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Agenzia Italiana del Farmaco
Requests for authorisation of conferences and meetings
Any Italian or foreign marketing authorisation holder (or company engaged in the marketing of pharmaceuticals based on an agreement with the respective MAH), wishing to organise or participate in the organisation of a conference or a meeting on topics related to the use of pharmaceuticals, should submit to AIFA a request for authorisation of a proposed conference or meeting, whose technical nature will be then assessed by AIFA.
This is in line with article 124 of Italian legislative decree 219/2006.
Requests should be submitted exclusively on-line via the “Impresa in un giorno” portal. For companies which are unable to finalise the procedure through such portal, the request may be submitted via the dedicated AIFA webpage.
Any requests submitted through other channels will not be taken into consideration.
To access this service, it is necessary to refer to the "Company Credentials Administrator", the person in each company who is responsible for accessing AIFA’s online services.
Information for organising secretariats/providers
When more than one pharmaceutical company participate in organising a conference or meeting, communications should be sent jointly via the organising secretariats/providers, and a list of participating companies should be included.
At least 70 days before the event start date, the organising company should complete a pre-authorisation request, which allows to enter the request from each participating company at the same time.
The pre-authorisation request should be submitted by the organisers only via the “Impresa.gov” portal (if companies are unable to finalise the procedure through the Impresainungiorno.gov portal, the request may be submitted via the AIFA portal). Through Impresa.gov, it is possible to communicate to AIFA the information regarding a new event and the related list of participating companies. Subsequently, pharmaceutical companies wishing to participate in the event are required to complete and forward the respective request to the Italian Medicines Agency (AIFA), in line with article 124 of Italian legislative decree 219/2006.
For accessing this service, the organising secretariats are required to register to the portal and use a smart card with a standard authentication certificate (CNS) that can be obtained from a Chamber of Commerce.
Data should be entered in three consecutive steps:
- Information about the conference/meeting
- List of participating companies
- Sending of a single file to all participating companies
Information for pharmaceutical companies
Pharmaceutical companies which have a SIS code will be able to automatically submit the authorisation requests through the ACC system (single-sponsor event) via their ACC manager with a digital signature.
Additionally, companies wishing to participate in multi-sponsor events may finalise requests already submitted by organisers such as organising secretariats and/or providers.
The validation procedure may take up to 60 days, as provided for in article 124, paragraph 1, of Italian legislative decree 219/06.
The authorisation requests will be managed by the competent office entirely through the ACC system and any communication to users will be sent by e-mail.
It should be noted that the requesting company is required to pay an amount equal to the estimated event fee, as established by Health Ministry Decree dated 6 December 2016.
For further information, clarifications or in case of problems submitting or managing the pre-authorisation requests via the Impresainungiorno.gov portal, contact the Company Portal Help Center.
For further information and clarifications concerning the procedure and the payment of fees for the authorisation of conferences and meetings, contact the “Authorisation of conferences and meetings” office at integraconvcong@aifa.gov.it.
For further information, clarifications or in case of problems submitting or managing the requests via the AIFA portal, contact the AIFA Help Desk.
