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.
This publication features the latest Employment developments in Italy.
This publication features the latest Employment developments in Italy.
In the Official Journal of 13 June 2023, the Decree of the Ministry of Health dated 12 April 2023 governing the national administrative procedures for the submission of clinical investigation applications for devices that are not CE-marked and CE-marked but used outside their intended use and the Decree of the Ministry of Health dated 12 April 2023 governing the national administrative procedures for the submission of clinical investigation applications for CE-marked devices used within their intended use were published. These decrees are provided for in article 16, paragraphs 2 and 3 of Legislative Decree No. 137/2022 issued to bring national legislation in compliance with the provisions of Regulation (EU) 2017/745.
On 27 June 2023, the Italian Medicines Agency (AIFA) announced the release of new features for the e-Dossier Price and Reimbursement web portal. The portal, available at the AIFA Services Portal, enables the preparation of dossiers in digital format to support reimbursement and price claims.
On 22 June 2023, the Court of Justice of the European Union ruled in the Joined Cases C-6/21 P and C-16/21 P on the impartiality requirement of the scientific committees’ members and experts involved in the European Medicines Agency’s activities.
On 23 June 2023, EMA’s GCP Inspectors Working Group updated the Q&A on Good Clinical Practices. In particular, the update has allowed for the possibility, if in compliance with applicable European regulations and the requirements of ICH E6 guideline, that the sponsor may support the investigator by identifying or contracting service providers or personnel to be directly involved in the conduct of the clinical trial (e.g., by providing additional resources to the clinical trial site or qualified personnel).