This content is current only at the time of printing. This document was printed on 25 February 2017. A current copy is located at http://apvma.gov.au/node/960
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1. What is this guideline about?
- This guideline is made pursuant to section 6A of the Agvet Code.
- 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 altering application made under sections 10, 26B, 27, 48 and 110 of the Agvet Code.
- It covers the circumstances in which we will consider altering applications, and how we will obtain consent.
- The provisions of the Agvet Code and the Agvet Code Regulations covered by this guideline are outlined in the annexure to this guideline.
- This guideline commences on 1 July 2014.
2. What are the circumstances in which we will consider altering an application?
- We expect applicants or holders to lodge an application that contains or is accompanied by all relevant information such that the application ‘meets the application requirements’.
- We may ask you to consent to our alteration of an application where:
- the alteration is necessary for us to continue to assess an application (rather than propose to refuse it), and
- it would be more efficient to alter the application than to refuse the application and have the applicant or holder resubmit the application.
- We will take into account the following considerations in determining whether altering an application might be efficient:
- whether we have done work that we would need to re-do if the application were not altered and consequently refused by us and then resubmitted by the applicant or holder
- the extent and complexity of alteration required
- the degree to which the proposed alteration would affect the time available to us to determine the application
- our resourcing capacity (and the capacity of the bodies that we consult with in assessing applications) and our other regulatory responsibilities.
- We are not required to alter an application to correct a deficiency.
Any amendment of an application must be consistent with the Agvet Code and the Agvet Code Regulations.
- An application has been made that contains typographical or other minor errors or omissions. We will seek to alter the application to correct those errors or omissions.
- An application has been made for registration of a novel active constituent. The application assessment process has been proceeding for 11 out of the maximum 14 months. Some components of the assessment have already been completed, and other components are almost finished. A problem is discovered in the application which could be remedied by altering the application without affecting our ability to complete the assessment of the application within the timeframe. In this case, we will seek to alter the application and continue the assessment rather than give notice to the applicant under section 8S of the Agvet Code of our proposal to refuse the application (and potentially have the applicant or holder resubmit the application).
3. Obtaining consent—when and how?
- If we decide that an application should be altered (in accordance with this guideline), we will make contact with the applicant or the holder to discuss the reasons for proposing to alter the application, and to seek their consent to the alteration.
An email exchange between us and the applicant or holder confirming the terms of the alteration would satisfy the requirements for written consent.
- After submitting an application for registration of a chemical product (and before its determination), the applicant becomes aware of new evidence that says one of the proposed uses of the product is unsafe. After the applicant notifies us of that new information, as required by section 160A of the Agvet Code, we discuss with the applicant or holder the possible alteration of the application to remove the unsafe proposed use. The applicant agrees to the alteration and we exchange emails with the applicant in which the terms of the alteration and the applicant’s consent to it are clearly set out.
4. Annexure—relevant legal provisions
- We have the power to alter certain applications made under the Agvet Code. Such alterations may only be made with the written consent of the applicant or holder.
- We have the power to alter the following applications:
- applications for the approval of an active constituent for a proposed or existing chemical product, for registration of a chemical product, or for approval of a label for containers for a chemical product;
- applications for the variation of a relevant particular prescribed by legislative instrument of an approval or registration;
- applications for the variation of the relevant particulars or conditions of an active constituent, a chemical product, or a label for a chemical product;
- applications for the renewal (or further renewal) of the registration of a chemical product;
- applications for a permit.
Some applications can only be altered after they have passed preliminary assessment.
Note: Section 11(4) of the Agvet Code deals with altering applications for approval or registration. Sections 26B(3) and 28(4) deal with altering applications for variation. Section 48(5) deals with altering applications for renewal. Section 110A(5) deals with altering applications for a permit.