Apply for a licence to conduct a human clinical trial of a GMO

Human clinical trials of GM therapeutics may require either a DIR or DNIR licence. Find out how to apply for a licence to conduct a human clinical trial of a GMO.

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

Application process

  1. Complete the application form.
  2. Submit the application to an Institutional Biosafety Committee (IBC).
  3. The IBC reviews your application and adds supporting information.
  4. Send the application to us.
  5. 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.
  6. We prepare a risk assessment and risk management plan (RARMP) for the application.
  7. The Regulator makes a decision on the application and notifies you of the outcome.
  8. We record the decision on the public GMO record.

Decision timeframes

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.

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