The Australian Pesticides and Veterinary Medicines Authority (APVMA) has reviewed and revoked the information ‘Preliminary Assessment guideline’ as a guideline made pursuant to section 6A of the Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals Code Act 1994 (Cth) (Agvet Code), as it does not meet the intent of section 6A guidelines. However, the information contained within may still be useful and relevant to applicants, so it has been retained for information purposes.
1. What is this guideline about?
- The purpose of this guideline is to set out our principles and processes in relation to performing our functions and exercising our powers relating to preliminary assessments under sections 11, 28 and 110A of the Agvet Code.
- It covers what we mean by, and what we take into account in conducting, a preliminary assessment (among other things).
- The provisions of the Agvet Code covered by this guideline are outlined in the annexure to this guideline.
- This guideline has been revoked as a 6A Guideline on 9 January 2023, however, is retained for information purposes.
2. What do we mean by a preliminary assessment?
- For an application to pass preliminary assessment, it must appear from the preliminary assessment that the application ‘meets the application requirements’.
Note: Section 8A of the Agvet Code defines ‘meets the application requirements’.
- Generally, an application will pass preliminary assessment if, on an initial examination only, it appears that the form and content of the application meet the application requirements. In other words, the outward look of the application and its accompanying information must appear to be in order and complete. This is a lower threshold than the requirement of ‘satisfaction’ in the case of a ‘full evaluation’ of an application (for example, under section 14 of the Agvet Code), reflecting the limited timeframe available to us to complete a preliminary assessment.
3. What do we take into account in conducting a preliminary assessment?
- In undertaking a preliminary assessment, we will take into account all of the information in or accompanying the application form. However, we will only do so to the extent necessary to ensure that the form and content of the application meet the application requirements – that is, that the information provided looks or appears to be what is actually required to meet the requirements.
- We will not delve into the substance of the information provided with an application to ensure that the information is sufficient for us to determine, for example, whether the safety or other relevant criteria are met (this is instead the purpose of the ‘full evaluation’).
- We will not conduct any scientific or technical analysis of the information provided with an application.
- If an application requirement is that a particular scientific study be provided, it will be sufficient, for the purposes of preliminary assessment, that the study that is provided have the outward look of the required study (an email in place of an expected 500 page document will not be sufficient).
- If a study on a particular species of plant is required, and a document that has the outward look of being a study on that species of plant is provided, that will be sufficient. It is irrelevant, for the purposes of preliminary assessment, that it may turn out on substantive examination that the study provided does not address all of the things it was required to address so that we can satisfy ourselves of relevant matters as part of our ‘full evaluation’.
4. Rectifying defects in an application
- If it appears from the preliminary assessment of an application for a product registration, active approval, variation or permit that the application does not meet the application requirements, but that the defects in the application can be reasonably rectified, we will give the applicant an opportunity to rectify those defects. We consider that a defect can be reasonably rectified if it is capable of being rectified:
- without significantly changing the nature of the application
- within one month of us giving the applicant written notice requiring the defect to be rectified.
- The relevant notice will be issued (s 11(3) for product registration or active approval applications; s 28(3) for variation applications; and s 110A(3) for permit applications) listing the reasons why an application does not meet the application requirements, and what is required for your application to pass preliminary assessment.
- An application for a permit has been made that contains typographical or other minor errors or omissions. We will likely give the applicant an opportunity to rectify those defects.
- An application for a permit is made but information that is required to be provided or that we consider necessary to assess the application has not been provided. We will likely give the applicant an opportunity to rectify those defects.
5. Amending the application after preliminary assessment
- We may alter an application, after it has passed preliminary assessment, and with the written consent of the applicant, in accordance with information contained within Altering applications.
6. Annexure – relevant legal provisions
- We are required to conduct a preliminary assessment in respect of certain applications made under the Agvet Code (see sections 11, 28, and 110A). The application must pass the preliminary assessment before we can proceed to a ‘full evaluation’ of the application.
- Section 11 of the Agvet Code provides for preliminary assessment in respect of applications for either:
- approval of an active constituent for a proposed or existing chemical product
- registration of a chemical product
- approval of a label for containers for a chemical product.
- Section 28 provides for preliminary assessment in respect of applications for variation.
- Section 110A provides for preliminary assessment in respect of applications for permits.