General Requirements for the Labelling of Sterile Therapeutic Goods - Australian Government

Description

You may be required to comply with this code if you intend to manufacture, research or test sterile therapeutic drugs and devices supplied in Australia for human use. The requirements of this code are specified in the British Pharmacopoeia which constitutes the standard for therapeutic devices that are labelled as sterile or sterilised or otherwise purported to be sterile or sterilised.

The British Pharmacopoeia is the principal standard applying to medicines and other therapeutic goods that are not medical devices. This document provides an authoritative collection of standards for medicinal substances and is an essential reference point for everyone involved in their research, development and manufacture.

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:

Enquiries

Therapeutic Goods Administration

Department of Health

Operating address: 136 Narrabundah Lane
Symonston, Australian Capital Territory 2609
Mailing address: PO BOX 100
Woden, Australian Capital Territory 2606
Toll Free: 1800 020 653
Email: info@tga.gov.au
Website: Therapeutic Goods Administration (Opens in new window)