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Quarterly activities reports
These reports detail the monitoring and compliance activities by the Office of the Gene Technology Regulator (OGTR) for each quarter.
Communique of GTTAC meeting of 18 December 2023
This Communiqué covers matters considered at the 37th videoconference of the Gene Technology Technical Advisory Committee (18 December 2023).
Addressing misinformation on the regulation of mRNA vaccines
Misinformation has been circulating about the regulation of the Pfizer and Moderna mRNA COVID-19 vaccines. The following statement addresses this misinformation.
OGTR Newsletter Issue 9
This issue focusses on the updated CCI application form and the updated Notification of Minor Works form.
Communique of GTTAC meeting of 14 November 2023
This Communiqué covers matters considered at the 36th videoconference of the Gene Technology Technical Advisory Committee (14 November 2023).
Annual reports on the Operations of the Gene Technology Regulator
The Gene Technology Act 2000 requires Gene Technology Regulator to report annually on their operations. The reports are produced for the Minister as soon as practicable after the end of each financial year.
Communique of GTECCC meeting of 30 October 2023
This Communique covers matters considered at the 19th meeting of the Gene Technology Ethics and Community Consultative Committee (30 October 2023).
Operations of the Gene Technology Regulator Annual Report 2022-23
The report describes the roles and responsibilities of the Gene Technology Regulator (the Regulator) and the Office of the Gene Technology Regulator (OGTR) during 2022-23.
Application for a confidential commercial information (CCI) declaration
Use this form to apply for a declaration that specified information is confidential commercial information (CCI) under the Gene Technology Act 2000.
Application for declaration that specified information is CCI- examples for the CCI form
This document provides examples of the details you may need to supply in describing the information for which you are seeking declaration as CCI.
Application for declaration that specified information is CCI - information for completing the CCI form
This document contains general information about the CCI application form and specific information for individual sections and questions in the form.
Construction, repair, and maintenance work in a low-level certified facility – decision tree
This decision tree provides assistance on which type of form needs to be completed when conducting maintenance or repair work on a low level containment facility.
Communique of GTTAC meeting of 4 September 2023
This Communiqué covers matters considered at the 35th videoconference of the Gene Technology Technical Advisory Committee (4 September 2023).
Communique of GTTAC meeting of 2 August 2023
This Communiqué covers matters considered at the 34th videoconference of the Gene Technology Technical Advisory Committee (2 August 2023).
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Registering for the OGTR Online Services Portal – Instructional Video
This guide will instruct users through the initial log in process for the OGTR Online Services Portal.
GTR Statement of Intent
This Statement of Intent outlines the activities of the Gene Technology Regulator (the Regulator) and the Office of the Gene Technology Regulator (OGTR) over the next 3 years from 2023 to 2026.
Letter of Expectations
This letter lays out the Minister's expectations of the Gene Technology Regulator.
OGTR Online Services Portal NLRD Form Guide
This document provides a step by step guide on how to access the NLRD Form in the OGTR's Online Services Portal.
Notifiable Low Risk Dealing (NLRDs) Reporting Form
Use this form to notify the Regulator of any NLRDs assessed during the financial year.
Quarterly activities report for April – June 2023
Details of OGTR monitoring and compliance activities during the quarter ended 30 June 2023.
Application for a DIR licence for limited and controlled release of GM plants - example answers
This is a hypothetical case study provided as an example. It should not be cited as evidence in an application. Although the data and discussions are representative, this example may not include all considerations needed when assessing risks from a proposed GM plant limited and controlled release.
Application for a DIR licence for the limited and controlled release of GM plants
This application form is for dealings (activities) involving limited and controlled release of genetically modified (GM) plants into the environment.
Communique of GTTAC meeting of 15 May 2023
This Communiqué covers matters considered at the 33rd videoconference of the Gene Technology Technical Advisory Committee (15 May 2023).
Communique of GTECCC meeting of 10 May 2023
This Communique covers matters considered at the 18th meeting of the Gene Technology Ethics and Community Consultative Committee (10 May 2023).
Infographic outlining OGTR and FSANZ regulatory remits
This infographic gives a brief description of the difference between OGTR and FSANZ regulatory remits, where the OGTR conducts risk analysis and licensing for commercial cultivation, while FSANZ conducts food safety assessments, approves food for sale and sets labelling requirements.