Notice to Pharmaceutical Companies - AIFA 17/12/2018

The art. 122 paragraph 1 of legislative decree 24 April 2006, n.219 (issued in implementation of directive 2001/83/EC and directive 2003/94/EC) provides that “[…] In January of each year, each pharmaceutical company must notify AIFA, on a regional basis, of the number of healthcare professionals visited by its scientific representatives in the previous year, specifying the average number of visits made. To this end, within the month of January of each year, each pharmaceutical company must communicate to AIFA the list of scientific representatives employed during the previous year, with an indication of the educational qualification and type of employment contract with the pharmaceutical company”.

In compliance with the regulation, we inform you that the deadline for the transmission of the lists of Scientific Representatives of the drug for the year 2018, to be carried out by entering the data on the AIFA Medical Scientific Information Front End, is set for 31 January 2019.

In order to facilitate this operation, the computer interface makes the data entered in previous years available, allowing them to be confirmed and modified.

The company that owns at least one AIC valid is not subject to the obligation to transmit the lists of scientific representatives if, during the reference year, it has not placed any medicines on the market and has not carried out any form of advertising of medicines. This situation is self-certified by the legal representative of the company by filling in the appropriate Declaration in lieu of the deed of notoriety form (attached to the press release of the IS office of 06/16/2017).

We take this opportunity to remind the corporate user how to access the AIFA Front End: 

1. access the site https://servizionline.aifa.gov.it/registrazione/ and fill in the screen with your personal data;
2. in the second screen, check the data entered and enter a "CAPTCHA" code to register;
3. after this operation the user will receive a confirmation email containing a link; click on the link to finalize the registration;
4. after this operation the user will receive a second email containing a temporary password to the AIFA services portal;
5. at this point the user can access the services portal (at the address: https://servizionline.aifa.gov.it/portale/) entering, as username, the combination of your "name.surname" and, as password, the temporary password sent by email;
6. on first access, the system will ask for a mandatory password change;
7. once exited from the change password function, the user will be able to access again a https://servizionline.aifa.gov.it/portale/ entering your username and password. At this point the user will see his own dashboard (which will initially be empty as it is not enabled for any application);
8. to enable the applications, access the address: https://servizionline.aifa.gov.it/jam/UI/Login?goto=https%3A%2F%2Fservizionline.aifa.gov.it%2FGestioneProfiliAifa%2F and log in with the same credentials used in point 7. Here the user will be able to choose which applications to request authorization for (e.g. IMS – Scientific Representatives) and, subsequently, which company to work for (even more than one) ;
9. after the user has finalized point 8, the AUA (administrator user) of the chosen company will be able to accept the request and therefore allow the use of the application;
10. when the AUA has accepted the request, the user, by repeating the operation referred to in point 7, will see the button for accessing the application in his dashboard.

As regards the indication of the period of activity of the ISF, it is recommended to carefully read the user manual, in particular paragraph 1.5.3 Management of Pharmaceutical Representatives (IFS). Please note that the start date of the drug sales representative's employment relationship with the reporting company must be entered in the "from ___ (mandatory)" field, while the date must be entered in the "to _____ (optional)" field of termination of the employment relationship.

Related news: AIFA. Scientific Informers User Manual