8Information to be included on the label

8 Information to be included on the label

(1) Subject to the qualifications and requirements specified in sections 9 and 10 below, the labels of a medicine must include:

(d) the name of the dosage form; and

(e) the quantity of the medicine; and

(f) the batch number of the medicine preceded by the batch number prefix; and

(g) the expiry date of the medicine, preceded by the expiry date prefix; and

(h) the storage conditions applicable to the medicine; and

(i) the name and contact details of the sponsor or distributor of the medicine; and

(j) where:

(i) a substance or substance within the group of substances referred to in Column 1 of Schedule 1 to this Order is present in the medicine; and

(ii) the circumstances as set out in Column 2 of Schedule 1 exist in relation to such a substance or no circumstances are set out in Column 2; and

1. the medicine is intended to be administered via any one or more of the route(s) of administration referred to in Column 3 of Schedule 1,

then:

1. a statement:

2. indicating that the medicine contains the substance expressed using the Name stated in Column 4 of Schedule 1; and

3. where any of the circumstances and requirements set out in Column 2 of Schedule 1 exist in relation to the substance – a statement of the kind referred to as a ‘requirement’ in that Column (if any)

except where a statement is included on the label advising consumers to refer to the Consumer Medicine Information for information about other ingredient(s) present in the medicine that are referred to in Column 1 of Schedule 1 to this Order and where any of the circumstances and requirements in column 2 of Schedule 1 exist in relation to the ingredient (s); and

(k) relevant warning statements, where these are required in relation to a particular medicine; and

(l) if the medicine requires some preparation, such as dissolving, suspending, diluting or reconstituting before use - instructions for its preparation and, where relevant, a statement of the conditions of storage and the maximum period of storage between preparation and use, except where:

(i) there is insufficient space on either the label of the container or the primary pack, or both, to include this information; and

(ii) this information is set out in a package insert provided in the primary pack of the medicine; and

(iii) a statement is included on whichever label on the container, or the primary pack, or both, that does not set out the information itself, that those instructions are set out in the package insert; and