Required information

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 how we can be satisfied that it 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 supported by a dossier: a data list must be supplied 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 the manufacturer of the registered chemical product and the proposed chemical product. The manufacturer’s declaration must include all of the following statements with regard to the proposed repack and registered products:
    • the sites of product manufacture will be the same (same sites of manufacture using the same equipment)
    • the formulations will be the same (same ingredients of the same standards at the same concentrations)
    • the manufacturing processes will be the same (including quality assurance and test procedures)
    • the formulation type, physico-chemical properties (including pH, particle size, crystal form and, where applicable, dissolution profile, payout rate and payout period), and product specifications (release and expiry limits and test methods) will all be the same
    • the immediate containers will be the same (same packaging materials and closure systems, and no additional pack size)
  • 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.

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