AIFA

AIFA Mandatory Procedure for Pharmaceutical Companies

AIFA (Italian Drug Agency) is the national authority responsible for drug regulation in Italy.

FARGO INTERNATIONAL has been appointed to collect – on behalf of ESCRS – all applications from Italian companies and file them with the appropriate Italian Health Ministry officials.

Please find the Fargo International contact details below:

Fargo International di Giulia Cambria

Via Pietro Maroncelli, 32

50137 Firenze

Email: info@fargointernational.it

Please note that the AIFA authorisation is NOT necessary when:

  • A company promotes only medical devices or food supplements during a congress (products without marketing authorisation) but subject to MEDTECH authorisation (if the company is associated).
  • 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 congress (Section 9 art. 124 D.L. n.219/06).