(6) Medicine kits(6) Medicine kits

(6) Medicine kits

The label on a package that, together with medicines, constitutes a medicine kit must include the following information:

(a) the name given to the kit; and

(b) the name and contact details of the sponsor of the kit; and

(c) the name of each of the medicines within the kit and its dosage form; and

(d) the name, and quantity or proportion, of all active ingredients in each of the medicines within the kit; and

(e) the quantity of each medicine within the kit; and

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

(g) an expiry date for the kit, being the earliest expiry date of the medicines within the kit, preceded by the expiry date prefix; and

(h) any warning statements that relate to any of the medicines within the kit; and

(i) storage conditions applicable to the kit, being the most restrictive of the storage conditions for any of the medicines within the kit; and

(j) the listing number given to the kit, set out on the label consistent with the requirements specified in the Regulations.

Note: The label on the container and on the primary pack (if any) of each medicine within a medicine kit must comply with the requirements of this Order.