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.