Search for:
Category

Italy

Category
In Anti-Corruption

Italy: The Council of State on the separation of tenders into different lots

by 2 Mins Read

The Council of State, in its judgment No. 2905 of 24 October 2023, reaffirmed that the principle of separation of tenders into lots may be derogated only to the extent that an adequate and specific motivation is provided, taking into account the principles of proportionality and reasonableness. The principle of subdivision into lots is an instrument which guarantees access to the market for small and medium-sized enterprises (SMEs) and it aims at increasing the efficiency of public expenditure, in particular by facilitating the participation of SMEs in public procurement.

Read More
In Product Regulation & Liability

Italy: Medical devices – The National Health Technology Assessment Program gets underway

by 1 Min Read

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 Product Regulation & Liability

Italy: European Medicines Agency trials the package leaflet 2.0

by 1 Min Read

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.

In

Italy: Clinical trials: EMA “simplifies” the Clinical Trials Information System

by 1 Min Read

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.

In Anti-Corruption

Italy: Sunshine Act – The draft decree and related technical regulations on the “Transparent Healthcare” public register

by 2 Mins Read

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.

In Europe

Italy: Switzerland has been removed from the blacklist for natural persons

by 2 Mins Read

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.

Read More
Load More