Baker McKenzie’s Sanctions Blog published the alert titled “Russia imposes a ban on foreign aircraft flights from 36 states” on 1 March 2022. Read the article via the link here. Please also visit our Sanctions Blog for the most recent updates.
On 22 February 2022, the Chamber of Deputies approved the bill for the conversion into law of decree-law No. 228/2021, which shall now be discussed by the Senate for its final approval by 28 February 2022.
On 31 January 2022, Regulation (EU) 2022/123 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (EMA) was published in the Official Journal of the EU.
On 24 January 2022, the Decree of the Ministry of Health dated 10 November 2021 updating the National Classification of Medical Devices was published in the Italian Official Gazette.
With its judgment No. 946/2022, the Council of State confirmed the legitimacy of the Guidelines for the treatment of patients with SARS-CoV-2 infection issued by the Ministry of Health. In this respect, the administrative judge emphasized, however, that the Guidelines provide mere recommendations rather than mandatory provisions, which, from a legal standpoint, must be considered as nonbinding indications for the prescribing physician.
On 28 January 2022 Regulation (EU) 2022/112 amending Regulation (EU) 2017/746 on in vitro diagnostic medical devices was published in the Official Journal of the EU.
In January 2022, the Medical Device Coordination Group published a notice addressed to manufacturers of in vitro diagnostic medical devices with the intended purpose to detect and/or quantify markers of SARS-CoV-2 infection based in non-EU countries and who place such products on the EU market. The purpose of the notice is to address some issues identified by EU national authorities in the course of their surveillance activities on the compliance of such devices with the requirements of Directive 98/79/EC on IVDD.
On January 19, 2022, Farmindustria published an updated version of its Code of Conduct introducing relevant changes on Patient Support Program.
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.
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.