Marketing Authorisation Holders (MAHs) of medicinal products approved through the centralised procedure are hereby informed that, effective from 1 September 2026, for new medicinal products/new presentations, C(nn) classification decisions will be issued without prior approval of the additional risk minimisation measures.

In order to avoid the sanctions provided for under Legislative Decree No. 291/2006, the obligation remains on the part of the MAH, pursuant to Article 21bis indent 1 (a) and (d) of Directive 2001/83/EC and Article 5 indent 1 (a) and (d) of Ministerial Decree of 30 April 2015, to comply with the conditions or restrictions concerning the safe and effective use of the medicinal product as set out in the European Commission decision, by obtaining approval from the AIFA Risk Management Measures Office before commencing marketing of the new medicinal product/new presentation in Italy.

It should be noted that this practice does not apply to new medicinal products/new presentations already assessed by the Scientific and Economic Commission for medicines (CSE) whose C(nn) classification decisions are still pending due to the MAH's failure to submit the additional risk minimisation measures and/or where such measures are currently under evaluation by the AIFA Risk Management Measures Office.

Specific cases may be submitted to the competent AIFA offices for assessment.