Medicine labels: Guidance on TGO 91 and TGO 92

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Version 1.0, August 2016

17 August 2016

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[1]:

Note

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.

Transition period

A four (4) year transition period has been provided for the implementation of TGO 91 and 92 which, together, will eventually replace Therapeutic Goods Order No. 69 - General requirements for labels for medicines (TGO 69).

  • Specific transition period provisions are described in section 4 of the Orders.
  • During this time, medicines must comply with either TGO 69 or TGO 91/TGO 92 (whichever is relevant).
  • At the end of the transition period, medicines must comply with either TGO 91 or TGO 92, whichever is relevant.
  • TGO 69 will cease to exist ('sunset') in October 2017. As the transition period extends beyond October 2017, TGO 69 will be remade so that it remains in existence until the end of the 4 years.

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.

Note

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.

Footnote

  1. Some medicines are exempt from the Orders, and these are described in section 5 of each Order.

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