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NLRD import instructions for online forms
This document helps with the completion of the NLRD online form.
Guidance on making a record of Assessment for NLRD and on responsibilities of those undertaking NLRDs
This guidance is to help Institutional Biosafety Committees (IBCs) prepare a record of Assessment (RoA).
Guidance Note - Minimum information required to submit a request to modify certifications
This guidance note indicates the minimum information that must accompany any request to modify a certification, such as a variation, suspension, lift of suspension, surrender and transfer.
Classification of Notifiable Low Risk Dealings (NLRDs) - reporting form requirements
This documents helps with the correct classification of NLRDs being included in the Record of Assessment for reporting online.
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).
Guidance on the classification of contained dealings with viral vectors
Look-up tables for classification of contained dealings with viral vectors based on the vector type, characteristics and whether in vitro or in vivo.
Guidance on making an application to vary a DNIR licence
This document provides guidance on the information required in the Application to vary a DNIR licence form for a range of common variation categories.
Guidelines for Certification of a Physical Containment Level 2 Large Scale Facility
These guidelines contain the requirements and conditions for certification of a Physical Containment Level 2 (PC2) Large Scale Facility issued pursuant to section 90 of the Gene Technology Act 2000 (the Act).
Guidance for sponsors of clinical trials in humans 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).
Guidelines for Certification of a Physical Containment Level 2 Large Grazing Animal Facility
The guidelines (Part A) contain the requirements for certification of a Physical Containment Level 2 (PC2) Large Grazing Animal Facility issued pursuant to section 90 of the Gene Technology Act 2000 (the Act).
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.
Explanatory Information - Certification of Physical Containment Facilities
This document provides further details on certification, how to get a facility certified and how to maintain a certification.
Explanatory Information on the Guidelines for Accreditation of Organisations
This document provides further information about how to get accredited and how to stay accredited.
Guidelines for Certification of a Physical Containment Level 2 Plant Facility
The guidelines (Part A) contain the requirements for certification of a Physical Containment Level 2 (PC2) Plant Facility issued pursuant to section 90 of the Gene Technology Act 2000 (the Act).
Guidelines for Certification of a Physical Containment Level 2 Invertebrate Facility
The guidelines (Part A) contain the requirements for certification of a Physical Containment Level 2 (PC2) Invertebrate Facility issued pursuant to section 90 of the Gene Technology Act 2000 (the Act).
Guidelines for Certification of a Physical Containment Level 2 Laboratory
The guidelines (Part A) contain the requirements for certification of a Physical Containment Level 2 (PC2) Laboratory issued pursuant to section 90 of the Gene Technology Act 2000 (the Act).
Guidelines for Certification of a Physical Containment Level 2 Aquatic Facility
The guidelines contain the requirements for certification of a Physical Containment Level 2 (PC2) Aquatic Facility issued pursuant to section 90 of the Gene Technology Act 2000 (the Act).
Guidelines for Certification of a Physical Containment Level 2 Animal Facility
The guidelines (Part A) contain the requirements for certification of a Physical Containment Level 2 (PC2) Animal Facility issued pursuant to section 90 of the Gene Technology Act 2000 (the Act).
Guidelines for Accreditation of Organisations
The guidelines detail the requirements for, and the conditions of, accreditation.
Guidelines for Certification of a Physical Containment Level 3 Laboratory
These guidelines for certification of a Physical Containment Level 3 (PC3) Laboratory have been issued pursuant to section 90 of the Gene Technology Act 2000 (the Act) and state legislation.
Guidelines for Certification of a Physical Containment Level 3 Invertebrate Facility
The guidelines contain the requirements for certification of a Physical Containment Level 3 (PC3) Invertebrate Facility issued pursuant to section 90 of the Gene Technology Act 2000 (the Act) and state legislation.
Guidance Notes for the Containment of Exempt Dealings
These notes help organisations or persons in determining how to undertake exempt dealings to avoid intentional release.
Guidance for IBCs assessing NLRDs involving retroviral (including lentiviral) vectors
This guidance document assists Institutional Biosafety Committees (IBCs) with assessing NLRD proposals involving dealings with retroviral vectors able to transduce human cells.
Guidelines for the Transport, Storage and Disposal of GMOs
The Gene Technology Regulator may invoke these guidelines when determining licence and certification conditions.
Guidelines for Certification of a Physical Containment Level 2 Constant Temperature Room
The guidelines contain the requirements for certification of a Physical Containment Level 2 (PC2) Constant Temperature Room issued pursuant to section 90 of the Gene Technology Act 2000 (the Act) and any corresponding state legislation.