Elisa Cappelli -

We are getting close to the deadline relevant to the payment of the annual fee due to AIFA.

Every year, within the end of July, each Marketing Authorisation Holder (MAH) is required to pay to AIFA an annual fee for each of its marketing authorization (MA 6 digits) valid at December 31st of the previous year, as arranged by the deliberation No. 21 of May 30th 2012 by virtue of which the AIFA board of directors has implemented the art. 4, par. 5 of the Ministry of Health Decree dated March 29th 2012, No. 53 and the annual fee has been introduced.

The annual fee has to be paid through the online system available on the AIFA institutional portal (AIFA Front-End), via the specific Company access.

A fee reduction is applied for Small-medium enterprises (SMEs) upon submission of the appropriate documentation.

The fee is not due for MAs registered through centralized procedure.

AIFA publishes an alert close to the deadline on its institutional website and each MAH entering into the AIFA system can retrieve the amounts to be paid, and the payment modalities.

Companies are required to check the accuracy of the amounts assigned and to communicate with appropriate documentation the relevant amendments, if necessary.

Regulatory Pharma Net team is available to support companies to comply with this requirement.

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