The Australian Pesticides and Veterinary Medicines Authority (APVMA) has introduced a new approach to pre-application assistance (PAA). This approach will enable our staff to focus on core regulatory functions, while supporting our stakeholders through the delivery of efficient regulatory decisions.
What is pre-application assistance?
PAA can assist prospective applicants to understand regulatory requirements before submitting a subsequent application. PAA is a discretionary service and the APVMA may decide whether to provide PAA for an application.
PAA can require substantial scientific, regulatory and administrative resources to review prospective applications, provide advice, and engage directly with applicants. In the context of current regulatory demands, this level of effort for a discretionary service diverts resources from the APVMA’s mandatory statutory obligations.
New process for applying for PAA
The APVMA will generally only accept PAA applications that fall within one of the 4 circumstances shown in Table 1.
| PAA circumstance | Tier available |
|---|---|
| PAA2 |
| PAA2 |
| PAA3 |
| PAA3 |
* Applications for novel technology or requests from government agencies addressing biosecurity risks which also include a study protocol review, Global Joint Reviews, or other international collaboration will require a Tier 3 PAA.
Applications outside these circumstances may still be accepted where there is a strong or compelling reason to provide PAA.
What you need to do
If you wish to apply for PAA, you will need to email the APVMA Enquiries Team. In your email, you should provide the following information:
- Identify which of the 4 circumstances and tier option in Table 1 your application relates to.
- Outline the purpose of your PAA application.
- Provide details on information that will be submitted, such as a proposed label, directions for use, or any other reference material.
- Advise if you are requesting a meeting. Meetings will be reserved for matters where direct engagement adds the greatest value.
What happens after you apply
The Enquiries Team will email you to inform you of whether the APVMA will accept your application for pre-application assistance. If the APVMA accepts the application, you will be provided with a ‘Decision ID’ by email from the Enquiries Team. You can then use the Decision ID to create, complete and submit your application through the Online Services Portal.
If you have paid an additional fee for a meeting and the APVMA delegate later determines that a meeting is not required, the additional meeting fee will be refunded.
Please note that the Enquiries Team cannot provide detailed advice that would ordinarily be provided through PAA. This includes individual advice about whether a particular product requires registration.
Previously submitted PAA requests
If you submitted your PAA request before 16 October 2026, the APVMA will finalise your application, generally by providing written advice. Meetings will be reserved for matters where direct engagement adds the greatest value. You do not need to resubmit your application under the new process.
The new process applies to all PAA requests submitted on or after 16 October 2026.
What to do if you require further advice
If you require advice related to agvet chemical products, but your application for PAA is not accepted by the APVMA, you may wish to seek the assistance from your relevant industry body who may be able to recommend an appropriate regulatory consultant.