Pre-application assistance (PAA) assists applicants with preparing or making applications to the APVMA under the Agricultural and Veterinary Chemicals Code Act 1994 and associated regulations.

The APVMA offers pre-application assistance on a fee-for-service basis. This can take the form of a written response, a meeting, or both. Pre-application assistance is divided into 3 tiers and the fees we charge reflect the level of complexity of each request.

Applicants intending to submit primary and secondary applications are encouraged to apply for PAA to confirm the relationship between applications and the appropriate level of assessment for each of the secondary applications.

Tier 1

This tier is for applicants seeking guidance in the early stages of preparing an application. It is to assist applicants in clarifying the types of regulatory assessments likely to be conducted for a particular submission to inform that applicant in collating relevant information and data likely to be necessary. 

Advice may include which application type (item number), assessment modules and fees that are likely to be applicable. It may also include advice regarding if an application for registration is required.

The timeframe for providing Tier one pre-application assistance is not prescribed, however the APVMA aims to provide the assistance in one month.

Tier 2

This tier includes all the aspects of Tier one, with further support for applicants who are seeking guidance relating to the types of information and data that may be appropriate for their application.

In addition to Tier one advice, assistance provided under this tier could include:

  • types of supporting data or information appropriate to the application
  • the types of trials needed to generate appropriate data
  • specific aspects of the design of a study or trial.

The timeframe for Tier 2 pre-application assistance is not prescribed, however the APVMA aims to provide it within 2 months.

Tier 3

This tier includes all the aspects of Tier one and Tier 2, with further support for applicants seeking to have the design of relevant studies appraised.

In addition to Tier one and 2 advice, assistance provided under this tier could include:

  • appraisal of trial protocols before commencement of studies
  • assistance on a proposed new methodology or variations to existing data guidelines for generating data for specific assessments
  • a project plan for Global Joint Reviews. 

Advice provided on the adequacy of trial protocols does not guarantee that the data generated from the study will satisfy the statutory criteria. 

The APVMA will not assess data, or undertake formulation comparisons, as part of providing pre-application assistance. If you have technical data you wish to be assessed by the APVMA, a technical assessment is required under an Item 25 application.

The timeframe for providing Tier 3 pre-application assistance is not prescribed, however the APVMA aims to provide the assistance in three months.