Biologicals application form - a step-by-step guide

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:

• cancelling an existing biological ARTG entry. You will need to go to Request a cancellation to an ARTG entry.

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.

• If you want to include a new biological on the ARTG, the complete process together with a checklist of required information is provided in the following documents:
  • Applying for inclusion of a Class 2, 3 or 4 biological on the ARTG
  • Applying for inclusion of a Class 1 biological on the ARTG
• If you want to vary an existing ARTG entry, the process is outlined in Varying biological entries on the ARTG.
• To confirm if you need to apply for a new biological or to vary an existing entry, read new biologicals based on a parent biological.
• If you are applying for a Class 1 biological, you will need to have all of the required documentation outlined in Applying for inclusion of a Class 1 biological on the ARTG.

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

You cannot submit your documentation with the application form.

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, and you wish to provide documentation to the TGA in relation to your application, it can be emailed to bloodandtissues@health.gov.au with the application number in the Subject header.