Biological application

26 October 2012

Biological application form

The form to apply for inclusion of a biological in the Australian Register of Therapeutic Goods (ARTG) is an electronic application form, available on the TGA eBusiness Services portal.

Requirements for biologicals applications

An application for inclusion of a biological in the ARTG is not effective unless:

  • it is made on the electronic application form for biologicals
  • it is accompanied by any documents required by the form - this includes the dossier for class 2-4 biologicals
  • the application fee is paid
  • the documentation and printed application form is delivered to the address specified on the form
  • samples of the biological, if requested, are provided.

Further information

Details on the application process for biologicals are available in the following sections of the Australian Regulatory Guidelines for Biologicals: