Technical guideline for Out of Specification veterinary vaccine permit applications

Consultation period: 
18 December 2019 to 28 February 2020
Please note: the closing date for submissions has been extended to 28 February 2020.

Background

Submissions are invited from those interested in a new guideline that outlines the technical requirements for the assessment of certain permit applications that are common to a range of veterinary vaccines.

Consultation information

The APVMA is seeking feedback in relation to guidance for Out of Specification (OOS) veterinary vaccine permit applications.

The APVMA administers a permits scheme that allows for the legal use of chemicals in certain ways that are contrary to the label instructions or, in certain circumstances allows for the limited use of an unregistered chemical product. The scheme allows for the legal use of products that may be contrary to the label instructions of a registered vaccine.

The guideline outlines the technical requirements for the assessment of certain permit applications that are common to a range of veterinary vaccines, providing specific examples and associated technical requirements that would facilitate the issuing of a permit with minimal technical assessment whilst ensuring the quality, safety and efficacy of vaccines on the market.

Making a submission

The consultation period is open until close of business on 28 February 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:

Registration Management
Martin.Ilott@apvma.gov.au
Australian Pesticides and Veterinary Medicines Authority
GPO Box 3262
Sydney NSW 2001

To protect your privacy, please do not include contact information in your feedback. If you would like a response, please contact us.