Standards for Blood and Blood Components - Australian Government

Description

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 by your business.

Service type

Code of Practice

A code of practice can be either a legal requirement or non-legal requirement. Legal codes of practice are defined as a result of legislation. Non-legal codes of practice are defined by industry regulators and bodies.

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.

Information Officer

Operating address: 136 Narrabundah Lane
Symonston
Australian Capital Territory 2609
Mailing address: PO BOX 100
Woden, Australian Capital Territory 2606
Phone: 02 6232 8644
Phone: 1800 020 653
Fax: 02 6203 1605
Email: info@tga.gov.au