Document ID: chunk:federal_register_of_legislation:F2021L00056:clause:2_1:p1
Version: federal_register_of_legislation:F2021L00056
Segment Type: clause
Provision Reference: sch 2 cl 1 (pt 1/72)
Character Range: 1549–4856

1  Name
  This instrument is the Therapeutic Goods (Permissible Indications) Determination (No. 1) 2021.

       2  Commencement

        (1) Each provision of this instrument 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 instrument  The day after this instrument is registered.

Note:  This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

        (2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

       3  Authority

         This instrument is made under section 26BF of the Therapeutic Goods Act 1989.

       4  Definitions

            Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:
               (a)      health practitioner;
               (b) indications;
               (c) label;
               (d) medicine;
               (e) presentation;
               (f) Register; and
               (g) Therapeutic Goods Advertising Code.

         In this instrument:

       Act means the Therapeutic Goods Act 1989.

       code tables means the tables accessed via the Code Tables item in the Public TGA Information menu in TGA eBusiness Services, as in force or existing at the time this instrument commences.

       dentist means a person registered as a dentist under a law of a State or Territory that provides for the registration of dentists.

       doctor means a medical practitioner.

       Evidence Guidelines means the document titled Evidence guidelines: Guidelines on the evidence required to support indications for listed complementary medicines, published by the Therapeutic Goods Administration, as in force or existing at the time this instrument commences.

            Note: The Evidence Guidelines are published at www.tga.gov.au.

       health professional means a person mentioned in section 42AA of the Act.

       medically diagnosed, in relation to a disease, ailment, defect or injury, means a disease, ailment, defect or injury that is diagnosed by a suitably qualified medical practitioner.

       medical practitioner means a person registered as a medical practitioner under a law of a State or Territory that provides for the registration of medical practitioners.

       Regulations means the Therapeutic Goods Regulations 1990.

       scientific, in relation to the type of evidence for an indication, means evidence that is based on scientific research and quantifiable data, as described in the Evidence Guidelines.

            Note: Scientific evidence includes relevant clinical trials on humans and systematic reviews.

       serious, in relation to a form of a disease, ailment, defect or injury, has the same meaning as in section 28 of the