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In brief

On 27 June 2023, the Italian Medicines Agency (AIFA) announced the release of new features for the e-Dossier Price and Reimbursement web portal (“Portal”). The Portal, available at the AIFA Services Portal, enables the preparation of dossiers in digital format to support reimbursement and price claims.

Key takeaways

Among the new features introduced is the extension of the Portal to the dossiers of the following simplified procedures: i) reimbursement of extensions of indications already reimbursed to the originator for equivalent medicines or biosimilars; ii) reimbursement of new packages due to changes in the primary packaging; and iii) new packages referring to changes (increases and reductions) in the number of dosage units or changes (increases and reductions) in the dosages of medicines with a different number of dosage units or dosages from the medicines.


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.


Riccardo Ovidi is an Associate in Baker McKenzie Rome office.


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

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