Standard for Labels of Prescription and Related Medicines - Australian Government

Description

You must comply with this standard if you intend to label prescription and related medicines. You have obligations to label medicines according to the requirements prescribed by the Therapeutic Goods Administration, and compliance with this code should achieve this aim.

The standard requires that you describe label parts from a consumer's perspective, and named to reflect how consumers are likely to use the medicine.

Please note that the Agency has advised that there are various codes for medicines, medical devices and chemicals which are often amended.

Please consult the Contact Officer for more information and to ascertain the level of compliance (if any) that may be required.

Service type

Code of Practice

A code of practice is a set of rules which details how people in a certain industry should behave. A code of practice can be defined as a result of legislation or by industry regulators and bodies.

Act(s) name

Therapeutic Goods Act 1989 Australian Government

Regulation(s) name

Therapeutic Goods Regulations 1990 Australian Government

Administering agency

Department of Health

Therapeutic Goods Administration

Contact details

Contact Email, Phone and Address Details for this service in simple two column table format, header then data.

Please use these contact details for help or more information:

Information Officer

Therapeutic Goods Administration

Department of Health

Operating address: 136 Narrabundah Lane
Symonston, Australian Capital Territory 2609
Phone: 02 6232 8644
Fax: 02 6203 1605
Email: info@tga.gov.au
Website: Therapeutic Goods Administration (Opens in new window)