Information lists

An information list is a list of the details about the information submitted with an application to meet administrative requirements and address the safety, efficacy and trade criteria. The Agvet Code requires us to publish this information at particular stages in the assessment of the application, with a summary of the application after the application passes preliminary assessment and with notices that are required to be published if we grant the application. The information list is also necessary for any relevant limitations on use (data protection) to be appropriately administered.

Information lists must be submitted electronically. The online application form assists you to enter the information required for the information list when you upload the information to the application portal. Alternatively, if you intend to provide the information supporting your application by electronic media (CD or USB) by mail rather than uploading it through the application portal an ‘Information List Editor’ is available to assist you in completing the information list.

The Agvet Code and the Agvet Code Regulations require us to record and publish a short descriptioin of each item of information contained in or accompanying applications for approval or registration, or for variation of relevant particulars or conditions of approvals and registration. These includes the following details:

  • the title shown on the item of information
  • the name of the author, or each of the authors, of the information
  • the date shown on the item of information (if any)
  • if no date is shown on the item of information, the date when the preparation of the information was completed
  • if the information was published
    • the date when it was published
    • the name of the publication in which it was published
  • a unique identifier for the item of information that indicates the location of the item in the application (for example the volume and page number where the item of information is located in the application)
  • the name and address of the authorising party for the information.

Further guidance about information lists and how to prepare them is available here.

 

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