This content is current only at the time of printing. This document was printed on 12 September 2020. A current copy is located at http://www.xlg888.com/node/623
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The application must be accurately completed and be accompanied by the prescribed fee. The legislation includes penalties for the provision of false or misleading information.
You will be required to provide certain information to support your application, including information that enables the APVMA to be satisfied your application meets the relevant statutory criteria. When the application is made, the following information may be required:
- information that will allow us to consider our satisfaction against the safety criteria, efficacy criteria, trade criteria and labelling criteria
- for the appointment or variation of a nominated agent: written consent from the proposed nominated agent
- for a timeshift application: the project plan agreed to by the applicant and the APVMA
- for an application that requires a data list: the data list must be provided electronically
- for an application supported by reference to information where the use of that information is limited, consent from the authorising party of that information (unless the applicant is also the authorising party, in which case consent is not required)
- for an application for registration of a chemical product that is the same as another chemical product, except for the distinguishing name, number and proposed holder: a declaration from, or on behalf of, each manufacturer of the proposed chemical product that the product will be the same as the reference product. Each manufacturer of the proposed product must be a manufacturer of the reference product. Each manufacturer’s declaration, or set of manufacturer's declarations where different manufacturers undertake different manufacturing steps, must include words to the effect that:
- the site(s) of manufacture and the equipment used will be the same?
- the formulation and the ingredients will be the same?
- the manufacturing processes will be the same (including quality assurance and test procedures)
- the formulation type, physico-chemical properties and product specifications will all be the same
- the immediate containers will be the same and there will be no additional pack size
- a template for a manufacturer's declaration is available here.?
- for registration of an agvet chemical product and approval of a label: the required information for the label must be provided electronically
- for a variation of the label approval: the required information for the label must be provided electronically.