Labelling of Medicines - Australian Government


You will need to comply with these standards if you intend to package therapeutic goods or medicines for use within Australia. These standards include requirements for:

  • label size
  • font size
  • measurements of the product contained
  • product name
  • storage conditions
  • directions for use.

Currently, there is a transition period where you can choose to comply with either Therapeutic Goods Order No. 69 - General requirements for labels of medicines (TGO 69) which is considered the old labelling requirements or the new labelling requirements under TGO 91 / 92 (whichever applies). The labels must fully comply with all the requirements of either the old or the relevant new Order. You may not selectively comply with parts of different orders. After 31 August 2020, you must comply with either TGO 91 or TGO 92.

You must submit your intended label to the administering agency before it is able to be placed on the market.

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 and Aged Care

Therapeutic Goods Administration

Contact details

Contact Email, Phone and Address Details for this service in simple two column table format, header then data.