Part Introduction - Therapeutic Goods Order No. 69 - General requirements for labels for medicines (27/08/2001) - Introduction

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Turn the raw legal text into a practical explanation grounded in Therapeutic Goods Order No. 69 - General requirements for labels for medicines (27/08/2001).

Introduction

The purpose of a medicine label is to provide information about the product such as its identity, potency, content, storage, expiry date, registration status and sponsor. Medicine labels also include other information not required by the Order, but which may be required by other legislative instruments or for commercial purposes. These include items such as signal headings (eg. Prescription only, pharmacist only), bar codes and sponsor’s logos.

For non-prescription medicines, the aim is that the information on the label is presented in such a way that consumers can:

(a) choose an appropriate medicine on their own;

(b) use the medicine safely and effectively;

(d) access further information, if they want to know more about the medicine.

Although there may be various means of achieving the aim stated above, products with labels that have been designed in accordance with the industry code of practice entitled Labelling Code of Practice: Designing usable non-prescription medicine labels for consumers, published by the Communications Research Institute of Australia Inc. and accessible from the Therapeutic Goods Administration web site (http://www.tga.gov.au) should achieve this aim.

The mandatory aspects of the Order for all medicines are contained in clauses 1 - 7 inclusive and the Schedules to the Order. All medicine labels must comply with Clauses 1 - 7 and the Schedules to the Order, regardless of whether they have been designed in accordance with the industry Code of Practice.