case study - therapeutic good hand sanitiser

In this case study scenario, the hand sanitiser will be supplied to the healthcare sector (e.g. hospitals and aged-care facilities) for use as either a surgical hand disinfectant or general hygienic hand rub.  The product will be regulated as an OTC medicine by the TGA and require inclusion on the ARTG before it can be supplied. 

The landscape flow chart presented below is a representative example of the requirements, predominantly TGA, expected to apply throughout the pre-market life cycle (Scoping, Design, Development and Evaluation) of an antiseptic hand rub manufactured and supplied as a therapeutic good in Australia. After evaluation by the TGA, and entry on to the ARTG, the product can be supplied in Australia as an OTC Medicine.