Italy Archives

In Europe

Italy: Regulatory Financial Newsletter – General Italian Law

January 1, 2022 by Eugenio Muschio 2 Mins Read

In connection with the opening of the first window for the presentation of FinTech projects in order to participate to the FinTech regulatory sandbox, which started on 15 November 2021 and will last until 15 January 2022 , the three Italian supervisory authorities in charge of running the experimentation, the Bank of Italy, the Consob, and the IVASS, issued a set of regulations that implement the administrative procedures required in connection with the admission to the FinTech regulatory sandbox and the other procedural phases of the experimentation.

In Corporate Compliance

Italy: Regulatory Financial Newsletter – Investment Services – Consob’s Supervision

December 31, 2021 by Eugenio Muschio 4 Mins Read

On 8 October 2021, the Consob launched a public consultation concerning proposed amendments to the Consob Regulation No. 11971 of 14 May 1999 (the “Italian Issuers’ Regulation”). The amendments to the Italian Issuers’ Regulation aim at aligning the domestic regulations with the latest legislative developments on prospectus requirements at Italian and EU level.

In AML/Money Laundering

Italy: Regulatory Financial Newsletter – Payment and Banking Services – Bank of Italy’s supervision

December 31, 2021 by Eugenio Muschio 7 Mins Read

On 24 November 2021, the Bank of Italy issued an order concerning amendments to the Bank of Italy’s Circular No. 285 of 17 December 2013 on “Supervisory provisions for banks” (the “Circular No. 285”). The amendments to the Bank of Italy’s Circular No. 285 aim at aligning the Italian regulations with the latest EU legislative developments on sound remuneration policies and practices, in particular exempted entities, financial holding companies, mixed financial holding companies, remuneration, supervisory measures and powers and capital conservation measures.

In AML/Money Laundering

Italy: Regulatory Financial Newsletter – Anti-money laundering

December 31, 2021 by Eugenio Muschio 3 Mins Read

On 20 October 2021, the Financial Intelligence Unit communicated that as of January 2022 the following data will no longer be accepted by the systems used to make the suspicious transactions reporting and the objective communications: G5 credit instrument and cash deposit (residual), U3 cash deposit < EUR 15,000, U4 cash withdrawal < EUR 15,000.

In Europe

Italy: New document on relabeling and repackaging of medical devices

December 15, 2021 by Roberto Cursano and Riccardo Ovidi 2 Mins Read

On October 21, 2021, the MDCG published a new question and answer document on the procedures governing the relabeling and repackaging of medical devices under Article 16 of the MDR and IVMDR.

In Europe

Italy: AIFA – new simplified negotiation procedures

December 15, 2021 by Roberto Cursano and Riccardo Ovidi 3 Mins Read

On November 25, 2021, the AIFA published two new simplified negotiation procedures for (i) the negotiation of generic or biosimilar drugs and reimbursement applications for the extension of indications already reimbursed for the originator, and (ii) the reimbursement of new packages for changes in the primary packaging.

In Europe

Italy: Consolidated Law on rare diseases

December 15, 2021 by Roberto Cursano and Riccardo Ovidi 2 Mins Read

On 27 November 2021, Law No. 175/2021 (“Consolidated Law”) was published in the Official Journal. The Consolidated Law’s main objective is the protection of the right to health of those suffering from rare diseases through measures aimed at ensuring the uniform distribution of services and medicines, including orphan drugs, throughout the Italian territory, the surveillance, diagnosis and treatment of rare diseases as well as the support to research activities.

In Europe

Italy: Medical device coordination group: Update of the document on the operating procedures of notified bodies

December 14, 2021 by Roberto Cursano and Riccardo Ovidi 1 Min Read

In October 2021, the Medical Device Coordination Group (MDCG) published the third revision of the MDCG 2019-6 Questions and answers: Requirements relating to notified bodies, which provides clarification on the operating procedures of notified bodies responsible for performing conformity assessment activities under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices.

In Europe

Italy: Circular of the Ministry of Health: clarifications on the application of Regulation (EU) 2017/745 on medical devices

December 11, 2021 by Roberto Cursano and Riccardo Ovidi 2 Mins Read

On November 17, 2021, the Ministry of Health published a circular letter to clarify certain aspects related to the application of Regulation 2017/745 on medical devices, including those concerning the registration in the national database of medical devices, custom-made devices, and medical device advertising.

In Europe

Italy: New guidance on the classification of medical devices

November 13, 2021 by Roberto Cursano and Riccardo Ovidi 1 Min Read

In October 2021, the Medical Device Coordination Group published the Guidance on the classification of medical devices. In particular, the purpose of the Guidance is to ensure the proper application of the classification rules set forth in Annex VIII to the Medical Device Regulation (EU) 2017/745 (MDR).