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Licence Application & Assessment Process

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Other information relating to Licences and Applications

Application assessment process

The Act, the Gene Technology Regulations 2001 (the Regulations) and corresponding state and territory law govern the comprehensive and highly consultative processes undertaken by the Regulator in making a decision about whether or not to issue a licence to deal with a GMO.

Outlined below are some generalised steps involved in DNIR and DIR licensing processes.
  1. An application form must be completed
DNIR and DIR licence application forms

  1. The application must be reviewed/supported by an Institutional Biosafety Committee (IBC) and supporting information provided in the application by the IBC, and forwarded to the Regulator.


  2. Once the application is received by the Regulator it is acknowledged and a DNIR or DIR identification number assigned


  3. The Regulations prescribe how many working days the Regulator has to make a decision to issue, or refuse to issue, a licence for the dealings proposed in the application:
      For DNIR applications - 90 working days*
      For DIR applications
        - 255 working days* (except for limited and controlled release applications)
        - 150 working days* (170 working days* if significant risk identified) for limited and controlled release applications
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      * The working day period does not include weekends or public holidays in the Australian Capital Territory. Also, this period does not include any days in which the Regulator is formally seeking further information from the applicant in relation to the application.

  4. The Regulator may consult experts, agencies, or authorities about the application


  5. A Risk Assessment and Risk Management Plan (RARMP) is prepared


  6. The Regulator must consult the Gene Technology Technical Advisory Committee, prescribed agencies and authorities and public on the RARMPs prepared for all DIR application. Details of DIR evaluation process are at: Application assessment process for dealings involving intentional release (DIR) of a GMO into the environment (PDF 176 KB)


  7. The Regulator makes a decision to issue, or refuse to issue, a licence


  8. The decision on the licence application is recorded in the GMO Record on the website. For DIR licences, the RARMP, the licence conditions and other supporting information can be downloaded. For DNIRs, typical licence conditions are provided here.

Related links:
List of applications and licences for Dealings NOT involving Intentional Release (DNIR) of GMOs into the environment

List of applications and licences for Dealings involving Intentional Release (DIR) of GMOs into the environment

For any further information about either DNIR or DIR applications please contact the OGTR.
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GMO Licence

A GMO licence is a legal instrument issued by the Gene Technology Regulator (the Regulator) under the Gene Technology Act 2000 (the Act) that sets down the conditions under which specified dealings with genetically modified organisms (GMOs) must be undertaken. Licences may be issued for Dealings Not involving Intentional Releases (DNIRs), Dealings involving Intentional Releases (DIRs) or Inadvertent Dealings.

A person who deals with a GMO without a licence is guilty of an offence, punishable under Section 32 of the Act if:
  1. the person deals with a GMO, knowing that it is a GMO; and
  2. the dealing with the GMO by the person is not authorised by a GMO licence, and the person knows or is reckless as to that fact; and
  3. the dealing with the GMO is not specified in an Emergency Dealing Determination, and the person knows or is reckless as to that fact; and
  4. the dealing is not a Notifiable Low Risk Dealing, and the person knows or is reckless as to that fact; and
  5. the dealing is not an Exempt Dealing, and the person knows or is reckless as to that fact; and
  6. the dealing is not included on the GMO Register, and the person knows or is reckless as to that fact.Top of page