Notice about the procedure for authorisation request for congresses and meetings (05/14/2015)
Procedure for authorisation request for congresses and meetings
Every Marketing Authorisation Holder (MAH) or the company responsible for the marketing of medicinal products, organizing or contributing to organize in Italy or abroad, through direct or indirect funding, a congress, a convention or a meeting about the use of its pharmaceutical products, should submit to the competent Unit of the Italian Medicines Agency (AIFA) at least 60 days before the event, an application form containing the following information:
- Name, postal address and corporate data of the pharmaceutical company.
- Venue and starting day of the event.
- Categories of participants addressed by the event.
- Topic of the event and its correlation with the pharmaceutical company’s medicinal products.
- Professional qualifications and scientific title of the speakers.
- Provisional analytical budget of the expenses.
The application form mentioned above is to be forwarded through “Autorizzazione Convegni e Congressi (ACC)” on-line portal available at the link , by the responsible for congresses and meetings, designated by the company (Representative).
In order to use this application:
- the representative should apply for a user identification and password on AIFA website, as described here.
- "Company User Administrator" (for further details, please refer to AIFA new information systems) have to send representative approval request via email to AIFA Helpdesk (firstname.lastname@example.org).
The authorization request have to be submitted and validated (through the online portal Autorizzazione Convegni e Congressi) within 60 days preceding the date of the event.
The validation of the request must be done only through the electronic signature, for this reason the representative must necessarily be provided with a smart card certificated. To obtain a smart card certificated for electronic signature working in Italy, it is necessary to refer to a Qualified Certification Service Providers, as specified in the Agenzia per l’Italia Digitale website at this page