The Australian Therapeutic Goods Act regulates the import, export, manufacture and supply of therapeutic goods in Australia. It is a complex regulatory regime and its application can sometimes catch clients unaware.
We regularly advise clients on their compliance with the regulatory regime, including advertising and labelling requirements and conduct of clinical trials.
With the growth in digital health and other innovative health and medical technologies, we also assist clients navigate the path to market for new products at the boundaries of current regulation (including advising on related issues such as privacy). Our team also advises clients on the interfaces between therapeutic goods, foods and cosmetics.