Document ID: chunk:federal_register_of_legislation:C2025C00090:section:101:p2
Version: federal_register_of_legislation:C2025C00090
Segment Type: section
Provision Reference: s 101 (pt 2/5)
Character Range: 514461–517423

and medicinal preparations, should be made available as pharmaceutical benefits under this Part, but only in certain circumstances, the Committee shall, in its recommendation under subsection (3), specify those circumstances.

Functions relating to declarations under subsection 85(2)
 (4) A drug or medicinal preparation shall not be declared, pursuant to paragraph 85(2)(a), to be a drug or medicinal preparation in relation to which this Part applies unless:
 (a) the drug or medicinal preparation was, immediately before the commencement of this subsection, a pharmaceutical benefit; or
 (b) the Committee has recommended to the Minister that it be so declared.
 (4A) A class of drugs or medicinal preparations, or of drugs and medicinal preparations, shall not be declared, pursuant to paragraph 85(2)(a), to be a class of drugs or medicinal preparations, or of drugs and medicinal preparations, in relation to which this Part applies unless:
 (a) each member of that class was, immediately before the commencement of this subsection, a pharmaceutical benefit; or
 (b) the Committee has recommended to the Minister that the class be so declared.
 (4AAA) The Minister may, by legislative instrument, revoke or vary a declaration under subsection 85(2) in relation to a drug or medicinal preparation.
 (4AAB) If:
 (a) under subsection (4AAA), the Minister proposes to revoke or vary a declaration under subsection 85(2) in relation to a drug or medicinal preparation; and
 (b) on and after the day the revocation or variation comes into force, the drug or medicinal preparation would cease to be a listed drug;
then, before making the revocation or variation, the Minister must obtain the advice in writing of the Pharmaceutical Benefits Advisory Committee in relation to the proposed revocation or variation.
 (4AAC) An advice under subsection (4AAB) must be laid before each House of the Parliament with the declaration under subsection (4AAA) to which the advice relates.

Functions relating to determinations under section 88
 (4AACAA) The Pharmaceutical Benefits Advisory Committee may give advice to the Minister as to which PBS prescribers should be authorised to write prescriptions for the supply of a pharmaceutical benefit.

Functions relating to declarations under subsection 85(2AA)
 (4AACA) The Pharmaceutical Benefits Advisory Committee must make recommendations to the Minister from time to time as to the drugs and medicinal preparations which it considers should only be supplied under one or more of the prescriber bag provisions.
 (4AACB) The Minister may, by legislative instrument, revoke or vary a declaration under subsection 85(2AA) in relation to a drug or medicinal preparation.
 (4AACC) If:
 (a) under subsection (4AACB), the Minister proposes to revoke or vary a declaration under subsection 85(2AA) declaring that a drug or medicinal preparation (the drug) can only be supplied under one or more of the prescriber bag provisions;