AIFA regulation for pharmaceutical companies
In Italy each pharmaceutical company that sponsors a meeting or a congress on topics in anyway related to the use of their own pharmaceutical products, must submit an application to the competent Unit of the Italian Medicines Agency (AIFA) to obtain a specific authorization.
AIFA authorisation 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.
AIFA authorisation is not necessary
- when a company promotes by advertising only medical devices or food supplements during a congress (products without Marketing Authorisation);
- when a company sponsors a meeting on topics not related to the use of any of their 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).
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.
Further information is available at the following link http://www.agenziafarmaco.gov.it/en/content/authorization-congresses-and-meetings.
