Document ID: chunk:federal_register_of_legislation:C2024C00632:section:63:p1
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 63 (pt 1/2)
Character Range: 1144744–1147640

63  Regulations
 (1) The Governor‑General may make regulations, not inconsistent with this Act, prescribing matters:
 (a) required or permitted to be prescribed by this Act; or
 (b) necessary or convenient to be prescribed for carrying out or giving effect to this Act.
 (2) The regulations may:
 (a) make provision in relation to:
 (i) the establishment of committees to advise the Minister or the Secretary on matters relating to therapeutic goods; and
 (ii) the functions and powers of those committees; and
 (iii) the payment of remuneration and allowances to members of those committees; and
 (b) prescribe requirements for the storage and transport of therapeutic goods; and
 (c) prescribe requirements for the advertising of therapeutic goods; and
 (d) provide for the procedures to be followed in the sampling and testing of any of the following:
 (i) therapeutic goods;
 (ii) vaping goods;
 (iii) any kind of goods, for the purpose of ascertaining whether or not they are therapeutic goods or vaping goods; and
 (da) provide for the periods within which evaluations under section 25 in relation to specified therapeutic goods or specified classes of such goods are to be completed; and
 (daaaa) provide for the periods within which evaluations under section 26AE in relation to specified medicines or specified classes of medicines are to be completed; and
 (daaa) provide for the periods within which a decision under paragraph 26BE(4)(a) or (b), in relation to an application under subsection 26BD(1), must be made; and
 (daa) provide for the periods within which evaluations under section 32DE in relation to specified biologicals or specified classes of biologicals are to be completed; and
 (db) provide for the periods within which decisions under section 41EP to revoke suspensions of conformity assessment certificates are to be made, in cases where applications for revocation have been made under paragraph 41EP(2)(a); and
 (dc) provide for the periods within which decisions on applications for the issuing of conformity assessment certificates under Part 4‑4 are to be made if considering the applications involves examining the design of medical devices; and
 (dd) provide for the periods within which decisions under section 41GD to revoke suspensions of entries on the Register are to be made, in cases where applications for revocation have been made under paragraph 41GD(2)(a); and
 (de) provide for the periods within which the performance of specified functions conferred on the Secretary by this Act is to be completed; and
 (df) provide for the periods within which specified decisions under this Act are to be made by the Secretary; and
 (e) prescribe requirements for informational material that is included with therapeutic goods; and
 (f) make provision for the transfer of registration, listing or inclusion in the Register of therapeutic goods and of licences;