Standard for Diagnostic Goods of Human Origin - Australian Government

Description

You must comply with this standard if you are involved in the preparation of goods which contain materials of human origin and are intended as laboratory reagents for diagnostic tests.

You are exempt from complying with this licence if either the goods prepared:

  • have been heat treated at 60 degrees C for 10 hours
  • cannot be prepared from material that is non-reactive when testing for Hepatitis B virus or antibody to HIV.

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 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.

Act(s) name

Therapeutic Goods Act 1989 AG

Regulation(s) name

Therapeutic Goods Order No. 34 - Standard for Diagnostic Goods of Human Origin 1990 AG

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.

Enquiries

Therapeutic Goods Administration

Department of Health

Operating address: 136 Narrabundah Lane
Symonston
Australian Capital Territory 2609
Mailing address: TGA, PO Box 100
Woden
Australian Capital Territory 2606
Phone: 1800 020 653
Email: info@tga.gov.au