This guidance supports psychiatrists in understanding their regulatory requirements when prescribing products containing MDMA and psilocybin from 1 July 2023.
Contents
- About this guidance
- The role of the Therapeutic Goods Administration (TGA)
- Changes to MDMA and psilocybin access
- The Authorised Prescriber (AP) scheme
- Prescriber eligibility
- How to become an approved Authorised Prescriber
- Part 1: Submit an application to a HREC and receive approval
- Part 2: Complete an Authorised Prescriber application
- TGA decision
- State and Territory requirements
- Reporting requirements
- Six monthly reporting
- Reporting adverse events and product defects
- Considerations for clinical practice
- Importing MDMA and psilocybin
- Manufacturing MDMA and psilocybin in Australia
- Ensuring legal supply
- Safety considerations
- Clinical protocols
- Cost
- Advertising requirements
- Clinical Trials Notification (CTN) scheme
Supporting documents
Topics