Italy Archives

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).

In Europe

Italy: The European Commission launches a public consultation on the reform of the EU legislation on medicines for human use

November 9, 2021 by Roberto Cursano and Riccardo Ovidi 1 Min Read

On 28 September 2021, the European Commission launched a public consultation on the proposed revision of the current EU’s general legislation on medicines for human use referred to in Directive 2001/83/EC and Regulation 726/2004 in order to ensure a future-proof and crisis-resistant medicines regulatory system.

In Europe

Italy: New guidance on translation of labels and repackaging of medical devices

October 8, 2021 by Roberto Cursano and Riccardo Ovidi 2 Mins Read

On 18 August 2021, the Medical Device Coordination Group, composed of representatives of all Member States and chaired by a representative of the European Commission, published the guidance on procedures for the translation of labels and instructions for use, as well as the repackaging of medical devices. The guidance is intended to provide assistance to distributors and importers carrying out the above activities by clarifying the relevant requirements, pursuant to Article 16 of the Regulations (EU) 2017/745 and 2017/746 on medical devices and in vitro diagnostic medical devices, respectively.