Insights

As of 1 September 2026, for new medicinal products and new presentations authorized through the centralized procedure, AIFA will issue C(nn) classification decree without prior approval of the additional risk minimization measures.

This change introduces greater flexibility in the procedural timeline but does not alter the obligations of the Marketing Authorization Holder (MAH). Before commercializing the product in Italy, the risk minimization measures must still be approved by AIFA’s Risk Management Measures Office.

The new procedure does not apply to C(nn) procedures already assessed by the Scientific and Economic Committee for Medicines (CSE) that are still pending due to the failure to submit the risk minimization measures or because these measures are still under assessment by the competent AIFA office.

For companies, it is therefore essential to anticipate the preparation of risk minimization measures and ensure effective coordination between Regulatory Affairs, Pharmacovigilance and Launch Management. Timely and integrated management can help prevent potential issues and reduce the risk of delays in market access.

In this context, a structured and proactive regulatory strategy becomes a key element of launch readiness, helping to make the path to commercialization more efficient and predictable.

RPN is available to support companies in assessing regulatory requirements, preparing and managing risk minimization measures, and navigating the national regulatory pathway, with an integrated approach focused on successful product launch.