You may need to comply with these guidelines if you intend to manufacture, research or test sterile therapeutic drugs and devices supplied in Australia for human use. The requirements of these guidelines 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.
