5Permissible indications and requirements applying in relation to those indications

5 Permissible indications and requirements applying in relation to those indications

Permissible indications in Tables 1 to 15

1.  The indications in column 2 of Tables 1 to 15 in Schedule 1 to this instrument are specified for the purposes of paragraph 26BF(1)(a) of the Act.
2.  The indications in column 2 of Tables 1 to 15 in Schedule 1 to this instrument when modified using the qualifying statements in the Code Tables under the headings:
3.     ‘Traditional context qualifier’;
4.     ‘Population qualifiers’; 
5.     ‘Time of use qualifiers’; or
6.     for TCM indications, ‘TCM pattern qualifiers’;

  are also specified for the purposes of paragraph 26BF(1)(a) of the Act.

Requirements for permissible indications

 (3) For the purposes of paragraph 26BF(1)(b) of the Act, the indications specified under subsections 5(1) and 5(2) are subject to the following requirements:

 (a) they may only be used for a medicine if supported by the type of evidence specified in column 3 of Tables 1 to 15 in Schedule 1; and

 (b) they must comply with the requirements set out in column 4 of Tables 1 to 15 in Schedule 1; and

 (c) where:

1.      the wording of an indication is varied on the label of a medicine; or
2.    where more than one indication is used and they are combined on the label of a medicine to form simple sentences where appropriate; or
3. both (i) and (ii);

 then:

1. the meaning of the indication must not be changed; and
2.     the varied or combined indications must not infer or imply that a medicine is for the treatment of a serious disease, ailment, defect or injury; and
3. the varied or combined indications must not infer or imply that a medicine is for preventing or curing a disease, ailment, defect or injury;

 (d) where an indication in column 2 of Tables 1 to 15 in Schedule 1 to this instrument is modified using a qualifying statement in the Code Tables as mentioned in subsection 5(2) and where that indication, including as varied or combined with another indication, is used on the medicine’s label:

1.      the qualifying statement must also be included on the medicine’s label; and
2.    the modified indication, including as varied or combined with another indication, must not infer or imply that a medicine is for the treatment of a serious disease, ailment, defect or injury

 (e) A medicine using traditional indications must also comply with the following requirements:

(i) the traditional indication must be qualified with an appropriate “Traditional context qualifier” from the Code Tables; and