Italy's official gazette lists rare-disease orphan drug rules and Hantavirus added to notifiable diseases
Italy's official gazette issue of 29 October 2026 is a table of contents listing several government acts. The most notable is a Ministry of Health regulation, dated 5 August 2026, that sets out how article 12 of a 2021 law on rare diseases is to be applied to orphan drugs. Other entries include a Ministry of Health decree adding Hantavirus infection to the list of notifiable diseases, and agriculture decrees confirming or extending consortium roles for two protected food and wine designations.
What does it mean?
The new Ministry of Health regulation sets the rules for how orphan drugs, which are medicines for rare diseases, are cared for and produced in Italy. Hantavirus is now on the official list of infectious diseases that must be reported to health authorities.
Who is affected?
Patients with rare diseases, pharmaceutical producers of orphan drugs, and health authorities that monitor infectious diseases.