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Product Regulation & Liability

Italy: Ministry of Health: clarifications on the distribution license for medicinal products

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In brief

In a circular letter sent to the Regional and Autonomous Provinces Health Departments on 27 March 2023, the Ministry of Health clarified that the marketing authorizations holders directly engaged in the distribution of their medicinal products are required to obtain a distribution license under Article 100 of Legislative Decree 219/2006.

With the same circular letter, the Ministry of Health also clarified that said licensing requirement does not apply to holders of manufacturing licenses only with respect to medicinal products and active substances covered by the relevant manufacturing license.

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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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Riccardo Ovidi is an Associate in Baker McKenzie Rome office.

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

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