Commonwealth Consolidated Regulations Commonwealth Consolidated RegulationsNote: A number of expressions used in this instrument are defined in the Act, including the following:
(a) designated vaccine;
(b) Secretary;
(c) vaccine.
In this instrument:
"Act" means the National Health Act 1953 .
"amount" includes a nil amount.
"approved ex-manufacturer price" has the meaning given by subsection 84(1) of the Act.
"ATAGI" means the Commonwealth body known as the Australian Technical Advisory Group on Immunisation.
"ATAGI advice" has the meaning given by subsection 7(1).
"ATAGI application" has the meaning given by subsection 7(1).
"ATAGI application due day" has the meaning given by subsection 10(3).
"Australian Register of Therapeutic Goods" means the register maintained under section 9A of the Therapeutic Goods Act 1989 .
"brand" has the meaning given by subsection 84(1) of the Act.
"Committee" means the Pharmaceutical Benefits Advisory Committee established under section 100A of the Act.
complex category ATAGI application fee has the meaning given by subsection " " 7(2).
"cost-effectiveness test" means an assessment of:
(a) the extent (if any) to which the efficacy and toxicity of the therapy proposed in a submission for a disease or disorder differs from the efficacy and toxicity of any alternative therapy for the disease or disorder; and
(b) the cost of the proposed therapy relative to the cost of the alternative therapy.
"designated orphan drug" has the same meaning as in the Therapeutic Goods Regulations 1990 .
"economic evaluation" , for a submission and a drug, medicinal preparation or vaccine the subject of the submission, means data that is a comparative analysis of the costs and outcomes of:
(a) the therapy to be provided by the drug, medicinal preparation or vaccine; and
(b) any other therapy that the applicant nominates as an alternative therapy to the drug, medicinal preparation or vaccine.
evaluation category means an evaluation category referred to in the table in subsection " " 22(2).
"high added therapeutic value" : a drug, medicinal preparation or vaccine has high added therapeutic value if the drug, medicinal preparation or vaccine:
(a) addresses a high and urgent unmet clinical need; and
(b) is expected to provide a substantial and clinically relevant improvement in efficacy, or reduction of toxicity, over any alternative therapy.
"listed brand" of a pharmaceutical item has the meaning given by subsection 84(1) of the Act.
"listed drug" has the meaning given by subsection 84(1) of the Act.
"list management application" has the meaning given by paragraph 56(1)(a).
"list management services" has the meaning given by subsection 56(1).
"medicinal food" means food that is therapeutic goods within the meaning of paragraph (a) or (b) of the definition of therapeutic goods in subsection 3(1) of the Therapeutic Goods Act 1989 .
"MSAC" means the body known as the Medical Services Advisory Committee.
"notification" :
(a) for an ATAGI application--means a notification given under whichever of subsections 11(1), (2) and (3) is relevant to the ATAGI application or a notice of intent in relation to the ATAGI application; or
(b) for a pre - submission meeting application--means a notification given under subsection 17(1); or
(c) for a submission--means a notification given under whichever of subsections 33(1), (2) and (3) is relevant to the submission or a notice of intent in relation to the submission; or
(d) for a pricing application--means a notification given under whichever of subsections 50(1), (2) and (3) is relevant to the pricing application or a notice of intent in relation to the pricing application; or
(e) for a list management application--means a notification given under section 58.
"PBS prescriber" has the meaning given by subsection 84(1) of the Act.
"pharmaceutical item" has the meaning given by section 84AB of the Act.
"pre-submission meeting application" has the meaning given by paragraph 14(a).
"pricing application" has the meaning given by subsection 40(1).
"pricing category" means a pricing category referred to in the table in subsection 41(1).
"pricing services" has the meaning given by subsection 40(1).
"reviewable decision" has the meaning given by section 71.
"submission" means a submission referred to in subsection 21(1).
"submission due day" has the meaning given by subsection 31(3).
"submission services" has the meaning given by subsection 22(1).
"Therapeutic Goods Administration" means the part of the Department known as the Therapeutic Goods Administration.