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Pricing and Reimbursement


The prices of pharmaceuticals reimbursement by the National Health Service is set through negotiation between the Italian Medicines Agency (AIFA) and the Pharmaceutical Companies, in accordance with Law n. 326 of November 24, 2003 and Interministerial Committee for Economic Planning (Comitato Interministeriale per la Programmazione Economia – CIPE) Resolution of February 1st 2001. The aim of these legislative measures is to regulate the temporary redefinition of the industry margin and the new positive reimbursement list based on cost and efficacy in order to ensure the full respect of Pharmaceutical Price Regulation criteria.

Within this specific competence the whole preliminary activity - an economic evaluation of the different products - is carried out by the Price Reimbursement and Marketing Department, also supported by the consumption and pharmaceutical expenditure databases carried out by the Medicines Utilization Monitoring Centre (OSMED), for the AIFA’s Committee Prices and Reimbursement (CPR), composed of expert members using state-of-the-art knowledge and expertise in different fields to evaluate applications which are submitted by contractors in order to get the reimbursement of their pharmaceutical products.

Contractors reach an agreement on the various applications which have been recorded by an Italian marketing authorization, a Mutual recognition and an European marketing authorization - respectively called National, Mutual and Centralized procedures - by fixing the prices and the conditions of reimbursement* during the AIFA’s Committee Prices and Reimbursement (CPR) Meeting; this agreement  will be firstly subordinated to the Management Board for the examination and therefore it will be ratified for  the following and final deliberation.

*Companies are  required by CIPE Resolution of February 1st 2001 to submit, in the web site, the following documentation for pricing and classification procedures:  

  1. Access the system to obtain an account and a password. For more information  link to the following URL address:
  2. Send an e-mail to, asking for the “SIS code”  (the number which identifies and accredits the Companies within the Italian Medicines Agency (AIFA)
  3. Once this code has been received, proceed to insert the drug’s authorisation demand  filling in the form found on the on-line system clearly and completely without abbreviations,  providing  the requested information which will be stored on the Price and Reimbursement data base and managed in accordance with Italian Privacy Laws.
  4. It is also required to send a dossier with  all the drug’s information (with attached SPC, EPAR, official letter  by the Company, Ema Notification when applicable) which will constitute integral part of that application form,  to the AIFA’s  Price and Reimbursement Department.

Economic Strategy of Pharmaceutical Products Department

Head of office: DG Regency

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