The Italian Medicines Agency (AIFA) provides an integrated platform of digital services reserved for Regions, National Health Service (SSN) bodies, pharmaceutical companies and members of the public. The system enables secure access to institutional IT applications for the management of administrative, regulatory and monitoring processes.
 
From 19 October 2026, the portal will introduce an updated version of its identification, registration and authorisation management features. This update addresses the need to simplify the user access process whilst ensuring a more efficient, traceable and controlled service authorisation process
 
Users can access the platform directly via the dedicated web address https://servizionline.aifa.gov.it it or by selecting the "Online Services" section on the home page of AIFA’s institutional website.

Three-Step Access Procedure

The process for accessing application services that require a specific authorisation profile consists of three sequential stages. Each stage verifies the applicant’s identity and forwards the authorisation request to the relevant body.

Step 1: User Registration and Identification

Before being able to access restricted applications, new users must complete the digital identification process. Authentication is provided via the main national digital identity systems or dedicated credentials:

• PA Digital Identity (SPID, CIE, CNS): Priority and direct authentication method based on the Public Digital Identity System (SPID), Electronic Identity Card (CIE) or National Services Card (CNS).
• Credentials and OTP Code: An authentication system based on a username, password and one-time password (OTP) for users authorised to use this channel.

Step 2: Logging in to the Personal Area and Submitting an Authorisation Request (RdA)

Once registration is complete and the identification procedures have been carried out, the user can log in to the AIFA online services portal.
Within their personal area, users will immediately find links to freely accessible services, which can be used without the need for specific prior authorisation. To access specialist IT applications, however, users must submit an Authorisation Request (RdA) by selecting one or more relevant application services from the catalogue in their personal area.

Step 3: Verification and Approval of the Request

Every Authorisation Request (RdA) submitted by a user is processed and assessed by the designated approver responsible for verifying requirements and organisational roles.

Architecture of Approval Roles and Monitoring

The process for authorising and managing user accounts varies depending on the type of organisation or body the applicant belongs to. The system clearly distinguishes between the responsibilities of the industrial sector and those of regional administrations to ensure maximum organisational compliance.
 
The assessment of Authorisation Requests can lead to two distinct outcomes, both of which are promptly communicated to the applicant via an automated email notification:

• Positive Outcome (Approval):The request is accepted and the user is immediately authorised to use the requested application service.
• Negative Outcome (Rejection): The request is rejected if the necessary requirements are not met or if the supporting documentation is incomplete. In the event of a rejection, the email sent to the user includes the specific reason provided by the approver.

The following table summarises the approval governance model on the basis on the user’s institutional profile:

Reference Documentation and Support Tools

To support users and those with approval roles, the Italian Medicines Agency provides a comprehensive suite of operational manuals in PDF format and dedicated video tutorials, designed to guide users step-by-step through every operation within the portal.
Each stage of the process has specific tools for consultation and further information:

• Registration Manual (PDF)
• Manual for requesting authorisation (PDF;Video)
• Manual for managing and monitoring requests (Corporate User Administrator – Regional Approver) (PDF; Video)