The Australian Pesticides and Veterinary Medicines Authority (APVMA) has published new guidance on how to use reference products to satisfy the statutory criteria. This clarifies how applicants can nominate reference products as part of an application, and how the APVMA considers reference products and other information against our statutory criteria. We are updating our web pages that set out requirements for applications relying on reference products. The new guidance sets out the requirements in one place while this update is underway.
A reference product is an agvet chemical product described on our register, with associated data items that have been relied upon during its assessment to determine that the product met the statutory safety, efficacy and trade criteria. Nominating reference products creates a streamlined pathway for applicants, reducing the need to generate new data.
The new guidance builds on the APVMA’s update on expectations around what data must be held on reference products in the update on application requirements for ‘closely similar’ item 6 and 7 applications published 11 June 2025. Reference products are relevant to applications with no or minimal technical data, including application Items 6, 7, 10, 12 and 14, which rely on nominated reference products and/or other information sources to satisfy the statutory criteria.
Applications in progress on 11 June 2025 that relied on reference products
The APVMA is contacting applicants with applications that were in progress on 11 June 2025 that relied on reference products to discuss next steps. Applicants can withdraw their application and request a refund of the original application fee, and are encouraged to submit a new application in line with the updated guidance.
If you have an application that is affected and you have not heard from us, please contact casemanagement@apvma.gov.au.