Product-specific risk minimisation material

The risk management plans for medicinal products often include additional risk minimisation materials (educational materials, instructions for physicians and patients, patient charts, checklists etc.).

The content and dissemination of such product-specific risk management materials are agreed with the marketing authorisation holder of the medicinal product and Fimea. The marketing authorisation holder holds copyrights to the materials and is responsible for the content and dissemination of the material.

Instructions for the submission of product-specific risk minimisation material (pdf)