Draft APVMA guideline 'Adjuvants in vaccines intended for food producing animals'

Submissions are invited from interested stakeholders on the draft guideline Adjuvants in vaccines intended for food producing animals.

Background

The purpose of guidelines is to increase the transparency and predictability of APVMA decision making under the Agvet Code. APVMA data guidelines provide guidance on what information should be provided with an application, increase understanding and predictability of our decisions and demonstrate how we ensure that the agvet chemicals for supply in Australia can be used safely and are effective.

Call for public comment

The APVMA is seeking stakeholder input on two user guides for efficacy label claims on veterinary vaccines and toxicology and residues data requirements for an immunobiological product containing an adjuvant not contained in an approved vaccine for food product animals.

The consultation period is open until close of business on 6 October 2017. Following consideration of comments received during the consultation period the data guideline will be finalised and made available on the APVMA website by 1 November 2017.

All submissions will be published unless you state in your submission that you do not want the submission to be published.

Please send your written submission by email, post or fax to:

Enquiries
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
Kingston ACT 2604

Phone: +61 2 6210 4701
Fax: +61 2 6210 4721
Email: enquiries@apvma.gov.au