Basics of therapeutic goods regulation

It’s important that we all 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. The agency has released a document (http://www.tga.gov.au/sme-assist/basics-therapeutic-goods-regulation)., which serves as a general introduction to therapeutic goods regulation in Australia. This information is relevant if you’re looking to import, supply, export or manufacture a therapeutic good, as 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. It’s important to note that this is simply an overview of the regulation process, 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.

TGA, 9 June 2017 ;http://www.tga.gov.au/ ;