This consultation closed on 8 April 2025
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).
Submissions received
The APVMA sought comments from interested stakeholders on the Draft Guideline on Data Requirements for Veterinary Immunobiological Products, in a consultation that closed on 8 April 2025.
A total of 4 relevant submissions were received from stakeholders or industry groups.
A copy of the published submissions (where consent to publish was provided) is available on apvma.gov.au.