Contact us first
We encourage you to contact us before applying. We can advise you about the appropriate licence type and discuss information requirements.
Apply for a licence
Apply for a human clinical trial licence
Apply for a licence to conduct a human clinical trial of a GMO.
- Complete the application form.
- Submit the application to an Institutional Biosafety Committee (IBC).
- The IBC reviews your application and adds supporting information.
- Send the application to us.
- We acknowledge receipt of the application, then screen it for completeness. Once we accept the application, we assign it an ID number. Use this ID when enquiring about the application.
- We prepare a risk assessment and risk management plan (RARMP) for the application.
- The Regulator makes a decision on the application and notifies you of the outcome.
- We record the decision on the public GMO record.
The Gene Technology Regulations 2001 prescribe how many working days the Regulator has to make a decision about an application:
- for DNIRs – 90 days
- for limited and controlled release DIRs – 150 days
- for limited and controlled release DIRs, where significant risk is identified – 170 days.
This does not include weekends, ACT public holidays, or time spent waiting for applicants to respond to certain requests for additional information.