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:

• Part 2: Regulatory life cycle for biologicals
• Appendix 10: Guide to Biologicals application form