Contents Introduction The Therapeutic Goods Act 1989 (the Act) requires that applications for a product registration be evaluated regard to whether the quality, safety and efficacy of the goods for the purposes for “having 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 safety and efficacy of the product. This part of the guidance document describes
Contents Introduction 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 safety and efficacy of the product. This part of the guidance document describes