AIFA – Requests for authorisation of conferences and meetings in Italy

https://www.aifa.gov.it/en/web/guest/acc

Any Italian or foreign marketing authorisation holder (or company engaged in the marketing of pharmaceuticals based on an agreement with the respective MAH), wishing to organise or participate in the organisation of a conference or a meeting on topics related to the use of pharmaceuticals, should submit to AIFA a request for authorisation of a proposed conference or meeting, whose technical nature will be then assessed by AIFA.

This is in line with article 124 of Italian legislative decree 219/2006.

We have chosen the following partner:

Atlante Viaggi Italia Srl

Via Bandello, 1

20123 Milano

Barbara.Mantegazza@atlanteviaggi.com

As per Italian law,

the AIFA authorization is necessary:

• for each pharmaceutical company (with Marketing Authorization Holder or the companies responsible for the actual marketing of pharmaceutical products) sponsoring the congress on topics in any way related to the use of its own pharmaceutical products.

The AIFA authorization is not necessary:

• when a company promotes by advertising only medical devices or food supplements during a congress (products without Marketing Authorization)
• when a company sponsors a meeting about topics not related to the use of any of its own medicinal 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)

Any pharmaceutical company that sponsors a congress on topics related to the use of its pharmaceutical products, must apply to the competent unit of the Italian Medicines Agency (AIFA) to obtain a specific authorization. If your pharmaceutical company has a marketing authorization (MAH or AIC) or the companies responsible for the effective marketing of your pharmaceutical products and sponsor the congress on topics related to the use of your pharmaceutical products, you should contact Atlante Viaggi communicating your SIS code, by 15 February 2024: barbara.mantegazza@atlanteviaggi.com.

If you don’t have a SIS code yet, we recommend that you contact your Italian branch, your regulatory office or your representative in Italy as soon as possible, to start the procedure to obtain the SIS code necessary to be included in the procedure by 15 February 2024 or have more information on Italian legislation.