On this page:
- Overview
- Policy and Procedures
- Application Process
- Application Form
- Application Fee
- Templates
- 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. It is a two-step process to become an authorised practitioner of an unapproved medicine, with the first step being approved by an HREC or specialist college and the second step being approval by the TGA (TGA gives the final approval).
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 by the NIIM HREC Executive Committee in accordance with the NIIM HREC: TGA Authorised Prescriber Scheme Application Approval Policy and its related Procedures. Please allow three (3) weeks for the processing of a complete, complying and paid for application.
Application Forms
Please use the links below to gain access to the appropriate application form:
APS Medicinal Cannabis Schedule-Based New Application Form
APS Medicinal Cannabis Schedule-Based Renewal Application Form
APS Medicinal Cannabis Schedule-Based Amendment Application Form
APS NON-Medicinal Cannabis Product-Based New Application Form
Application Fee
The application fee for assessment of a new application is $1,500 and for a renewal or amendment $750. An invoice will be raised when the application is received. Approval letters will not be issued where payment has not been received.
Templates
These templates are designed to assist applicants in preparing their applications for review by the NIIM HREC.
Medicinal Cannabis Informed Consent Form Template
Medicinal Cannabis Dosing Guidelines
APS MC Six-month Report Template
APS NON-MC Six-month Report Template
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.
