The Therapeutic Goods Act 1989 (the Act) requires that applications for a product registration be evaluated "having regard to whether the quality, safety and efficacy of the goods for the purposes for which they are to be used have been satisfactorily established".
All applications for over-the-counter (OTC) medicine registration must be supported by evidence to substantiate the quality of the product. This part of the guidance document describes the information regarding the quality of the product should be submitted for OTC medicine applications. It is divided into eleven sections as follows:
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.