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Purpose
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 guidance describes the information regarding the quality of the product should be submitted for OTC medicine applications.