General Requirements for the Labelling of Biologicals - Australian Government


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 general practitioners.

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