Standards for Donor Selection, Testing, and Minimising Infectious Disease Transmission - Australian Government

Service summary

You must comply with this standard if you use:

  • Human blood and blood components;
  • Human tissues; or
  • Human cellular therapy products.

These types of therapeutic goods are used in association with:

  • Donor selection;
  • Donor testing; and
  • Blood, blood component, cells and tissue collection and manufacture.

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

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

Act(s) name

Therapeutic Goods Act 1989 (Australian Government)

Regulation(s) name

Therapeutic Goods Order No. 88 - Standards for donor selection, testing, and minimising infectious disease transmission via therapeutic goods that are human blood and blood components, human tissues and human cellular therapy products 2013 (Australian Government)

Contact details

Enquiries
Department of Health
Therapeutic Goods Administration


Operating address:
136 Narrabundah Lane
Symonston
Australian Capital Territory 2609
Mailing address:
TGA, PO Box 100
Woden
Australian Capital Territory 2606

Phone:

1800020653
info@tga.gov.au

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