AIFA Procedure

In Italy each pharmaceutical company which sponsors a meeting or a congress on topics in anyway related to the use of their own pharmaceutical products, must be submit to the competent Unit of the Italian Medicines Agency (AIFA) an application to obtain a specific authorization.

The AIFA authorization is necessary for every pharmaceutical company ( Marketing Authorisation Holder or the companies responsible for the actual marketing of pharmaceutical products) which sponsors a meeting or a congress on topics in anyway related to the use of their own pharmaceutical products.

 

Procedure for the AIFA authorization

In order to obtain the authorization, an application containing the details of the expenses is to be submitted 60 days before the day of the meeting by the pharmaceutical company ( Marketing Authorisation Holder or the companies responsible for the actual marketing of pharmaceutical products) to the competent Unit of Aifa, which will issue its approval after 45 days from the moment the application form has been received

the authorization procedure is carried out through the Aifa website area ACC (authorization for congresses and meetings) and on this purpose, pharmaceutical companies must be registered:

www.agenziafarmaco.gov.it

www.agenziafarmaco.gov.it/ACC

In the past (at the time of EAU Milan) there was a procedure in which all companies (Italian & foreigners) were sending the AIFA paper forms to be completed.

The new procedure requires all companies to apply online on the AIFA website.

In order to be able to follow the online procedure, every company must obtain a SIS* code and a CUA

The procedure for obtaining the code can be found here

 

Agency

Emilia Viaggi Congressi & Meeting
Via Porrettana, 76/2
40033, Casalecchio di Reno (BO)
Tel. +39 051 6194911
Fax +39 051 6194900
elenalegnani@emiliaviaggi.it
www.emiliaviaggi.it