In light of the Covid-19 emergency and considering that the service of documents has been suspended at AIFA premises, the Italian Medicines Agency (AIFA) hereby informs that any document issued by the Offices belonging to the Medicinal Products Authorisation Department and by the HTA and Pharmaceutical Economics Division will be served electronically.

Such documents will be produced and signed digitally, in accordance with Italian Legislative Decree No 82/2005, and will be served by certified e-mail.

As regards certificates of pharmaceutical products with a marketing authorisation in Italy, where such certificates do not require signature authentication, service may be carried out as described above.

In accordance with Article 47 of the Italian Civil Code in conjunction with Articles 3bis and 6 of Italian Legislative Decree No 82/2005, companies interested in having documents served electronically are required to indicate, including by means of their accredited attorneys, a digital address for service of the documents and decisions referred to in this notice, by sending the duly completed form available at the following (Digital address for service) to the certified email address area.legale@pec.aifa.gov.it

The digital address for service may be communicated by the legal representative of the company or by its attorney already registered in the AIFA database of companies’ accredited attorneys. The declarant will be responsible for communicating any subsequent changes in the digital address.

Companies will be required to pay the stamp duty and provide proof of payment before being served the digital document.
It should be noted that, in accordance with Annex A – Tariff (Part I) to Italian Presidential Decree No 642/19721, for documents issued electronically, the tax due is equal to EUR 16.00, regardless of the size of the document.

Specifically, in order to facilitate verification by the Offices and to streamline the procedure, the stamp duty may be paid in one of the following ways:

1. Payment via the F23 form of the Italian Revenue Office (1): the MAH or his representative is required to complete the F23 form with an amount equal to the stamp duty to be paid. Instructions on how to complete the F23 form are given below. Once the form is completed, the payment may be made via online banking, at banks, post offices or collection agents. The company is required to send a PDF copy of the completed F23 form to be used for paying the stamp duty as well as the proof of payment (electronic receipt in case of online banking, scanned copy of the paper receipt in case of in-person payment) to the Office issuing the document.
2. Purchase of a paper revenue stamp: the MAH or his representative is required to purchase a revenue stamp and communicate its serial number to the Office issuing the document. In addition, a scanned copy of the stamp (in PDF or image format - jpg, png) will also have to be sent to the above-mentioned Office, together with a self-certification that can be found at the following: (Self-certification)

The self-certification may be signed digitally or with a handwritten signature. In the latter case, it has to be accompanied by a copy of the signatory's ID document.

Any further methods of payment of the stamp duty for the purposes of the service of documents will be communicated at a later stage.

The procedure described above will be followed also for type I variations not falling within the tacit acceptance procedure provided for in AIFA Decision of 25 August 2011, as amended, and for authorisations referred to in Article 79 of Italian Legislative Decree No 219 of 24 April 2006, as amended.

As regards documents already produced in paper format and signed before the introduction of the new method of service, it should be noted that the Offices concerned will ensure that relevant extracts of such documents are published in the Italian Official Journal in order to attribute them legal validity.

In case of type I variations or authorisations as per Article 79 of Italian Legislative Decree No 219 of 24 April 2006, as amended, which have already been produced in paper format and whose publication in the Italian Official Journal is entrusted to MAHs, the documents and corresponding extracts will be forwarded to the MAHs by certified e-mail. In this regard, the MAHs are invited to report any urgent, duly substantiated needs to the Post Authorisation Procedures Office.

A certified copy of the documents produced in paper format will be delivered in accordance with a procedure that will be communicated to each company at a later stage.

Published on: 24 April 2020
Last updated on: 11 May 2020