AIFA Submissions
It is mandatory for foreign Pharmaceutical Company to register in AIFA in order to can submit an application to obtain AIFA authorization, to be able to participate as sponsor at the meeting/congress.
In order to simplify this new procedures, Companies not register in Italy (without a SIS Code), which have a branch or a representation in Italy could contact directly the Italian affiliate to submit the application through the Italian subsidiary This is possible for Pharmaceutical Companies with an affiliated branch in Italy registered in AIFA website.
If the Company does not have an affiliated Italian Company registered in AIFA, it has to start with AIFA Process (very long, it take more or less 120 gg.) max within 20 December 2021.
The AIFA authorization is NOT necessary:
- when a company promotes only medical devices or food supplements during a congress (products without Marketing Authorization)
- when a company sponsors a meeting about arguments not related to the use of any of its pharmaceutical products; in this case the company is not allowed to expose or distribute any kind of advertising material during the meeting (Section 9 art. 124 D.L. n.219/06)
Official Agency for AIFA submissions (Pre-richiesta AIFA)
Any Italian pharmaceutical company supporting or participating in a congress abroad, is subjected to an authorization by AIFA (Italian Drug Agency), according to an Italian Government Decree (Decreto Legislativo 219/06 – art. 124).
The request of authorization must be submitted within 60 days before the starting date of the event. The appointed agency to collect all applications from pharmaceutical companies and file them with the AIFA is:
AIM Group International - AIM Education S.r.l.
Cristina Ghidoli
Via G. Ripamonti, 129
20141 Milan, Italy
Tel. +39 02 56601.1
FAX +39 02-70048585
e-mail: aifa@aimgroup.eu; c.ghidoli@aimgroup.eu