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 guidance document assists Institutional Biosafety Committees (IBCs) with assessing NLRD proposals involving dealings with retroviral vectors able to transduce human cells.
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.
These notes help organisations or persons in determining how to undertake exempt dealings to avoid intentional release.
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).
This guidance is to help Institutional Biosafety Committees (IBCs) prepare a record of Assessment (RoA).
Look-up tables for classification of contained dealings with viral vectors based on the vector type, characteristics and whether in vitro or in vivo.
These guidelines apply to facilities containing dealings that are required to be conducted in a PC1 facility certified by the Gene Technology Regulator.
This first issue focuses on Notifiable Low Risks Dealings (NLRDs).
The guidelines detail the requirements for, and the conditions of, accreditation.