What is involved in the licence application and 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.
- An applicant must be an accredited organisation under the Act.
- An application form must be completed
- 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.
- Once the application is received by the Regulator it is acknowledged and a DNIR or DIR identification number assigned
- 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
* 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.
- The Regulator may consult experts, agencies, or authorities about the application
- A Risk Assessment and Risk Management Plan (RARMP) is prepared
- 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: Evaluation process and flow chart for intentional release licence applications (PDF 32 KB)
- The Regulator makes a decision to, issue or refuse to issue, a licence
- 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.
List of applications and licences for Dealings NOT involving Intentional Release (DNIR) of GMOs into the environment
Intentional release (DIR) licence applications under evaluation
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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