Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(1) For the purposes of subsection 22D(2) of the Act, the criteria are all of the following:
(a) an indication of the medicine is the treatment, prevention or diagnosis of a life - threatening or seriously debilitating condition;
(i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or
(ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)--there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;
(c) there is preliminary clinical data demonstrating that the medicine is likely to provide a major therapeutic advance;
(d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person's plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.
(2) However, paragraphs (1)(b) and (c) do not apply if:
(a) the application under subsection 22C(1) of the Act is made on or after the commencement of this subregulation; and
(b) an indication of the medicine is the treatment or prevention of the disease known as coronavirus disease (COVID - 19).