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Biologicals application form - a step-by-step guide

Australian Regulatory Guidelines for Biologicals (ARGB)

27 July 2018

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This application form can only be used to:

  • include a new biological on the ARTG
  • vary an existing biological entry on the ARTG

This form is not used for:

Once you have all of the required information, this guide will step you through completion and submission of the application form.

Before you complete this form

You need to read the relevant documents below, otherwise you may not have all of the information you need to complete the form.

Overview of the submission process

The application form

You need to complete all of the information on each tab of the form.

Once you have finished, then you will need to validate the form, and correct any errors or missing information, before you finally submit the form to us.

Accompanying documentation

Class 2, 3 or 4 biologicals

If you are submitting a Class 2, 3 or 4 biological application, or a variation to your ARTG entry, you cannot submit your documentation with the application form.

You will need to send us the required documentation according to the options provided in the General dossier requirements.

Class 1 biologicals

If you are submitting a Class 1 biological, details of how to attach your documentation to the submission form is provided in this guidance.

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