Using reference products to meet statutory criteria

The APVMA welcomes feedback on this guidance regarding reference products until 28 February 2026. Please provide suggestions by email to APVMAConsultation@apvma.gov.au.

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has updated guidance on how nominated reference products and other information are assessed against statutory criteria. 

This page brings the requirements together in one place while our web pages are being revised..

This guidance applies to applications with little or no technical data – including items 6, 7, 10, 12 and 14 – which rely on nominated reference products and/or other information sources to meet statutory criteria. This update follows the APVMA clarifying 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.  

This update covers all applications that depend on a reference product. 

1. Application requirements and statutory criteria

Applications must meet the application requirements before being assessed against the statutory safety, efficacy, trade and labelling criteria.

When the application is made it must include information that addresses the safety criteria, efficacy criteria and trade criteria. In particular, it must meet the Application Requirements Instrument. This includes information to allow us to assess chemistry and manufacturing processes and the impacts on human health, environment, residues, trade, efficacy and crop safety/target animal safety. If the application does not specifically contain this information, it can only meet the application requirements if the APVMA appears to hold sufficient information for the nominated reference product, including supporting technical data.

To assess an application that relies on a reference product, we conduct a detailed review of the relevance and adequacy of the information held on the nominated reference product. We approve applications where there is sufficient information to be satisfied that the proposed product can meet the safety, efficacy, trade and labelling criteria. 

More information on both the application requirements and the statutory criteria is available on the APVMA website:

• Application requirements
• Statutory criteria

2. Reference products

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, trade and labelling criteria. 

Using reference products streamlines registration by allowing applications to rely on existing data instead of generating new data. A nominated reference product can be used to satisfy one or more statutory criteria.

Data held on reference products can be used unless it is ‘protected information’ within its protection period, or information with limits on use within the limitation period. If the product contains protected information (under limitations on use periods), written consent from the authorising party is required for the APVMA to access it.

Applications can be approved efficiently when the information provided and the APVMA’s data on the reference product meets requirements. If insufficient information is available, applications may be refused at Preliminary Assessment or during evaluation.

3. When a single reference product is sufficient

In some cases, one reference product may be sufficient to meet statutory criteria.

The proposed product must have the same use patterns, packaging, and a similar formulation as the reference product. The APVMA must also hold data on the reference product that is sufficient for us to consider our satisfaction against the safety criteria, efficacy criteria and trade criteria. This includes information to allow us to assess chemistry and manufacturing processes and the impacts on human health, environment, residues, trade, efficacy and crop safety/target animal safety.

4. What to consider when choosing a reference product

• Check for differences in use pattern, specifications, packaging, or formulation that may require justification or further information.
• Review PubCRIS before lodging an application to confirm:
  • the APVMA holds data items on the reference product
  • those data items meet the application requirements
  • any limits on use of information have expired, or seek written consent from the authorising party.
• Please refer to our quick reference guide for searching PubCRIS.
• Confirm the product’s registration status, including reasons for deregistration, if no longer registered.
• Note that some data items (e.g. chemical reviews and advice summaries) may not appear on PubCRIS. See Table 2 for more details.

The APVMA does not hold data for all registered products. For example, some products transferred into the National Registration Scheme in the mid-1990s were originally registered by state governments, so the APVMA may not hold their information. Products without data are not suitable to be nominated as reference products.

5. An application may rely on multiple reference products and other information

In many cases, a single reference product does not provide enough data to meet requirements. When this happens, there are several methods available to satisfy the statutory criteria.

This may include nominating additional reference products, as shown in Table 1. Each potential reference product should be carefully assessed for suitability, as explained in section 4.

Table 1: Example multi-reference product application in product assessment

Note that applications that use multiple reference products, or scientific arguments are not suitable for Item 6 or item 7, but may be submitted under modular assessments, such as an Item 10.

Table 2 includes other information sources that could be considered to help determine if a nominated reference product has data that could support meeting statutory criteria.

Table 2: Additional information sources for potential reference products

International assessments and assessments from other national regulators may also be submitted to help meet requirements. The APVMA provides criteria for accepting these assessments, along with details on the countries and official bodies whose assessments are recognised.

6. Explaining reference products in applications

You must indicate in your application how you expect us to be satisfied that all the statutory criteria relevant to your application have been addressed. 

Applicants must explain in the executive summary section (of the application form) how the nominated reference product/s and other information supports their application and which areas of application requirements a reference product covers. If no explanation is provided, the APVMA will request one during evaluation, resulting in delays.

When assessing an application, the APVMA only considers whether the proposed product meets the statutory criteria — the reference product itself is not re-evaluated.