Notice to pharmaceutical companies - Information regarding the online system for payment of fees

The Italian Medicines Agency, in collaboration with the Directorate General of Drugs and Medical Devices of the Ministry of Health and Poste Italiane S.p.A., launched a new system of payment of fees owed by the pharmaceutical companies under Ministerial Decree 24 May 2004.

The main features of the system and the operational stages for the payment procedure were explained in a notice published on the Italian Medicines Agency's website on last 31 July 2009. The pharmaceutical companies are required to use the new operating system starting from 7 November 2009, for all types of issues including those subject to implied assent.

The data regarding the first few months of utilization of the new processing system have confirmed the predictions of a much-improved service in favour of the pharmaceutical companies and at the same time a major reduction of time for audit and reporting activities.

However, few operational adjustments are needed in order to make the system even faster and more efficient with regards to the accounting and the control of the payments made by pharmaceutical companies. In particular, the architecture of the system, which allows the users to proceed with registration and payments through a completely computerized procedure, requires compliance with the following steps:

1. The "POL" Code assigned by the self-certification system must necessarily be reported in the reason of payment (regardless of the chosen method of payment) of the owed tariff: therefore, Companies can proceed with the online transaction only once received the above mentioned Code;
2. The transaction must be completed immediately after the acquisition of the POL Code.

Therefore, from 1 March 2010 the pharmaceutical companies must follow the above described procedures. Any failure to comply with the above mentioned procedure, resulting in problems for the computerized procedure in combining data with those of self-payment, could lead to a time dilation for the definition of application procedures required and the submission of additional documentation by the Companies.

Finally, in order to simplify and improve the service, pharmaceutical companies are encouraged to prefer the deposit via electronic way.