AIFA MANDATORY PROCEDURE for pharmaceutical companies

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

Any Italian (and non-Italian in this case because the congress is organized by a non-Italian secretariat and it will be taking place in Italy) 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.

FARGO INTERNATIONAL has been appointed as the preferred Italian agency to support all sponsors and exhibitors for this Congress.

To be supported for the AIFA procedure please contact: 

Fargo International di Giulia Cambria

Via Pietro Maroncelli, 32

50137 Firenze

Email: info@fargointernational.it

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 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).

Please note as well the timings:

Congress starting on 11 September 2025.

2025/05/01 – deadline for Pharma Companies without AIFA SIS code to start the procedure.

2025/07/01 – deadline for the Italian Official Agency to upload the application (pre-request) on AIFA website.

2025/07/11 – last deadline for Pharma Companies to complete and validate the application on AIFA website.