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Guidance for Certification of a Physical Containment Level 3 Facility – to be read with new Guidelines effective 1 December 2022
This guidance accompanies the Guidelines for certification of a Physical Containment Level 3 (PC3) Facility effective 1 December 2022.
Annual Inspection Checklist for a PC3 Facility - For facilities certified or re-certified after December 2022
Checklist for annual inspection against the usual Conditions of Certification as detailed in the Gene Technology Regulator’s Guidelines for Certification of a Physical Containment Level 3 Facility.
Application Checklist for a new Physical Containment Level 3 Facility
Checklist for the inspection of a new facility against the usual Conditions of Certification as detailed in the Gene Technology Regulator’s Guidelines for Certification of a Physical Containment Level 3 Facility Version 1.0 - 1 December 2022
Guidelines and checklists for certification of PC3 facilities
Documents supporting applications for the certification of Physical Containment Level 3 (PC3) facilities.
Guidelines for the certification of physical containment facilities
These guidelines describe the requirements for the certification of each level and type of physical containment facility as per section 90 of the Gene Technology Act 2000 (the Act).
Application checklists for the certification of physical containment facilities
These checklists list the requirements of the Gene Technology Regulator’s guidelines for certification of a physical containment facility.
Inspection checklists for physical containment facilities
These checklists set out the criteria for an inspection against the usual conditions of certification of physical containment facilities.
Communique of GTECCC meeting of 22 November 2022
This Communique covers matters considered at the 17th meeting of the Gene Technology Ethics and Community Consultative Committee (22 November 2022).
Communique of GTTAC meeting of 29 November 2022
This Communiqué covers matters considered at the 58th meeting of the Gene Technology Technical Advisory Committee (29 November 2022).
The Biology of Lolium multiflorum Lam. (Italian ryegrass), Lolium perenne L. (perennial ryegrass), Lolium arundinaceum (Schreb.) Darbysh (tall fescue)
This document provides baseline information about the parent organism in risk assessments of genetically modified L. multiflorum, L. perenne and L. arundinaceum that may be released into the Australian environment.
Explanatory Information - Guide to Physical Containment Levels and Facility Types
This document describes the Physical Containment (PC) levels used by the Gene Technology Regulator in the certification of facilities. It also explains the categories of organisms and types of dealings intended to be contained in each facility type and PC level.
Operations of the Gene Technology Regulator Annual Report 2021-22
The report describes the roles and responsibilities of the Gene Technology Regulator (the Regulator) and the Office of the Gene Technology Regulator (OGTR) during 2021-22.
Quarterly activities report for April - June 2022
Details of OGTR monitoring and compliance activities during the quarter ended 30 June 2022.
Quarterly activities report for July - September 2022
Details of OGTR monitoring and compliance activities during the quarter ended 30 September 2022.
OGTR Newsletter Issue 7
This issue focuses on what we mean by intentional release as well as providing information about the new clinical trial licence application form.
Guidance for conducting human clinical trials involving GMOs
This guidance provides basic information to organisations in Australia wishing to conduct human clinical trials involving an experimental product that is, or contains, a genetically modified organism (GMO).
Communique of GTTAC meeting of 12 September 2022
This Communiqué covers matters considered at the 32nd videoconference of the Gene Technology Technical Advisory Committee (12 September 2022).
Application for a licence to conduct a human clinical trial of a GMO
This application form is for licences to conduct human clinical trials of GMOs.
Communique of GTTAC meeting of 15 August 2022
This Communiqué covers matters considered at the 31st videoconference of the Gene Technology Technical Advisory Committee (15 August 2022).
What do we mean by Intentional Release?
Regulatory approvals for activities with GMOs include two licence types based on whether or not they involve an intentional release of the GMO into the environment. Here is an explanation of what this means.
Communique of GTECCC meeting of 24 June 2022
This Communique covers matters considered at the 16th meeting of the Gene Technology Ethics and Community Consultative Committee (24 June 2022).
Quarterly activities report for January - March 2022
Details of OGTR monitoring and compliance activities during the quarter ended 31 March 2022.
Quarterly activities report for October – December 2021
Details of OGTR monitoring and compliance activities during the quarter ended 31 December 2021
Communique of GTTAC meeting of 28 April 2022
This Communiqué covers matters considered at the 30th videoconference of the Gene Technology Technical Advisory Committee (28 April 2022).
OGTR Newsletter Issue 6
This issue provides an update on the OGTR office.