This consultation closed on 31 October 2023
The Australian Pesticides and Veterinary Medicines Authority (APVMA) administers a permit scheme, which allows for the legal use of chemicals under certain conditions. This may include uses that:
- are contrary to the label instructions of a registered vaccine
- are intended for the limited use of an unregistered chemical product (minor use, emergency use or research use)
- allow the manufacture and supply of a product that would otherwise be an offence to manufacture
- are for other purposes or circumstances that are product or batch-specific.
The APVMA, in consultation with manufacturers of veterinary immunobiological products, has developed a guideline to address the technical requirements for permit applications related to out of specification veterinary vaccines. This guideline was initially published for consultation in December 2019. The APVMA also sought comments and feedback from stakeholders in Veterinary Immunobiological Working Group (VIWG) meetings.
The APVMA has reviewed the submissions received from stakeholders and is now seeking feedback on the revised guideline.
We invite written comments on the revised guideline from 3 October to 31 October 2023.
Please note: submissions will be published on the APVMA’s website unless you have asked for the submission to remain confidential, or if the APVMA chooses at its discretion not to publish any submissions received (refer to the public consultation coversheet).
Please lodge your submission using the public consultation coversheet, which provides options for how your submission will be published.
Note that all APVMA documents are subject to the access provisions of the Freedom of Information Act 1982 and may be required to be released under that Act should a request for access be made.
Please send your written submission and coversheet by email or post to:
Case Management and Administration Unit
Australian Pesticides and Veterinary Medicines Authority
GPO Box 3262
Sydney NSW 2001
Phone: +61 2 6770 2300
Email: enquiries@apvma.gov.au
Submissions received
The APVMA sought feedback on a revised guideline to address the technical requirements for permit applications related to out of specification veterinary vaccines, in a consultation that closed on 31 October 2023.
A total of 2 submissions were received from industry groups.
A copy of the published submissions is available on our website.
Consultation feedback
The APVMA is considering the submissions received as part of this consultation.