XVI.App1.4. Pack size

The pack size of the medicinal product should be appropriate to the usual treatment duration. A small pack size can be useful if overdose or diversion is a risk to minimise. Depending on the number of dosage units in the pack of a prescription-only medicine (see XVI.App1.5.), the exposure will be limited and the patient will need to see a healthcare professional at the interval corresponding to the pack size and dosing if a new prescription is necessary, thus increasing the opportunity for therapeutic monitoring and reducing the length of time a patient will be without medication review. Where the SmPC requires therapeutic monitoring or medication review at specified intervals, the adaptation of the pack size to the corresponding prescribing interval may support the effective implementation of this RMM.