application Due Dates and HREC Meeting Dates

The NIIM HREC generally meets 6 times per year, or more often in accordance with demand. Click below for a list of dates. Note that applications must be received at least 3 weeks ahead of the HREC meeting date.

NIIM HREC Meeting Dates 2019 

Where several applications are received from, for example a group of doctors, it may be possible to schedule a special HREC meeting to assess these applications. Please contact the HREC Secretary, hrec@niim.com.au

 

Application Fee

The application fee for assessment of an application is: $500. Payment should be made at the time of submission of the application form. Applications will not be assessed where payment has not been received. Click the link below for payment details.

HREC Application Fees and payment details.

 

Appeals Against the Outcome of an Application

Applicants who are dissatisfied with a HREC decision in relation to an Authorised Prescriber application may appeal against the decision. The process for appeals is set out in the NIIM HREC: TGA Authorised Prescriber Scheme Application Approval Procedures.