Medical Devices Regulation: Note issued by the Ministry of Health to regulate the transition period
On November 12, 2021, the Ministry of Health published a note providing guidance on the provisions of Legislative Decree No. 46/1997 that shall still be considered applicable following the date of the application of Regulation (EU) 2017/745 on medical devices and the issuance of the legislative decrees envisaged by Article 15 of Delegation Law No. 53/2021.
New national guidelines on telerehabilitation
Last October, the State-Regions Conference approved a document submitted by the Ministry of Health containing national guidelines for the delivery of telerehabilitation services by healthcare professionals.
The Consolidated Act on Rare Diseases is finally approved
After three years, Italy has finally adopted its first law on rare diseases. On November 3, 2021, the Italian Senate unanimously approved the Consolidated Act on Rare Diseases, or “Testo Unico sulle malattie rare”.
Dematerialization of prescriptions: Ministerial Decree allowing e-prescriptions for drugs not reimbursed by the NHS has been published in the Italian Official Journal.
Advertising condoms: No need to request prior authorization from the Ministry of Health
The rules on advertising condoms are expected to change in the next few days.
Important news regarding non-therapeutic use of cannabis: the Italian Ministry of Health finally sets limits for THC in hemp food products
After a long wait, the Italian Ministry of Health has finally identified the maximum THC amounts that can be contained in food products.