The Italian Medicines Agency announces that the second transition phase, originally scheduled for a duration of 3 months (31 May-31 August 2021) is extended until 30 November 2021. This is to implement some changes to the new e-Dossier Price and Reimbursement portal owing to comments and suggestions received from users and trade associations and to release additional functions, including e.g. the Deposit function, the compilation of the Dossier relating to simplified procedures and the request for recognition of innovativeness.

Without prejudice to what specified in the Clarifications regarding compilation of Dossiers for the price and reimbursement application of a medicine for simplified procedures, whose compilation through the e-Dossier portal has not yet been implemented, it is underlined that, during the transition, it will be possible to draft the Dossier also through writing tools alternative to the new e-dossier Portal, and send it in .pdf and word format, pursuant to the provisions of the Ministerial Decree of 2 August 2019 "Criteria and methods whereby the Italian Medicines Agency determines, through negotiation, the prices of medicines reimbursed by the National Health System"(Official Gazette no. 185 of 24 July 2020) and the subsequent Guidelines published on 30 December 2020, adopted with Directorial Resolution no. 1372 of 23 December 2020.

In both cases, the Dossier must in any case be filed, together with the additional supporting documentation (e.g. cover letter, SPC, EU decision, etc.), through the current online negotiating system, providing appropriate communication by certified e-mail to the HTA & Pharmaceutical
Economy Division, at hta.prezzo@pec.aifa.gov.it, also copying hta.prezzo@aifa.gov.it.

Please also note that from 31 May 2021 dossiers in paper format are no longer accepted in any case.