General Requirements for the Labelling of Biologicals - Australian Government

Description

You must comply with these requirements if you intend to deposit blood, cells and tissues collected from a donor in a container.

These requirements must be complied with in all circumstances, including but not limited to:

  • collection at a pathology
  • collection at a hospital
  • collection at a general practitioners.

General requirements state that containers of blood, cells and tissues collected from a donor as starting material for a biological must be labeled and traceable to that donor in each step of manufacture of the biological and in relation to the released biological. The labels or labels must be clearly visible and in the English language, durable and legible characters, in letter height of not less than 1.5 millimeters and in metric units of measurement (if applicable).

Please consult the Contact Officer for more information.

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 AG

Regulation(s) name

Therapeutic Goods Order No. 87 - General Requirements for the Labelling of Biologicals 2011 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

Mailing address: 136 Narrabundah Lane
Symonston, Australian Capital Territory 2609
Mailing address: PO BOX 100
Woden, Australian Capital Territory 2606
Toll Free: 1800 020 653
Email: info@tga.gov.au
Website: Therapeutic Goods Administration (Opens in new window)