Labelling of Medicines - Australian Government

Description

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.

The TGA introduced new labelling requirements for medicines supplied in Australia on 31 August 2016. All affected medicines released for supply from 1 September 2020 must comply with the labelling requirements of TGO 91 or 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.