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THERAPEUTIC GOODS ACT 1989 - SECT 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 by the Department in the sampling and testing of therapeutic 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; and

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

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

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

             (3)  The regulations may:

                     (a)  prescribe different fees under this Act in relation to:

                              (i)  different classes of goods; or

                             (ii)  in the case of fees under Part 3-3--different steps in the manufacture of goods; or

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

                     (c)  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.

          (3A)  The regulations may provide for:

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

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

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

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

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

             (4)  The regulations may make provision for a matter by applying, adopting or incorporating, with or without modification, any matter contained in an instrument:

                     (a)  as that instrument is in force at the time when the regulations take effect; or

                     (b)  as that instrument is in force from time to time.

             (5)  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.

   

   



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