AIFA procedure - International Congresses in Italy

Dear Sponsors and Exhibitors,

AIFA (Italian Drug Agency) is the national authority responsible for drugs regulation in Italy.

Any Italian Pharmaceutical Company that is going to organize or support a congress by any kind of sponsorship, is
subjected to an authorization by AIFA (Italian Drug Agency) (Decreto Legislativo 219 / 06 – art. 124).

According to Italian laws, the authorization for all the Companies must be made by an Italian Agency.
AIM GROUP INTERNATIONAL has been appointed as the preferred Italian agency to support all sponsors and exhibitors.

For all foreign Pharmaceutical Companies the following applies:

The AIFA authorization is NOT necessary:

- when a company promotes only medical devices or food supplements during a congress (products without Marketing Authorization) but subjected to MEDTECH authorization (if the company is associated)

- 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)

Decreto Legislativo 219 / 06 – art. 124

If you need to apply for an AIFA authorization or need additional information, please contact AIM GROUP INTERNATIONAL.

Please find here the contact information:

AIM Group International - AIM Education S.r.l.
Mrs. 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

Please note as well the timing:

Congress starting on September 7, 2024

2024/03/15 - deadline for Pharma Companies without AIFA SIS code to start the procedure
2024/06/24 - deadline for the Italian Official Agency, to receive from the organizing secretariat the documents required for AIFA submission
2024/06/26 - deadline for the Italian Official Agency to upload the application (pre-request) on AIFA website
2024/07/09 - last deadline for Pharma Companies to complete and validate the application on AIFA website