Document ID: chunk:federal_register_of_legislation:F2021L00056:clause:2_1:p2
Version: federal_register_of_legislation:F2021L00056
Segment Type: clause
Provision Reference: sch 2 cl 1 (pt 2/72)
Character Range: 4587–7625

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 Therapeutic Goods Advertising Code, in relation to a form of a disease, condition, ailment or defect.
       TGA eBusiness Services means TGA eBusiness Services on the Therapeutic Goods Administration's website which may be accessed on the internet at www.ebs.tga.gov.au.

       Therapeutic Goods Administration has the same meaning as in the Regulations.

       traditional, in relation to the type of evidence for an indication, means evidence of traditional use in a recognised paradigm outside modern conventional medicine, as described in the Evidence Guidelines.

            Note: Traditional evidence is a term of broad application and applies to different traditional paradigms, for example, traditional Ayurvedic medicine, traditional Chinese medicine and Western herbal medicine.

       traditional Ayurvedic medicine, in relation to the type of evidence for an indication, means evidence that is based on traditional use in the Ayurvedic medicine paradigm.

       traditional Chinese medicine or TCM, in relation to the type of evidence for an indication, means evidence that is based on traditional use in the traditional Chinese medicine paradigm.

       traditional use has the same meaning as in the Regulations.

       5  Permissible indications

        The following indications are covered by this instrument under paragraph 26BF(1)(a) of the Act:
           (a) each indication specified in an item in column 2 of a table in Schedule 1; and
           (b) each indication specified in an item in column 2 of a table in Schedule 1, as modified by the use of one or more qualifying statements set out in the code tables under one of the following headings:
              (i) traditional context qualifiers;
              (ii) population qualifiers;
              (iii) time of use qualifiers;
              (iv) in relation to an indication that is based on TCM evidenceTCM pattern qualifiers.

       6  Requirements in relation to permissible indications

        (1) The requirements in this section are specified in relation to an indication covered by this instrument under paragraph 26BF(1)(b) of the Act.

        (2) In relation to a medicine:
           (a) the indication mentioned in an item in column 2 of a table in Schedule 1 (the relevant indication) may only be used for the medicine if that indication is supported by evidence of the type that is specified in column 3 of the item; and
           (b) the requirements, if any, in relation to the relevant indication, set out in column 4 of that item must be met.

        (3) If the wording of an indication is varied on the label of a medicine, then the indication, as varied, must not:
           (a) change the meaning or intent of the indication as specified in an item