L'The Italian Medicines Agency, in accordance with current legislation on the subject of administrative procedure, will shortly make available on its Portal the AIFA transparency system which will allow Pharmaceutical Companies to monitor the progress of their procedures online.
Summary tables will be available for consultation which will contain the information relating to each procedure (type of application, name of the medicinal product, date of presentation of the request, state of progress, etc.).
In the first phase of implementation, it will be possible to consult the constantly updated situation of the procedures pertaining to the "National Marketing Authorisations", "Community Marketing Authorisations Procedures" and "Prices and Reimbursement" regulatory offices.
The new System will offer, as a further integration of the detailed information, an area called "Box Office" through which the Company can forward queries relating to individual cases and receive the necessary clarifications from the Offices. This communication tool will be supported by structured archiving and message search functions to facilitate the organization and tracking of correspondence.
Starting from 11 October 2006, Pharmaceutical Companies will be able to proceed with online registration through a Web transaction which requires, for accreditation, the insertion of the identification data of the Company and of the person in charge of receiving the password. The communication of the successful registration will also indicate the date and time in which the delegate can collect the password at the AIFA headquarters equipped with a specific proxy with authenticated signature of the legal representative of the Company.
