Biologicals

Quick links

Biologicals are defined in Part 3-2A of the Therapeutic Goods Act 1989. For more information, see: Products regulated as biologicals.

Regulatory framework for biologicals
The regulatory framework for biologicals commenced on 31 May 2011
Australian Regulatory Guidelines for Biologicals
Guidelines to assist applicants and sponsors to understand their responsibilities and include or vary entries of biologicals in the ARTG
Standards and publications (biologicals)
Standards, guidelines and publications about the regulation of biologicals
Forms for the biologicals industry
Links to forms for the biologicals industry
Regulatory decisions and notices (biologicals)
Links to regulatory decisions and notices about the regulation of biologicals

If your enquiry is not about biologicals, see: Contact the TGA

Contact details
Email	bloodandtissues@tga.gov.au
Phone	1800 678 799 (freecall within Australia) +61 2 6232 8443 Users who are deaf or have a hearing or speech impairment can call through the National Relay Service: TTY or computer with modem users: phone 1800 555 677 then ask for 1800 678 799 Speak and listen (speech to speech relay) users: phone 1800 555 727 then ask for 1800 678 799
Fax	+61 2 6232 8939
Postal address	Scientific Evaluation Branch Therapeutic Goods Administration PO Box 100 Woden ACT 2606 Australia
Street address (for deliveries)	Therapeutic Goods Administration 136 Narrabundah Lane Symonston ACT 2609 Australia