Italian Medicines Agency

The Italian pharmacovigilance system is based on the National Pharmacovigilance Network (RNF) which ensures the collection, management and analysis of reports of suspected adverse drug reactions (ADRs).

1) How the Network works for users related to local health units (ASL), hospital enterprises (AO), National Institutes for Research and Treatment (IRCCS), Regions and Autonomous Provinces

• Connect to the Online Services website and fill in the registration form (see "Related Links")
• Following the registration of the electronic form, the Health Officer shall transmit by fax to the number 06/59784142 or by email to the address: ReteFV@aifa.gov.it, an appointment note confirming the details of the appointed Person responsible for Pharmacovigilance, indicating the telephone number, fax and email address.
• In case of replacement of the previously registered Person responsible for Pharmacovigilance, the request for disabling the name must be included in the same note.  
• Once the documentation and the correct registration on the portal have been verified, AIFA enables the user who is required to access with his/her credentials and click on the link "pharmacovigilance" in order to complete the registration to the system

2) For pharmaceutical companies:

• Connect to the Online Services website and fill in the registration form (see "Related Links").
• Connect to the Network and log in with the credentials received (new ID and password). After accessing, request the activation of the functionality "Pharmacovigilance" by filling in an electronic form similar to the previous one with the Company’s data.
• Following registration of the electronic form, the company's legal officer shall transmit by fax to the number 06/59784142 or by email to the address: ReteFV@aifa.gov.it, an appointment note confirming the details of the appointed Person responsible for Pharmacovigilance, with attached documentation proving powers of the legal representative (e.g. copy of Company Registration Report).
• It is important to specify in the note whether the appointed Person responsible for Pharmacovigilance plays a role in the EUQPPV because in this case it is necessary to notify the EMA on the name by updating the European database provided for in Art. 57 of Regulation (EC) No 726/2004.
• The note shall specify if the registration relates to the function of "local contact" for Pharmacovigilance, indicating also the name of the EUQPPV (in this case it is not necessary to modify the Art. 57 database).

3) Request for the substitution of the Person responsible for Pharmacovigilance resgistered in the RNF

In the case of a request for replacement of the previously registered Person responsible for Pharmacovigilance, the request for disabling the name must be included in the same note.

Once the documentation and the correct registration on the portal have been verified, AIFA enables the user who is required to access with his/her credentials and click on the link "pharmacovigilance" in order to complete the registration to the system

In case the residence of the Person responsible for Pharmacovigilance is outside the Italian territory, considering that all the communications are presented exclusively in Italian, a “declaration” signed by the legal representative shall be attached, and with this declaration the MAH shall assume full responsibility for equipping itself with all those language interpretation resources that may be necessary in order to comply with regulatory obligations.

4) For the Persons responsible for Pharmacovigilance already registered in the RNF

In order to be able to associate an account in RNF to a second company, the responsible will have to access directly to the Network of Pharmacovigilance with his credentials (those of the already associated company), fill out a new registration form in the “new profile request” section and wait for endorsement.