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LYON25 - AIFA Regulations TXT
AIFA Procedure
AIFA (Italian Medecines Agency) is the national authority responsible for the regulation of pharmaceutical products in Italy.
For the EFORT Annual Congress Lyon 2025 Congress, only Italian pharmaceutical companies attending or supporting the event through any form of sponsorship are required to obtain authorization from AIFA, as per Italian law (Decreto Legislativo 219/06, art. 124).
Non-Italian pharmaceutical companies are not required to follow this procedure.
According to Italian law, this authorization process for Italian companies must be managed by an Italian agency.
FARGO INTERNATIONAL has been appointed as the preferred agency to support Italian sponsors and exhibitors with AIFA-related procedures for the congress.
CONTACT INFORMATION:
Fargo International di Giulia Cambria
Via Pietro Maroncelli, 32
50137 Firenze, Italy
Email: [email protected]
IMPORTANT DEADLINES:
- 01/04/2025 - Deadline for the Italian Official Agency to upload the application (pre-request) on AIFA website.
- 11/04/2025 - Last deadline for Pharma Companies to complete and validate the application on AIFA website.
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).