case study - EXCLUDED GOOD HAND sanitiser

In this case study, the hand sanitiser will be supplied predominantly to the aged care market, and there will also be some supply to the general consumer market.  Ordinarily, because aged care is considered a healthcare environment, the product would require evaluation as an OTC medicine. However, to support an effective response to COVID-19 the TGA excluded certain products from TGA regulation provided they met specified formulation, manufacturing, labelling and advertising criteria; defined by the TGA Excluded Goods Determination. Compliance with the Excluded Goods Determination means a hand sanitising product can be provided to aged care facilities, and the general consumer market, without formal TGA evaluation being required.

The landscape flow chart presented below is a representative example of the specific requirements that will apply to a product manufactured in accordance with the TGA Excluded Goods Determination. These pre-market life cycle criteria (Scoping, Design, Development and Supply) will need to be met prior to release of the product for use as a hand sanitiser by aged care customers.