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Access information
The Italian Medicines Agency (AIFA) makes available a series of digital services on its institutional portal for companies operating in the pharmaceutical sector.
To use these digital services, companies must first request the assignment of the SIS code (a unique code associated with each company) and then appoint a Company User Administrator (CUA). The CUA is responsible for enabling/disabling their users.
To request the SIS code, the legal representative of the company must send a specific request to the certified email address protocollo@pec.aifa.gov.it . Foreign companies without a certified email address should send the request to the email address sisdomanda@aifa.gov.it . Please follow the instructions contained in the document “SIS code assignment form” published in the “Related documents” section.
To enable the Company User Administrator, the legal representative of the company must send the form “Mod. enabling information systems – Company User Administrator” to AIFA at the certified email address protocollo@pec.aifa.gov.it . The form, available in the “Related documents” section, should be completed with information about the person who will hold the role of CUA.
The person appointed as CUA must register with AIFA's online services at https://servizionline.aifa.gov.it/. The CUA can access the services using their digital identity (SPID, CNS, Login eIDAS) or by using the “Register” link (for foreign users).
Users, including the CUA user, who intend to access AIFA's digital services on behalf of one or more companies, must ensure that they are already registered. They must then request access to a specific service (e.g., the POL online payment system) using the “Profile management for registered users” online administrative service.
The CUA user can approve the activation requests of their company's users, including themselves, using the “Company user authorization – CUA and Regional Approvers” online administrative service.
For further details, please refer to the documentation published in the “Related documents” section.
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request registration in the AIFA systems through the attribution of a SIS code. The forms are available in the "Related documents" section;
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subsequently, through its legal representative, the Notified Body shall appoint a Business Users Manager and notify AIFA of his/her appointment, by filling in and sending the form in the "Related documents" section;
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as soon as authorised, the Business Users Manager shall access the AIFA system and enable each additional business user, expressly dedicated to accessing the Agency’s various IT applications (e.g. Online Payments), provided that the user registers before on the abovementioned system;
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the Business Users Manager can also be registered and enabled as a business user for one or more applications;
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the business user enabled for Online Payments can then proceed to pay the fee;
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subsequently, as reported in the dedicated Guideline (https://www.aifa.gov.it/sostanze-medicinali-ancillari), the Notified Body can submit all the documentation requested therein, the fee payment certification, the Application Form and the additional annexes provided for the acquisition of the scientific opinion, through the Common European Submission Portal (CESP): https://cespportal.hma.eu/Account/Login?ReturnUrl=%2f.
For technical assistance, you may use the Rexpondo help desk service (https://helpdesk.aifa.gov.it/rexpondo/customer.pl) and the telephone number +390662289430.
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Portale dei servizi - Registrazione e richiesta profilo [0.7 Mb] [PDF] >
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Appointment of Company Users’ Administrator (CUA) (02/08/2022) [0.13 Mb] [PDF] >
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Access request for "Company Users Administrator" [0.12 Mb] [PDF] >
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Access request for "Company Users Administrator" [0.05 Mb] [DOC] >
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Informativa ai sensi degli artt. 13 e 14 del Regolamento europeo 2016/679 (GDPR) [0.12 Mb] [PDF] >
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Manuale Utente per la registrazione [0.95 Mb] [PDF] >
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Assignment for the SIS codes [0.68 Mb] [PDF] >
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Assignment for the SIS codes [0.02 Mb] [DOCX] >