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Product Regulation & Liability

Italy: Countering pharmaceutical cybercrime

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In brief

In the course of 2022, the Health Protection Command of the Carabinieri Corp enforced 61 orders, issued by the competent directorates general of the Ministry of Health, providing for the shutdown of websites selling different types of prescription-only medicines in breach of the existing legislation.

Key takeaways

Indeed, Article 112-quater of Legislative Decree No. 219/2006 prohibits the online sale of drugs subject to medical prescription and only allows for the sale of prescription-free drugs, including over-the-counter medicines. In addition, 112-quater above provides that the online sale of prescription-free drugs can only be carried out by pharmacies and commercial establishments — “para-pharmacies” or “health corners” — that have previously obtained an ad hoc authorization issued by the competent authority and identified by the relevant regional or provincial legislation.

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Author

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.

Author

Riccardo Ovidi is an Associate in Baker McKenzie Rome office.

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