AIFA Mandatory Procedure 

AIFA MANDATORY PROCEDURE for pharmaceutical companies

AIFA (Italian Drug Agency) is the national authority responsible for drug, regulation in Italy.
 
As the EAHAD 2025 congress will be held in Italy, every Pharmaceutical Company (Italian or Non-Italian) that is going to attend or support the congress by any kind of sponsorship, is subjected to an authorisation by AIFA. (Decreto Legislativo 219 / 06 – art. 124).
 
According to Italian laws, the authorization for all the Companies must be made by an Italian Agency.
 
FARGO INTERNATIONAL has been appointed as the preferred Italian agency to support all sponsors and exhibitors for this Congress.
 
PLEASE FIND BELOW FARGO INTERNATIONAL CONTACTS:
Fargo International di Giulia Cambria
Via Pietro Maroncelli, 32
50137 Firenze
 
Please note that 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 authorisation (if the company is associated)
  • 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)
 
Please note as well the timings:
2024/10/15 – deadline for Pharma Companies without AIFA SIS code to start the procedure
2024/11/21 – deadline for the Italian Official Agency to upload the application (pre-request) on AIFA website
2024/12/01 – last deadline for Pharma Companies to complete and validate the application on AIFA website