This guidance is to help sponsors and manufacturers of medicines meet the Australian labelling requirements described in the new labelling Orders.
There are different risks and information requirements associated with medicines prescribed by a medical practitioner (or used in a clinical setting) to those self-selected by consumers. As a result, the labels for these two types of medicines need to reflect the different contexts in which they're used.
In recognition of this, medicine label requirements are specified in two separate labelling Orders :
In addition to the Orders, other Australian legislation applies to medicine labels. For example, State or Territory legislation for medicines and poisons, and Commonwealth advertising requirements for therapeutic goods.
Guidance on this additional legislation is outside the scope of this document.
Specific transition period provisions are described in section 4 of the Orders.
The transition period ended on 31 August 2020.
Medicines that are released for supply on or after 1 September 2020 must comply with either TGO 91 or TGO 92, whichever is relevant.
During the transition period, medicines must have complied with either TGO 69 or TGO 91/TGO 92 (whichever is relevant).
Sponsors, distributors and retailers can continue to supply TGO 69 compliant goods after 1 September 2020, if those goods were released for supply (the last step in their manufacturing process) on or before 31 August 2020.
How to use the guidance
This guidance is not provided as a legal interpretation of TGO 91 or TGO 92. It includes clarification on, and information relating to, the mandatory requirements. It also includes additional information outlining best practice recommendations for medicine labels.
Where the words 'must' or 'required' are used, a legal requirement is being described.
Following this guidance is not a guarantee that your label is fully compliant.
Structure of the guidance
This guidance is divided into four parts.
Part 1 describes the structure of the Orders and legal requirements that generally apply to all medicines.
Part 2 provides guidance to assist you to identify the legal mandatory requirements that apply to certain types of medicines. For each type of medicine, there are references to specific relevant sections of the Orders.
Part 3 provides guidance on the design of medicine labels and some 'best practice principles'. This information is not mandatory, but is included to further improve the safe and quality use of medicines.
Part 4 provides guidance on the tabulated display of Critical Health Information. This includes both mandatory requirements and best practice guidance.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.