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Application Requirements

This page details application requirements for Data Protection, Application Summaries and Advice Summaries.

On this page:

Application Requirements Overview

The Agricultural and Veterinary Chemicals Code 1994 (the Agvet Code) requires the APVMA to do, or not do certain things in relation to information supplied with applications.

This includes:

  • Data Protection – limitations on how the APVMA can use information in making certain decisions
  • Early Disclosure – publishing application summaries once an application has been accepted for assessment, and
  • Summaries of Advice– publishing a summary of the advice provided by other Government departments and agencies, and other specialists the APVMA consults, in relation to applications which are granted.

The Application Requirements for Data Protection, Application Summaries and Advice Summaries (PDF, 46kb) sets out what is required of applicants with respect to the above three matters. These requirements are only relevant for applications for active constituents, products and labels. They are not relevant to applications for permits.

A detailed background on the data protection and transparency provisions of the Agvet Code can be found in ‘Data Protection, Application Summary and Advice Summary Provisions of the Agvet Code and the Agvet Chemical Industry’ (PDF, 62kb).

Data Lists and Tools

A data list is required whenever data is submitted to the APVMA in connection with an application for active constituent approval or product registration; or in connection with an application for variation. Data lists are required to satisfy data protection and/or transparency requirements.

From 18 February 2010, the previous Microsoft Word and Rich Text templates will no longer be accepted by the APVMA. Applicants must use the Data List Editor (see below) to compile a data list in accordance with the relevant instructions for use. If an applicant does not provide a data list in the required format (.xml) the application may be rejected.

Inclusion of chemistry data in data lists

The APVMA requires the details of chemistry data provided with applications to be included in a data list that accompanies the application.

The ‘Instructions for using APVMA data list’ documents state that information considered ‘data’ for the purposes of a data list include:

  • A report describing one or more tests, analyses, trials or studies
  • A report summarising information necessary to meet APVMA data requirements
  • A description of a method of analysis
  • Expert opinion on a data requirement provided by someone other than the applicant

With respect to chemistry data, the items that will be considered ‘data’ for the purposes of a data list include reports of:

  • physico-chemical properties
  • stability studies (including in-use stability trials)
  • analytical methods details
  • validation data
  • batch analysis results for active constituents and/or formulated products
  • manufacturing/formulation process (including quality control during manufacture)

This information should be presented in report form. These data items must be included in the application data list.

Other information that may be required to be supplied in the Part 2 Chemistry and Manufacture data package, but will not be considered ‘data’ for the purposes of a data list include:

  • certificates of analysis (non-active constituents)
  • specification sheets
  • Declaration of Composition (DoC)
  • Material Safety Data Sheets (MSDS)
  • formulation composition details
  • product specifications
  • container specifications

As such these items should not be included as individual items in a data list.

Items not mentioned above

Any other items not mentioned above should only be included in a data list where they constitute a report on a scientific body of work intended to demonstrate a result to support a data requirement (i.e. a report with an intellectual property value).

If unsure whether certain data should or should not be included in a data list, please contact the APVMA.

Data List Editor

The Data List Editor is an easy to use tool that allows you to quickly build and edit data lists where a data list is required with an application.

Instructions for use explain how to download the tool to your computer and how to work with it.

Contact

For further information or assistance with using the Data List Editor, contact:

Application Management and Enquiries Team

Phone: +61 2 6210 4701

Fax: +61 2 6210 4721