Follows up on the AIFA communications of 26 March 2020 ‘Instances submitted to the Italian Medicines Agency by telematic means: modalities for the payment of stamp duty’ and of 24 April 2020 ‘Telematic notification of authorisation acts issued by the Medicinal Products Authorisation Division and by the HTA & Pharmaceutical Economics Department’ (accessible from the box ‘Related Links’) to provide the following clarifications.

In light of the difficulties encountered by foreign entities in paying the stamp duty provided for by Presidential Decree no. 642/72 using the methods indicated in the aforementioned communications, the following is hereby provided.

As for the current period, it is considered admissible, on an extraordinary basis, that the stamp duty payment can be made by bank transfer, addressed to the IBAN code IT07Y0100003245348008120501.

If requested by your bank, in the transfer order it is possible to indicate the BIC code “BITAITRRENT” (which identifies the Bank of Italy) and “Bilancio dello Stato” as beneficiary.

In order to reconcile the operation and to connect the transfer to the application or deed for which the stamp duty is due, it is necessary that the type and details of the application/deed are indicated in the reason for the transfer, as well as the tax code (or in its absence, the name) of the person required to pay the tax. In this regard, Companies are reminded to fill in the form correctly and punctually.
The Company must provide evidence of the payment of the stamp duty by sending the relevant receipt in order to be able to verify the actual execution of the transfers.

It should be noted that this method of paying stamp duty, which is allowed in exceptional and extraordinary cases, is reserved only for foreign companies that do not have a local representative or attorney accredited with the Agency. In all other cases, the procedures previously indicated in the above-mentioned communications remain valid.

Please note that, regardless of the method of payment used, the original documentation proving the payment of the stamp duty (bank transfer, F23 form, self-certification with stamp affixed and cancelled) must be kept in the records of the Applicant Company or MA Holder for possible controls by the Administration.