Bioproperties Pty Ltd
Vaccine - attenuated
This licence allows Bioproperties Pty Ltd to transport, store, dispose and test various modes of administration associated with the commercial supply of a GM vaccine against infectious laryngotracheitis virus (ILTV) in chickens within Australia. The Australian Pesticides and Veterinary Medicines Authority (APVMA) has responsibility for assessing the quality, safety and efficacy of any veterinary vaccine intended for use in Australia. Once approved for use, products are registered by the APVMA and can then be distributed.
The GM vaccine is manufactured in Australia and will be used to vaccinate chickens against ILTV infection.
The licence is for an ongoing commercial supply of a ILTV vaccine from Bioproperties Pty Ltd. The Gene Technology Regulator has imposed specific measures to manage risk in addition to general conditions to ensure that there is ongoing oversight of the release. The RARMP concluded that the commercial supply of the GM vaccine poses negligible risks to people and low to moderate risk to the environment. The GM vaccine is yet to be registered with the APVMA.
The risk analysis for this application was carried out in accordance with the Regulator’s Risk Analysis Framework.
Outlines the Regulator’s decision to issue a licence following the assessment of this application.
FAQs on the licence application and the Regulator’s decision to issue a licence for this application.
A summary of the Risk Assessment and Risk Management Plan prepared as part of the assessment of this application. It provides a brief description of the licence application, the risk assessment and risk management plan.
The final risk assessment and management plan prepared to support the Regulator's decision. It describes the GMO(s) and proposed work with the GMO(s) and provides an assessment of potential risks posed by the GMO(s). It also includes a summary of submissions received during the public consultation process.