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.
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.
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.
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 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.
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 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).
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.
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.
With a decision published in the EU Official Journal on 31 July 2021, the European Commission confirmed that the EU Portal and Database have achieved full functionality. This implies that Regulation (EU) No. 536/2014 on clinical trials will be applicable as of 31 January 2022, in accordance with the provisions of Article 99 of the same Regulation.