Early Access




  • Evaluation of feasibility of early access programs for the specific disease area, indication, product
  • Expert support to companies for regulatory and logistic aspects of setting up early access programs
  • Support to clinicians/scientific societies/patient associations for the preparation and follow-up of requests:
    • for inclusion in the list of reimbursed product according to Law 648/96
    • for named patient reimbursement according to Law 326/2003 (Fondo AIFA 5%)
    • for compassionate use/expanded access according to DM 7th September 2017