Today, the Italian Medicines Agency (AIFA) announced an update concerning the C(nn) classification for medicinal products authorized through the centralized procedure.
Starting from 1 September 2026, for new medicinal products/new packages, C(nn) classification decisions will be issued without prior approval of additional risk‑minimization measures.
The obligation remains for Marketing Authorization Holders (MAHs) to comply with the provisions set out in the European Commission Decision regarding the conditions or restrictions related to the safe and effective use of the medicinal product. MAHs must obtain approval from AIFA’s Risk Management Measures Office before the new medicinal product/new package can be placed on the Italian market.
This change does not apply to new medicinal products/new packages already assessed by the Scientific and Economic Commission (CSE), for which the C(nn) classification decision remains suspended pending the submission or evaluation by AIFA’s Risk Management Measures Office of the additional risk‑minimization measures.
AIFA source link: https://www.aifa.gov.it/-/provvedimenti-di-classificazione-c-nn-emissione-senza-preventiva-approvazione-delle-misure-aggiuntive-di-minimizzazione-del-rischio
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