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 specified in column 2 of an item in a table in Parts 1 to 17 of Schedule 1 (the relevant indication) may only be used for the medicine if the relevant 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 the item must be met.

 (3) The only indications that may be used in relation to a medicine that is a sunscreen product are the indications specified in column 2 of the table in Part 16 of Schedule 1.

Note: For the avoidance of doubt, the requirements in subsection (3) for medicines that are sunscreen products apply in addition to the requirements in subsection (2) for medicines.

 (4) 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 column 2 of an item in a table in Parts 1 to 17 of 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) Subject to subsection (6), 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 column 2 of an item in a table in Parts 1 to 17 of 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.

 (6) An indication specified in column 2 of an item in the table in Part 17 of Schedule 1 must not be combined on the label of a medicine with an indication specified in column 2 of an item in a table in Parts 1 to 16 of Schedule 1.

Note: For the avoidance of doubt, where appropriate, indications specified in column 2 of an item in the table in Part 17 of Schedule 1 and indications specified in column 2 of a table in Parts 1 to 16 of Schedule 1 may be listed separately on the label of a medicine. However, these indications must not be combined on the label to form simple sentences.

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