The Agenzia Italiana del Farmaco (Italian Medicines Agency, AIFA) has initiated the mandatory data verification phase for marketing authorisation holders. This procedure, Payback convenzionata 1,83% – Procedura di revisione dell’anagrafica dei medicinali movimentati nel corso del I semestre 2025 (Retail pharmacy payback 1.83% – Revision procedure for the master data of medicines moved during the first half of 2025), is a prerequisite for the enforcement of the 1.83% financial levy on reimbursed drugs.
Under the previous situation, sales records were based on preliminary consumption findings. The resulting change allows manufacturers to signal discrepancies or update master data, such as ownership transfers or changes in reimbursement class, for all medicines moved through pharmacies between 1 January and 30 June 2025. Any validated modifications are attributed to the month they officially took effect in the Gazzetta Ufficiale (Official Gazette).
This is a periodic update within the governance of national pharmaceutical expenditure, conducted twice annually to ensure the sustainability of the Servizio Sanitario Nazionale (National Health Service) budget. The review is managed via the Spending-Pha online platform, where the agency has released the relevant datasets for corporate inspection.
Following the closure of the revision window, the agency will publish the final list to proceed with the formal collection of the payback amounts, which companies must pay directly to the Regions. These measures ensure that the financial burden is correctly apportioned across the sector. Precise data are essential to prevent overpayments and reduce the likelihood of costly administrative appeals or litigation.
Source: Agenzia Italiana del Farmaco, AIFA
Link: Retail pharmacy payback 1.83% – Revision procedure for the master data of medicines moved during the first half of 2025
Date: 25 November 2025