Applications to register a medicine in the ARTG (made under section 23 of the Act) must be evaluated to confirm whether the quality, safety and efficacy of the goods (for the purposes they are intended to be used for) have been satisfactorily established (see subsection 25(1) of the Act).
5.2 Varying a medicine included in the ARTG
These applications (made under section 9D(3) of the Act) are evaluated to ensure that the variation which has been requested does not show any reduction in the quality, safety and efficacy of the goods for the purposes they are intended to be used for.
