AIFA, Italy will launch a new e-Dossier Price and Reimbursement Portal imminently.
What is the new portal called?
It is called the the AIFA Services Portal.
When will it be launched?
AIFA has confirmed that starting from 31 May 2021, the AIFA Services Portal, new e-Dossier Price and Reimbursement portal will be made available to pharmaceutical companies, for the preparation of dossiers in digital format to support requests for reimbursement and price, in accordance with the provisions of the Ministerial Decree of 2 August 2019.
What are the main purposes of the new portal?
The main purposes of the new e-Dossier Price and Reimbursement Portal are to support the Applicant in the correct and complete digital compilation of the Dossier, in which the individual relevant sections are automatically generated in line with the type and sub-type of negotiation selected, guaranteeing compliance to the Ministerial Decree of 2 August 2019. The portal will allow the saving, storage and standardisation of the data entered.
Will there be any additional implementation following the launch of the portal?
Yes there will be an additional implementation.
Additional functions e.g. the Filing function, the compilation of the Dossier relating to simplified procedures and application for recognition of innovativeness, as well as the additions and updates in the endo-procedural phase, will be implemented shortly after the initial launch, with further releases.
Will there be a transition phase to the new portal?
Yes, there will be a transition period of 3 months between 31 May-31 August 2021. During this period, user companies will have the opportunity to test the system and report any usability problems or improvements and functionality to be integrated.
The aim is to encourage both a gradual transition to the new method of compiling a dossier and to collect opinions, comments and suggestions from end users.
During the transition phase, will there be the scope to prepare a dossier with alternative writing tools, for submission via the new portal?
Except as specified in the Clarifications regarding the compilation of the Dossiers to support the request for reimbursement and price of a medicine for simplified procedures, whose compilation through the e-Dossier portal will be implemented with future releases, during the transition phase, it will be possible to prepare the Dossier also with alternative writing tools to the new Portal-dossier, and sent in pdf or word formats , in accordance with the provisions of the Guidelines.
When will the agency stop accepting paper dossiers?
Paper dossier will stop being accepted from 31 May 2021 paper dossiers will not be accepted.
Where can you find information on how to register to use the portal?
For information on how to register set up user profiles for the e-Dossier Price and reimbursement portal, please refer to the information provided by the Agency and available on the AIFA institutional portal ( ” Access to AIFA Information Systems“) and / or the video tutorial available on the Agency’s YouTube channel (” Service Portal – Registration and profile request “).
Will there be any training available to use the new portal?
Yes, in order to demonstrate the methods of access to the new portal and its functions, separate training sessions will be held for companies through the Agency’s YouTube channel on 27 May 2021, from 9:30 to 16:30.
Source: AIFA website