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, Good Manufacturing Practice (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 to the Australian Pesticides and Veterinary Medicines Authority (APVMA) by post on a USB drive.
The information list may be published on our website in application summaries and will be published to our registered chemical database PubCRIS once the product is registered. Refer to the guidance for preparing information lists for more information.
Uploading to the information list in an 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 an applicant intends to address the application criteria.
- Applicants should read the data guidelines to know what supporting documentation may need to be provided to address the statutory criteria for each type of application.
- The maximum upload 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 our Online Services Portal.
Preparing the information list
Applicants are required to complete some basic information about each piece of data that is uploaded 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 an 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
Manufacturers' declaration
Applicants seeking to repack an existing product, whether their own or someone else’s, can upload a manufacturer’s declaration to the information list – instead of providing formulation details.
Manufacturers’ declarations need to contain specific statements as detailed 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. Letters of consent should be uploaded to the information list with an application.
Consent to use information where there are limits on use
For applications that require the APVMA to access information where limits on use apply, 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 that has limits on use, unless an exception applies (consent from the authorising party being one of these exceptions). Consent for use letters should be uploaded to the information list with an application.
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. Scientific arguments should be uploaded to the information list.
Refer to the data guidelines for further information on using scientific justification to satisfy the statutory criteria.
Executive summary
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 application 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) where the:
- APVMA report states the data previously provided satisfied one or more of the relevant statutory criteria
- applicant can demonstrate the previously provided data or the APVMA report is still valid.
Overseas assessments
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 an application and explain:
- the similarities between the product registered in the foreign country and the product proposed for registration in Australia, including the 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 the guidance on the submission of international data, standards and assessment for more information.
Good Manufacturing Practice
Applications for veterinary products are required to provide evidence of GMP uploaded to the information list with an application.
Evidence of GMP is required for every manufacturer involved in any step of a 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.