Basics of therapeutic goods regulation

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9 June 2017

Contents

Introduction

It's important that Australians have access to quality therapeutic goods that are safe to use and fulfil their intended purpose. The Therapeutic Goods Administration (TGA), as part of the Department of Health, protects the health and wellbeing of the community by regulating and monitoring all therapeutic goods that are distributed here in Australia.

If you're looking to import, supply, export or manufacture a therapeutic good, you will need to meet certain requirements and obligations in accordance with the Therapeutic Goods Act 1989, in addition to any other relevant Commonwealth, state and/or territory legislation. Civil and criminal penalties may apply if you do not meet your legal requirements.

This material is an overview of therapeutic goods regulation in Australia, and should be used as a guide only. If you'd like more information about any of the topics, please refer to the additional links or the TGA website.

If you're looking to import, supply, export or manufacture a therapeutic good:
"It is easy to understand what is required, but what is required of you isn't necessarily easy."

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