Approvals and registrations

1. What is this guideline about?

  1. This guideline is made pursuant to section 6A of the Agvet Code.
  2. 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 approvals and registrations under Division 2 of Part 2 of the Agvet Code.
  3. It covers preliminary assessments, determining applications (including the information we take into account), restrictions on our power to approve or register, conditions on approvals and registrations, and notices of proposed decisions. 
  4. The provisions of the Agvet Code and the Agvet Code Regulations covered by this guideline are outlined in the annexure to this guideline. 
  5. This guideline commences on 1 July 2014.

2. Preliminary assessment—where can I get more information? 

  1. We expect applicants to lodge an application for approval or registration that contains or is accompanied by all relevant information such that the application ‘meets the application requirements’.

    Note: Section 8A of the Agvet Code defines ‘meets the application requirements’.

  2. We will undertake a preliminary assessment of applications for approval or registration in accordance with Section 6A guideline—preliminary assessment.
  3. For the purposes of section 11(4) of the Agvet Code, we may alter an application, after it has passed preliminary assessment, and with the written consent of the applicant, in accordance with Section 6A guideline—altering applications.
  4. Following preliminary assessment of an application, and prior to determination of that application, we may recategorise the application in accordance with Section 6A guideline—recategorising applications.

3. How will we determine applications for approval or registration?

  1. We must be satisfied of the relevant matters in section 14 of the Agvet Code before we can approve an active constituent or label, or register a chemical product. 

3.1. When will the safety criteria be met?

  1. To approve an active constituent or register a chemical product, we must be satisfied that, among other things, the constituent or product meets the safety criteria in accordance with section 5A of the Agvet Code. 
  2. In satisfying ourselves that an active constituent meets the safety criteria, we must have regard to the matters set out in section 5A(2)(a), and we may have regard to such other matters as we think relevant (section 5A(2)(b)). In satisfying ourselves that a chemical product meets the safety criteria, we must have regard to the matters set out in section 5A(3)(a), and we may have regard to the matters set out in section 5A(3)(b), including such other matters as we think relevant (section 5A(3)(b)(vi)).

3.2. When will the efficacy criteria be met?

  1. To register a chemical product, we must be satisfied that, among other things, the product meets the efficacy criteria in accordance with section 5B of the Agvet Code. 
  2. We must do this by having regard to the matters set out in sections 5B(1) and 5B(2) of the Agvet Code, but only to the extent that we think those matters are relevant (see section 5B(3)).
  3. For certain chemical products or classes of chemical products, we think that it is not relevant to have regard to the matters in sections 5B(1) and 5B(2) for the purposes of the operation of the Agvet Code in relation to those products or classes of products.
  4. [These guidelines or supporting materials are still to be developed. We are in the process of considering what these chemical products or classes of chemical products might be.]

3.3. When will the trade criteria be met?

  1. To register a chemical product, we must be satisfied that, among other things, the product meets the trade criteria in accordance with section 5C of the Agvet Code. 
  2. We must do this by having regard to the matters set out in sections 5C(1) and 5C(2) of the Agvet Code for chemical products where it can reasonably be expected that the product will be used in relation to:
    1. a crop or animal, a product of which might be provided to a place outside Australia, or
    2. a crop that will be fed to an animal, a product of which might be provided to a place outside Australia (see section 5C(3) and regulation 8AD).
  3. For any other chemical product, we need only have regard to the matters set out in sections 5C(1) and 5C(2) to the extent that we think those matters are relevant (see section 5C(3) and regulation 8AD).
  4. For certain chemical products or classes of chemical products, we think that it is not relevant to have regard to the matters in sections 5C(1) and 5C(2) for the purposes of the operation of the Agvet Code in relation to those products or classes of products.
  5. [These guidelines or supporting materials are still to be developed. We are in the process of considering what these chemical products or classes of chemical products might be.]

3.4. When will the labelling criteria be met?

  1. To approve a label for containers for a chemical product, we must be satisfied that the label meets the labelling criteria in accordance with section 5D of the Agvet Code.
  2. We must be satisfied that the label contains adequate instructions relating to such of the matters set out in section 5D(1) as are appropriate. We must do this by having regard to the matters set out in section 5D(2).

4. What information do we take into account in determining an application?

  1. Section 8C of the Agvet Code sets out the information that we must, may and must not take into account in determining an application.
  2. Despite section 8C, there is certain information that we cannot take into account in determining an application. This includes information subject to the limits on use of information provisions in Division 4A of Part 2 of the Agvet Code, and other similar provisions (see section 14B and Part 3 of the Agvet Code and Part 7B of the Admin Act). The details of the kind of information subject to the limits on use of information provisions in Division 4A of Part 2 of the Agvet Code, and the extent of the limits, are set out in Section 6A guideline—limits on use of information.
  3. Section 8C of the Agvet Code requires us, in determining an application, to have regard to any submission made in response to an invitation given by us in relation to the application. We will only invite a person to make a submission in relation to an application where we are required by the Agvet Code or the Agvet Code Regulations to invite submissions (see, for example, sections 8S, 12 and 13 of the Agvet Code).
  1. Under section 15 of the Agvet Code, we must not:
    1. register a chemical product unless we also approve each active constituent for the product, and approve a label for the containers for the product
    2. approve a label for containers for a chemical product unless we also register the product.
  2. Where we are required to assess related applications—that is, applications for active constituent and label approval and chemical product registration, where the applications relate to the same active constituent or chemical product—we will not take steps to grant any one application unless we are satisfied that all of the applications can be granted.
  3. If we are satisfied that any one of the applications cannot be granted, we will issue a notice proposing to refuse each of the applications under section 8S of the Agvet Code (see below).

6. What kinds of conditions will we impose on approvals and registration?

  1. Section 23(1) of the Agvet Code provides that approvals and registrations are subject to the conditions prescribed in the Agvet Code Regulations and any other conditions imposed that we think appropriate. 
  2. We think it will be appropriate to impose conditions on:
    1. the approval of an active constituent so that we can be satisfied that the constituent meets the safety criteria (and can, as a result, be approved)
    2. the registration of a chemical product so that we can be satisfied that the product meets the safety criteria, the trade criteria and the efficacy criteria (and can, as a result, be registered)
    3. the approval of a label for containers for a chemical product so that we can be satisfied that the label meets the labelling criteria (and can, as a result, be approved).
  3. Any conditions that we impose on an approval or registration will be:
    1. consistent with the Agvet Code and the Agvet Code Regulations, and otherwise lawful
    2. consistent with our regulatory approach as set out in the guidelines
    3. capable of being monitored and measured.

7. Notice of a proposed decision (section 8S)

7.1. How much time is there to respond to the notice?

  1. Once we have assessed an application, and except where we decide to grant the application in accordance with the terms of the application, we will give the applicant a notice of our proposed decision and invite them to make written submissions within 28 days or within a further period specified in the notice (see section 8S of the Agvet Code).
  2. In deciding whether to specify a ‘further period', we will take the following matters into account:
    1. the statutory timeframe for assessing the application, and
    2. our reasons for proposing to take the action set out in the section 8S notice.

7.2. To what extent do we take into account a response to the notice? 

  1. In determining an application, we must take into account anything given in response to our invitation to make written submissions in the section 8S notice (see section 8C(1)(a)(iii)). However, we are not required to take account of anything given in response to the invitation that is not related to information:
    1. already given to us by or on behalf of the applicant, or
    2. on which our reasons for the proposed course of action are based, as set out in the notice (including information not given to us by the applicant) (see section 8S(3)). 
  2. The following are examples of the kinds of things that are likely to be ‘not related’ to this information:
    1. reports, data sets or other information that would change fundamentally the nature of the application
    2. reports, data sets or other information that would require us to consider the application anew, based on the new information rather than on the information already provided
    3. reports, data sets or other information that would require us to ignore the information already provided.

8.1. Applying for approval or registration

  1. The Agvet Code provides that a person may apply to us:
    1. for approval of an active constituent for a proposed or existing chemical product
    2. for registration of a chemical product, or
    3. for approval of a label for containers for chemical product.
  2. The application:
    1. must meet the application requirements, and 
    2. for an active constituent or chemical product—must include proposed instructions for the use of the constituent or product. 
  3. Within 10 working days of receiving the application, we will notify the applicant that the application has been received. 

    Note: Section 10 of the Agvet Code deals with the making of applications. Section 8A defines ‘meets the application requirements’. Regulation 75 of the Agvet Code Regulations deals with the notice requirements.

8.2. Preliminary assessment

  1. The Agvet Code provides that we must complete a preliminary assessment of the application within one month after it is lodged.
  2. If it appears from the preliminary assessment that the application meets the application requirements, we must, within 14 days:
    1. give the required form of written notice to the applicant, and
    2. publish a summary of the application that includes any details prescribed in the Agvet Code Regulations.
  3. If it does not appear from the preliminary assessment that the application meets the application requirements, we must refuse the application.
  4. The Agvet Code provides that we may alter an application, after it passes preliminary assessment, with the written consent of the applicant.

    Note: Section 11 of the Agvet Code deals with preliminary assessments (see also regulations 8B, 8D and 8E of the Agvet Code Regulations in relation to summary publication and notice requirements). Section 8A defines ‘meets the application requirements’. 

8.3. Determining the application

  1. The Agvet Code requires us to approve the active constituent or label, or register the chemical product, if we are satisfied:
    1. that the application meets the application requirements, and 
    2. for an active constituent—that the constituent meets the safety criteria, and
    3. for a chemical product—that the product:
      1. meets the safety criteria, the trade criteria and the efficacy criteria, or
      2. complies with the established standard for the product, and
    4. for a label for a chemical product—that the label:
      1. meets the labelling criteria, or
      2. complies with the established standard for the product
  2. If we are not satisfied of the relevant matters in respect of a particular application, we must refuse the application. 
  3. The Agvet Code sets out information that we must, may and must not take into account in determining an application.
  4. At any time after an application is made and before it is determined, the applicant may withdraw it by giving us notice of the withdrawal signed by the applicant.

    Note: Section 14 of the Agvet Code deals with determining an application. Section 8A defines ‘meets the application requirements’ (see also section 8B). Section 5A defines ‘meets the safety criteria’ (see also regulation 8AB of the Agvet Code Regulations). Section 5B defines ‘meets the efficacy criteria’. Section 5C defines ‘meets the trade criteria’ (see also regulation 8AD of the Agvet Code Regulations). Section 5D defines ‘meets the labelling criteria’ (see also regulation 8AE of the Agvet Code Regulations). Section 8U deals with the ‘established standard’ for the product. Section 8C deals with the information to be taken into account in determining an application (see also sections 14A and 14B). Section 15 deals with restrictions on our power to register products and approve labels. Section 16 deals with multiple approvals or registrations. Section 23 deals with conditions of approval or registration. Section 8D deals with the withdrawal of applications.

8.4. Notice of proposed decision

  1. Before determining an application, we must, in specified circumstances, give the applicant written notice of what we propose to do:

    Note: Section 8S of the Agvet Code deals with these notices. 

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