Italy Archives

In Europe

Italy: Regulation EU 2917/746 on in vitro diagnostic medical devices – extension of transitional periods

February 8, 2022 by Roberto Cursano and Riccardo Ovidi 1 Min Read

On 20 December 2021, the European Parliament and the Council adopted a Regulation amending the transitional provisions set forth in Regulation EU 2017/746 on in vitro diagnostic medical devices (“IVDR”). In particular, the amending Regulation provides for the introduction of longer transitional periods with respect both to the validity of the certificates issued by notified bodies in accordance with Directive 98/79/EC (“IVDD”) and for the placing on the market and putting into service of in vitro diagnostic medical devices pursuant to the IVDD.

In Europe

Italy: AIFA (Agenzia Italiana del Farmaco) – clarifications on the renewal procedure of parallel import licenses

February 8, 2022 by Roberto Cursano and Riccardo Ovidi 2 Mins Read

On 23 December 2021, the AIFA published a note providing clarifications on the renewal procedures for parallel import licenses of medicinal products (“AIP”). In this respect, the note clarifies that AIP holders must submit to the AIFA a renewal application for each authorized package at least nine months before the expiry of the validity of the relevant AIP, whose duration is five years from the date of publication in the Official Journal of the granting decree.

In Environment

Italy: Technical guidelines for the environmental labeling of packaging

February 8, 2022 by Roberto Cursano and Riccardo Ovidi 1 Min Read

As known, Article 11 of Decree Law No. 228/2021, entered into force on 31 December 2021, provided for the further suspension, until 30 June 2022, of the environmental labeling obligations of packaging pursuant to Article 219, paragraph 5, of Legislative Decree No. 152/2006. In this respect, of special relevance is paragraph 2 of Article 11 above, which entrusts the Ministry of the environmental transition with the tasks of adopting, within thirty days of the date of entry into force of Decree Law No. 228/2021, the technical guidelines for the environmental labeling.

In AML & Financial Services Regulatory

Italy: Corporate administrative liability – amendments made to Legislative Decree No. 231/2001

January 21, 2022 by Roberto Cursano and Riccardo Ovidi 2 Mins Read

On 14 and 15 December 2021, Legislative Decree No. 184/2021 and Legislative Decree No. 195/2021, which significantly amended Legislative Decree No. 231/2001 on corporate liability and the Italian Criminal Code entered into force.

In Europe

Italy: Medical Device Coordination Group published a new document on the obligations applicable to importers and distributors

January 14, 2022 by Roberto Cursano and Riccardo Ovidi 1 Min Read

On 9 December 2021, the Medical Device Coordination Group published a question and answers document concerning obligations applicable to importers and distributors under Articles 13 and 14 of Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices.

In Covid-19

Italy: European Commission – New provisions for the export of COVID-19 vaccines

January 14, 2022 by Roberto Cursano and Riccardo Ovidi 1 Min Read

On 25 November 2021, the European Commission adopted Implementing Regulation (EU) 2021/2071 subjecting vaccines against COVID-19 and active substances used for the manufacture of same to export surveillance for a period of 24 months starting from 1 January. This Regulation will replace the existing regulatory framework requiring vaccine exports to be subject to an authorization by Member States.

In Cybersecurity, Data and Tech

Italy: Eudamed – published the Implementing Regulation containing the application rules

January 14, 2022 by Riccardo Ovidi and Roberto Cursano 2 Mins Read

Pending the full functionality of the European Database on Medical Devices, the European Commission made available two new modules, to be used on a voluntary basis, for the registration of medical devices by economic operators and for the registration of certificates of conformity by notified bodies.

In Europe

Italy: Sanctions for violations of Regulation (EU) No. 528/2012-Concerning the making available on the market and use of biocidal products

January 13, 2022 by Roberto Cursano and Riccardo Ovidi 1 Min Read

On 29 November 2021, Legislative Decree No. 179/2021 was published in the Official Journal, introducing the applicable sanctions for violations of Regulation (EU) No. 528/2012 concerning the making available on the market and use of biocidal products. The new sanctions entered into force on 14 December 2021.

In March 2021, the EU approved new reporting rules in a directive known as DAC7. The directive will require the operators of online platforms for the sale of goods and certain services, to collect, verify and share data on their sellers and their transactions concluded on the online platform. EU member states have until 31 December 2022 to implement DAC7 into national law. Certain platform operators will become a reporting platform and will need to start collecting and verifying data points in compliance with the DAC7 reporting requirements. The collected data points must be reported to the tax authorities of the relevant EU member state annually.

In Antitrust / Competition

Italy: Competition Bill – Provisions concerning the healthcare and pharmaceutical sector

January 2, 2022 by Roberto Cursano and Riccardo Ovidi 2 Mins Read

On 4 November 2021, the Council of Ministers approved the Competition Bill for 2021 (“Competition Bill”), to be submitted to the Parliament for its examination. The provisions of the Competition Bill affect various sectors, including the healthcare one. In this regard, the most important innovations are those concerning (i) medicines for which the pricing and reimbursement procedure is still pending; (ii) the reimbursement of generic drugs; (iii) the distribution of medicines; and (iv) the production of blood-derivative drugs.