Ireland
Risk minimisation materials
Medicinal products may have risk minimisation materials (educational materials, instructions for physicians and patients, patient alert cards, checklists etc.) that are intended to promote the safe and effective use of the medicinal product. The materials are targeted for healthcare professionals (e.g. doctors, pharmacists and nursing staff) and/or patients and care-givers. Risk minimisation materials are produced by the marketing authorisation holder of the medicinal product. The content and dissemination of the materials are agreed with the national competent authority.