6Requirements in relation to permissible indications

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 in column 2 of a table in Schedule 1; and

 (b) infer or imply that the medicine is for the treatment of a serious form of a disease, ailment, defect or injury; and

 (c) infer or imply that the medicine is for preventing or curing a disease, ailment, defect or injury.

 (4) If two or more indications are combined on the label of a medicine to form simple sentences where appropriate in the circumstances, then the indication, as combined, must not:

 (a) change the meaning or intent of each indication as specified in an item in column 2 of a table in Schedule 1; and

 (b) infer or imply that the medicine is for the treatment of a serious form of a disease, ailment, defect or injury; and

 (c) infer or imply that the medicine is for preventing or curing a disease, ailment, defect or injury.

 (5) If an indication in relation to a medicine is modified by one or more qualifying statement in accordance with paragraph 5(b) (whether or not the indication is varied or combined as described in subsection (3) or (4)), then:

 (a) each qualifying statement must be set out on the label of the medicine; and

 (b) the indication, as modified, varied or combined, must not infer or imply that a medicine is for the treatment of a serious form of a disease, ailment, defect or injury.

 (6) If an indication in relation to a medicine is supported by traditional evidence, then:

 (a) the indication must be qualified with an appropriate traditional context qualifier as set out in the code tables; and

 (b) the traditional context qualifier mentioned in paragraph (a) must be set out on the label of the medicine.