Access information | Italian Medicines Agency Aifa toggle bar Search Search keywords The Agency The Agency Mission and values Organisation Scientific and Economic Committee for Medicines Support and Coordination Secretariats and Advisory Committees International Collaborations EU Projects Legislation Forms Competition notices Resolutions Tenders and contracts Quality assurance Guarantee Committee Atti di notifica Associazioni dei pazienti AIFA Incontra Contacts Certified email COVID-19 COVID-19 Communications about COVID-19 COVID-19 Vaccines Medicines usable for treatment of COVID-19 disease Use of monoclonal antibodies for COVID-19 Use of antivirals for COVID-19 Monitoring of medicinal products used during the COVID-19 epidemic Clinical Trials - COVID-19 Compassionate Use Programs - COVID-19 Access to medicinal products Access to medicinal products Early access and off-label use Authorisation of medicinal products Medicine shortages Antibiotic medicinal products Biological medicinal products Vaccines Blood derivatives Generic medicinal products Biosimilar medicinal products Orphan medicinal products Advanced therapies Homeopathic medicinal products Allergens Medicinali di origine vegetale Ancillary medicinal substances incorporated in medical devices Safety of medicinal products Safety of medicinal products Pharmacovigilance National Pharmacovigilance Network Adverse Reactions to medicinal products Persons in charge of Pharmacovigilance European Eudravigilance System Accesso alle segnalazioni - ADRreports Regional pharmacovigilance funds Segnali di sicurezza Risk management measures Medicinal products subject to additional monitoring Quality and Inspections Quality and Inspections Quality defects Inspections and authorisations Qualified person Fight of pharmaceutical crime Research and Clinical trials Research and Clinical trials Clinical trials concerning medicinal products EU Regulation on Clinical trials National Observatory on Clinical Trials Registro Studi Osservazionali Comitati Etici Nazionali (CEN) Ethics Committees Coordination Centre Independent clinical research Mappa dei centri di Sperimentazione Clinica Pricing and reimbursement Pricing and reimbursement Negotiation and reimbursement Economic evaluations Monitoring Registers AIFA Notes Lists of Class A and Class H medicinal products Innovative medicinal products Transparency Lists Consumption and pharmaceutical expenditure Consumption and pharmaceutical expenditure The Medicines Utilization Monitoring Centre (OsMed) Governance of pharmaceutical expenditure Monitoring pharmaceutical expenditure Innovation and planning Innovation and planning Innovation and scientific advice Horizon scanning Information and communication Information and communication FarmaciLine Medical and scientific information FAQ Publications Communication campaigns Eventi AIFA Scientific Seminars Press releases Dossier AIFA Mobile APP AIFA APP Firstline AIFA - Antibiotici ABC della Ricerca Clinica Presentations and speeches Public consultations and documents Documents shared with scientific communities Calendario eventi Archivio AIFA data AIFA data OsMed Data Open Data Companies Section Companies Section Requests for authorisation of conferences and meetings Payment of fees and annual duties MA Electronic invoicing Application for reimbursement and pricing Access information Notifica concessionari di vendita Comunicazione prima commercializzazione Open governance Open governance Disposizioni Generali Organizzazione Consulenti e collaboratori Personale Bandi di Concorso Performance Enti controllati Attività e procedimenti Provvedimenti Bandi di gara e contratti Sovvenzioni, contributi, sussidi, vantaggi economici Bilanci Beni immobili e gestione patrimonio Controlli e rilievi sull'Amministrazione Servizi Erogati Pagamenti dell'Amministrazione Opere pubbliche Pianificazione e governo del territorio Informazioni ambientali Interventi straordinari di emergenza Altri Contenuti Access information Access to AIFA's IT Systems 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. Please note that to access the "Online Payments" system to pay the fee and obtain the related certification, the Notified Body shall: request registration in the AIFA systems through the attribution of a SIS code. The forms are available in the "Related documents" section; 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; 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; the Business Users Manager can also be registered and enabled as a business user for one or more applications; the business user enabled for Online Payments can then proceed to pay the fee; 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): Access to the Portal is subject to prior registration with the said Portal. For assistance regarding the transmission of the documentation for obtaining the opinion, please contact: scientificopinion@aifa.gov.it For technical assistance, you may use the Rexpondo help desk service (https://helpdesk.aifa.gov.it/rexpondo/customer.pl ) and the telephone number +390662289430. Related documents Portale dei servizi - Registrazione e richiesta profilo [0.7 Mb] [PDF] > Appointment of Company Users’ Administrator (CUA) (02/08/2022) [0.13 Mb] [PDF] > Access request for "Company Users Administrator" [0.12 Mb] [PDF] > Access request for "Company Users Administrator" [0.05 Mb] [DOC] > Informativa ai sensi degli artt. 13 e 14 del Regolamento europeo 2016/679 (GDPR) [0.12 Mb] [PDF] > Manuale Utente per la registrazione [0.95 Mb] [PDF] > Assignment for the SIS codes [0.68 Mb] [PDF] > Assignment for the SIS codes [0.02 Mb] [DOCX] > Link correlati Video - Modalità di registrazione e richiesta profilo (26/11/2020) Companies Section Requests for authorisation of conferences and meetings Payment of fees and annual duties MA Electronic invoicing Application for reimbursement and pricing Access information Notifica concessionari di vendita Comunicazione prima commercializzazione Share Cookie Bar Footer The agency Home Page FarmaciLine User participation and satisfaction Citizens' access Modulistica Open governance Acts of notification Legal notification TrovaNormeFarmaco Competition notices Tenders and contracts Contacts Via del Tritone, 181 00187 Roma Contacts Certified e-mail (PEC) contacts VAT number: 08703841000 Tax code: 97345810580 IPA AIFA code: aifa_rm IPA UCB code: UFE1TR FOLLOW US ON label.button.spotify Bluesky FEED RSS Feed Rss Cookie management Sezione Link Utili Legal notice Social Media Policy Dichiarazione di accessibilità Web accessibility Website statistics Online services go to beginning of content