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Guidance for IBCs: Regulatory requirements for contained research with GMOs containing engineered gene drives
This document provides guidance for Institutional Biosafety Committees (IBCs) and researchers on the regulatory requirements for organisms containing engineered ‘gene drives’, including the physical containment (PC) level of facilities for notifiable low risk dealings (NLRDs).
Look-up tables for classification of contained dealings with viral vectors based on the vector type, characteristics and whether in vitro or in vivo.
This application form must be used for applications for a licence for dealings (activities) NOT involving the intentional release of a GMO into the environment (DNIR).
The purpose of this document is to inform researchers undertaking NLRDs about the Gene Technology Regulator’s (the Regulator’s) operational policy for considering requests to conduct NLRDs in alternate facilities, pursuant to regulation 13(2)(c).
This protocol is to provide inquiring third parties with the appropriate information on how to report matters of non-compliance to the OGTR.
This document describes how the potential risks of regulatory sequences in GM plants are considered when preparing Risk Assessment and Risk Management Plans (RARMPs).
This Communique covers matters considered at the 12th meeting of the Gene Technology Ethics and Community Consultative Committee (25-26 June 2019, Melbourne).
This conceptual discussion paper proposes a generic framework for the environmental risk assessment (ERA) of organisms including a set of generic risk factors based on biological attributes of organisms and bio-physical characteristics of interactions of organisms with the environment.
These documents support the Risk Assessment and Risk Management Plans (RARMPs) prepared for applications for dealings involving intentional release (DIRs) of GMOs into the environment. They address matters common to many DIR risk assessments and are referred to in relevant RARMPs.
This document describes how the potential risks of GM crop field trials are considered when preparing Risk Assessment and Risk Management Plans (RARMPs).
This document provides baseline information about the parent organism for use in risk analysis of genetically modified (GM) chickpea that may be released into the Australian environment.
This document provides guidance on the information required in the Application to vary a DNIR licence form for a range of common variation categories.
This document describes how the potential risks of RNAi technology (gene silencing) are considered when preparing Risk Assessment and Risk Management Plans (RARMPs).
Use this form to apply for a variation of a licence for dealings not involving intentional release (DNIR) of a GMO into the environment under the Gene Technology Act 2000 (the Act).
Use this form to apply for a variation of a licence for dealings involving intentional release (DIR) of a GMO into the environment under the Gene Technology Act 2000 (the Act).
This document provides information on the scope of changes which may be made to a genetically modified organism (GMO) licence after the licence has been issued, and outlines the Gene Technology Regulator’s (the Regulator’s) approach to considering applications to vary conditions of a GMO licence.
This application form is for dealings (activities) involving the release of GM plants into the environment that would not qualify as a limited and controlled release.