Italy
ITEurope
Regulatory Overview
Italy is regulated by the AIFA (Agenzia Italiana del Farmaco). The country has 3 documented regulatory pathways for accessing unapproved or unlicensed medicines, covering named patient programs, compassionate use schemes, and special access arrangements.
Regulatory Authority
AIFA (Agenzia Italiana del Farmaco)
Regulatory Pathways (3)
EMA Article 83 compassionate use framework allowing access to unauthorised medicinal products for groups of patients with a chronically or seriously debilitating or life-threatening disease in Italy.
Italian compassionate use under Ministerial Decree of 7 September 2017 for individual patients with serious, rare or life-threatening diseases.
Italian Law 648/96 allows off-label reimbursement of medicines not yet authorised in Italy for rare diseases or conditions where no valid alternative exists.
Drugs Available (120)
| ISO Code | IT |
| Region | Europe |
| Regulatory Authority | AIFA (Agenzia Italiana del Farmaco) |
| Pathways | 3 documented |
| Drugs Available | 120 drug(s) |