Commonwealth Numbered Regulations Commonwealth Numbered RegulationsIn these Regulations:
"Act" means the National Health Act 1953 .
"brand" has the meaning given by subsection 84 (1) of the Act.
"Committee" means the Pharmaceutical Benefits Advisory Committee.
economic evaluation , for an application and a drug, medicinal preparation or vaccine the subject of the application (the proposed drug or vaccine ), means data that is a comparative analysis of the costs and outcomes of:
(a) the therapy to be provided by the proposed drug or vaccine; and
(b) any other therapy that the applicant nominates as an alternative therapy to the proposed drug or vaccine.
" evaluation fee " means a fee prescribed by regulation 4.1.
"listed brand" has the meaning given by subsection 84 (1) of the Act.
"listed drug" has the meaning given by subsection 84 (1) of the Act.
"medicinal food" means food that is a therapeutic good within the meaning of paragraphs (a) and (b) of the definition of therapeutic goods in section 3 of the Therapeutic Goods Act 1989 .
"pharmaceutical item" has the meaning given by section 84AB of the Act.
"pricing fee" means a fee prescribed by regulation 4.2.
"Secretary" has the meaning given by subsection 4 (1) of the Act.
" therapy " , for an application, means the clinical purpose stated in the application for a drug, medicinal preparation or vaccine.