About the GMO tables

The following tables provide a summary of GMOs released into the environment.

GMOs can be released for a limited time under specified conditions (limited and controlled release) or without a time limit on their release (“Commercial release”). Some restrictions on commercial releases may still apply.

All releases are assigned a licence number and referred to as “DIR” which is short for “Dealings involving intentional release” into the environment. “Dealing” with GMO includes many activities such as conduct experiments, make, develop, produce, transport and dispose.

In addition to licences, there is also a “GMO Register”. The Regulator can decide that certain dealings previously authorised by a licence may be included in the GMO Register. Dealings on the GMO register no longer require a licence, they can be conducted by anyone.

The following table provides summary information about DIR licences issued by the Gene Technology Regulator for commercial therapeutic GMOs, and contains links to detailed documentation relating to each application and assessment, including licence conditions.

Table of authorisations for commercial therapeutic GMOs (subset of list of licences involving Intentional Release)
Licence No Australian Product Name Organisation Parent Organism Target Disease Common Name Issue Date Licence Status
DIR 180AstraZeneca Pty LtdAdenovirus08 Feb 2021Current
DIR 174Biocelect Pty LtdCholera bacterium (Vibrio cholerae)17 Feb 2021Current
DIR 148Sanofi-Aventis Australia Pty LtdYellow fever virus (YF17D)Dengue27 Jun 2017Current
DIR 137FluMistŪAstraZeneca Pty LtdInfluenza virusInfluenza14 Jan 2016Current
DIR 132IMLYGIC Amgen Australia Pty LtdHerpes simplex virus-1Melanoma12 Aug 2015Current
DIR 125POULVAC® E. coliZoetis Australia Research & Manufacturing Pty LtdEscherichia coliAvian Pathogenic E. coli (APEC)18 Dec 2014Current
DIR 098IMOJEV vaccineSanofi-Aventis Australia Pty LtdYellow fever virus (YF 17D)Japanese Encephalitis19 Aug 2010Current
DIR 088Merial Australia Pty LtdEquine influenza vaccineWithdrawn
DIR 033/2002Orochol® vaccine CSL LtdCholera vaccine (Vibrio cholerae)Cholera 20 Jun 2003Surrendered