Document ID: chunk:federal_register_of_legislation:C2010A00126:clause:6_19
Version: federal_register_of_legislation:C2010A00126
Segment Type: clause
Provision Reference: sch 6 cl 19
Character Range: 54522–56702

19  After subsection 101(4A)
Insert:
 (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 declarations under subsection 85(2A)
 (4AAD) 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 be made available only under special arrangements under section 100.
 (4AAE) The Minister may, by legislative instrument, revoke or vary a declaration under subsection 85(2A) in relation to a drug or medicinal preparation.
 (4AAF) If:
 (a) under subsection (4AAE), the Minister proposes to revoke or vary a declaration under subsection 85(2A) in relation to a drug or medicinal preparation (the drug); and
 (b) on and after the day the revocation or variation comes into force, the drug could be supplied under this Part otherwise than under special arrangements under section 100;
then the Minister can only make the revocation or variation if:
 (c) the Minister also revokes or varies the declaration under subsection 85(2), in accordance with subsections (4AAA), (4AAB) and (4AAC) of this section, so that the drug ceases to be a listed drug on and after the day the revocation or variation of the subsection 85(2) declaration comes into force; or
 (d) the Pharmaceutical Benefits Advisory Committee recommends against the Minister taking the action in paragraph (c).