Ethical MedTech & AIFA Accreditation

AIFA (Italian Drug Agency) is the national authority responsible for drugs regulation in Italy. Any pharmaceutical company supporting or participating in a Congress in Italy, is subjected to an authorisation by AIFA (Italian Drug Agency), according to an Italian Government Decree (Decreto Legislativo 219/06 – art. 124).

When is the authorisation mandatory?

The AIFA authorisation is not necessary:

• When a company promotes only medical devices or food supplements during a congress (products without Marketing Authorisation);
• 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). 

AIFA authorisation is mandatory:

• If the company produces, sells or commercialises and promotes drugs/medicines authorised for marketing and related to the topics covered during the event;
• If the company participates with a drug that is not authorised in Italy but is authorised in Europe or in another country, the company is subject to AIFA authorisation.

The request has to be submitted within 60 days prior to the event. Failure to comply with the requirement may result in legal penalties and prevent the company from participating. According to Italian laws, the submission for all the companies taking part in the Congress must be made by a single Italian Agency, appointed by the Congress Organiser.

The official appointed Italian agency for AIFA authorisation is:
Fargo International di Giulia Cambria
Via Pietro Maroncelli, 32
50137 Firenze, Italy
info@fargointernational.it
Tel. +39 333 5202862

To obtain AIFA authorisation, a company must have a valid SIS Code, which is an identification code assigned by AIFA to identify each Company. Getting a SIS code takes at least a month.

All non-Italian pharmaceutical companies without SIS Code are urged to contact the above appointed Official Italian Agency before 3 November 2026.

Note: Companies without a SIS Code, which have a branch or a representation in Italy can contact directly the Italian affiliate to submit the application to the Official Agency through the Italian subsidiary. This is possible for Companies with an affiliated branch in Italy registered in the AIFA website and only if the Italian Company does not participate in the Congress.

Companies with a SIS Code (or having an affiliate having a SIS Code) should contact the Official Italian Agency before 15 January 2027.

The appointed Official Agency for AIFA authorization (Fargo International) will facilitate the process and/or direct companies to a regulatory affairs agency that will assist them in obtaining the necessary credentials and codes required for the AIFA submission process.