On 15 November, the Minister of Health, together with the National Agency for Regional Health Services (Agenas) and the Conference of Regions and Autonomous Provinces, presented the Italian National Health Technology Assessment Program for Medical Devices covering the years 2023-2025, that was published in the Italian Official Gazette on 15 September 2023.
In July 2023 the European Medicines Agency, together with the network of the Heads of Medicines Agencies and the European Commission, started to work to in order to enable the use of the electronic product information, so called package leaflet 2.0. The package leaflet 2.0 consists of an electronic card that provides access to the information contained therein to the various telemedicine platforms; within that, the mandatory information on medicinal products, including the description of the product characteristics and the label, adapted for the electronic management, will be available.
On 18 November 2023, Germany, France, and Italy reached a significant agreement on the future of AI regulation, marking a step forward in shaping the AI landscape within the European Union.
Law no. 137 of 9 October 2023 introduced the offences of Bid Rigging (Article 353 of the Criminal Code), Interference with the Tender Process (Article 353-bis of the Criminal Code) and Fraudulent Transfer of Values (Article 512-bis of the Criminal Code) in the list of predicate crimes pursuant to Legislative Decree no. 231/2001.
On 5 October 2023, the European Medicines Agency amended its transparency rules on the publication of information on clinical trials submitted through the Clinical Trials Information System. This adjustment was made at the end of the public consultation, launched between May and June, to record stakeholders’ impressions and opinions a few months after European Regulation no. 536/2014 on clinical trials came into effect.
This publication features the latest Employment developments in Italy, including updates in relation to whistleblowing, electric cars, relocation of employees and more.
On 17 August 2023, the Ministry of Health published the draft decree, and related technical regulations, on the “Transparent Healthcare” public register and launched a public consultation to gather comments and contributions from stakeholders, including manufacturers of health products, healthcare professionals and organizations.
On 21 July 2023 the Ministry of Health published on its website new guidelines on the advertising of over-the-counter (OTC) and prescription-free medicinal product (SOP).
Pursuant to Law No. 83 of 13 June 2023 (which ratified the protocol signed in Rome on 23 December 2020 between Italy and Switzerland related to the income taxation of cross-border workers) the ministry of finance issued the decree of 23 July 2023, which removed Switzerland from the blacklist contained in the decree of 4 May 1999. The blacklist is aimed at tackling fictitious transfers of residence abroad by Italian citizens. The removal reflects a political agreement formalized on 20 April 2023 between the finance ministers of Italy and Switzerland and it will be effective from fiscal year 2024.
This publication features the latest Employment developments in Italy.