6
Jul 22
News on the reorganization of Ethics Committees: Latest updates
In the past few months great strides have been made to establish the national ethics committees envisaged by Law No. 3 of 2018 (the “Lorenzin Law”), which were supposed to be identified by the Ministry of Health within sixty days of the Lorenzin Law taking effect.
19
Apr 22
Deblistering: A new frontier for the “pharmacy of services”
The note on “the preparation of personalized packaging to improve therapeutic adherence of patients” released on February 3 by the Regione Lombardia sets a milestone in Italy for deblistering, which could soon become a standard service provided by Italian pharmacies as it already is provided by pharmacies in many other countries around the world.
19
Apr 22
The new decree on non-profit studies: Data and results may now be sold
On February 16, 2022, more than two years later than planned, the Ministerial Decree of November 30, 2021, containing measures to facilitate and support the development of nonprofit clinical trials of medicinal products and observational studies, as well as to regulate the transfer of data and results of nonprofit trials for registration purposes, was finally published in the Official Gazette.
19
Apr 22
Import and Distribution of Medical Devices in Switzerland – Amended Rules
The import and distribution of medical devices in Switzerland is governed by the Swiss Therapeutic Products Act and the Swiss Medical Devices Ordinance (MedDO). As of 26 May 2021, MedDO has been revised, foreseeing stricter and additional obligations for the operators active on the Swiss market.
