Section 159 in the context of applications under the Agvet code

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 the operation of section 159 of the Agvet Code (which empowers us to require an applicant to do specified things or provide us information, reports or samples).
  3. It covers the operation of section 159 of the Agvet Code in the context of the applications under the Agvet code. It does not deal with section 159 of the Agvet Code in the context of suspensions or cancellations. 
  4. The provisions of the Agvet Code covered by this Guideline are outlined in the Annexure to this guideline.
  5. This guideline commences on 1 July 2014.

2. What are the circumstances in which we will issue a section 159 notice?

  1. We expect applicants to lodge an application that contains or is accompanied by all relevant information such that the application ‘meets the application requirements’.
  2. Where an application is deficient—such that we are unable to assess the application against the relevant statutory requirements and criteria (including the safety, efficacy, trade or labelling criteria, as the case may be)—we may issue a section 159 notice to the applicant requiring the applicant to provide specified information or to do some specified thing.
  3. We will issue a section 159 notice to an applicant where:
    1. the information sought or the thing required to be done is necessary for us to assess the application
    2. we consider that the deficiency in the application can be rectified within the timeframe for assessing the application, and
    3. where it would be more efficient for us to require further information from (or the thing to be done by) the applicant than to propose to refuse the application and potentially have the applicant resubmit the application (see below).
  4. The information referred to in section 159(e) of the Agvet Code means information that is already known or in existence. We will not issue a notice for the purposes of section 159(e) if it would require the applicant to undertake substantial work to generate information to comply with the notice. 
  5. We will not issue a section 159 notice to an applicant if to do so would likely compromise our ability to assess the application within the statutory timeframe. 

  6. What do we take into account to decide if it is efficient for us to require an applicant to provide further information?

    We will take into account the following considerations in determining whether it is efficient for us to require an applicant to provide further information or do further things to rectify deficiencies in the application:

    1. whether we view the application deficiency as being reasonably rectifiable
    2. the nature of the information required (including the quantity of information) or the things required to be done
    3. whether the information required is already known or in existence
    4. whether the applicant would be able to comply with the requirements within the statutory timeframe available to respond to the notice
    5. the extent to which issuing the notice and considering the applicant’s response to the notice would affect our ability to assess the application within the statutory timeframe for assessing the application, and
    6. whether we have done significant amounts of work that we would need to re-do if, rather than requiring an applicant to provide further information or do further things to rectify deficiencies in the application, we proposed to refuse the application (potentially resulting in the applicant resubmitting the application)

      Examples

    7. If an application is lodged which refers to studies, but those studies are not provided, a section 159 notice may be issued requiring the applicant to provide those studies
    8. If an application is lodged which contains missing pages or some other missing information, a section 159 notice may be issued requiring the applicant to provide the missing pages or information
    9. If an application is lodged which is unclear in some respect, a section 159 notice may be issued requiring the applicant to clarify that aspect of the application
    10. If an application is lodged for a number of uses of an active constituent, and supporting information is provided for all but one of those uses, a section 159 notice may be issued requiring additional information with respect to that use
    11. We will not issue a section 159 notice requiring an applicant to conduct a new study or analysis and provide the results
    12. If an application is lodged without any studies or supporting information attached, we will not issue a section 159 notice for the purpose of obtaining that information and will propose to refuse the application.

3. When will we issue a section 159 notice and how many will we issue?

  1. If we decide to issue a section 159 notice, we will do so:
    1. as early in the assessment process as is appropriate (see below), and
    2. by issuing one consolidated notice to the applicant in relation to all of the deficiencies in the application (rather than issuing multiple notices in respect of the same application), where appropriate (see below).
  2. When will we issue a notice?

    If we discover a deficiency or deficiencies in an application, we will generally issue a section 159 notice after the following has occurred:

    1. the application has passed preliminary assessment
    2. we have commenced the assessment of the application (in consultation with any relevant bodies), and
    3. we have taken into account the considerations listed above and determined that it is both necessary and efficient to issue the notice.
  3. When will we issue more than one notice?

    We will only issue a further notice (or further notices) in relation to the same application if, after taking into account the considerations listed above we have determined that it is both necessary and efficient to issue the notice, and one of the following situations applies:

    1.  we (or a body we have consulted in relation to the application) have made an error and failed in the first notice (or a previous notice) to account for all of the deficiencies in the application of which we were aware at the time of issuing that notice
    2. we consider it necessary to issue a further notice to the applicant to afford the applicant procedural fairness (for example, to allow the applicant an opportunity to give us information to respond to information we have that is adverse to their application and that they have not previously been given an opportunity to comment on), or
    3. the applicant has provided information or done a thing in response to the first notice (or a previous notice) and we require clarification of that information or thing done to complete the assessment of the application.

    Note: When we issue the first section 159 notice in relation to an application, the assessment period for the application is extended in accordance with regulation 76A of the Agvet Code Regulations. However, the assessment period for the application is not further extended as a result of further section 159 notices being issued in relation to the application.

4. What is a ‘reasonable period’ within which to respond to a section 159 notice?

  1. In determining what constitutes a ‘reasonable period’ for the purposes of section 159(1), we will take the following into account:
    1. the maximum period prescribed by regulation 65A of the Agvet Code Regulations
    2. the original assessment period for the application (prescribed by column 2 of Part 2 of Schedule 6 of the Agvet Code Regulations)
    3. the requirements of the proposed notice, such as the kind of information required to be provided, whether the information is likely to be readily available, and the steps the recipient would need to take to provide the information.

5. When will we allow a further period to respond to a section 159 notice?

  1. We may allow an applicant a further period to respond to a section 159 notice if an extraordinary event or circumstance beyond the control of the applicant prevents the applicant from fulfilling the obligations in the notice (section 159(1AB) and regulation 65(5)).
  2. An extraordinary event or circumstance may include such things as natural disasters and similar events beyond the control of the applicant (for example, the destruction of premises or documents by flood or fire).
  3. An impending refusal of an application is not, in and of itself, an extraordinary event or circumstance.

6. What happens if an applicant fails to comply with a section 159 notice? 

  1. If an applicant fails to comply with a section 159 notice, we may take steps to refuse the application (by issuing a notice of proposed refusal or other action under section 8S of the Agvet Code). 

    Note: Section 8S of the Agvet Code deals with notices of certain proposed decisions by the APVMA.

  1. Section 159 of the Agvet Code provides that we may require an applicant or a holder to provide specified information to us (or other bodies), or do specified things for the purposes of:
    1. determining an application in relation to an active constituent for a proposed or existing chemical product, a chemical product, or a label for containers for a chemical product
    2. determining an application relating to a permit in respect of an active constituent for a proposed or existing chemical product, or a chemical product
    3. deciding whether to suspend or cancel an approval for an active constituent for a proposed or existing chemical product, the registration of a chemical product, the approval of a label for containers for a chemical product, or a permit in respect of an active constituent for a proposed or existing chemical product or a chemical product. 

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