Published on Friday, 24 April 2026 at 10:34:46 AM
The Application
Licence application DIR 224 is for commercial supply of a GM vaccine to prevent Newcastle disease, infectious laryngotracheitis and Marek’s disease in chickens.
Intervet is seeking approval for the import, transport, storage, supply and disposal of the GM vaccine. The use of the GM vaccine will also require a separate approval by the Australian Pesticides and Veterinary Medicines Authority (APVMA). A permit from the Department of Agriculture, Fisheries and Forestry (DAFF) will also be required for import of the GM vaccine into Australia.
A summary of the application is attached, along with a set of ‘Questions and Answers’ that provide an overview of the application and an outline of the assessment process. A copy of the application is available from my Office upon request.
Consultation process for this DIR application
As this application is for commercial purposes, the Act specifies two rounds of consultation.
Before a RARMP is prepared in accordance with the Act, I am required to seek advice from prescribed agencies and authorities, including any local council that I consider appropriate, which in this case I consider to be all local councils in Australia. Public consultation is not required at this stage.
The second round of consultation required by the Act, will occur after a consultation version of the RARMP has been prepared. I must seek advice on the RARMP from the same prescribed experts, agencies and authorities consulted initially. In addition, I must seek public comment on the RARMP.
Timeframe for comments
In order to comply with the legislative timeframe for this application, I require your advice on matters related to risks to human health and safety and the environment that I should consider in preparing the RARMP by 22 May 2026.
Please note that if I do not receive advice by this date, I am required to proceed with the evaluation. However, you will have a further opportunity to comment on the RARMP once it has been prepared.
My office would be happy to discuss any issues or concerns relating to the application or the preparation of the RARMP. If you have any questions, please contact the OGTR by email to ogtr@health.gov.au or by telephone on 1800 181 030. Please quote application number DIR 224.
Dr Raj Bhula
Gene Technology Regulator
DIR-224 - Summary of Licence Application
DIR-224 - Questions and Answers
Back to All News