Guidelines and procedures for submitting to AIFA applications for reimbursement and pricing by pharmaceutical companies are available on this page, in accordance with the provisions of the Ministerial Decree. 2 August 2019, Criteria and methods by which the Italian Medicines Agency determines, through negotiation, the prices of medicines reimbursed by the National Health Service (GU no. 185 of 24 July 2020):

• "Guidelines for filling in the dossier to support the Health Technology Assessment of a medicinal product for reimbursement and pricing by the National Health Service” (AIFA Resolution No. 88/2025 of 23/12/2025); effective as of 01/04/2026.
• "Guidelines for filling in the dossier to support the application for reimbursement and pricing of a medicine" (Resolution DG/1372/2020 of 23/12/2020); applicable until 31 March 2026.
• Simplified pricing and reimbursement procedure for the negotiation of equivalent/biosimilar medicines prepared in accordance with the AIFA CTS/CPR Advisory Committee.
• Simplified procedure for price negotiation and reimbursement for medicines of parallel import (Resolution DG/357/2021).
• Equivalent or biosimilar medicines - simplified procedure for reimbursement of extensions of indications already reimbursed for the originator.
• Simplified procedure for the reimbursement of new packages due to modification of the primary packaging.

The “Guidelines for filling in the dossier to support the Health Technology Assessment of a medicinal product for reimbursement and pricing by the National Health Service” (AIFA Resolution No. 88/2025 of 23 December 2025) will become effective as of 01/04/2026, in order to allow pharmaceutical companies an adequate transition period to comply with the new requirements for the submission of reimbursement and pricing applications for medicinal products.

Furthermore, there are information and documents for the use of the new e-Dossier Pricing and Reimbursement platform for the preparation of dossiers in digital format to support applications for reimbursement and pricing.

The main purposes are to support the Applicant in the correct and complete digital compilation of the Dossier, to ensure compliance with the Ministerial Decree of 2 August 2019, to promote dematerialisation and to allow the saving, storage and standardisation of the data entered.