MANDATORY PROCEDURE FOR ALL PHARMACEUTICAL EXHIBITORS IN ORDER TO PARTICIPATE TO THE CONGRESS2
Authorization for congresses and meetings
According to Legislative Decree no. 219/06E, any Marketing Authorization Holder (MAH) or Pharmaceutical Company responsible for the commercialization of a drug which organizes, or helps to organize, whether by direct or indirect funding a Congress in Italy, shall notify the competent Unit of the Italian Medicines Agency (AIFA) and obtain the formal authorization for the support.
Any kind of support paid to the BCa19 Congress falls into this mandatory procedure (for example even one single registration offered to a Delegate needs to fulfil AIFA procedure).
The authorization request must be submitted and validated (through the online portal Autorizzazione Convegni e Congressi) within 60 days before the date of the event.
Please note that if a Pharma Company fails to apply to AIFA procedure or the authorization is denied, it will not be allowed to support and/or participate to the Congress.
Medical Devices Companies are not involved in the procedure.
The online procedure requests a SIS code delivered from the Ministry itself (Companies not in possession of SIS code should require it to the Ministry in advance) and AIFA will authorize by online system.
In case of a multi-located Company each country must proceed with its own SIS code.
AIFA requires a fee that needs to be paid 60 days prior to the event
Emilia Viaggi is the only Agent authorized from EAU to collect all the documents from the companies and forward them to the Ministry of Health. Therefore all companies must inform Emilia Viaggi Congressi & Meeting about their intention to support the meeting (indicating their SIS code) at least 70 days before the Congress (March 8th, 2019).
Emilia Viaggi Congressi & Meeting requires a fee of 500 Euro + 22%VAT (if applicable) in order to process the documents for the AIFA authorization.
More useful links:
How to obtain a SIS CODE
Details of the procedure: