Educational materials are additional risk minimization measures (RMM) designed to provide targeted communication that complements the information found in the Summary of Product Characteristics (SmPC) and the Package Leaflet (PL).

As part of the Risk Management Plan (RMP), these are mandated by regulatory authorities and must obtain national approval before a medicinal product can be authorized in Italy.

In Italy, the Italian Medicines Agency (AIFA) is responsible for ensuring that the content of the educational materials is accurate, accessible, and appropriate for the intended audience—whether healthcare professionals or patients. Both the materials and the relevant dissemination plan must be approved by the Authority before any distribution can take place.

RPN supports pharmaceutical companies throughout the entire process of educational material management: from drafting and content review to submission and approval by national health authorities. Our expertise ensures full compliance with both EU and local regulatory frameworks.