Nectarios Garzella -

The Marketing Authorization Holder or the pharmaceutical company responsible for the commercialization of medicinal products in Italy, in order to organize, or help to organize, a congress, a convention or a meeting in Italy or abroad about topics related to the use of its own medicinal products, must send to AIFA a request of authorization, at least 60 days prior to the beginning of the event.

 

The request of authorization must include:

  • The name of medicinal product related to the topics of the event;
  • The details on target audience, rationale, scientific program, professional and scientific qualifications of the speakers;
  • The summary of the expenses.

 

The request of authorization is electronically signed by the reference person of the company and submitted to AIFA using the on line Application for conferences and congresses of the AIFA Front End system.

A fee is due only if the provisional budget exceeds a certain amount (approx. 26.000 €) or in case the meeting is held abroad. The payment should be performed following the generation of a specific code, using the Application for fee Payment of the AIFA Front End system.

Within 45 days from the submission of the request of authorization for a congress, AIFA can approve, deny or request further information to be provided within 15 days.

At the end of the congress, the company is requested to enter the final balance of the expenses; confirming or modifying the expenses previously submitted.

Pharmaceutical companies can pay the expenses for travelling and/or hospitality for healthcare professional only and hospitality should be limited to the congress duration.

Farmindustria has issued a code of conduct, binding for affiliated companies, in which the limitations regarding the sponsorship of congresses is provided.

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