Insights

As of 18 December 2025, amendments to Legislative Decree No. 219 of 24 April 2006 concerning the management of medicinal product shortages officially entered into force. The updated provisions introduce significant changes for Marketing Authorisation Holders, with a direct impact on notification obligations and compliance strategies.

Below is a summary of the key updates:

• Reduced advance notification period: from four months to two months prior to the shortage/interruption (applicable also for extension notifications).

• Increased administrative penalties: from €3,000–18,000 to €6,000–36,000.

While the reduced notification timeframe offers greater operational flexibility, the higher penalties underline the importance of accurate, timely and compliant communications with AIFA. Effective shortage management remains essential to ensure continuity of supply and to mitigate regulatory and reputational risks.

Regulatory Pharma Net supports companies in preparing mandatory notifications and meeting AIFA deadlines, ensuring clarity, accuracy and regulatory compliance.