Use of Unapproved Goods: Clinical Trials, Authorised Prescribers and Special Access Scheme
In Australia, the Therapeutic Goods Administration approves goods (medicines, devices and biologicals) that are available in Australia and they are listed on the Australian Register of Therapeutic Goods.
There are three ways to access unapproved goods:
1. Clinical Trials
All Clinical Trials using an unapproved good at the Eye and Ear must be approved by a Human Research Ethics Committee and must have Research Governance Authorisation for the Eye and Ear Hospital site.
A CTN or CTX Form must be submitted to the TGA by the Sponsor.
Eye and Ear additional information
CTN and CTX Form submission instructions at the Eye and Ear.
Further information
2. Authorised Prescriber
Medical Practitioners with an appointment at the Eye and Ear can apply to the Ear and Ear HREC for endorsement of their application to the TGA.
All procedures are available on the Eye and Ear intranet.
Further information
TGA Authorised Prescribers website
3. Special Access Scheme
Medical Practitioners with an appointment at the Eye and Ear can apply to the TGA to prescribe an unapproved good to a patient via the Ear and Ear HREC for endorsement of their application to the TGA.
All procedures are available on the Eye and Ear intranet.
Further information
TGA Special Access Scheme website
Updated 30 January 2019