Payback for medical devices: Decree quantifying the exceeding of the expenditure ceiling for medical devices at national and regional level for the years 2015, 2016, 2017 and 2018 published in the Official Gazette
Electronic prescriptions: Recent updates
A note published by the Ministry of Health and the Ministry of Economy and Finance on March 3, 2022, announced that as of January 31, 2022, electronic prescriptions for drugs that are not reimbursed by the National Health System are operational in parts of the Italian territory.
The Italian Medicines Agency provides additional information on the new simplified classification procedure for generics and biosimilars
The Italian Drug Agency (AIFA) provided further information on the new simplified pricing and reimbursement procedure introduced in October 2020 for generics and biosimilars.
Parallel import of medicines: New simplified AIFA procedure for negotiating price and reimbursement
On March 25, 2020, the Italian Agency of Medicines (AIFA) published a resolution on the simplified procedure for negotiating the price and reimbursement of parallel imported medicines.
New AIFA guidelines for compiling dossiers for medicine reimbursement and pricing requests effective March 1, 2021
On December 23, 2020, the Italian Agency of Medicines (Agenzia Italiana del Farmaco – the “AIFA”) issued Guidelines for the compilation of the dossier to support the request for reimbursement and pricing of a medicine (“Guidelines”), pursuant to the Ministerial Decree of August 1, 2019 (“Decree”).
Generic and biosimilar medicines: Italian Medicines Agency adopted a new simplified pricing and reimbursement procedure
On October 15, 2020, the Italian Medicines Agency (Agenzia Italiana del Farmaco – “AIFA”) published a new simplified pricing and reimbursement procedure for generics and biosimilars.