Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines

The purpose of the label on a medicine is to provide information about the medicine, including its name, strength, ingredients, storage requirements, expiry date, dosage, directions for use, sponsor details and registration or listing status. The labelling requirements depend on the type of medication, its use, and its packaging.

This document sets out the labelling standards for prescription medicines and composite packs containing a subscription medicine.

Main sections:

- Application - therapeutic goods to which this Order applies

- Transition arrangements

- Exemptions - medicines to which this Order does not apply

- Interpretation

- General requirements, including label presentation

- Information to be included on the label

- Information to be included on the main label

- Qualifications and special requirements

- How information is to be expressed

- Schedule 1 - substances or groups of substances present in medicines that are required be declared on the label

- Schedule 2 - specified ingredient names, including dual labelling

- Schedule 3 - specified neuromuscular blocking agents (or salts thereof)