To enable marketing authorisation procedures to be concluded more rapidly, as from 1 August 2025, pharmaceutical companies are required to pay both the revenue stamp due for the submission of a Marketing Authorisation/Line Extension Application, and the revenue stamp due for the issuance of the final decision thereof. The payment of both revenue stamps must be made at the time of submitting the application for a new MA/Line Extension.

Companies which, at the time of publication of this press release, have already submitted an application for a marketing authorisation and paid the relevant revenue stamp, but the procedure of which is still ongoing, are required to pay the additional revenue stamp due for the issuance of the final decision. In such case, the payment must be made following the instructions provided in this news: Istanze presentate all'Agenzia Italiana del Farmaco per via telematica: modalità di assolvimento dell'imposta di bollo" (in italian, available in related link). At the same time, the above-mentioned companies are required to send a relevant communication and proof of payment to bollonuoveaic@gov.it. 

The subject of the email message should be the following:

[Type of procedure: NATIONAL/MR/DC] + [New MA or Line Extension application] + [case number] + [6-digit MA number] + [name of medicinal product].

It should be noted that the revenue stamp payment is due irrespective of the final decision issued by the Marketing Authorisation Office (whether positive or negative).  

Lastly, pursuant to Presidential Decree No 642 of 26 October 1972, in case of applications submitted electronically and decisions issued electronically, the overall amount of the revenue stamps is equal to EUR 16.00 for application submission, plus EUR 16.00 for issuance of the decision, irrespective of the size of the document sent.