Insights

Medicinal shortages: amendments to Legislative Decree No. 219/2006 Now Effective

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.

Matteo Ferretti 23-12-2025

Publications

Latest Updates on the Sunshine Act Implementation in Italy

Italy is making significant progress in implementing the Sunshine Act, a legislative measure designed to ensure transparency in interactions between the pharmaceutical and medical device industries and healthcare professionals.

Under the Sunshine Act, companies will be required to report payments, goods, services, or other benefits when their value exceeds:

 

  • €100 per unit or €1,000 annually for a healthcare professional.
  • €1,000 per unit or €2,500 annually for a healthcare organization.

Failure to comply, including omissions or false reporting, will result in sanctions.

 

At the core of this initiative is the digital platform “Sanità Trasparente”, which will publicly disclose financial contributions and other benefits provided to healthcare stakeholders.

 

In October 2024, the Ministry of Health initiated a pilot test of the platform with some pharmaceutical companies. However, there are still no feedbacks available about the access to the platform, underscoring potential delays or operational challenges in the testing phase.

Despite this, the platform's official launch could happen potentially at the end of 2024. If confirmed, from January 2025, companies will be required to collect data on value transfers, with the first disclosures anticipated by December 2025.

While a transitional period has been speculated, no official confirmation has been provided.

Companies are advised to proactively establish robust data collection systems and provide comprehensive training to their teams to ensure compliance with the upcoming requirements.

 

Regulatory Pharma Net is available to keep your company updated on the Sunshine Act regulatory framework and to support all your regulatory needs related to this initiative.

For assistance, please contact us at info@rpngroup.com

 

Matteo Ferretti 25-11-2024