Background
The Australian Pesticides and Veterinary Medicines Authority (APVMA) is seeking feedback on proposed updates to the Draft Guideline on Data Requirements for Veterinary Immunobiological Products (previously known as Guidelines for Registration and Data for New Veterinary Immunobiological Products).
This guideline has been reviewed and updated by the APVMA in consultation with registrants and manufacturers of veterinary immunobiological products to ensure that it remains fit-for-purpose in a modern regulatory environment.
The purpose of this guideline is to outline the minimum data requirements and structure of the dossier for registering a veterinary vaccine, immunosera, or colostrum product with the APVMA. It also provides guidance for manufacturers seeking to vary the particulars of a registered product. Consequently, the updated document is now called Guideline on Data Requirements for Veterinary Immunobiological Products.
Where relevant, the guidance is also applicable to other immunobiological products.
We invite written comment on the Draft Guideline on Data Requirements for Veterinary Immunobiological Products from 11 March to 8 April 2025.
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).
Making a submission
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:
Email: enquiries@apvma.gov.au
Post:
Director, Veterinary Medicines
Australian Pesticides and Veterinary Medicines Authority
GPO Box 574
Canberra ACT 2601, Australia