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Product Regulation & Liability

Italy: EMA – Plan to prevent drug shortages

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In brief

In a statement published on 18 June 2024, the European Medicines Agency (EMA) called on marketing authorization holders (MAHs) to adopt a Medicines Shortage Prevention Plan to reduce and prevent possible shortages and critical issues.

Key takeaways

The purpose of such a Plan is to collect information on the product, european and international marketing, supply chain vulnerabilities, measures to prevent shortages and, where appropriate, to reduce their impact on public health, and must contain appropriate measures to address shortages and mitigate their impact on patients.

MAHs are invited to adopt a Plan for each medicinal product for human use they place on the EU market, to monitor its adequacy on an annual basis and to update it periodically or when major changes occur. To this end, the EMA has made available a template for drafting the Plan.

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Roberto Cursano has been a lawyer in Baker McKenzie since September 2007. He focuses on healthcare law and compliance, and assists in tender procedures, the negotiation of public contracts and litigation before administrative courts. Mr. Cursano is a former administrative officer in the Italian Ministry of Health and helps clients work closely with the Italian Public Administration. He is admitted to the bar before the Italian Supreme Court and the Council of State. As well as training and tutoring in the master’s degree program on clinical trials of pharmaceutical products at the University of Rome Sapienza, Mr. Cursano regularly publishes articles and scientific contributions. He also frequently hosts and participates in seminars and presentations on pharmaceutical and administrative law matters.

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Francesca R. Baratta is an Associate in Baker McKenzie Rome office.

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Riccardo Ovidi is an Associate in Baker McKenzie Rome office.

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