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Product Regulation & Liability

Italy: The Italian Medicines Agency updates operating instructions related to the import and the export of human blood and blood components

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In brief

On 21 December 2023, the Italian Medicines Agency updated the operating instructions and forms that can be used for the submission to the Biological Medicinal Product Evaluation Office of the documentation regarding the import and the export of human blood and blood components.

Key takeaways

In particular, the new operating instructions concern the telematic submission of import notifications for blood and its components, the annual import statement and its updates, and import or export authorization applications.

The AIFA also published new templates for the notification of imports of human blood and its components, for the annual import statement, pursuant to Art. 4 or Art. 6 of the Ministerial Decree of 2 December 2016, and for the update of the annual import statement.

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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

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

Author

Riccardo Ovidi is an Associate in Baker McKenzie Rome office.

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