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In brief

With a press release dated 20 May 2021, the Italian Medicine Agency (AIFA) informed that starting from 31 May 2021 the new e-Dossier Pricing and Reimbursement portal (“Portal“) is available on its website. The purpose of the Portal is to support the submission of pricing and reimbursement applications by allowing the preparation of the relevant dossiers in digital format.


What’s New 

In particular, the Portal has been set up to ensure the correct and complete preparation of dossiers, whose individual sections are automatically generated according to the type of negotiation, compliance with the Decree of the Ministry of Health dated 2 August 2019 providing the criteria and methods according to which the AIFA establishes, through negotiation, the prices of drugs reimbursed by the NHS, and promote dematerialization by allowing the saving, storage and standardization of data. In this regard, the AIFA also announced that further functions will soon be made available, including those for the filing and compilation of dossiers relating to simplified procedures and recognition of innovativeness, and those for adding integrations and updates during the relevant procedure.

In order to ensure a smooth transition to the new regime and collect reports and proposals from users, the AIFA established that from 31 May to 31 August 2021 companies have the possibility of testing the Portal and reporting any problems or suggesting improvements. During the transition period, companies are still allowed to prepare dossiers according to alternative methods and submit the same in .pdf and word format.

Author

Roberto Cursano is a counsel in Baker Mckenzie since 2007 in Rome, Italy office. His practice focus more in pharmaceutical and healthcare law matters and compliance, and assists in tender procedures, the negotiation of public contracts and litigation before administrative courts.

Author

Riccardo Ovidi is an associate in Baker McKenzie's Rome office.

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