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.
With judgment No. 5212 of 9 July 2021, the Council of State confirmed the decision of the Italian Medicine Agency whereby the latter requested a pharmaceutical company to remove from the package leaflet of an over-the-counter medicine all references to the indication concerning spastic-painful symptoms of the genitourinary tract, considering the relevant data inadequate to support such an indication.
“Semplificazioni” Decree-bis (Law Decree No. 77 of 31 May 2021) was converted into Law No. 108 of 29 July 2021.Upon conversion into law, the text of the Decree was subject to further amendments and adjustments. The most significant changes regarding public contracts, environment, renewable energy, town planning and construction, and administrative procedures are set forth in this article.
This article contains the latest updates from the Energy and Sustainability sector in Italy. Updates include; EUR 1.1billion has been allocated to the development of agrivoltaics by the Italian NRRP, the Ministry of Economic Development has signed a decree implementing an IPCEI fund, and the Bank of Italy has adopted its Responsible Investment Charter to foster ESG finance.
On 2 July 2021, the Decree of the Ministry of Economy and Finance No. 100 of 30 April 2021 (“MEF Implementing Decree”) was published on the Official Journal of the Republic of Italy (Gazzetta Ufficiale). The MEF Implementing Decree (i) regulates the tasks attributed to the newly-established FinTech Committee, its functioning and composition, and (ii) provides a comprehensive framework for the FinTech experimentation, including setting out the requirements for participating to the Sandbox, the operational perimeter during the participation, and the regime for the termination of the experimentation.
The Italy: Financial Services Regulatory Newsletter contains an updated summary of the most recent regulatory developments for Italy. It covers topics such as FinTech, corporate governance, and supervisory requirements.
On 13 July 2021, the EU Council of Ministers approved the national recovery and resilience plans (RRPs) of 12 Member States. This means that Austria, Belgium, Denmark, France, Germany, Greece, Italy, Latvia, Luxembourg, Portugal, Slovakia and Spain are now able to tap into the EU recovery and resilience funding. This will allow them to start spending the money on projects and reforms for national economic recovery and resilience, as well as the green transition and digital transformation.
On 30 June 2021, the Bank of Italy issued amendments to Circular No. 285 of 17 December 2013 on “Supervisory provisions for banks”. In particular, these amendments replace Part First, Title IV, Chapter 1, of Circular No. 285, on corporate governance requirements, and aim at aligning Circular No. 285 with the provisions of Directive (EU) 2019/878 of 20 May 2019.