Proposed changes to data guidelines for veterinary active constituents

Submissions are invited from interested stakeholders on proposed changes to the data guidelines for chemistry and manufacture requirements for veterinary active constituents to update and clarify the guidance for new veterinary actives and also to add a section describing reduced data requirements for new sources of existing veterinary active constituents.

The APVMA is also planning to rename the page additional data guidelines for veterinary chemistry and manufacture to international data guidelines for veterinary chemistry and manufacture to more accurately describe the contents of that page.

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.

Previously the APVMA did not have published guidance for reduced data requirements for new sources of existing veterinary active constituents where information submitted for an existing approved actives may be used to support an application for a new source of that active.

Invitation for submissions or to use the new guidelines

The APVMA is seeking stakeholder input on these proposed changes.

Additionally stakeholders are encouraged to use the proposed reduced data requirements as a basis for applications for new sources of existing actives during the consultation period to further test the guidelines.

The consultation period is open until close of business on 19 March 2018. Following consideration of comments received during the consultation period the proposed changes will be finalised and made to the existing data guideline on the APVMA website.

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

Director Scientific Standards and Data Guidelines
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
KINGSTON ACT 2604
Telephone: +61 2 6210 4701
Fax: +61 2 6210 4776
Email: enquiries@apvma.gov.au