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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

TGA Clinical Trials website

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