This content is current only at the time of printing. This document was printed on 28 August 2020. A current copy is located at http://www.gitygostar.com/node/26696
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Data and information lists
The information list is where applicants can upload all supporting documentation/data for an application.
An information list may include files containing scientific data, reports, declarations, GMP certificates and other types of supporting documentation needed to meet the application requirements. More information is available under required information.
Alternatively, you can choose to download and use the information list editor program and supply supporting documentation by post on hard media, such as a USB drive or CD/DVD.
The information list may be published to the APVMA website in application summaries and/or decision summaries and will be published to our registered chemical database once the product is registered. Refer to guidance for preparing information lists for more information.
Uploading to the information list in the online application is the preferred way of providing supporting documentation to the APVMA.
What to upload
The final information list for each application will be unique. What to include depends on the nature of the application and how the applicant intends to address the criteria.
- applicants need to read the data guidelines to know what supporting documentation they may need to provide to address the statutory criteria for their type of application
- the maximum file size is 35 MB and the maximum number of files that can be uploaded is 50. If an application requires more than 50 files, please complete and submit the additional data pack form available from the left hand navigation bar when logged into Online services.
Preparing the information list
You are required to complete some basic information about each piece of data that you upload to the information list. This includes: reference number, data type, data sub-type, study date, author, title and authorising party. This information will appear on your information list.
Refer to the dossier page for more information about the requirements for preparing a data package.
Read the Guidance for preparing information lists for further assistance.
Special data types
Applicants seeking to repack an existing product, whether their own or someone else’s, can upload a manufactures declaration to the information list—instead of providing formulation details.
Manufacturer’s declarations need to contain specific statements as listed in the application requirements.
Consent to CCI
While not a requirement, for applications that require the APVMA to access a third party’s confidential commercial information (CCI) a consent for use letter may be provided. If you are providing a letter of consent with your application, please upload it to your information list.
Consent to use information where there are limits on use
For applications that require the APVMA to access information where limits on use applies, a consent for use letter from the authorising party (this is usually, but not always, the owner) is required. Under the AGVET Code, the APVMA is proscribed from using information which has limits on use, unless one of the exceptions applies (consent from the authorising party being one of these exceptions). Please upload the consent for use letter to the information list.
A consent letter needs to:
- be signed by the authorising party and on their letterhead
- state the name and registration or approval number of the referenced product or chemical
- identify the applicant’s name, organisation and the relevant APVMA application or data number
- specify the information covered by the consent for use, and any limits to the consent.
Valid scientific argument
A scientific argument can be provided in place of data to satisfy the APVMA of one or more of the statutory criteria for safety, trade or efficacy. The scientific argument should be uploaded to the information list.
Refer to the data guidelines for further information on using scientific justification to satisfy the statutory criteria.
Applicants need to provide an executive summary either by uploading it to the information list or by entering it in the text fields on the executive summary page.
The executive summary needs to:
- include a succinct statement on the purpose of the application and how the applicant intends to address the criteria
- describe any potential or existing issues associated with the application
- highlight any information about the application the applicant wants to bring to the APVMA’s attention.
Previously provided report from the APVMA
Applicants can choose to upload a report from the APVMA referring to data previously supplied in support of an application (instead of resupplying the data) when:
- the APVMA report states the data previously provided satisfied one or more of the relevant statutory criteria
- the applicant can demonstrate the previously provided data or APVMA report is still valid.
Applicants can choose to upload copies of overseas assessment reports to support an application.
The documents uploaded must be supported by a statement, plus underpinning data, from the applicant to justify how the data supports and is relevant to their application and explain:
- the similarities between the product registered in the foreign country and the product proposed for registration in Australia, including formulation
- any significant differences in the use of the constituent or product in Australia and in the foreign country
- any different environmental factors, or agricultural practices affecting the use of the constituent or product in Australia and in the foreign country
- any significant additional information relating to the properties of the constituent or product that has become available since the conduct of those experiments or trials.
Refer to guidance on the submission of international data, standards and assessment for more information.
Good Manufacturing Practice
Applications for veterinary products need to upload evidence of Good Manufacturing Practice (GMP) to their information list.
Evidence of GMP is required for every manufacturer involved in any step of the manufacturing process. Acceptable evidence of GMP compliance varies depending on the country of manufacture and the type of product. Refer to providing evidence of good manufacturing practice for more information.