Therapeutic Goods Act 1989

The Governor‑General may make regulations, not inconsistent with this Act, prescribing matters:

required or permitted to be prescribed by this Act; or

necessary or convenient to be prescribed for carrying out or giving effect to this Act.

The regulations may:

make provision in relation to:

the establishment of committees to advise the Minister or the Secretary on matters relating to therapeutic goods; and

the functions and powers of those committees; and

the payment of remuneration and allowances to members of those committees; and

prescribe requirements for the storage and transport of therapeutic goods; and

prescribe requirements for the advertising of therapeutic goods; and

provide for the procedures to be followed in the sampling and testing of any of the following:

therapeutic goods;

vaping goods;

any kind of goods, for the purpose of ascertaining whether or not they are therapeutic goods or vaping goods; and

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

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

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

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

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

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

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

provide for the periods within which the performance of specified functions conferred on the Secretary by this Act is to be completed; and

provide for the periods within which specified decisions under this Act are to be made by the Secretary; and

prescribe requirements for informational material that is included with therapeutic goods; and

make provision for the transfer of registration, listing or inclusion in the Register of therapeutic goods and of licences; and

make provision for the testing of therapeutic goods or vaping goods, the inspection of manufacturing operations or the evaluation of data concerning therapeutic goods or vaping goods by the Department at the request of persons; and

make provision for the reporting of matters relating to therapeutic goods; and

prescribe fees in respect of matters under this Act or the regulations; and

prescribe penalties not exceeding 10 penalty units for offences against the regulations.

The regulations may:

prescribe different fees under this Act in relation to:

different classes of goods; or

in the case of fees under Part 3‑3—different steps in the manufacture of goods; or

provide for the refund, reduction or waiving of fees or charges in cases identified in the regulations; or

specify the type of information relating to therapeutic goods manufactured by licence holders that the Secretary may, under subsection 37(2), require to be supplied by the holders of licences at the time of payment of annual licensing charges in respect of the licences.

The regulations may provide for:

the granting of a licence or permission to import or export therapeutic goods; and

licences or permissions to import or export therapeutic goods to be subject to conditions or requirements; and

the assignment of a licence or permission to import or export therapeutic goods; and

the surrender of a licence or permission to import or export therapeutic goods; and

the revocation of a licence or permission to import or export therapeutic goods.

Despite subsection 14(2) of the Legislation Act 2003, the regulations may make provision in relation to a matter by applying, adopting or incorporating, with or without modification, any matter contained in an instrument or other writing as in force or existing from time to time.

For the purposes of section 2, regulations may be made before the commencement of this Act as if this Act were in force, but do not come into effect on a day earlier than the day on which this Act commences.