21
Sep 23
Whistleblowing Decree: Key points for the pharmaceutical sector
Large multinational companies are being called to assess the compatibility of existing reporting channels with the requirements of the new regulation published on March 15, 2023 on the Official Journal of the Italian Republic, implementing the EU Directive 2019/1937 on whistleblowing.
12
Sep 23
Clinical investigation of medical devices: implementation rules set out in Italy
In Italy, the process of establishing national regulations for clinical investigation of medical devices continues: in June, four new decrees were published, dealing with the modalities for submitting clinical investigation applications and communications according to the national procedure.
10
Dec 19
Case-law clarifications concerning telemedicine
On June 20, 2019, the Court of Cassation issued a relevant ruling on telemedicine. Indeed, it clarified which activities, in the context of telemedicine, shall be qualified as typical health services and, therefore, are subject to the prior authorization of the competent Italian Region under Article 193 of Royal Decree No. 1265 of July 27, 1934 (hereinafter, “TULPS”).
