Revised guidance for autogenous vaccine permits

Background

Submissions are invited from those interested in the revision of the guidance for autogenous vaccine permits. The new guidance aims to provide additional guidance and clarity on specific data requirements for autogenous vaccine permit applications for minor use.

Consultation information

The APVMA is seeking feedback in relation to technical data requirements for autogenous vaccine applications for minor use. The current guidance can be found on our website.

The new guidance aims to provide additional technical guidance and clarity for the production of autogenous vaccine production from new and existing seeds, starting material and testing requirements, renewal procedures and when permit applications are required for changes to existing permits for autogenous vaccines.

Making a submission

The consultation period is open until close of business on 4 June 2020.

Note that all submissions received are subject to legislation, including the Freedom of Information Act 1982, the Privacy Act 1988 and the Agvet Codes. In providing your submission to the APVMA, you agree to the APVMA publicly disclosing your submission in whole or summary form.

Electronic submissions are preferred, and may be sent to martin.ilott@apvma.gov.au.

Hardcopy submissions can be sent to:

Registration Management
Australian Pesticides and Veterinary Medicines Authority
GPO Box 3262
Sydney NSW 2001