Document ID: chunk:federal_register_of_legislation:F2017L01637:body:0:p1
Version: federal_register_of_legislation:F2017L01637
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Therapeutic Goods Information (Approvals relating to Medicine Shortages) Specification 2017
Therapeutic Goods Act 1989

I, LARRY KELLY, a delegate of the Minister for Health, make this specification under subsection 61(5D) of the Therapeutic Goods Act 1989.

Dated 15 December 2017

(Signed by)

LARRY KELLY

Delegate of the Minister for Health

     1 Name of specification
         This specification is the Therapeutic Goods Information (Approvals relating to Medicine Shortages) Specification 2017.
     2 Commencement
         (1) Each provision of this specification specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

Commencement information
Column 1                             Column 2                                         Column 3
Provisions                           Commencement                                     Date/Details
1.  The whole of this specification  The day after this specification is registered.  19 December 2017

       Note: This table relates only to the provisions of this specification as originally made. It will not be amended to deal with any later amendments of this specification.
         (2) Any information in column 3 of the table is not part of this specification. Information may be inserted in this column, or information in it may be edited, in any published version of this specification.
     3 Authority
         This specification is made under subsection 61(5D) of the Therapeutic Goods Act 1989.
     4 Definitions
              In this specification:
              Act means the Therapeutic Goods Act 1989.
         active ingredient has the meaning as in section 2 of the Therapeutic Goods Regulations 1990.

              Note A number of expressions used in this specification are defined in the Act, including the following:
                (a)     included in the Register;
                (b)    indications;
                (c)     Register;
                (d)    registered goods;
                (e)     registration number;
                (f)     sponsor;
                (g)    therapeutic goods;

                (h)    therapeutic goods information; and
                (i)      therapeutic use.
     5 Therapeutic goods information
      The kinds of therapeutic goods information mentioned in Schedule 1 are specified under subsection 61(5D) of the Act for the purposes of subsection 61(5C) of the Act.

          Note Kinds of therapeutic goods information specified under subsection 61(5D) of the Act may be released by the Secretary to the public under subsection 61(5C).

Schedule 1 Specified kinds of therapeutic goods information
(section 5)

For each item in column 1 of the following table, the kind of therapeutic goods information specified in column 2 has the description given in column 3.

  Kinds of therapeutic goods information
Column 1                                    Column 2                                                               Column 3
  Item                                      Information                                                            Description
  1                                       name of active ingredient of registered goods                          the name of one or more active ingredients of the registered goods described in column 3 of item 3
  2                                       particulars of specified therapeutic goods approved under section 19A  the name of specified therapeutic goods approved under section 19A of the Act for which the registered goods