Standards for Blood and Blood Components - Australian Government


You may be required to comply with this standard if you intend to manufacture blood or blood components.

This standard applies to blood and blood components other than blood and blood components that are:

  • collected by a medical practitioner in the course of medical treatment and for the purposes of diagnosis of testing for, a medical condition
  • manufactured by a medical practitioner for therapeutic application to a particular patient under the practitioner's care
  • manufactured by a blood collection centre for a medical practitioner for therapeutic application to a particular patient under the practitioner's care.

The Therapeutic Goods Order No. 81 Standards for Blood and Blood Components, states that blood and blood components must meet the requirements of the Council of Europe document 'Guide to the preparation, use and quality assurance of blood components' 14th edition and must only be manufactured from blood that tests negative for HIV-1 and HCV using Nucleic Acid Amplification Technology.

Please note that the Agency has advised that there are various codes for medicines, medical devices and chemicals which are amended on a regular basis.

Please consult the Contact Officer for more information and to ascertain the level of compliance (if any) that may be required.

Service type

Code of Practice

A code of practice is a set of rules which details how people in a certain industry should behave. A code of practice can be defined as a result of legislation or by industry regulators and bodies.

Act(s) name

Therapeutic Goods Act 1989 Australian Government

Regulation(s) name

Therapeutic Goods Regulations 1990 Australian Government

Administering agency

Department of Health

Therapeutic Goods Administration

Contact details

Contact Email, Phone and Address Details for this service in simple two column table format, header then data.

Please use these contact details for help or more information:

Information Officer

Therapeutic Goods Administration

Department of Health

Operating address: 136 Narrabundah Lane
Symonston, Australian Capital Territory 2609
Phone: 02 6232 8644
Fax: 02 6203 1605
Website: Therapeutic Goods Administration (Opens in new window)