Claudia Garimberti -

new electronic interface for the preparation of Pricing and Reimbursement e-Dossiers has been developed by AIFA and has become available since 31st May 2021.

The new tool allows the preparation of dossiers in electronic format to support pricing and reimbursement requests in accordance with the provisions of the Ministerial Decree of 2nd August 2019 “Criteria and methods by which the Italian Medicines Agency determines, through negotiation, the prices of drugs reimbursed by the National Health Service” (Italian OJ n. 185 of 24th July 2020) and of the subsequent Guidelines published on 30th December 2020, adopted with Directorial Resolution no. 1372 of 23rd December 2020.

The main purposes of the new P&R portal are to support the Applicant in the correct and complete electronic preparation of the Dossier, in which the individual relevant sections are automatically generated in line with the selected negotiation type and sub-type, guaranteeing the compliance with the Ministerial Decree of 2nd August 2019, favor the dematerialization and allow the saving, storage and standardization of the entered data.

With the aim of encouraging both a gradual transition to the new method of compiling the dossier, and to collect opinions, comments and suggestions from usersa transitional phase lasting 3 months (31st May-31st August 2021) has been launched, during which the Companies will have the opportunity to test the system and report any problems or improvements to be implemented.

During the transitional phase it will be possible to prepare the Dossier also with alternative writing tools and send it in pdf and word format in accordance with the provisions of the Guidelines.

After 31st August 2021, the submission of P&R dossiers prepared in electronic format through the new portal will become mandatory.

Additional features are going to be implemented by AIFA in the upcoming months, which include the possibility to also prepare simplified e-dossiers and innovation applications and the possibility to amend already submitted e-dossiers.

Regulatory Pharma Net is ready to support pharmaceutical Companies with strategic analysis and advice, development of economic models, preparation of the Pricing and Reimbursement application in accordance with the new requirements, e-dossier creation, submission and follow-up of the procedure, including attendance to negotiation meetings with the Authority.

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